InternetAmbulanceMedical portal. Medicinal guide geotar Diana 35 from unwanted hair

Low-dose monophasic contraceptive with antiandrogenic effect. Contains cyproterone acetate (2 mg) and ethinyl estradiol (0.035 mg). The contraceptive effect is provided by a combination of factors, the most important of which is the inhibition of ovulation and changes in the viscosity of cervical mucus. Diane-35 also changes the structure of the endometrium - it turns out to be unprepared for egg implantation, and in case of fertilization, it will not be able to gain a foothold.

Cyproterone acetate, which is the main active substance of the drug, inhibits the production of androgens (male sex hormones), which are produced in excess in the female body. Thus, Diane-35 treats diseases caused by increased level androgens in the blood or hypersensitivity to these hormones. Under the influence of Diane-35, the activity of the sebaceous glands decreases, which plays an important role in the occurrence of acne, acne and seborrhea ( oily skin) face and head. After 3-4 months of therapy, acne becomes much less or disappears completely. Excessive oiliness of hair and skin disappears even earlier. It also reduces hair loss, which often accompanies seborrhea.

Another therapeutic effect of Diane-35 is that it reduces the manifestations of mild forms of hirsutism (increased male pattern hair growth) in women. reproductive age on the success of treatment - a similar result can be achieved after several months of continuous use. Like other combined oral contraceptives, Diane-35 reduces the risk of anemia, pain before and during menstruation.

Diane-35 can be recommended by a gynecologist to patients who have increased manifestations of androgenization. External signs similar condition: acne (acne), seborrhea, inflamed redheads, alopecia (hair loss), hirsutism (excessive body and face hair).

Contraindications to taking Diane-35 are:

diseases associated with thrombosis (currently or in history);
disorders of the cardiovascular system (angina pectoris, myocardial infarction, chest pain);
stroke;
diabetes mellitus with vascular complications;
jaundice or severe forms of liver disease;
current or previous history of breast or genital cancer;
benign or malignant neoplasm in the liver at present or in history;
vaginal bleeding, the cause of which has not been identified.

If any of the listed conditions appear for the first time while taking Diane-35, you should immediately stop therapy and consult a doctor. To prevent unwanted pregnancy, you need to use barrier methods (candles, pastes, condoms). The drug should not be taken during pregnancy and lactation.

During a conversation with a gynecologist who selects a contraceptive for you, be sure to tell him the following information:

do you smoke;
Your weight;
do you suffer from high blood pressure, how often, how much pressure rises;
do you suffer from migraines, severe headaches, how often;
whether you have a tendency to diabetes;
Have you or a family member been diagnosed with valvular heart disease or serious heart rhythm disturbances, inflammation of the veins (superficial vein phlebitis), thrombosis, myocardial infarction, stroke, epilepsy, liver or gallbladder disease.

If you are taking Diane-35 for a long period, you should be especially careful about your annual preventive examinations by a gynecologist. An extraordinary visit to the gynecologist should be made in situations where:

you have noticed local seals in the mammary gland;
you are prescribed a serious course of treatment;
a long period with limited mobility is predicted (for example, with a broken leg);
there is atypical severe vaginal bleeding;
no menstrual bleeding for two cycles in a row;
there are signs of thrombosis;
headaches more often than before;
severe pain in the legs, swelling.

Possible side effects which are most likely in the first 2-3 months of taking the drug:

headache;
engorgement of the mammary glands, pain in the chest, discharge from the mammary glands;
changes in libido (sex drive);
frequent depression, bad mood, irritability;
intolerance to contact lenses;
nausea, vomiting;
changes in the density and structure of vaginal discharge;
fluid retention in the body, swelling;
change in body weight.

Reception scheme

Packing Diane-35 contains 21 pills. One tablet is taken every day - preferably at the same time. On the package, the tablets are marked according to the days of the week. Accordingly, if you start packing, for example, on Wednesday, you need to take the first tablet from the box labeled “Wednesday”. Next, you need to take the pills, focusing on the direction of the arrow.

When all the pills from the package are taken, a week break begins. During the break, menstrual-like bleeding (withdrawal bleeding) usually occurs. In most cases, it starts 2-3 days after taking the last Diane-35 dragee. After a week break, the pills from the next package are started - regardless of whether the bleeding has stopped or not. It turns out that a new pack always starts on the same day of the week, and bleeding also occurs on about the same day of the week.

