Description:

Modern combined hormonal contraceptive (ring) for intravaginal administration.

Manufacturer:

ORGANON (Netherlands)

Composition and form of release

The vaginal ring is smooth, transparent, colorless or almost colorless, without large visible damage, with a transparent or almost transparent area at the junction.

Active ingredients: ethinylestradiol 2.7 mg, etonogestrel 11.7 mg. Excipients: ethylene vinyl acetate copolymer (28% vinyl acetate), ethylene vinyl acetate copolymer (9% vinyl acetate), magnesium stearate.

pharmachologic effect

Combined hormonal contraceptive preparation for intravaginal use. Contains etonogestrel, which is a progestogen, a derivative of 19-nortestosterone, and ethinylestradiol, which is an estrogen. The main mechanism of the contraceptive action of NovaRing is the inhibition of ovulation. The progestogen component (etonogestrel) inhibits the synthesis of LH and FSH by the pituitary gland and thus prevents the maturation of the follicle (blocks ovulation).

The Pearl Index, an indicator that reflects the frequency of pregnancy in 100 women during the year of contraception, when using the drug NuvaRing is 0.96. Against the background of the use of the drug, the pain and intensity of menstrual-like bleeding decreases, the frequency of acyclic spotting and the likelihood of developing iron deficiency conditions. In addition, there is evidence of a reduced risk of endometrial and ovarian cancer with the use of the drug. NuvaRing does not reduce bone mineral density.

Indications for use

Intravaginal contraception (prevention of unwanted pregnancy) in women.

Mode of application

NuvaRing is inserted into the vagina once every 4 weeks. The ring is in the vagina for 3 weeks and then removed on the same day of the week that it was placed in the vagina; after a week break, a new ring is introduced. For example: if the NuvaRing was inserted on Wednesday at about 10 pm, then it should be removed on Wednesday after 3 weeks at about 10 pm; on the next Wednesday, a new ring is introduced.

Bleeding associated with the cessation of the drug usually begins 2-3 days after removal of NovaRing and may not completely stop until a new ring is installed.

Getting Started with Nuvaring

Hormonal contraceptives were not used in the previous menstrual cycle
NuvaRing should be administered on the first day of the cycle (i.e. the first day of menstruation). It is allowed to install the ring on the 2-5th day of the cycle, however, in the first cycle, in the first 7 days of using NovaRing, additional use of barrier methods of contraception is recommended.

Switching from taking combined oral contraceptives

NuvaRing should be administered on the last day of the free interval for combined hormonal contraceptives (tablets or patches). If a woman has been taking the combined hormonal contraceptive correctly and regularly and is sure that she is not pregnant, she can switch to using the vaginal ring on any day of the cycle. The duration of the interval in taking hormonal contraceptives should not exceed the recommended period.

Switching from progestin-based contraception (mini-pill, implant, or injectable contraception) or progestogen-releasing intrauterine device (IUD)

A woman taking mini-pills can switch to the use of NuvaRing on any day (the ring is inserted on the day the implant or IUD is removed or on the day of the next injection). In all these cases, the woman must use a barrier method of contraception during the first 7 days after the introduction of the ring.

After an abortion in the first trimester of pregnancy

NuvaRing can be used immediately after an abortion. In this case, there is no need for additional use of other contraceptives. If the use of NuvaRing immediately after an abortion is undesirable, the use of the ring should be carried out in the same way as if hormonal contraceptives not used in the previous cycle. At interval, the woman is recommended an alternative method of contraception.

After childbirth or abortion in the second trimester of pregnancy

The use of NuvaRing should begin within the 4th week after childbirth (if the woman is not breastfeeding) or abortion in the second trimester. If the use of NuvaRing is started in more than late dates, then additional use of barrier methods of contraception is necessary in the first 7 days of using NovaRing. However, if sexual intercourse has already taken place during this period, it is necessary to first exclude pregnancy or wait for the first menstruation before using NovaRing.

The contraceptive effect and cycle control may be impaired if the patient does not comply with the recommended regimen. To avoid losing the contraceptive effect in case of deviation from the regimen, the following recommendations should be followed.

Extension of the break in the use of the ring

If during the break in the use of the ring there were sexual intercourse, pregnancy should be excluded. The longer the break, the higher the chance of pregnancy. If pregnancy is ruled out, insert a new ring into the vagina as soon as possible. An additional barrier method of contraception, such as a condom, may be used for the next 7 days.

If the ring has been temporarily removed from the vagina

If the ring was left outside the vagina for less than 3 hours, the contraceptive effect will not decrease. The ring should be reinserted into the vagina as soon as possible.

If the ring has been outside the vagina for more than 3 hours during the first or second week of use, the contraceptive effect may be reduced. The ring should be placed in the vagina as soon as possible. For the next 7 days, you must use a barrier method of contraception, such as a condom. The longer the ring has been out of the vagina and the closer this period is to the 7-day break in the use of the ring, the higher the likelihood of pregnancy.

If the ring was outside the vagina for more than 3 hours during the third week of its use, then the contraceptive effect may be reduced. The woman should discard this ring and choose one of two methods:
Immediately install a new ring. Keep in mind that a new ring can be used within the next 3 weeks. In this case, there may be no bleeding associated with the cessation of the drug. However, spotting of blood or bleeding in the middle of the cycle is possible.

Wait for bleeding associated with the termination of the drug, and introduce a new ring no later than 7 days after removing the previous ring. This option should only be selected if the ring has not been previously broken during the first 2 weeks.

Extended use of the ring

If the drug NovaRing was used for no more than a maximum period of 4 weeks, then the contraceptive effect remains sufficient. You can take a week off from using the ring, and then introduce a new ring. If NuvaRing remained in the vagina for more than 4 weeks, then the contraceptive effect may worsen, so pregnancy must be excluded before the introduction of a new ring.

To change the time of onset of menstrual bleeding

To delay (prevent) menstrual-like withdrawal bleeding, you can insert a new ring without a week break. The next ring must be used within 3 weeks. This may cause bleeding or spotting. Further, after the usual weekly break, you should return to the regular use of NuvaRing.

To move the onset of bleeding to another day of the week, it may be recommended to take a shorter break from using the ring (for as many days as necessary). The shorter the break in ring use, the more likely there is to be no bleeding after ring removal and bleeding or spotting while the next ring is in use.

Ring damage

In rare cases, when using NovaRing, a ring rupture was observed. The core of the NovaRing ring is solid, so its contents remain intact, and the release of hormones does not change significantly. If the ring breaks, it usually falls out of the vagina. If the ring breaks, a new ring must be inserted.

Ring drop

Sometimes there was a prolapse of NovaRing from the vagina, for example, when it was inserted incorrectly, when a tampon was removed, during intercourse, or against the background of severe or chronic constipation. In this regard, it is advisable for a woman to regularly check the presence of the NuvaRing ring in the vagina.

Incorrect insertion of the ring

In very rare cases, women have inadvertently injected NovaRing into the urethra. When symptoms of cystitis appear, the possibility of incorrect insertion of the ring must be considered.

Rules for using NovaRing

The patient can independently insert NuvaRing into the vagina. To introduce the ring, a woman should choose the most comfortable position for her, for example, standing, raising one leg, squatting, or lying down. NuvaRing must be squeezed and passed into the vagina until the ring is in a comfortable position. The exact position of NuvaRing in the vagina is not decisive for the contraceptive effect.

After insertion, the ring must remain in the vagina continuously for 3 weeks. If the ring is accidentally removed, it must be rinsed with warm (not hot) water and inserted into the vagina immediately.

To remove the ring, you can pick it up with your index finger or squeeze it between your index and middle fingers and pull it out of the vagina.

Side effect

When using Nuvaring, the following side effects may occur:

System organ class	Often (? 1/100)	Infrequently (< 1/100, ? 1/1000)	Seldom (< 1/1000)
Infections and infestations	Vaginal infection (candidiasis, vaginitis)	Cystitis, cervicitis, urinary tract infections
The immune system			Hypersensitivity
Metabolic disorders	Weight gain	Increased Appetite
Mental disorders	Depression, decreased libido	Mood change
From the side nervous system	Headache, migraine	Dizziness
From the organ of vision		visual impairment
From the side of the cardiovascular system		"Tides"
From the digestive system	Abdominal pain, nausea	Bloating, diarrhea, vomiting, constipation
From the side of the skin		Alopecia, eczema, pruritus	Skin rash
From the musculoskeletal system		Pain in the lumbar region, muscle spasms, pain in the extremities
From the urinary system		Dysuria, urgency, pollakiuria
From the reproductive system	Breast engorgement and soreness, genital itching in women, pelvic pain, vaginal discharge	Amenorrhea, cervical polyps, contact (during sexual intercourse) spotting (bleeding), dyspareunia, uterine ectropion, fibrocystic mastopathy, menorrhagia, metrorrhagia, premenstrual syndrome, dysmenorrhea, uterine spasm, burning sensation in the vagina, dryness of the vulva and vaginal mucosa.	Local reactions from the penis (sensation of a foreign body by a partner during intercourse, irritation of the penis with hypersensitivity to the components of the drug)
	prolapsed vaginal ring	Rupture (damage) of the ring, fatigue, malaise, abdominal pain, swelling, sensation of a foreign body in the vagina

Contraindications for use

Venous thrombosis (including history), including deep vein thrombosis, pulmonary embolism;
- arterial thrombosis (including history), including stroke, transient cerebrovascular accident, myocardial infarction and / or precursors of thrombosis, including angina pectoris, transient ischemic attack;
- heart defects with thrombogenic complications;
- changes in blood parameters indicating a predisposition to the development of venous or arterial thrombosis, including resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anti-cardiolipin antibodies, lupus anticoagulant);
- migraine with focal neurological symptoms;
- arterial hypertension (systolic blood pressure? 160 mm Hg or diastolic blood pressure? 100 mm Hg);
- diabetes mellitus with vascular damage;
- pancreatitis incl. in history, in combination with severe hypertriglyceridemia;
- severe liver disease, until the normalization of its function;
- liver tumors (including history);
- hormone-dependent malignant tumors (for example, breast cancer), established, suspected or in history;
- bleeding from the vagina of unknown etiology;
- pregnancy (including intended);
- lactation period;
- surgical interventions followed by prolonged immobilization;
- smoking (15 or more cigarettes per day) in women 35 years and older;
- Hypersensitivity to the components of the drug.

With caution, the drug should be prescribed in the presence of any of the following disease conditions or risk factors; in such cases, the doctor must carefully weigh the benefit-risk ratio of using NovaRing:

Venous or arterial thrombosis (in brothers and sisters and / or parents);
- obesity (body mass index over 30 kg/m2);
- dyslipoproteinemia;
- varicose veins (in combination with thrombophlebitis of superficial veins);
- atrial fibrillation;
- diabetes;
- systemic lupus erythematosus;
- hemolytic-uremic syndrome;
- epilepsy;
- chronic inflammatory bowel disease (Crohn's disease and ulcerative colitis);
- sickle cell anemia;
- congenital hyperbilirubinemia (Gilbert, Dubin-Johnson, Rotor syndromes);
- chloasma;
- fibromyoma of the uterus;
- fibrocystic mastopathy;
- conditions that make it difficult to use the vaginal ring: prolapse of the cervix, hernia Bladder, rectal hernia, severe chronic constipation;
- adhesions in the vagina;
- smoking (less than 15 cigarettes per day) in women 35 years and older.

In case of exacerbation of diseases, deterioration of the condition, or the appearance of other risk factors, a woman should also consult a doctor and, possibly, stop the drug.

Although a causal relationship has not been convincingly proven, caution should be exercised when prescribing NovaRing if the following conditions/diseases have developed or worsened during the use of any other hormonal contraceptives or a previous pregnancy: jaundice and / or itching associated with cholestasis, formation of stones in the gallbladder, porphyria, Sydenham's chorea, herpes of pregnancy, otosclerosis with hearing loss, (hereditary) angioedema.

Recurrence of cholestatic jaundice and / or cholestasis with itching, which were observed during pregnancy or previous use of sex hormones, is the basis for discontinuing the use of NovaRing.

The use of NuvaRing during pregnancy and lactation

The use of NovaRing during pregnancy, suspected pregnancy and lactation is contraindicated. NovaRing is contraindicated during the period breastfeeding. NuvaRing is able to influence lactation, reduce the amount and change the composition of breast milk. Small amounts of contraceptive steroids and/or their metabolites may be excreted in milk.

Application for violations of liver function

NuvaRing is contraindicated in severe liver disease (until normalization of function parameters).

special instructions

Before prescribing or resuming the use of NovaRing, a medical examination should be carried out: analyze the history (including family history) and exclude pregnancy; measure blood pressure; conduct an examination of the mammary glands, pelvic organs, including a cytological examination of smears from the cervix; conduct some laboratory tests to exclude contraindications and reduce the risk of possible side effects of the NovaRing drug. The frequency and nature of medical examinations are carried out by a specialist, taking into account the individual characteristics of each woman, but at least once every 6 months.

The patient should read the instructions for use of the NuvaRing drug and follow all recommendations.

It should be borne in mind that NovaRing does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Women aged 40 years and older, women with cervical intraepithelial neoplasia, and women who smoke at any age require additional consultation with a gynecologist before prescribing NovaRing.

The effectiveness of the drug NovaRing may decrease if the regimen is not followed.

During the use of NuvaRing, acyclic bleeding (spotting or sudden bleeding) may occur. If such bleeding is observed after regular cycles while using NovaRing in accordance with the instructions, you should contact your gynecologist for the necessary diagnostic tests, incl. to rule out cancer and pregnancy. Diagnostic curettage may be required.

Some women do not bleed after the ring is removed. If NuvaRing has been used as directed, it is unlikely that the woman is pregnant. If the recommendations of the instructions are not followed and there is no bleeding after the removal of the ring, as well as in the absence of bleeding in two cycles in a row, pregnancy must be excluded.

The most important risk factor for developing cervical cancer is infection with the human papillomavirus (HPV). Epidemiological studies have shown that long-term use of combined hormonal contraceptives leads to an additional increase in the degree of this risk, but it remains unclear how much this is due to other factors. The positive role of regular examinations of a woman by a gynecologist and the use of barrier methods of contraception are obvious. There is no information on an increased risk of developing cervical cancer in HPV-infected women using NovaRing.

Studies have found a slight increase in the relative risk (1.24) of developing breast cancer in women taking combined hormonal oral contraceptives, but this risk gradually decreases over 10 years after drug withdrawal. Breast cancer is rare in women under 40 years of age, so the additional incidence of breast cancer in women who have taken or continue to use combined oral contraceptives is small compared to the overall risk of developing breast cancer. There is evidence that women taking oral combined contraceptives have a less common breast cancer than women who have never used such drugs. The possibility of the influence of the drug NovaRing on the incidence of breast cancer is being studied.

In rare cases, women taking combined oral contraceptives have observed benign liver tumors and, even more rarely, malignant ones. In some cases, these tumors have led to the development of life-threatening bleeding into the abdominal cavity. If there is severe pain in the upper abdomen, liver enlargement or signs of intra-abdominal bleeding in a woman using NovaRing, a liver tumor should be excluded.

Although many women taking hormonal contraceptives experience a slight increase in blood pressure, clinically significant hypertension is rare. A direct relationship between the use of hormonal contraceptives and the development of arterial hypertension has not been established. However, if a constant increase in blood pressure is noted during the use of NovaRing, the patient should contact the attending gynecologist; in such cases, the ring should be removed, antihypertensive therapy should be prescribed, and the issue of choosing the most appropriate method of contraception, incl. possible resumption of the use of the drug NovaRing.

Although estrogens and progestogens can affect peripheral insulin resistance and tissue glucose tolerance, there is no evidence to support the need to change hypoglycemic therapy during the use of hormonal contraceptives. However, women with diabetes should be under constant medical supervision when using NovaRing, especially in the first months of contraception.

The use of contraceptive steroids may affect the results of certain laboratory tests, including biochemical parameters of liver function, thyroid gland, adrenals and kidneys, plasma levels of transport proteins (eg, corticosteroid-binding globulin and sex hormone-binding globulin), lipid/lipoprotein fractions, carbohydrate metabolism, and coagulation and fibrinolysis. Indicators, as a rule, change within normal values.

Serious surgical intervention (including on the lower extremities) is a contraindication to the use of the drug. In the case of a planned operation, it is recommended to stop using the drug at least 4 weeks in advance, and resume it no earlier than 2 weeks after the full restoration of motor activity.

Women who are predisposed to the development of chloasma should avoid exposure to sunlight and ultraviolet radiation while using NuvaRing.

The degree of exposure and possible pharmacological effects of ethinyl estradiol and etonogestrel on the mucous membrane of the head and the skin of the penis have not been studied.

Influence on the ability to drive vehicles and control mechanisms

Given the pharmacodynamic properties of the drug NovaRing, it is not expected to affect the ability to drive a car and use complex equipment.

Overdose

Serious consequences of an overdose of hormonal contraceptives are not described. Suggested symptoms: nausea, vomiting, slight vaginal bleeding in young girls.

Treatment: carry out symptomatic therapy. There are no antidotes.

drug interaction

Interactions between hormonal contraceptives and other drugs may lead to the development of acyclic bleeding and / or contraceptive failure. Possible interaction with drugs that induce microsomal enzymes, which can lead to increased clearance of sex hormones.

The effectiveness of the drug NovaRing may decrease with the simultaneous use of antiepileptic drugs. medicines(phenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate), anti-tuberculosis drugs (rifampicin), antimicrobial drugs (ampicillin, tetracycline, griseofulvin), possibly antiviral drugs (ritonavir) and drugs containing St. John's wort.

When treating any of the listed drugs, a woman should temporarily use a barrier method of contraception in combination with NuvaRing or choose another method of contraception. In the treatment of drugs that cause the induction of liver enzymes, the barrier method (condom) should be used during treatment and within 28 days after the withdrawal of such drugs.

If concomitant therapy is to be continued after 3 weeks of ring use, then the next ring must be administered immediately without the usual interval.

During treatment with antibiotics (excluding amoxicillin and doxycycline), it is necessary to use a barrier method of contraception (condom) during treatment and for 7 days after their withdrawal. If concomitant therapy is to be continued after 3 weeks of ring use, then the next ring must be administered immediately without the usual interval.

As a result of studies of the pharmacokinetics of the effect on the contraceptive efficacy and safety of the NovaRing drug, when it was used simultaneously with antifungal agents and spermicides, it was not revealed. With the combined use of suppositories with antifungal agents, the risk of ring rupture slightly increases.

Hormonal contraceptives can cause a violation of the metabolism of other drugs. Accordingly, their plasma and tissue concentrations may increase (eg, cyclosporine) or decrease (eg, lamotrigine).

To exclude a possible interaction, it is necessary to study the instructions for use of other drugs.

The use of tampons does not affect the effectiveness of NuvaRing. In rare cases, the ring may be accidentally removed when the tampon is removed.

Terms and conditions of storage

NuvaRing should be stored out of the reach of children at a temperature of 2 ° to 8 ° C (in the refrigerator).

NuvaRing: instructions for use and reviews

NovaRing is a combined hormonal contraceptive for intravaginal use.

Release form and composition

Dosage form of NovaRing - vaginal ring: transparent, smooth, almost colorless or colorless, without visible significant damage, at the junction - a transparent or almost transparent area (1 pc. in sealed aluminum foil bags, in a carton pack 1 or 3 bags) .

• Etonogestrel - 11.7 mg;
• Ethinylestradiol - 2.7 mg.

Auxiliary components: ethylene and vinyl acetate copolymer (28% vinyl acetate), magnesium stearate, ethylene and vinyl acetate copolymer (9% vinyl acetate).

Pharmacological properties

Pharmacodynamics

NovaRing is a hormonal combined contraceptive that contains ethinyl estradiol and etonogestrel. Etonogestrel is a progestogen (a derivative of 19-nortestosterone) that binds with high affinity to progesterone receptors localized in target organs. Ethinyl estradiol is an estrogen and is widely used in the production of contraceptives.

The contraceptive effect of NovaRing is due to a combination of various factors, the most important of which is the suppression of ovulation.

The results of clinical studies indicate that the Pearl index (a parameter showing the frequency of pregnancy when observing 100 women for 1 year while using contraceptives) in patients aged 18-40 years for this drug was 0.96 in a statistical analysis of all randomized participants (PT analysis) and 0.64 (95% CI ranged from 0.35 to 1.07) in the analysis of participants who completed them according to the protocol (PP analysis). These results were similar to Pearl Index values ​​determined during comparative studies of combined oral contraceptives (COCs) containing drospirenone/ethinylestradiol (3/0.3mg) or levonorgestrel/ethinylestradiol (0.15/0.03mg) .

Against the background of the use of NuvaRing rings, the cycle normalizes (becomes more regular), and the intensity and soreness of menstrual-like bleeding also weakens, which reduces the incidence of iron deficiency conditions. There is evidence that the use of this drug reduces the risk of ovarian and endometrial cancer.

For 1 year, in 1000 women who used NovaRing and COCs, which include levonorgestrel / ethinylestradiol (0.15 / 0.03 mg), a comparison was made of the characteristics of the nature of bleeding. The results of the study confirmed that with the use of NovaRing, the frequency of spotting or breakthrough bleeding was significantly reduced compared with COCs. Also, cases in which bleeding was observed only during a break in the use of a contraceptive were significantly more common in women who used vaginal rings.

Comparative study of the effects of NovaRing and non-hormonal intrauterine device conducted for 2 years, did not reveal a clinically significant effect on bone mineral density in women.

Pharmacokinetics

Etonogestrel

Etonogestrel, which is released from the vaginal ring, is rapidly absorbed through the vaginal mucosa. Its maximum plasma concentration is approximately 1700 pg / ml and is reached on average 1 week after the installation of the ring. The level of the substance in the blood plasma changes in a small range and gradually decreases to approximately 1600 pg / ml after 1 week, 1500 pg / ml after 2 weeks and 1400 pg / ml after 3 weeks after the start of the drug. Absolute bioavailability reaches 100%, which exceeds the bioavailability when taking etonogestrel orally. The results of measuring the concentrations of this active ingredient inside the uterus and in the cervical region confirm that the determined concentrations of etonogestrel in patients using NuvaRing and patients taking COCs that contain 0.02 mg of ethinyl estradiol and 0.15 mg of desogestrel were comparable.