Start taking Diane-35

If no hormonal contraceptive was used in the previous month, Diane-35 should be started on the first day of the cycle, that is, on the first day of menstrual bleeding. You can start taking it on the 2-5th day of the menstrual cycle, but in this case, during the week, you must additionally use a barrier method of contraception.
When switching from other combined oral contraceptives, Diane-35 should be started the next day after the last tablet of the previous package was taken - that is, without a break in taking the dragee. If the previous preparation contains 28 tablets, you can start taking Diane-35 the next day after taking the last active tablet. You can start taking later, but in no case later than the next day after the usual weekly break in taking (for preparations containing 21 tablets) or after taking the last inactive tablet (for preparations containing 28 tablets per package).
When switching from a mini-pill, you can start taking Diane-35 on any day. It is advisable to take the first tablet of Diane-35 at the same time as the mini-pill tablets were taken. During the week, it is recommended to additionally use a barrier method of contraception (for example, a condom).
When switching from an injectable contraceptive, Diane-35 should be started on the day of the next injection. During the first 7 days of taking the pills, you must also use an additional barrier method of contraception (for example, a condom).
When switching from an implant, Diane-35 should be taken on the day the implant is removed. During the first 7 days of taking the pills, you must also use an additional barrier method of contraception (for example, a condom).

After a spontaneous miscarriage or abortion in the first trimester of pregnancy, the doctor may recommend that you start taking it immediately. Under this condition, there is no need for additional contraceptive protection.

For the purpose of contraception, as well as to achieve an antiandrogenic effect, Diane-35 can be taken for a long period of time. In the treatment of androgen-dependent conditions, the duration of use is determined by the severity of the disease. After the disappearance of symptoms, it is recommended to take Diane-35 for at least another 3-4 months. In the event of a relapse, the course of treatment with Diane-35 can be repeated.

What to do if you forget to take a pill.

If the gap in taking the next pill is less than 12 hours, the contraceptive effect of Diane-35 is preserved. You need to take the pill immediately. The next tablet is taken at the usual time.

If the gap in admission is more than 12 hours, the contraceptive reliability of Diane-35 is reduced. And each subsequent pass reduces contraceptive reliability more and more. The risk of pregnancy is especially high when skipping a pill at the beginning or at the end of the package. In such situations, the sequence of actions depends on how many pills are missed and which pills are missed in order.

If more than one tablet is forgotten from the package, the drug should be stopped and consult a doctor.

If one tablet is missed, then it should be taken immediately, even if it means taking two tablets at the same time. Then the drug is taken according to the usual schedule.

If a tablet is missed and the pack ends in less than 7 days (third week of use), you should start taking a new pack as soon as the current pack ends, without taking a week break. There will be no withdrawal bleeding, but spotting may occur. bloody issues or breakthrough bleeding while taking pills from the second pack. In this case, within a week after missing the pill, you must use additional contraceptives.

The absence of menstruation during the week break indicates a probable pregnancy. Do a test or ultrasound before you start taking the pills from the new pack.

If vomiting occurs after 4 hours after taking the Diane-35 tablet, this may reduce the contraceptive effect. In this situation, you should proceed in the same way as in the case of missing a tablet.

In this article, you can read the instructions for using the drug Diana-35. Reviews of site visitors - consumers of this medicine, as well as opinions of doctors of specialists on the use of Diane-35 in their practice are presented. A big request to actively add your reviews about the drug: did the medicine help or not help get rid of the disease, what complications and side effects were observed, perhaps not declared by the manufacturer in the annotation. Diana 35 analogs in the presence of existing structural analogs. Use of a hormonal contraceptive drug for contraception and acne (acne) treatment in adults, children, and pregnancy and breastfeeding.

Diana-35- combined low-dose monophasic oral contraceptive with antiandrogenic effect, containing estrogen - ethinyl estradiol and antiandrogen with progestogenic activity - cyproterone acetate.

Cyproterone acetate contained in Diana-35 inhibits the influence of androgens, which are also produced in the female body. Thus, it becomes possible to treat diseases caused by increased production of androgens or specific sensitivity to these hormones.

Against the background of taking Diane-35, the increased activity of the sebaceous glands decreases, which plays an important role in the occurrence of acne (pimples) and seborrhea. After 3-4 months of therapy, this usually leads to the disappearance of the existing rash. Excessive oiliness of hair and skin disappears even earlier. It also reduces hair loss, which often accompanies seborrhea. Diane-35 therapy in women of reproductive age reduces clinical manifestations mild forms of hirsutism; however, the effect of the treatment should be expected only after several months of use.