Etonogestrel binds to sex hormone-binding globulin (SHBG) and plasma albumin. The apparent volume of distribution of the substance is 2.3 l/kg.

Biotransformation of etonogestrel is carried out through known pathways of sex hormone metabolism. The apparent clearance of blood plasma is approximately 3.5 l / h. There is no direct interaction of etonogestrel with ethinyl estradiol taken simultaneously.

Plasma levels of etonogestrel decrease biphasically. The terminal phase has a half-life of approximately 29 hours. Etonogestrel and its metabolites are excreted through the kidneys and intestines with bile in a quantitative ratio of approximately 1.7:1. For metabolites, the half-life is about 6 days.

Ethinylestradiol

When released from the vaginal ring, ethinylestradiol is rapidly absorbed through the vaginal mucosa. Its peak plasma concentration is approximately 35 pg / ml and is reached 3 days after the installation of the ring, after which it gradually decreases to 19 pg / ml after 1 week and 18 pg / ml after 2-3 weeks after the start of use. Absolute bioavailability is approximately 56% and is comparable to that of oral ethinylestradiol. In accordance with the results of determining the concentrations of this active substance inside the uterus and in the cervical region, the measured concentrations of ethinylestradiol were comparable in patients taking oral contraceptives containing 0.02 mg of ethinylestradiol and 0.15 mg of desogestrel, and patients using NovaRing. The content of ethinylestradiol in the body was studied during a comparative randomized study of the drug NovaRing (when the ring is inserted into the vagina, 0.015 mg of ethinylestradiol is released per day), COCs (levonorgestrel / ethinylestradiol; 0.03 mg of ethinylestradiol is released per day) and transdermal patch (norelgestromin / ethinylestradiol; for 0.02 mg of ethinylestradiol is released per day) during one cycle in healthy women. It was found that the systemic exposure of ethinylestradiol throughout the month for NovaRing vaginal rings was statistically significantly weaker than for COCs and the patch: AUC was 10.9 ng h / ml compared to 22.5 and 37.4 ng h /ml for COC and patch, respectively.

Ethinylestradiol is characterized by nonspecific binding to albumin contained in the blood plasma. The apparent volume of distribution is approximately 15 l/kg.

Ethinylestradiol is metabolized by aromatic hydroxylation. Its biotransformation leads to the formation of a large number of methylated and hydroxylated metabolites. They circulate in the blood either in free form or as glucuronide and sulfate conjugates. The apparent clearance is approximately 35 l/h.

The concentration of ethinylestradiol in the blood plasma decreases in a two-phase manner. In the terminal phase, the half-life varies widely, and the median is approximately 34 hours. Ethinylestradiol is not excreted unchanged. Its metabolites are excreted through the kidneys and intestines with bile in an approximate ratio of 1.3:1. For metabolites, the half-life is on average 1.5 days.

The pharmacokinetics of NovaRing rings when used in healthy adolescent girls who have not reached the age of 18 and who have already started menstruating has not been studied. The effect of liver and kidney diseases on the pharmacokinetic parameters of the drug has not been sufficiently studied, however, in patients with liver dysfunctions, a deterioration in the metabolism of sex hormones is allowed. The pharmacokinetics of NovaRing in representatives of various ethnic groups has not been specifically studied.

Indications for use

According to the instructions, NovaRinga is indicated for intravaginal contraception.

Contraindications

• Multiple or severe risk factors for arterial or venous thrombosis: hereditary predisposition (the presence of thrombosis in close relatives at a young age, cerebrovascular accident or myocardial infarction), damage to the valvular apparatus of the heart, arterial hypertension, atrial fibrillation, obesity (body mass index of more than 30 kg per 1 m 2), extensive trauma and/or surgery, smoking over the age of 35, prolonged immobilization;
• Arterial and venous thrombosis, thromboembolism, including pulmonary embolism, deep vein thrombosis, cerebrovascular disorders, myocardial infarction (including history);
• Tendency to develop arterial or venous thrombosis, including hereditary diseases such as antithrombin III deficiency, resistance to activated protein C, protein C deficiency, protein S deficiency, antiphospholipid antibodies (lupus anticoagulant, antibodies to cardiolipin) and hyperhomocysteinemia;
• Transient ischemic attacks, angina pectoris and other pathologies preceding thrombosis (including history);
• Migraine with focal neurological symptoms (including history);
• Pancreatitis (including history) with concomitant severe hypertriglyceridemia;
• Benign or malignant neoplasms of the liver (including history);
• Severe liver pathology;
• Diabetes mellitus with vascular damage;
• Suspected or diagnosed malignant hormone-dependent tumors (including genital organs, mammary glands);
• Pregnancy period or suspicion of it;
• Vaginal bleeding of unknown etiology;
• The period of breastfeeding;
• Hypersensitivity to drug substances.

The efficacy and safety of NuvaRing in patients under the age of 18 have not been established.

If symptoms of any of the above conditions occur, the drug should be discontinued immediately.

The appointment of NovaRing should be done with extreme caution (after a careful assessment of the benefit-risk ratio of contraception): in the presence of risk factors for the development of thromboembolism and thrombosis, including cardiac arrhythmias, arterial hypertension, heart valve disease, hereditary predisposition (presence of thrombosis, myocardial infarction or cerebral blood circulation in close relatives at a young age), obesity, smoking, dyslipoproteinemia, migraine without focal neurological symptoms, major surgery, prolonged immobilization; patients with dyslipoproteinemia, thrombophlebitis of superficial veins, controlled arterial hypertension, valvular heart disease, diabetes mellitus without vascular complications, cholelithiasis, acute or chronic liver dysfunction, porphyria, hemolytic-uremic syndrome, systemic lupus erythematosus, hearing loss due to otosclerosis, minor chorea (Sydenham's chorea), angioedema (hereditary) edema, sickle cell anemia, chronic inflammatory bowel pathologies (ulcerative colitis, Crohn's disease), chloasma; with pathologies that make it difficult to use the vaginal ring (hernia of the bladder and / or rectum, prolapse of the cervix, chronic severe constipation), with skin itching and / or jaundice against the background of cholestasis.

In the event of the appearance / exacerbation of any of these conditions or deterioration of health, you should consult a doctor.

Instructions for use NovaRing: method and dosage

The NovaRing contraceptive ring is used by insertion into the vagina. The procedure is performed once every 4 weeks, in the supine position, standing (raising the leg bent at the knee) or squatting. After squeezing the ring, it is inserted into the vagina and placed in a comfortable position, the accuracy of the location does not affect the effectiveness of contraception.

In the absence of hormonal contraception in the previous menstrual cycle, the ring is inserted on the first day of menstrual bleeding. After 3 weeks, on the day of the week and at about the same time when the ring was installed, it is removed. During the absence of the ring, menstrual-like bleeding occurs, which occurs 2-3 days after removal. A new ring is inserted after one week off on the set day of the week, even if withdrawal bleeding has not ended.

If the use of NuvaRing is started from the second to the fifth day menstrual cycle, during the first 7 days it is necessary to additionally use barrier contraceptives.

When switching from combined oral contraceptives, it is recommended to introduce the ring on the last day of the break between cycles of use or on any day of the cycle, but subject to regular use of the previous combined hormonal agent and full confidence in the absence of pregnancy.

When switching from progestogen contraceptives, the contraceptive ring can be inserted on the day of removal of the implant or hormone-containing intrauterine system, the next injection, or any day after the use of the minipill. In each of these cases, during the first 7 days of use, the use of additional barrier methods of contraception is required.

After an abortion in the first trimester of pregnancy, the NovaRing ring can be inserted immediately after the operation without resorting to additional contraceptives.

The introduction of the ring is recommended within the fourth week after an abortion in the second trimester of pregnancy or childbirth (in the absence of breastfeeding). With more late period the beginning of use, additional use of condoms during sexual intercourse during the first 7 days of hormonal contraception is recommended.

If a woman had sexual intercourse after childbirth or abortion, then before inserting the ring, it is necessary to confirm the absence of pregnancy or insert the ring at the beginning of the menstrual cycle.

After the introduction of the ring for 3 weeks must be constantly in the vagina. In case of accidental removal, in order not to disturb the contraceptive effect, it should be washed with warm water and placed in the vagina within the next 3 hours.

If the period of absence of the ring in the established place exceeds 3 hours in the first or second week of use, it is recommended that after inserting it into the vagina for the next 7 days, use additional barrier means contraception.

If accidental removal occurred in the third week of use, and the ring was absent for more than 3 hours, then the risk of violating the contraceptive effect is very high. In this case, the dropped ring should be discarded and one of the following actions should be chosen.

You can immediately enter a new ring, which must be worn for the next 3 weeks. Menstrual-like bleeding may not occur, and the risk of spotting or breakthrough bleeding in the middle of a new cycle increases.

The next option can be selected only if there are no violations in the regimen of the ring during the first 2 weeks. He suggests waiting for withdrawal bleeding and inserting a new ring no later than 1 week after the removal of the previous ring.

If a woman had sexual intercourse during a week-long break, then pregnancy must be excluded before the introduction of a new ring. In the absence of pregnancy and after the introduction of NovaRing, it is necessary to use additional barrier contraceptives during the first 7 days.

The contraceptive property of the ring remains sufficient for up to 4 weeks of use. If the ring is not removed for more than 4 weeks, then there is a risk of pregnancy, since the contraceptive effect has been exhausted. Therefore, it is necessary to make sure that there is no pregnancy before the next administration of NovaRing.

To delay withdrawal bleeding, the next ring should be inserted on the first day of the intended break and used for 3 weeks. During this period, spotting and breakthrough bleeding may occur. Then you should follow the usual regimen of regular use of the ring.

In order to transfer the onset of withdrawal bleeding to another day of the week, the ring should be removed not on the set day of the week, but later, reducing the break in use. It should be borne in mind that the shorter the break, the greater the risk of the absence of menstrual-like bleeding and the appearance of spotting in the next cycle of using the ring.

If damage (rupture) of the ring is detected, it should be replaced with a new one.

To remove the ring, hook it with your index finger and pull it out of the vagina, then discard it after placing it in a bag.