Along with the above-described antiandrogenic effect of cyproterone acetate, it also has a pronounced progestogenic effect.

The contraceptive effect of Diane-35 is based on the interaction of various factors, the most important of which are the inhibition of ovulation and changes in the secretion of cervical mucus.

The cycle becomes more regular, painful periods are less common, the intensity of bleeding decreases, resulting in a reduced risk of iron deficiency anemia.

Composition

Ethinylestradiol + cyproterone acetate + excipients.

Pharmacokinetics

Cyproterone acetate

After taking Diane-35 cyproterone acetate is completely absorbed from the gastrointestinal tract. Cyproterone acetate is almost completely bound to plasma albumin, approximately 3.5-4.0% is in the free state. Since protein binding is nonspecific, changes in the level of sex steroid-binding globulin (SHBG) do not affect the pharmacokinetics of cyproterone acetate. Up to 0.2% of the dose of cyproterone acetate is excreted in breast milk. It is excreted mainly in the form of metabolites with urine and bile in a ratio of 1: 2, a small part - unchanged with bile.

Ethinylestradiol

After taking Diane-35, ethinylestradiol is rapidly and completely absorbed from the gastrointestinal tract. In the process of absorption and "first passage" through the liver, ethinylestradiol undergoes intensive metabolism, which leads to a bioavailability of approximately 45%, and its significant individual variability. Ethinylestradiol is excreted from the body as metabolites; about 40% - with urine, 60% - with bile.

Indications

contraception in women with androgenization phenomena;
androgen-dependent diseases in women: acne (especially their pronounced forms, accompanied by seborrhea, inflammatory phenomena with the formation of nodes (papular-pustular acne, nodular cystic acne)), androgenetic alopecia and mild forms of hirsutism.

Release forms

Dragee 35 mcg + 2 mg (sometimes erroneously called tablets, although there are no tablet forms of the hormonal contraceptive Diane-35).

Instructions for use and regimen

Diane-35 is taken orally 1 tablet per day. Dragees are taken without chewing and washed down with a small amount of liquid. The time of taking the drug does not play a role, but the subsequent dose should be taken at the same selected hour, preferably after breakfast or dinner.

Diane-35 intake is started on the 1st day of the cycle, using pills of the corresponding day of the week from the calendar package.

The daily intake of the drug is carried out using dragees from the calendar package sequentially in the direction of the arrow printed on the foil until all the dragees are taken. After the end of taking all 21 pills from the calendar package, a break is made in taking the drug for 7 days, during which menstrual bleeding occurs.

After 28 days from the start of taking the drug (21 days of admission and 7 days off), i.e. on the same day of the week as at the beginning of the course, continue taking the drug from the next package.

When switching from combined oral contraceptives, Diane-35 should be started the next day after taking the last pill with the active components of the previous drug, but in no case later than the next day after the usual 7-day break in taking (for drugs containing 21 pills) . Further according to the scheme described above. If the patient has taken the previous contraceptive daily for 28 days, Diane-35 should be started after taking the last inactive dragee.

When switching from contraceptives containing only gestagens ("mini-pill"), Diane-35 can be used without interruption. When using injectable forms of contraceptives, Diane-35 begins to be taken from the day the next injection is to be made. When switching from an implant - on the day of its removal. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the dragee.

After an abortion in the 1st trimester of pregnancy, a woman can start taking the drug immediately. In this case, the woman does not need additional methods of contraception.

After childbirth or abortion in the 2nd trimester of pregnancy, the drug should be taken on the 21-28th day. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills.

If a woman had a sexual life between childbirth or abortion and the start of taking Diane-35, then pregnancy should first be excluded or it is necessary to wait for the first menstruation.

A woman should take the missed pill as soon as possible, the next pill is taken at the usual time. If the delay is less than 12 hours, the reliability of contraception does not decrease. If the delay in taking the pills was more than 12 hours, the reliability of contraception may be reduced. It should be borne in mind that the intake of dragees should never be interrupted for more than 7 days, and that 7 days of continuous intake of dragees are required to achieve adequate suppression of the function of the hypothalamic-pituitary-ovarian system.

If the delay in taking the pill was more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours) during the first and second weeks of taking the drug, then the woman should take the last missed pill as soon as possible, as soon as she remembers (even if this means taking two pills at the same time). The next dragee is taken at the usual time. Additionally, you should use a barrier method of contraception for the next 7 days.

If the delay in taking the pill was more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours) during the third week of taking the drug, then the woman should take the last missed pill as soon as she remembers (even if this means taking two pills at the same time ). The next dragee is taken at the usual time. In addition, taking pills from a new package should be started as soon as the current package is over, i.e. nonstop. The woman is most likely not to have withdrawal bleeding until the end of the second pack, but she may experience spotting or breakthrough bleeding on the days she takes the pills.

If a woman has had vomiting within 3 to 4 hours after taking Diane-35, absorption of the active substances may be incomplete. In this case, it is necessary to focus on the recommendations when skipping the dragee.

In order to delay the onset of menstruation, a woman should continue taking the pills from the new Diane-35 package immediately after taking all the pills from the previous one, without interrupting the intake. Dragees from this new package can be taken for as long as the woman wishes (until the package runs out). While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. Resume taking Diane-35 from a new package should be after the usual 7-day break.

In order to move the day of the start of menstruation to another day of the week, a woman should shorten the next break in taking pills by as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and will have further spotting and breakthrough bleeding during the second pack (just as she would like to delay her period).

In the treatment of hyperandrogenic conditions, the duration of administration is determined by the severity of the disease. After the disappearance of symptoms, it is recommended to take Diane-35 for at least another 3-4 months. In the event of a relapse a few weeks or months after the completion of the course, repeated therapy with Diane-35 can be performed.

Side effect

engorgement, soreness, enlargement of the mammary glands and discharge from them;
chest pain;
change in body weight;
intermenstrual bleeding (bleeding without menstruation);
changes in the vaginal secretion;
change in libido;
headache;
migraine;
decreased mood;
nausea, vomiting;
poor tolerance to contact lenses;
allergic reactions;
the appearance of age spots on the face (chloasma).

Contraindications

thrombosis and thromboembolism, incl. in history (deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
conditions preceding thrombosis (including transient ischemic attacks, angina pectoris);
diabetes mellitus complicated by microangiopathies;
the presence of severe or multiple risk factors for venous or arterial thrombosis;
diseases or severe violations of the liver;
liver tumors (including history);
hormone-dependent malignant tumors, incl. tumors of the breast or genital organs (including history);
uterine bleeding of unknown etiology;
pancreatitis (including history), if it was accompanied by severe hypertriglyceridemia;
a history of migraine, which was accompanied by focal neurological symptoms;
lactation (breastfeeding);
pregnancy or suspicion of it;
hypersensitivity to the components of the drug.

Use during pregnancy and lactation

Diane-35 is contraindicated for use during pregnancy and lactation.

special instructions

Before starting the use of Diane-35, it is necessary to conduct a general medical examination (including the mammary glands and a cytological examination of cervical mucus), exclude pregnancy, disorders of the blood coagulation system. At long-term use drug preventive control examinations should be carried out every 6 months.

The approximate incidence of venous thromboembolism (VTE) when taking oral contraceptives with a low dose of estrogen (less than 50 micrograms of ethinyl estradiol) is up to 4 per 10,000 women per year, compared with 0.5-3 per 10,000 women who do not take oral contraceptives. At the same time, the frequency of VTE when taking combined oral contraceptives is less than the frequency of VTE associated with pregnancy (6 per 10,000 pregnant women per year).

The patient should be warned that with the development of symptoms of venous or arterial thrombosis, you should immediately consult a doctor. These symptoms include unilateral leg pain and/or swelling; sudden severe chest pain radiating to left hand or without irradiation; sudden shortness of breath; sudden onset of coughing; any unusual, severe, prolonged headache; increased frequency and severity of migraine; sudden partial or complete loss of vision; diplopia; slurred speech or aphasia; dizziness; collapse with/without partial seizure; weakness or very significant loss of sensation that suddenly appeared on one side or in one part of the body; movement disorders; symptom complex "acute" abdomen.

The relationship between taking combined oral contraceptives and arterial hypertension has not been established. If persistent arterial hypertension occurs, Diane-35 should be canceled and appropriate antihypertensive therapy prescribed. Reception of a contraceptive can be continued with the normalization of blood pressure.

If abnormal liver function occurs, Diane-35 may need to be temporarily discontinued until laboratory parameters return to normal. Recurrent cholestatic jaundice that develops for the first time during pregnancy or previous use of sex hormones requires discontinuation of combined oral contraceptives.