Side effects

• Genital organs and mammary glands: often - itching of the vulva, painful withdrawal bleeding, vaginal discharge, pain in the pelvic area, soreness and engorgement of the mammary glands; infrequently - absence of menstrual bleeding, enlargement of the mammary glands, discomfort in the mammary glands and / or in the pelvic area, lumps in the mammary glands, spotting (bleeding) during intercourse, painful intercourse, cervical polyps, cervical ectropion, acyclic bleeding, heavy withdrawal bleeding, fibrocystic mastopathy, burning sensation and / or soreness inside the vagina, premenstrual-like syndrome, vaginal odor, dryness and discomfort of the vulva and vaginal mucosa; the frequency is unknown - galactorrhea, local reactions in the partner from the penis, such as pain, bruising, hyperemia, abrasions;
• Immune system: frequency unknown - hypersensitivity;
• Infections and infestations: often - vaginal infection; infrequently - cystitis, cervicitis, urinary tract infections;
• Metabolism: often - weight gain; infrequently - increased appetite;
• Digestive system: often - nausea, abdominal pain; infrequently - vomiting, bloating, constipation, diarrhea;
• Mental disorders: often - decreased libido, depression; infrequently - a change in mood;
• Organ of vision: infrequently - visual impairment;
• Nervous system: often - headache, migraine; infrequently - hypesthesia, dizziness;
• Cardiovascular system: infrequently - hot flashes, increased blood pressure (BP); rarely - venous thromboembolism;
• Skin: often - acne; infrequently - pruritus, alopecia, rash, eczema; frequency unknown - urticaria;
• Urinary system: infrequently - pollakiuria, dysuria, imperative urge to urinate;
• Musculoskeletal system: infrequently - muscle spasms, pain in the back and / or in the limbs;
• General ailments: infrequently - irritability, fatigue, painful condition, swelling;
• Other: often - discomfort during the use of the vaginal ring, prolapse of the vaginal ring; infrequently - difficulties in application, damage (rupture) of the ring, sensation of a foreign body.

In addition, against the background of the use of NovaRing, the development of cholecystitis, pancreatitis, cerebrovascular disorders, chloasma, benign and malignant liver tumors, changes in insulin resistance are possible.

In hereditary forms of angioedema, combined hormonal contraceptives can cause or aggravate the symptoms of angioedema.

Overdose

Cases of complications leading to serious health consequences and associated with an overdose of NovaRing are not described. Possible symptoms include minor bleeding from the vagina in young women, nausea, and vomiting. There are no specific antidotes. In this case, symptomatic therapy is prescribed.

special instructions

The appointment of NovaRing is indicated only after the exclusion of pregnancy and a complete gynecological examination (including the mammary glands, pelvic organs, cytological examination of cervical smears), measurement of blood pressure, and some laboratory tests that exclude contraindications. During the period of using the contraceptive ring, a woman should undergo a medical examination at least once every six months.

With an exacerbation or the appearance of symptoms of diseases, a deterioration in well-being, a woman should consult a doctor for advice.

The use of NovaRing can cause circulatory disorders and, as a result, cause the development of deep vein thrombosis, pulmonary embolism, arterial thrombosis and complications associated with these pathologies, sometimes with a risk of death.

In exceptionally rare cases, women taking complex hormonal contraceptives experience thrombosis of the veins and arteries of the liver, mesenteric vessels, vessels of the brain, retina, kidneys and other blood vessels, although the relationship with NovaRing has not been definitely established.

The manifestation of symptoms of arterial or venous thrombosis can be: severe sudden chest pain with possible recoil in left hand, prolonged and intense headaches, coughing or shortness of breath, acute abdomen, sudden weakness or severe numbness of one side or any part of the body, movement disorders, double vision, sudden loss of vision (partial or complete), aphasia, dizziness, appearance in lower limb unilateral swelling and/or pain, localized fever, skin discoloration or flushing, collapse with or without a focal epileptic seizure.

Risk factors that can cause venous thrombosis and embolism can be: age, family history of thrombosis, obesity (body weight index more than 30 kg per 1 m 2), prolonged immobilization, extensive surgical interventions, any operations on the legs, serious injuries, maybe, varicose veins and thrombophlebitis of superficial veins.

The use of NuvaRing should be stopped 4 weeks before the planned operation and resumed only with full recovery of motor activity after 2 weeks.

In addition to age, obesity and heredity, the following factors for the possible occurrence of complications of arterial thromboembolism can be: heavy smoking (especially in women over 35), dyslipoproteinemia, migraine, atrial fibrillation, arterial hypertension, valvular heart disease.

If there is a predisposition to thrombosis in the family history (close relatives of the patient: parents in their youth, brothers, sisters), it is impossible to start using any hormonal contraceptives without consulting a specialist.

Undesirable circulatory disorders can occur with biochemical factors predisposing to venous or arterial thrombosis (hyperhomocysteinemia, resistance to activated protein C, protein C deficiency, antithrombin III deficiency, antibodies to phospholipids, protein S deficiency), diabetes mellitus, hemolytic uremic syndrome, systemic lupus erythematosus, chronic inflammatory bowel disease, sickle cell anemia, in the postpartum period.

An increase in the frequency or severity of migraine while taking hormonal contraceptives may cause them to be discontinued.

According to epidemiological studies, the risk of developing tumors in long-term use hormonal oral contraceptives is increased. How much this is related to the use of NuvaRing has not been established, since the diagnosis of a tumor in this category of patients may be associated with more frequent follow-up with a doctor.

Against the background of the use of the drug, the development of benign or malignant liver tumors is possible, which can cause life-threatening bleeding into the abdominal cavity. Therefore, in the differential diagnosis of diseases in women taking hormonal contraceptives, it is necessary to take into account the possibility of a liver tumor with signs of intra-abdominal bleeding, acute pain in the upper abdomen, or liver enlargement.

The use of NuvaRing can cause a slight increase in blood pressure, with a pronounced persistence of this pathology, the question of the advisability of further hormonal contraception should be considered.

In case of recurrence of cholestatic jaundice that first occurred during pregnancy or previously taken sex steroids, the development of acute or chronic liver dysfunction, NovaRing should be canceled.

If a woman has diabetes constant medical supervision is necessary, especially in the first cycles of the drug.

The cause of improper insertion or frequent loss of the ring can be the existing pathologies: hernia of the bladder and / or rectum, prolapse of the cervix, severe chronic constipation.

In case of sudden onset of symptoms of cystitis, the correct insertion of the ring should be checked.

The effectiveness of NuvaRing may decrease if the regimen is violated or other drugs are used simultaneously.

If acyclic bleeding occurs during the use of the ring, you should consult a gynecologist to rule out pregnancy or organic pathology.

In the absence of withdrawal bleeding after removing the ring for two cycles in a row, you should consult a doctor.

When conducting laboratory tests, the health worker should be informed about the use of contraceptive hormonal drugs.

The contraceptive ring does not protect against sexually transmitted diseases, including HIV infection (AIDS).

The effect of NovaRing on the ability to drive vehicles and mechanisms has not been established.

Use during pregnancy and lactation

NuvaRing is designed to prevent pregnancy. If a woman wants to stop using the ring in order to become pregnant, conception should be delayed until the natural cycle is restored, as this will help determine the date of conception and delivery as accurately as possible.

Insertion of a vaginal ring during pregnancy is contraindicated. In the case of a diagnosed pregnancy, it must be removed immediately. Extensive epidemiological studies do not support an increased risk of developing birth defects in children born to women who took COCs before pregnancy, as well as teratogenic effects in cases where women took contraceptives for early dates pregnancy without knowing it. However, at the moment it is not known whether this applies to NuvaRing. A clinical study conducted in a small group of patients showed that, despite the introduction of the ring into the vagina, the level of sex hormones that have a contraceptive effect when using NuvaRing is similar to that when taking other COCs. Pregnancy outcomes in women who used the drug during the clinical study are not described.

The use of NovaRing rings during lactation is contraindicated. The active components of the contraceptive can affect the production of breast milk, changing its composition and reducing its amount. Contraceptive sex hormones and / or their metabolites can be excreted in small concentrations in breast milk, but there is no evidence of their negative impact on the health of children.

drug interaction

If concomitant therapy is necessary against the background of the use of a contraceptive ring, it is necessary to consult a doctor in order to avoid the development of unwanted side reactions.

Analogues

NuvaRing's analogues are: Janine, Logest, Midiana, Novinet, Yarina.

Terms and conditions of storage

Store at 2-8°C. Keep away from children.

Shelf life - 3 years.

NovaRing is a hormonal contraceptive, which is a vaginal ring. It is introduced intravaginally, independently, it is also removed without the help of a doctor. Provides a high level of protection against unwanted pregnancy.

Description of the drug

NuvaRing is a thin, soft polymer ring containing small doses of ethinyl estradiol and etonogestrel. The product must be partially or completely transparent, from a homogeneous smooth material. The instructions for the NovaRing contraceptive necessarily disclose the characteristic features of the remedy and the technique of its use.

Composition

The composition of hormonal substances includes ethinylestradiol and etonogestrel - in the amount of 2.7 and 11.7 mg, respectively. The basis is made of copolymers of ethylene and vinyl acetate. It also contains a small amount of magnesium stearate.

Mode of action

The ring delivers hormonal substances directly to the uterus, they enter the bloodstream, being absorbed by the vaginal mucosa. The concentration of active hormones in the blood is the same as with the use of COCs. The drug prevents the development of the follicle by inhibiting ovulation. There is also evidence that the contraceptive improves the general condition of a woman during menstrual bleeding.

Application

The price of the NovaRing contraceptive is average compared to COCs, and in pharmacies it is sold both individually and three pieces in one package. It is installed on the first day of the cycle, and removed exactly 21 days later. So that the woman does not forget about the time of removing the old ring, two stickers are placed in the box with the product. One sticker reminds you to remove the old product, and the other about the time to install a new one.

How to apply:

1. Wash hands with soap before insertion.
2. Take a comfortable position that gives access to the vagina.
3. Squeeze the product with two fingers and insert inside, as deep as possible.
4. Make sure it is in a comfortable position.

It is convenient to perform manipulation while squatting, lying down, standing, bending and moving one leg to the side. Its position inside is not important, the main guideline is the convenience of a woman. No lubricant, excipients or applicators are needed to perform these actions. It is removed with two fingers in the same comfortable position.

Important! If the ring is inserted according to the instructions, retains its integrity, then the woman herself ceases to feel it immediately after the introduction. Her sexual partner also does not feel the presence of the product during intercourse.

The ring is removed after 21 days.. After 1-2 days, menstrual bleeding occurs. A new product is installed exactly one week later. During this time, as a rule, the bleeding stops completely.

It is allowed to extract funds for up to three hours, while maintaining its effectiveness. If a break was allowed for more than the specified time, additional barrier contraception will be required. If the product has been removed by accident, it must be washed immediately. running water temperature 30-37 degrees and set again.

Deviations in the usual mode of application of NuvaRing

In case of unforeseen situations, there may be violations of the mode of use of the tool. So that it doesn't lead to undesirable consequences, you need to follow simple instructions. Possible regime violations:

• the break between cycles is lengthened;
• extended operation of one ring;
• shortened break between two cycles.

If, after the removal of one contraceptive ring, the break lasts more than 7 days, then pregnancy must be excluded before installing a new remedy. If, as a result of a violation of the regimen, pregnancy has not occurred, then a new remedy is installed immediately. In this case, the next week after the start of the use of the new NovaRing, you will need to use any barrier contraceptives.

If the ring was not removed in time, then its contraceptive effect after the fourth week of use will begin to decline. It retains its high efficiency for 4 weeks, then additional means of protection against unwanted pregnancy are required. At the same time, at the end of the extended cycle, spotting may occur.