Although combined oral contraceptives have an effect on tissue resistance to insulin and glucose tolerance, it is usually not necessary to adjust the dose of hypoglycemic drugs in patients with diabetes mellitus. Nevertheless, this category of patients should be under close medical supervision.

Women with a tendency to chloasma while taking combined oral contraceptives should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.

If symptoms in women with hirsutism have developed recently or have increased significantly, other causes, such as an androgen-producing tumor, congenital adrenal dysfunction, should be considered in the differential diagnosis.

While taking Diane-35, irregular bleeding (spotting or breakthrough bleeding) can sometimes occur, especially during the first months of therapy. Therefore, evaluation of any irregular bleeding should be done only after an adaptation period of approximately 3 cycles.

If irregular bleeding recurs or develops after previous regular cycles, then non-hormonal causes should be considered and adequate diagnostic measures taken to rule out malignancy or pregnancy. These may include diagnostic curettage.

In some cases, withdrawal bleeding may not develop during a break in taking the dragee. In case of irregular intake of pills or in the absence of two menstrual-like bleeding in a row, pregnancy should be excluded before continuing to take the drug.

drug interaction

With the simultaneous use of Diane-35 with inducers of microsomal liver enzymes (hydantoins, barbiturates, primidone, carbamazepine and rifampicin; and possibly with oxcarbazepine, topiramate, felbamate and griseofulvin), the clearance of ethinylestradiol and cyproterone increases, which can lead to breakthrough uterine bleeding or decrease in the reliability of contraception.

With simultaneous use with ampicillins and tetracyclines, the contraceptive reliability of Diane-35 is reduced.

Analogues of the drug Diane-35

Structural analogues according to active substance:

Belluna 35;
Chloe.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.

Diane 35 is a monophasic low-dose combined oral contraceptive with a pronounced antiandrogenic effect. The composition of this drug also contains cyproterone acetate (an androgenic substance with a progestogenic effect), ethinyl estradiol (estrogen). What reviews about the medicine Diana 35 are left on the Internet by women who took it? Let's take a look at them.

Diane 35 is prescribed for the purpose of contraception for women with excessive androgenic manifestations, as well as for the treatment of androgen-dependent pathologies in the female body: acne, hirsutism, androgenic alopecia.

Reviews of patients taking Diana 35

“I have been taking Diana 35 for about 4 years. It has proven to be very effective for me both for acne and as a contraceptive. The ideal skin on my face did not become, however, I no longer had large and painful acne before and during menstruation. The positive effect of Diana 35 became noticeable from the second month, and finally fixed, as I believe, after 5 months.

The only drawback for me is the high price. It may not be suitable for all women, but for me it is a unique and ideal contraceptive.”

Olga

“For a long time I wanted to try oral contraceptives, but somehow I didn’t dare. I learned from a friend about the drug Diana 35, which was prescribed to her by her gynecologist. Since she is satisfied with this contraceptive, I also decided to take a chance. This drug is well tolerated.

leveled out menstrual cycle, even pain during menstruation disappeared while taking this medication. True, the sex life at that time was also regular. When they decided to have a baby, I stopped taking the drug a year before the onset of pregnancy.

Svetlana

“Diana 35 was assigned to me by my gynecologist, because after laboratory tests revealed an increase in one of the hormones. I was in a positive mood, as several of my friends took Diana 35 and were satisfied. The course was scheduled for 3 months.

At the end of the first month of taking the drug, I noticed that I had gained a few extra pounds. The doctor assured me that this is a completely normal reaction to this contraceptive. After the second month of taking Diana 35, I recovered even more. I did not wait for the effects from the third month of admission. In addition to weight gain, there was also weakness, nausea, which had not happened before.

Natalia

“I was diagnosed with a hormonal failure a few years ago. Now, in addition to this, they also revealed polycystic ovaries. The doctor prescribed Diana 35. After a week of taking this drug, its effects began to appear. My chest began to hurt so much that it was impossible to even wear underwear. In the chest, seals began to be felt on both sides. As it turned out, these are such side effects.

In general, I don't know how this remedy helped me in terms of my initial problem, but the undesirable effects clearly prevailed. I do not advise taking this contraceptive.