After extended use, a break is made standard - 7 days. Before installing a new ring, if no other contraceptives were used at the end of the extended cycle of use, pregnancy should be excluded.

A shortened break between two cycles is possible if you need to quickly end the withdrawal bleeding, and move the next cycle a few days. However, in this case, there may be a slight bleeding in the next after a shortened period of use of the drug.

A woman may forget to remove or insert the NuvaRing, or disrupt the seven-day rest period in between. In this case, it is important to rule out pregnancy before inserting a new ring.

Changing the timing of menstruation

If there is a need to shift the timing of menstruation, you can deliberately increase or decrease the period of the break between cycles. However, with an increase in the rest period, barrier contraceptives should be used along with NovaRing.

Sometimes it is allowed not to take a break between two contraceptives. In this case, menstruation will only start after the start of the next break, i.e. 6 weeks after the last withdrawal bleeding.

Important! Any changes to the standard application schedule vaginal contraceptive NuvaRing are undesirable, therefore, it is especially necessary to carefully monitor the state of the body, well-being, the presence of untimely spotting and bleeding. As soon as a violation of the schedule has been detected, you need to return to the standard use of contraception.

Cancellation of the contraceptive

Cancellation is carried out upon completion of the full cycle of use. That is, after the removal of the next ring, a new one is simply not placed after 7 days. As a result of withdrawal, such phenomena can be observed in the period following the first cycle without the drug:

• increased menstrual bleeding;
• swelling, soreness of the chest;
• painful menstruation.

Starting the use of NuvaRing, many women notice an improvement in their condition during menstruation. No premenstrual pain, bleeding is reduced. The effect of reducing the load of the menstrual cycle on the body lasts all the time while the remedy is used. This is a good prevention of severe blood loss during menstruation. But after the cancellation, the body returns to its normal state.

Cancellation may be associated with pregnancy planning, in which case it is recommended to wait until the normal menstrual cycle is established. This will make it easier for doctors to calculate the gestational age. Otherwise, conception immediately after cancellation is allowed and does not affect the course of pregnancy in any way.

Important! If pregnancy occurs as a result of a violation of the contraceptive schedule, the device must be removed immediately. This contraceptive is also contraindicated for HB, as it can reduce the level of milk production or lead to lactation cessation.

Possible side effects

According to the instructions for the reviews of doctors, the NovaRing contraceptive has a number of possible side effects. They appear rarely (less often 1/100, but more often 1/1000). These include:

• vaginal infections;
• vaginal discharge;
• discomfort in the genital area (itching, pain, irritation);
• pain, pulling sensations in the abdomen;
• engorgement of the mammary glands;
• headaches;
• decreased libido;
• weight gain;
• skin rashes.

If side effects occur, it is better to consult a specialist. Depending on the situation, the doctor recommends that you either remove the ring immediately or complete the cycle. He may also prescribe medications to relieve unpleasant symptoms.

Very rarely there is an allergy to the product, or increased sensitivity and soreness during sexual intercourse with a partner. According to reviews, men do not feel the presence of this contraceptive during sex.

Contraindications

Contraindications for the use of the ring are the same as for other hormonal contraceptives. These include:

• venous or arterial thrombosis, disposition to it;
• heart defects;
• migraine (especially with focal symptoms);
• hypertension;
• gastrointestinal diseases (pancreatitis, liver tumors, chronic liver diseases);
• hormone-dependent tumors;
• vaginal bleeding with an unclear diagnosis;
• rehabilitation after surgery;
• diabetes mellitus with vascular damage;
• pregnancy and lactation;
• allergic reactions to the components of the drug;
• smoking in women over 35.

Before using the drug, you should consult with an experienced gynecologist, the use of the drug and treatment without consultation can lead to unexpected side effects.

The NovaRing contraceptive is a soft and smooth ring that is inserted into the vagina for a period of 3 weeks. In the internal cavity of the genital organs, it occupies the most convenient position for a woman, adjusting to the individual characteristics of the physique. Due to its flexibility, the ring does not bring the slightest discomfort and does not create obstacles for sports. Moreover, during intercourse, none of the partners of the ring feels.

NuvaRing sizes are universal for women of any weight and build: its size is 54 mm in diameter and 4 mm thick. The ring is made in the Netherlands. Please note that the namesake birth control pills can not be.

How does the NovaRing ring work?

Under the anti-allergic shell of this remedy contains minimal portions of estrogen and progestogen. These are the sex hormones of a woman, which are of great importance for her reproductive system. Inside the vagina, the ring acquires the temperature of the human body, and its shell becomes porous and secretes hormones enclosed under it into the cavity of the uterus and ovaries. The action of active substances is targeted, hormonal effects on other organs in the body, except for the genitals, do not apply. The concentration of these hormones is enough to nullify the process of egg maturation and its release from the follicle. This means that pregnancy under such conditions will not occur.

Advantages of the hormonal ring

1. Undeniable reliability.
2. Simplicity and comfortable use (you only need to change the ring once a month).
3. A microscopic portion of hormones in the ring, which makes it absolutely safe.
4. Exclusively local action of active substances.
5. The use of NuvaRing does not affect the weight of a woman.
6. thanks to the ring monthly cycle becomes more regular, and the pain during menstruation dulls.

Disadvantages of the hormone ring

1. For some women, this method of protection seems unusual from a psychological point of view.
2. NuvaRing manufacturers do not guarantee complete protection against sexually transmitted diseases.
3. The hormonal ring has quite a few contraindications.

How to use Nuvaring

The ring is inserted during menstruation on the first to fifth day (but not later!). Wash your hands thoroughly, then take the most comfortable position for you: lie down, squat down, or lean your back against the wall and lift one leg.

Squeeze the pliable ring firmly with your fingers so that it decreases in diameter, and insert it deep into the vagina. If after insertion you feel the contraceptive device, adjust it with your fingers so that this discomfort disappears. Don't worry about the ring being in the wrong place - if you can't feel it, then it's in the right place in your vagina.

NuvaRing should stay inside you for three weeks. If you accidentally remove the ring (this can happen when changing a tampon), rinse it in warm water and reinsert it. When the period of use of the hormonal remedy expires, gently pull it out by prying it with your index finger or squeezing it with your middle and index fingers.

It is important!

MirSovetov hastens to draw your attention to the following rules for using the NovaRing hormonal ring.

One ring effectively acts for one. You need to pull it out by all means on the 22nd day after you installed it. In order not to get confused in the dates, you need to remember on which day of the week you put the ring - on the same day of the week you need to remove it. For example, put on Thursday - take out after 3 weeks on Thursday. It is most reliable, of course, to immediately mark the days of the beginning and end of the use of NovaRing on the calendar.

After the ring has been removed, rest for 7 days, and on the 8th day a new ring is introduced.

Attention! During the first week of using NuvaRing, doctors strongly recommend using a condom as an additional barrier method of preventing unwanted pregnancy.

How to apply a hormonal ring after an abortion or childbirth

If you did in the first 3 months of pregnancy, place the ring in your vagina immediately after the operation. Please note that the use of a condom in the first 7 days after the introduction of the drug is not required in this case.

If some time has passed since the abortion, wait until your period and enter the hormonal ring on any of the days of menstruation no later than the fifth day. Use during the first week is mandatory.

If the abortion was performed in the second trimester, you can apply NovaRing only 3-4 weeks after the abortion. The same rule applies to childbirth. The need for barrier contraception in the form of a condom in this case disappears.

If 21 days have passed since the abortion or childbirth and during this time you had sexual intercourse, wait until the first menstruation to make sure that you are not pregnant. Insert the ring during your period and be sure to use a condom for 1 week.

Bleeding while using NuvaRing and after removing it

Be prepared for the fact that in many women, the abolition of the hormonal ring provokes the development of bleeding, which is explained by the termination of the action of the active components of NovaRing on the reproductive system. You will most likely find blood 2-3 days after the birth control is removed. Bleeding may end immediately after the introduction of the next ring or earlier.

Sometimes temporary withdrawal of NuvaRing does not cause bleeding. This phenomenon is considered normal if the contraceptive ring was used strictly following the rules for its use, and there was no bleeding only once. However, if a woman deviated from these recommendations and there was no blood 2 times in a row, pregnancy is suspected. A gynecologist will help clarify the situation.

During the period of wearing the ring in the vagina, scanty and intermittent spotting can sometimes appear. There is also an unexpected appearance of intense bleeding. Spotting can be ignored (they usually stop quickly), but heavy bleeding is a good reason to visit an antenatal clinic immediately.

With the cancellation of NuvaRing, there will be no difficulties: just remove the ring when you decide not to use protection anymore. The body will free itself from the influence of estrogen and progestogen and will very quickly restore ovulation. Conception can occur in the first month after the cancellation of NovaRing. No unpleasant consequences for pregnancy after the use of the hormonal ring were noted.

Side effects of NovaRing

When using this contraceptive side effects are noted infrequently. Sometimes something can bother a woman at the beginning of using the ring, but all the unpleasant sensations quickly disappear on their own. Here are some of them.

Catad_pgroup Local contraceptives

Indications for use
- Contraception
- Idiopathic menorrhagia
- Prevention of endometrial hyperplasia during HRT

INFORMATION IS PROVIDED STRICTLY
FOR HEALTHCARE PROFESSIONALS

NuvaRing - official * instructions for use

*registered by the Ministry of Health of the Russian Federation (according to grls.rosminzdrav.ru)

INSTRUCTIONS
on the use of a medicinal product for medical use

Registration number:

Tradename:

NuvaRing ® (NuvaRing ®)

International non-proprietary name or grouping name:

ethinylestradiol + etonogestrel

Dosage form:

vaginal rings

Composition

1 vaginal ring contains:
active substances: etonogestrel - 11.7 mg, ethinylestradiol - 2.7 mg;
Excipients: ethylene and vinyl acetate copolymer - 1677 mg, ethylene and vinyl acetate copolymer - 197 mg, magnesium stearate - 1.7 mg.

Description

Smooth, transparent, colorless or almost colorless ring without much visible damage with a transparent or almost transparent area at the junction.

Pharmacotherapeutic group:

combined contraceptive (estrogen + gestagen)

ATX code: G02BB01

Pharmacological properties

Pharmacodynamics

Mechanism of action
NuvaRing ® is a hormonal combined contraceptive containing etonogestrel and ethinyl estradiol. Etonogestrel is a progestogen (a derivative of 19-nortestosterone) that binds with high affinity to progesterone receptors in target organs. Ethinylestradiol is an estrogen and is widely used in the manufacture of contraceptives.
The contraceptive effect of NovaRing ® is due to a combination of various factors, the most important of which is the suppression of ovulation.

Efficiency
In clinical studies, it was found that the Pearl Index (an indicator that reflects the frequency of pregnancy in 100 women during 1 year of contraception) in women aged 18 to 40 years for the drug NuvaRing ® was 0.96 (95% CI: 0.64 -1.39) and 0.64 (95% CI: 0.35-1.07) in the statistical analysis of all randomized participants (ITT analysis) and the analysis of participants in studies that completed them according to the protocol (PP analysis), respectively. These values ​​were similar to Pearl Index values ​​obtained from comparative studies of combined oral contraceptives (COCs) containing levonorgestrel/ethinylestradiol (0.150/0.030 mg) or drospirenone/ethinylestradiol (3/0.30 mg).
Against the background of the use of the drug NovaRing ®, the cycle becomes more regular, the pain and intensity of menstrual bleeding decreases, which helps to reduce the incidence of iron deficiency. There is evidence of a reduced risk of endometrial and ovarian cancer with the use of the drug.

The nature of bleeding
Comparison of bleeding patterns over one year in 1000 women who used NovaRing ® and COCs containing levonorgestrel / ethinyl estradiol (0.150 / 0.030 mg) showed a significant reduction in the frequency of breakthrough bleeding or spotting when using NovaRing ® compared with COOK. In addition, the frequency of cases when bleeding occurred only during a break in the use of the drug was significantly higher among women who used NovaRing®.

Effect on bone mineral density
A comparative two-year study of the effect of NovaRing ® (n=76) and a non-hormonal intrauterine device (n=31) did not reveal an effect on bone mineral density in women.

Children
The safety and efficacy of NovaRing ® for adolescent girls under the age of 18 has not been studied.

Pharmacokinetics

Etonogestrel

Suction
Etonogestrel, released from the NovaRing ® vaginal ring, is rapidly absorbed through the vaginal mucosa. The maximum concentration of etonogestrel in blood plasma, which is about 1700 pg / ml, is reached approximately 1 week after the introduction of the ring. Plasma concentrations change within a small range and slowly decrease to about 1600 pg/ml after 1 week, 1500 pg/ml after 2 weeks and 1400 pg/ml after 3 weeks of use. Absolute bioavailability is about 100%, which exceeds the oral bioavailability of etonogestrel. According to the results of measuring the concentrations of etonogestrel in the cervix and inside the uterus in women using the drug NovaRing ®, and women using oral contraceptives containing 0.150 mg of desogestrel and 0.020 mg of ethinyl estradiol, the observed values ​​of etonogestrel concentrations were comparable.

Distribution
Etonogestrel binds to plasma albumin and sex hormone-binding globulin (SHBG). The apparent volume of distribution of etonogestrel is 2.3 L/kg.

Metabolism
Biotransformation of etonogestrel occurs by known pathways of sex hormone metabolism. The apparent plasma clearance is about 3.5 l/h. Direct interaction with ethinyl estradiol, taken simultaneously, has not been identified.

breeding
Plasma concentrations of etonogestrel decrease in two phases. In the terminal phase, the half-life is approximately 29 hours. Etonogestrel and its metabolites are excreted by the kidneys and through the intestines with bile in a ratio of about 1.7:1. The half-life of metabolites is approximately 6 days.

Ethinylestradiol

Suction
Ethinyl estradiol, released from the NovaRing ® vaginal ring, is rapidly absorbed through the vaginal mucosa. The maximum plasma concentration of about 35 pg / ml is reached 3 days after the introduction of the ring and decreases to 19 pg / ml after 1 week, to 18 pg / ml after 2 weeks and 18 pg / ml after 3 weeks of use. Absolute bioavailability is approximately 56% and is comparable to that of oral administration of ethinyl estradiol. According to the results of measuring the concentrations of ethinylestradiol in the cervical region and inside the uterus in women using the drug NovaRing ®, and women using oral contraceptives containing 0.150 mg of desogestrel and 0.020 mg of ethinylestradiol, the observed values ​​of ethinylestradiol concentrations were comparable.
The concentration of ethinylestradiol was studied in a comparative randomized study of the drug NovaRing ® (daily release of ethinylestradiol in the vagina 0.015 mg), transdermal patch (norelgestromin / ethinylestradiol; daily release of ethinylestradiol 0.020 mg) and COC (levonorgestrel / ethinylestradiol; daily release of ethinylestradiol) cycle in healthy women. The systemic exposure of ethinylestradiol within a month (AUC0-?) for NovaRing ® was statistically significantly lower than that of the patch and COC, and amounted to 10.9, 37.4 and 22.5 ng h / ml, respectively.

Distribution
Ethinylestradiol binds nonspecifically to plasma albumin. The apparent volume of distribution is about 15 l/kg.

Metabolism
Ethinylestradiol is metabolized by aromatic hydroxylation. During its biotransformation, a large number of hydroxylated and methylated metabolites are formed. They circulate in free form or as sulfate and glucuronide conjugates. The apparent clearance is approximately 35 l / h.

breeding
Plasma ethinylestradiol concentrations decrease in two phases. The half-life in the terminal phase varies widely; the median is about 34 hours. Ethinylestradiol is not excreted unchanged. Metabolites of ethinylestradiol are excreted by the kidneys and through the intestines with bile in a ratio of 1.3:1. The half-life of metabolites is about 1.5 days.

Special patient groups

Children
The pharmacokinetics of NovaRing ® in healthy adolescent girls under the age of 18 years who have already begun menstruation has not been studied.

Impaired kidney function
The effect of kidney disease on the pharmacokinetics of NovaRing® has not been studied.

Impaired liver function
The effect of liver disease on the pharmacokinetics of NovaRing® has not been studied. However, in patients with impaired liver function, the metabolism of sex hormones may be impaired.

ethnic groups
The pharmacokinetics of the drug in representatives of ethnic groups has not been specifically studied.

Indications for use

Contraception.

Contraindications

NovaRing ® is contraindicated in the presence of any of the conditions listed below. If any of these conditions occur during the period of use of the drug NovaRing ®, the use of the drug should be stopped immediately.

• Thrombosis (arterial or venous) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders).
• Conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history.
• Predisposition to the development of venous or arterial thrombosis, including hereditary diseases: resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (cardiolipin antibodies, lupus anticoagulant).
• Migraine with focal neurological symptoms at present or in history.
• Diabetes mellitus with vascular damage.
• Pronounced or multiple risk factors for venous or arterial thrombosis: hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the closest relatives), hypertension, valvular heart disease, atrial fibrillation, extended surgery, prolonged immobilization, extensive trauma, obesity (body weight> 30 kg / m²), smoking in women over 35 years of age (see section "Special Instructions").
• Pancreatitis with severe hypertriglyceridemia, current or history.
• Severe liver disease.
• Tumors of the liver (malignant or benign), including a history.
• Known or suspected hormone-dependent malignant tumors (for example, genital or breast cancers).
• Bleeding from the vagina of unknown etiology.
• Pregnancy, including intended.
• Hypersensitivity to any of the active or excipients of NovaRing®.

Carefully

In the presence of any of the diseases, conditions or risk factors listed below, the benefits of using NovaRing ® and the possible risks for each individual woman should be evaluated before she starts using NovaRing ® (see section "Special Instructions"). In the event of an exacerbation of diseases, a deterioration in the condition, or the appearance of any of the conditions listed below for the first time, a woman should consult a doctor to decide on the possibility of further use of the drug NovaRing ®.

With caution, the drug NovaRing ® should be used in the following cases:

• risk factors for the development of thrombosis and thromboembolism: hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the closest relatives), smoking, obesity, dyslipoproteinemia, arterial hypertension, migraine without focal neurological symptoms, heart valve disease , cardiac arrhythmias, prolonged immobilization, major surgical interventions;
• thrombophlebitis of superficial veins;
• dyslipoproteinemia;
• heart valve disease;
• adequately controlled arterial hypertension;
• diabetes mellitus without vascular complications;
• acute or chronic liver disease;
• jaundice and/or itching caused by cholestasis;
• cholelithiasis;
• porphyria;
• systemic lupus erythematosus;
• hemolytic-uremic syndrome;
• Sydenham's chorea (small chorea);
• hearing loss due to otosclerosis;
• (hereditary) angioedema;
• chronic inflammatory bowel disease (Crohn's disease and ulcerative colitis);
• sickle cell anemia;
• chloasma;
• conditions that may make it difficult to use the vaginal ring: cervical prolapse, bladder hernia, rectal hernia, severe chronic constipation.

Use during pregnancy and during breastfeeding

NovaRing ® is intended to prevent pregnancy. If a woman wants to stop using the drug in order to become pregnant, it is recommended to wait for the restoration of the natural cycle to conceive, as this will help to correctly calculate the date of conception and delivery.

Pregnancy

The use of NovaRing ® during pregnancy is contraindicated. If pregnancy occurs, the ring should be removed. Extensive epidemiological studies have not revealed an increased risk of congenital malformations in children born to women who took COCs before pregnancy, as well as teratogenic effects in cases where women took COCs in early pregnancy without knowing about it. Although this applies to all COCs, it is not known if this also applies to NovaRing®. A clinical study in a small group of women showed that, despite the fact that NovaRing ® is administered into the vagina, the concentrations of contraceptive sex hormones inside the uterus when using NovaRing ® are similar to those when using COCs. Pregnancy outcomes in women who used the drug NovaRing ® during a clinical study are not described.

breastfeeding period

The use of the drug NovaRing ® during breastfeeding is not indicated. The composition of the drug can affect lactation, reduce the amount and change the composition of breast milk. Small amounts of contraceptive sex hormones and/or their metabolites may be excreted in milk, but evidence for them negative influence on the health of children is not received.

Dosage and administration

To achieve a contraceptive effect, NovaRing ® must be used according to the instructions.

A woman can independently insert the NovaRing ® vaginal ring into the vagina.

The doctor should inform the woman how to insert and remove the NovaRing ® vaginal ring. To introduce the ring, the woman should choose a comfortable position, for example, standing, raising one leg, squatting or lying down. The NovaRing ® vaginal ring should be compressed and inserted into the vagina until the ring is in a comfortable position. The exact position of the ring in the vagina is not critical for the contraceptive effect (Fig. 1-4).

After insertion (see subsection "How to start using NovaRing ®"), the ring should be constantly in the vagina for 3 weeks. It is advisable for a woman to regularly check whether it remains in the vagina. If the ring has been accidentally removed, then the instructions in the subsection “What to do if the ring has been temporarily removed from the vagina” must be followed.

The NovaRing ® vaginal ring should be removed after 3 weeks on the same day of the week when the ring was inserted into the vagina. After a week break, a new ring is inserted (for example, if the NovaRing ® vaginal ring was installed on Wednesday at about 22.00, then it should be removed on Wednesday after 3 weeks at about 22.00. A new ring is inserted on the next Wednesday). To remove the ring, it must be picked up with the index finger or squeezed with the index and middle fingers and pulled out of the vagina (Fig. 5). The used ring should be placed in a bag (keep out of the reach of children and pets) and discarded. Bleeding associated with the termination of the action of the drug NovaRing ® usually begins 2-3 days after removal of the NovaRing ® vaginal ring and may not completely stop until a new ring is installed.

How to start using NovaRing ® ?