Julia

Conclusion

So, on the Internet you can find many different comments and reviews regarding the use of the drug Diana 35. Most of them are positive, but there are also negative ones. Some of the patients who took Diana noted side effects in the form of itching, weight gain, and the appearance of skin rashes.

However, according to experts, these changes may be associated with individual intolerance to any medicinal components of the drug, or with the absence of indications for taking this drug (pronounced antiandrogenic effect in a normal hormonal background).

Based on the feedback from patients, it can be concluded that this drug is quite effective as a hormone-normalizing therapy and as a contraceptive, however, in relation to acne, the reviews are ambiguous.

Dosage form:

coated tablets

Composition:

Each coated tablet contains:

Active ingredients: 2.000 mg cyproterone acetate and 0.035 mg ethinyl estradiol.

Excipients: lactose monohydrate, corn starch, povidone 25, talc (hydrous magnesium silicate), magnesium stearate.

Shell composition: sucrose, g|ovidone 90, macrogol 6000, calcium carbonate, talc (magnesium hydrosilicate), titanium dioxide, glycerol 85%, mountain glycol wax, iron dye (II) yellow oxide.

Description:

Round, biconvex film-coated tablets, light yellow in color.

Pharmacotherapeutic group:Combined contraceptive (estrogen + antiandrogen) ATX:

G.03.H.B.01 Cyproterone and estrogen

Pharmacodynamics:

Pharmacodynamic Interactions

It has been shown that the combined use of ethinylestradiol-containing drugs and direct-acting antiviral drugs containing ombitasvir, paritaprevir, dasabuvir, or a combination of them, is detected by an increase in the concentration of ALT (alanine aminotransferase) more than 20 times the upper limit of normal in healthy and infected with the hepatitis virus From women (see section "Contraindications").

Other forms of interaction

The use of drugs such as Diane-35® may affect the results of some laboratory tests, including biochemical parameters of the liver, function thyroid gland, adrenal and renal function, plasma protein concentration (eg, corticosteroid-binding globulin, lipid/lipoprotein fraction), coagulation and fibrinolysis parameters, carbohydrate metabolism. These changes, as a rule, remain within normal physiological values.

Special instructions:

Diane-35® should not be used solely for the purpose of contraception. For the purpose of contraception, the drug can only be used in women with androgen-dependent diseases.

Diane-35® contains progestogen cyproterone acetate and estrogen and is used for 21 days monthly cycle. The drug has a composition similar to other COCs.

Clinical experience and epidemiological data regarding the combination of estrogen and progestogen, such as Diane-35®, are predominantly associated with COCs. Therefore, the following instructions related to the use of COCs also apply to Diane-35®.

If any of the conditions / diseases / risk factors listed below are currently present, then the potential risk and expected benefit of treatment with Diane-35® should be carefully weighed in each individual case and discussed with the woman before she decides start taking the drug. In case of aggravation, exacerbation or first manifestation of any of these conditions, diseases or risk factors, the woman should consult her doctor, who can decide on the need to discontinue the drug.

- Diseases of the cardiovascular system

There is evidence of an increased incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders) when taking COCs. These diseases are rare.

The risk of developing venous thromboembolism (VTE) is highest in the first year of taking these drugs. An increased risk is present after the initial use of COCs or the resumption of use of the same or different COCs (after a break between doses of 4 weeks or more).

Data from a large prospective study in 3 groups of patients show that this increased risk is present mainly during the first 3 months.

The results of epidemiological studies have shown that the incidence of VTE when using Diane-35® is 1.5-2 times higher than when using COCs containing , and the percentage of risks when using Diane-35® can be comparable to the percentage of risks when using COCs containing gestodene, drospirenone.

The overall risk of VTE in patients taking low-dose COCs (< 50 мкг этинилэстрадиола) в два-три раза выше, чем у небеременных пациенток, которые не принимают КОК, тем не менее, этот риск остается более низким по сравнению с риском ВТЭ при беременности и родах.

VTE can be life-threatening or fatal (in 1-2% of cases).

VTE manifesting as deep vein thrombosis or pulmonary embolism can occur with any COC.

Very rarely, when using COCs, thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, vessels of the brain or retina.

Symptoms of deep vein thrombosis include: unilateral swelling of the lower extremity or swelling along the vein in the lower extremity, pain or tenderness in the lower extremity only in an upright position or when walking, a local increase in temperature in the affected lower extremity, redness or discoloration of the skin on the lower extremity.