• In the previous cycle, hormonal contraceptives were not used
  NovaRing ® should be administered on the first day of the cycle (i.e. on the first day of menstruation). It is allowed to install the ring on the 2-5th day of the cycle, however, in the first cycle, in the first 7 days of using NovaRing ®, additional use of barrier methods of contraception is recommended.
• Switching from combined hormonal contraceptives
  A woman should enter the NovaRing ® vaginal ring on the last day of the usual interval between cycles in taking combined hormonal contraceptives (tablets or patch).
  If a woman has been taking the combined hormonal contraceptive correctly and regularly and is sure that she is not pregnant, she can switch to the use of the vaginal ring on any day of the cycle.
  In no case should the recommended hormone-free interval of the previous method be exceeded.
• Switching from progestogen-only products (mini-pill, progestin-only oral contraceptives, implants, injectables, or hormone-containing intrauterine systems - IUDs)
  A woman taking mini-pills or progestin oral contraceptives can switch to NovaRing ® on any day. The ring is inserted on the day the implant or IUD is removed. If the woman received injections, then the use of the drug NovaRing ® begins on the day when the next injection should have been made. In all these cases, the woman must use a barrier method of contraception during the first 7 days after the introduction of the ring.
• After an abortion in the first trimester
  A woman can insert the ring immediately after an abortion. In this case, she does not need additional contraceptives. If the use of the drug NovaRing ® immediately after an abortion is undesirable, it is necessary to follow the recommendations given in the subsection "In the previous cycle, hormonal contraceptives were not used." At interval, the woman is recommended an alternative method of contraception.
• After childbirth or after an abortion in the second trimester
  A woman is recommended to enter the ring no earlier than 4 weeks after childbirth (if she is not breastfeeding) or abortion in the second trimester. If the ring is installed at a later date, then the use of an additional barrier method is recommended for the first 7 days. However, if sexual intercourse has already taken place, then before using the drug NovaRing ®, it is necessary to exclude pregnancy or wait for the first menstruation.

The contraceptive effect and cycle control may be impaired if the woman does not follow the recommended regimen. To avoid a decrease in the contraceptive effect, the following recommendations should be followed.

• What to do in case of lengthening the break in the use of the ring?
  If during the break in the use of the ring there were sexual intercourse, pregnancy should be excluded. The longer the break, the higher the chance of pregnancy. If pregnancy is excluded, a woman should insert a new ring into the vagina as soon as possible. An additional barrier method of contraception, such as a condom, must be used for the next 7 days.
• What if the ring was temporarily removed from the vagina?
  The ring must be constantly in the vagina for 3 weeks. If the ring has been accidentally removed, it should be rinsed with cold or lukewarm (not hot) water and inserted into the vagina immediately.
  • If the ring was left outside the vagina for less than 3 hours, then its contraceptive effect is not reduced. A woman should insert the ring into the vagina as soon as possible (no later than 3 hours later).
  • If the ring was outside the vagina for more than 3 hours during the first or second week of use, the contraceptive effect may decrease. The woman should insert the ring into the vagina as soon as possible. For the next 7 days, you must use a barrier method of contraception, such as a condom. The longer the ring has been out of the vagina and the closer this period is to the 7-day break in the use of the ring, the higher the likelihood of pregnancy.
  • If the ring was outside the vagina for more than 3 hours in the third week of use, then the contraceptive effect may decrease. The woman should discard this ring and choose one of the two following methods.
    1. Immediately install a new ring.
       Note: a new ring can be used for the next 3 weeks. In this case, there may be no bleeding associated with the termination of the drug. However, spotting or bleeding in the middle of the cycle is possible.
    2. Wait for the bleeding associated with the termination of the drug, and introduce a new ring no later than 7 days after the removal of the previous ring.
       Note: this option should be chosen only if the regimen of the ring was not violated during the first two weeks.
• What to do in case of prolonged use of the ring?
  If the drug NovaRing ® was used for no more than a maximum period of 4 weeks, then the contraceptive effect remains sufficient. A woman can take a week off from using the ring and then insert a new ring.
  If the NovaRing ® vaginal ring has remained in the vagina for more than 4 weeks, then the contraceptive effect may worsen, so pregnancy must be excluded before the introduction of a new ring.
  If a woman does not adhere to the recommended regimen of application and bleeding does not occur after a week's break in the use of the ring, then pregnancy should be excluded before the introduction of a new ring.
• How to move or delay the onset of menstrual bleeding?
  To delay menstrual-like withdrawal bleeding, a woman can insert a new ring without a week's break. The next ring must be applied within 3 weeks. This may cause spotting or bleeding. Further, after the usual week-long break, the woman returns to the regular use of the drug NovaRing ®.
  To move the onset of bleeding to another day of the week, the woman may be advised to take a shorter break from the ring (for as many days as needed). The shorter the break in the use of the ring, the higher the likelihood of no bleeding that occurs after the removal of the ring, and the occurrence of bleeding or spotting during the period of application of the next ring.

Children

The safety and efficacy of NovaRing® in adolescent girls under 18 years of age have not been studied.

Side effect

When using the drug, there may be side effects that occur with different frequencies: often (? 1/100), infrequently (<1/100, ?1/1 000), редко (<1/1 000, ?1/10 000).

Serious consequences of an overdose of hormonal contraceptives are not described. Possible symptoms include nausea, vomiting, and slight bleeding from the vagina in young girls. There are no antidotes. Treatment is symptomatic.

Interaction with other medicinal products and other forms of interaction

Interaction with other drugs

Interactions between hormonal contraceptives and other drugs may lead to the development of acyclic bleeding and / or contraceptive failure.

The following interactions with combined oral contraceptives are described in the literature in general.

Hepatic metabolism: there may be interactions with drugs that induce microsomal liver enzymes, which can lead to an increase in the clearance of sex hormones. Interactions have been established, for example, with phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also with oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and preparations containing St. John's wort (Hypericum perforatum).

When treating with any of the listed drugs, you should temporarily use a barrier method of contraception (condom) in combination with the use of the drug NovaRing ® or choose another method of contraception. During the concomitant use of drugs that induce microsomal enzymes, and within 28 days after their withdrawal, barrier methods of contraception should be used.

If concomitant therapy is to be continued after 3 weeks of ring use, then the next ring must be administered immediately without the usual interval.

Antibiotics: a decrease in the effectiveness of oral contraceptives containing ethinyl estradiol has been observed with the concomitant use of antibiotics such as ampicillin and tetracyclines. The mechanism of this effect has not been studied. In a pharmacokinetic interaction study, ingestion of amoxicillin (875 mg, 2 times a day) or doxycycline (200 mg per day, and then 100 mg per day) for 10 days during the use of the drug NovaRing ® did not significantly affect the pharmacokinetics of etonogestrel and ethinyl estradiol. When using antibiotics (excluding amoxicillin and doxycycline), you should use a barrier method of contraception (condom) during treatment and for 7 days after stopping antibiotics. If concomitant therapy is to be continued after 3 weeks of ring use, then the next ring must be administered immediately without the usual interval.

Pharmacokinetic studies have not revealed the effect of the simultaneous use of antifungal agents and spermicides on the contraceptive efficacy and safety of NovaRing®. With the combined use of suppositories with antifungal drugs, the risk of ring rupture slightly increases.

Hormonal contraceptives may interfere with the metabolism of other drugs. Accordingly, their plasma and tissue concentrations may increase (eg, cyclosporine) or decrease (eg, lamotrigine).

To exclude possible interaction, it is necessary to read the instructions for use of other drugs.

Laboratory research

The use of hormonal contraceptives may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function; on the plasma concentration of transport proteins, for example, corticosteroid-binding globulin (CBG) and SHBG; on lipid/lipoprotein fractions; on indicators of carbohydrate metabolism; as well as on indicators of blood clotting and fibrinolysis. Indicators, as a rule, change within normal values.

Combined use with tampons

Pharmacokinetic data show that the use of tampons does not affect the absorption of hormones released from the NovaRing ® vaginal ring. In rare cases, the ring may be accidentally removed when removing the tampon (see subsection "What to do if the ring was temporarily removed from the vagina" in the section "Method of application and doses").

special instructions

If any of the diseases, conditions or risk factors listed below are present, the benefits of using NovaRing ® and the possible risks for each individual woman should be evaluated before she starts using NovaRing ®. In the event of an exacerbation of diseases, a deterioration in the condition, or the appearance of any of the conditions listed below for the first time, a woman should consult a doctor to decide on the possibility of further use of the drug NovaRing ®.

Circulatory disorders

The use of hormonal contraceptives may be associated with the development of venous thrombosis (deep vein thrombosis and pulmonary embolism) and arterial thrombosis, as well as associated complications, sometimes with a fatal outcome.

The use of any COC increases the risk of developing venous thromboembolism (VTE) compared with the risk of developing VTE in patients not using COCs. The greatest risk of developing VTE occurs in the first year of COC use. Data from a large prospective cohort study on the safety of various COCs suggest that the greatest increase in risk, compared with the level of risk in women who do not use COCs, occurs in the first 6 months after starting COC use or resuming their use after a break (4 weeks or more) . In non-pregnant women not using oral contraceptives, the risk of developing VTE is 1 to 5 cases per 10,000 woman-years (WY). In women using oral contraceptives, the risk of developing VTE is from 3 to 9 cases per 10,000 VL. The increased risk is less than in pregnancy, where the risk is 5-20 per 10,000 YL (pregnancy data are based on actual length of pregnancy in standard studies; based on a 9-month pregnancy, the risk is 7 to 27 cases per 10,000 YL). In women in the postpartum period, the risk of developing VTE is 40 to 65 cases per 10,000 VL. VTE is fatal in 1-2% of cases.

According to the results of studies, the increased risk of developing VTE in women using NovaRing ® is similar to that in women using COCs (adjusted risk ratio, see the table below). The large prospective observational study TASC (Transatlantic Active Study on the Cardiovascular Safety of NovaRing ®) assessed the risk of VTE in women who started using NovaRing ® or COCs, switched to NovaRing ® or COCs from other contraceptives or resumed the use of NovaRing ® or COC in a population of typical users. The women were followed up for 24-48 months. The results showed a similar level of risk of developing VTE in women using NovaRing ® (frequency 8.3 cases per 10,000 LL) and in women using COCs (frequency 9.2 cases per 10,000 LL). For women using COCs other than those containing desogestrel, gestodene and drospirenone, the incidence of VTE was 8.5 cases per 10,000 VL.

A retrospective cohort study initiated by the FDA (US Food and Drug Administration) showed that the incidence of VTE in women who started using NovaRing ® is 11.4 cases per 10,000 YL, while in women women who started using COCs containing levonorgestrel, the incidence of VTE is 9.2 cases per 10,000 VL.

Assessment of the risk (risk ratio) of developing VTE in women using NovaRing ®, compared with the risk of developing VTE in women using COCs

Epidemiological study, population	Comparator(s)	Risk ratio (RR) (95% CI)
TASC (Dinger, 2012) Women who started using the drug (including again after a break) and switched from other contraceptives.	All available COCs during the study 1 .	RR 2: 0.8 (0.5-1.5)
	Available COCs other than those containing desogestrel, gestodene, drospirenone.	RR 2: 0.9 (0.4-2.0)
"FDA Initiated Study" (Sydney, 2011) Women who started using combined hormonal contraceptives (CHCs) for the first time during the study period.	COCs available during the study period 3 .	RR 4: 1.09 (0.55-2.16)
	Levonorgestrel / 0.03 mg ethinyl estradiol.	RR 4: 0.96 (0.47-1.95)

1 Including low-dose COCs containing the following progestins: chlormadinone acetate, cyproterone acetate, desogestrel, dienogest, drospirenone, etinodiol diacetate, gestodene, levonorgestrel, norethindrone, norgestimate, or norgestrel.
2 Based on age, BMI, duration of use, history of VTE.
3 Including low-dose COCs containing the following progestins: norgestimate, norethindrone, or levonorgestrel.
4 Taking into account age, place and year of inclusion in the study.