Symptoms of pulmonary embolism: sudden unexplained shortness of breath or rapid breathing; sudden cough, including hemoptysis; sharp pain in the chest, which may worsen with a deep breath; sense of anxiety; severe dizziness; fast or irregular heartbeat. Some of these symptoms (eg, shortness of breath, cough) are nonspecific and may be misinterpreted as signs of other more common and less severe conditions/diseases (eg, respiratory infections). Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction.

Symptoms of a stroke are as follows: sudden weakness or loss of sensation in the face, limbs, especially on one side of the body, sudden confusion, disorientation and dysarthria; sudden unilateral or bilateral loss of vision; sudden disturbance of gait, dizziness, loss of balance or coordination of movements; sudden severe or prolonged headache for no apparent reason; loss of consciousness or fainting with or without seizures.

Other signs of vascular occlusion: sudden pain, swelling and slight cyanosis of the extremities, "acute" abdomen.

Symptoms of myocardial infarction include: pain, discomfort, squeezing, heaviness, a feeling of compression or bursting of the chest or behind the sternum, radiating to the back, jaw, left upper limb, epigastric region; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety, or shortness of breath; fast or irregular heartbeat.

Arterial thromboembolism can be life-threatening or fatal.

In women with a combination of several risk factors or a high severity of one of them (for example, complicated diseases of the valvular apparatus of the heart, uncontrolled arterial hypertension, extensive surgical interventions with prolonged immobilization, etc.), the possibility of their mutual reinforcement should be considered. In such cases, the total value of the existing risk factors increases. In this case, taking Diane-35® is contraindicated (see section "Contraindications").

The risk of developing thrombosis (venous and / or arterial) and thromboembolism or cerebrovascular disorders increases:

With age;

Smokers (with an increase in the number of cigarettes or an increase in age, the risk further increases, especially in women over 35 years old);

in the presence of:

Diseases of the vessels of the brain or coronary arteries of the heart;

Family history (i.e. venous or arterial thromboembolism ever in close relatives or parents under 50 years of age); in the case of a hereditary predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking COCs;

Obesity (body mass index 30 kg / m 2 or more);

Subacute bacterial endocarditis;

Dyslipoproteinemia;

arterial hypertension;

Migraine;

heart valve disease;

atrial fibrillation;

Prolonged immobilization in cases of: major surgical operations, any operation on lower limbs or extensive trauma. In these situations, it is necessary to stop taking Diane-35® (in the case of a planned operation, at least four weeks before it) and not resume taking it within two weeks after the end of immobilization.

An increased risk of thromboembolism in the postpartum period should be taken into account.

There is a possibility that among women using the drug Diane-35®, there may be patients with an increased risk of cardiovascular diseases, in particular, associated with polycystic ovary syndrome.

Circulatory disorders can also be observed with diabetes, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), and sickle cell anemia.

An increase in the frequency and severity of migraine during the use of the drug Diane-35® (which may precede cerebrovascular disorders) is the basis for the immediate discontinuation of the drug.

Biochemical indicators indicating a hereditary or acquired predisposition to venous or arterial thrombosis include the following: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antibodies to phospholipids (anticardiolipin antibodies, lupus anticoagulant).

When evaluating the benefit/risk ratio, it should be taken into account that adequate treatment of the relevant condition can reduce the associated risk of thrombosis and that the risk associated with pregnancy is higher than the risk associated with taking low-dose COCs (<0,05 мг этинилэстрадиола).

- Tumors

The most significant risk factor for developing cervical cancer is persistent human papillomavirus infection. There are reports of a slight increase in the risk of developing cervical cancer with long-term use of COCs. The connection with the use of COCs has not been proven. It remains a controversial question to what extent these findings are associated with screening for cervical pathology or with the characteristics of sexual behavior (more rare use of barrier methods of contraception).

A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of developing breast cancer diagnosed in women currently taking COCs (relative risk 1.24). The increased risk gradually disappears within 10 years after stopping these drugs. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the number of breast cancer diagnoses in women who are currently taking COCs or have recently taken them is insignificant in relation to the overall risk of this disease. Its association with COC use has not been proven. The observed increase in risk may be due not only to the earlier diagnosis of breast cancer in women using COCs, but also to the biological action of sex hormones or a combination of these two factors. In women who have ever used COCs, earlier stages of breast cancer are detected than in women who have never used them.