Extremely rare cases of thrombosis of other blood vessels (for example, arteries and veins of the liver, mesenteric vessels, kidneys, brain and retina) are known with the use of COCs. It is not known whether these cases are associated with the use of COCs.

Possible symptoms of venous or arterial thrombosis may include unilateral edema and/or pain in the lower extremity, localized fever in the lower extremity, redness or discoloration of the skin on the lower extremity; sudden severe chest pain, possibly radiating to the left arm; an attack of shortness of breath, cough; any unusual, severe, prolonged headaches; sudden partial or complete loss of vision; double vision; slurred speech or aphasia; dizziness; collapse, with or without focal epileptic seizure; sudden weakness or severe numbness on one side of the body or any part of the body; movement disorders; "sharp" abdomen.

Risk factors for the development of venous thrombosis and embolism:

• age;
• the presence of diseases in the family history (venous thrombosis and embolism in brothers / sisters at any age or in parents at a young age). If a hereditary predisposition is suspected, a woman should be referred to a specialist for advice before starting any hormonal contraceptive;
• prolonged immobilization, major surgery, any surgery to the lower extremities, or major trauma. In such situations, it is recommended to stop using the drug (in the case of a planned operation, at least 4 weeks in advance) with subsequent resumption of use no earlier than 2 weeks after the full restoration of motor activity;
• possibly thrombophlebitis of superficial veins with varicose veins.

There is no consensus on the possible role of these conditions in the etiology of venous thrombosis.

Risk factors for the development of complications of arterial thromboembolism:

• age;
• smoking (with heavy smoking and with age, the risk increases even more, especially in women over 35 years old);
• dyslipoproteinemia;
• obesity (body mass index over 30 kg/m²);
• increased blood pressure;
• migraine;
• heart valve disease;
• atrial fibrillation;
• the presence of diseases in a family history (arterial thrombosis in brothers / sisters at any age or in parents at a relatively early age). If a hereditary predisposition is suspected, a woman should be referred to a specialist for advice before starting the use of any hormonal contraceptives.

Biochemical factors that may indicate a hereditary or acquired predisposition to venous or arterial thrombosis include resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antibodies to phospholipids (cardiolipin antibodies, lupus anticoagulant).

Other conditions that can lead to unwanted circulatory disorders include diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome and chronic inflammatory bowel disease (eg Crohn's disease or ulcerative colitis), as well as sickle cell anemia.

It is necessary to take into account the increased risk of thromboembolism in the postpartum period.

An increase in the frequency or severity of migraine (which may be a prodromal symptom of cerebrovascular accident) during the use of hormonal contraceptives may prompt immediate discontinuation of hormonal contraceptive use.

Women using CHCs should be advised to contact their doctor if symptoms of thrombosis appear. If thrombosis is suspected or confirmed, CHC use should be discontinued. In this case, it is necessary to use effective contraceptives, since anticoagulants (coumarins) have a teratogenic effect.

The risk of developing tumors

The most important risk factor for developing cervical cancer is infection with the human papillomavirus (HPV). Epidemiological studies have shown that long-term use of COCs leads to an additional increase in this risk, but it remains unclear how much this is due to other factors, such as more frequent cervical smears and differences in sexual behavior, including the use of barrier contraceptives. It remains unclear how this effect is associated with the use of NovaRing®.

A meta-analysis of the results of 54 epidemiological studies revealed a small increase (1.24) in the relative risk of developing breast cancer in women taking combined hormonal oral contraceptives. The risk gradually decreases over 10 years after stopping the drugs. Breast cancer rarely develops in women under the age of 40, so the additional incidence of breast cancer in women who take or have taken COCs is small compared to the overall risk of developing breast cancer. Breast cancer diagnosed in women using COCs is clinically less pronounced than cancer detected in women who have never used COCs. An increased risk of developing breast cancer may be due to both the fact that in women taking COCs, the diagnosis of breast cancer is established earlier, and the biological effects of COCs, or a combination of both of these factors.

In rare cases, women who took COCs have experienced cases of benign, and even more rarely, malignant liver tumors. In some cases, these tumors have led to the development of life-threatening bleeding into the abdominal cavity. The doctor should consider the possibility of a liver tumor in the differential diagnosis of diseases in a woman taking NovaRing ® if the symptoms include acute pain in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding.

Other states

• Women with hypertriglyceridemia or a family history of hypertriglyceridemia have an increased risk of developing pancreatitis when taking hormonal contraceptives.
• Many women taking hormonal contraceptives experience a slight increase in blood pressure, but a clinically significant increase in blood pressure is rare. A direct relationship between the use of hormonal contraceptives and the development of arterial hypertension has not been established. If during the use of the drug NovaRing ® there is a constant increase in blood pressure, you should contact your doctor to decide whether it is necessary to remove the vaginal ring and prescribe antihypertensive therapy. With adequate control of blood pressure with antihypertensive drugs, it is possible to resume the use of the drug NovaRing ®.
• During pregnancy and during the use of combined oral contraceptives, the development or worsening of the following conditions was noted, although their relationship with the use of contraceptives has not been fully established: jaundice and / or itching caused by cholestasis, formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic - uremic syndrome, Sydenham's chorea (chorea minor), herpes of pregnancy, hearing loss due to otosclerosis, (hereditary) angioedema.
• Acute or chronic liver diseases may serve as a basis for discontinuation of the drug NovaRing ® until the normalization of liver function parameters. Recurrence of cholestatic jaundice, observed earlier during pregnancy or when using sex hormone preparations, requires discontinuation of the drug NovaRing ®.
• Although estrogens and progestogens may affect peripheral insulin resistance and tissue glucose tolerance, there is no evidence to support the need to change hypoglycemic therapy during the use of hormonal contraceptives. However, women with diabetes should be under constant medical supervision when using NovaRing®, especially in the first months of contraception.
• There is evidence of worsening of the course of Crohn's disease and ulcerative colitis with the use of hormonal contraceptives.
• In rare cases, pigmentation of the skin of the face (chloasma) may occur, especially if it occurred earlier during pregnancy. Women who are predisposed to the development of chloasma should avoid exposure to sunlight and ultraviolet radiation while using NovaRing ®.
• The following conditions may prevent proper insertion of the ring or cause it to fall out: cervical prolapse, bladder and/or rectal hernia, severe chronic constipation.
• In very rare cases, women have inadvertently inserted the NovaRing ® vaginal ring into the urethra and possibly into the bladder. When symptoms of cystitis appear, the possibility of incorrect insertion of the ring must be considered.
• Cases of vaginitis during the use of the drug NovaRing ® are described. There is no evidence that the treatment of vaginitis affects the effectiveness of the use of the drug NovaRing ®, as well as evidence of the effect of the use of the drug NovaRing ® on the effectiveness of the treatment of vaginitis.
• Very rare cases of difficult removal of the ring have been described, requiring its removal by a healthcare professional.

Medical examination / consultation

Before prescribing NovaRing ® or resuming its use, you should carefully review the medical history (including family history) of the woman and conduct a gynecological examination to exclude pregnancy. It is necessary to measure blood pressure, conduct an examination of the mammary glands, pelvic organs, including a cytological examination of cervical smears and some laboratory tests, to exclude contraindications and reduce the risk of possible side effects of the drug. The frequency and nature of medical examinations depend on the individual characteristics of each patient, but medical examinations are carried out at least once every 6 months. A woman should read the instructions for use and follow all recommendations. The woman should be informed that NovaRing ® does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of the drug NovaRing ® may decrease if the regimen is not followed or if concomitant therapy is carried out.

Reduced cycle control

During the use of the drug NovaRing ®, acyclic bleeding (spotting or sudden bleeding) may occur. If such bleeding is observed after regular cycles against the background of the correct use of the drug NovaRing ®, you should contact your gynecologist for the necessary diagnostic tests, including to rule out organic pathology or pregnancy. Diagnostic curettage may be required.

Some women do not bleed after the ring is removed. If the drug NuvaRing ® was used in accordance with the instructions, it is unlikely that the woman is pregnant. If the recommendations of the instructions are not followed and there is no bleeding after the removal of the ring, as well as in the absence of bleeding for two cycles in a row, pregnancy must be excluded.

Effects of ethinylestradiol and etonogestrel on the sexual partner

The possible pharmacological effects and degree of exposure of ethinyl estradiol and etonogestrel to male sexual partners (due to absorption through the tissues of the penis) have not been studied.

Ring damage

In rare cases, when using the drug NovaRing ®, a rupture of the ring was observed. The core of NovaRing ® is solid, so its contents remain intact, and the release of hormones does not change significantly. If the ring breaks, it usually falls out of the vagina (see the recommendations in the subsection "What to do if the ring was temporarily removed from the vagina" in the section "Method of application and doses"). If the ring breaks, a new ring must be inserted.

Ring drop

Sometimes there was a prolapse of the NovaRing ® vaginal ring from the vagina, for example, when it was inserted incorrectly, when a tampon was removed, during intercourse, or against the background of severe or chronic constipation. In this regard, it is advisable for a woman to regularly check the presence of the NovaRing ® vaginal ring in the vagina. In case of loss of the NovaRing ® vaginal ring from the vagina, it is necessary to follow the recommendations of the subsection “What to do if the ring was temporarily removed from the vagina” in the section “Method of application and doses”.

Influence on the ability to drive vehicles and work with mechanisms

Based on information about the pharmacodynamic properties of the drug NovaRing ®, it can be expected that it does not affect the ability to drive vehicles and work with mechanisms.

Release form

Vaginal rings 0.015 mg + 0.120 mg / day. 1 ring is packed in a waterproof aluminum foil bag, coated on the inside with a layer of low density polyethylene, on the outside with a layer of polyethylene terephthalate (PET). 1 or 3 bags in a cardboard box with instructions for use.

Storage conditions

Store at a temperature of 2 to 8 °C.
Keep out of the reach of children.

Best before date

3 years.
Do not use after the expiry date stated on the packaging.

Holiday conditions

On prescription.

Legal entity in whose name the registration certificate is issued

N.V. Organon, Netherlands

Manufacturer

Produced:
N.V. Organon, Netherlands

Issuing quality control:
N.V. Organon, Netherlands
N.V. Organon, Kloosterstraat 6, 5349 AB, Oss, the Netherlands
or
Organon (Ireland) Ltd., Ireland
Organon (Ireland) Ltd., P.O. Box 2857, Drynam Road, Swords, Co. Dublin, Ireland

Consumer claims should be sent to:
LLC "MSD Pharmaceuticals"
st. Pavlovskaya, d. 7, building 1
Moscow, Russia, 115093