In rare cases, against the background of the use of COCs, the development of benign, and in extremely rare cases, malignant liver tumors was observed, which in some cases led to life-threatening intra-abdominal bleeding. This should be taken into account when making a differential diagnosis in case of severe abdominal pain, liver enlargement, or signs of intra-abdominal bleeding.

Malignant tumors can be life-threatening or fatal.

- Other states

Women with hypertriglyceridemia while taking COCs (if there is a family history of this condition) may increase the risk of developing pancreatitis. Although a slight increase in blood pressure has been described in many women taking COCs, a clinically significant increase (above 140/90 mmHg) has rarely been noted. However, if the increase in blood pressure becomes persistent while taking COCs, these drugs should be discontinued and treatment of arterial hypertension should be started. Taking COCs can be continued if normal blood pressure values are achieved with antihypertensive therapy.

The following conditions have been reported to develop or worsen both during pregnancy and when taking COCs, but their relationship with taking COCs has not been proven: jaundice and / or itching associated with cholestasis; the formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis. Cases of Crohn's disease and ulcerative colitis have also been described with the use of COCs.

In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen the symptoms of angioedema.

Occasionally, chloasma may develop, especially in women with a history of chloasma of pregnancy. Women with a tendency to chloasma while taking COCs should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.

Acute or chronic liver dysfunction may require discontinuation of COCs until liver function tests return to normal. Recurrence of cholestatic jaundice, which developed for the first time during pregnancy or previous use of sex hormones, requires discontinuation of COCs.

Although COCs may have an effect on insulin resistance and glucose tolerance, as a rule, correction of the dosing regimen of hypoglycemic drugs in patients with diabetes mellitus using low-dose COCs (<0,05 мг этинилэстрадиола), не требуется. Тем не менее, женщины с сахарным диабетом во время приема КОК должны тщательно наблюдаться.

If a woman with hirsutism has recent or severe symptoms, a differential diagnosis should be made to identify a possible cause (androgen-producing tumor, adrenal enzyme deficiency).

Laboratory tests

Taking COCs may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal function, plasma transport proteins, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually do not go beyond the boundaries of normal values.

Reduced efficiency

The contraceptive efficacy of Diane-35® may be reduced in the following cases: missed tablets, gastrointestinal disturbances, or as a result of drug interactions.

Change in the nature of menstrual bleeding

While taking COCs, irregular bleeding ("spotting" spotting and / or breakthrough bleeding) may occur, especially during the first months of use. Therefore, evaluation of any irregular bleeding should be done only after an adaptation period of approximately three cycles.

If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be carried out to exclude malignant neoplasms or pregnancy.

Some women may not develop "withdrawal" bleeding during a pill break. If COCs were taken as directed, it is unlikely that the woman is pregnant. However, if COCs have been taken irregularly before, or if there are no consecutive "withdrawal" bleedings, pregnancy should be excluded before continuing to take the drug.

Medical examinations

Before starting the use of Diane-35®, a woman is recommended to undergo a thorough general medical and gynecological examination (including examination of the mammary glands and a cytological examination of the cervical epithelium), to exclude pregnancy. In addition, violations of the blood coagulation system should be excluded.

In the case of long-term use of the drug, it is necessary to conduct regular check-ups (approximately every 6 months).

A woman should be warned that Diane-35® does not protect against HIV infection (AIDS) and other sexually transmitted diseases!

Conditions requiring medical advice

Any changes in the state of health, especially the occurrence of conditions listed in the sections "Contraindications" and "Use with caution";

Local compaction in the mammary gland;

Simultaneous use of other drugs (see also "Interaction with other drugs");

If prolonged immobility is expected (for example, a cast is applied to the lower limb), hospitalization or surgery is planned (at least 4 weeks before the proposed operation);

unusually heavy bleeding from the vagina;

Missed a pill in the first week of taking the drug and had sexual intercourse seven days or less before;

Absence of another menstrual-like bleeding twice in a row or suspicion of pregnancy (do not start taking pills from the next package before consulting a doctor).

A woman should stop taking the pills and immediately consult a doctor if there are possible signs of thrombosis.

Influence on the ability to drive transport. cf. and fur.:

Not found.

Release form / dosage:Coated tablets, 2 mg + 0.035 mg. Package:

21 tablets in a blister made of PVC and colored aluminum foil. The blister, along with instructions for use, is placed in a cardboard box. with control of the first opening.

Storage conditions:

At a temperature not higher than 30 °C.

Keep out of the reach of children.

Best before date:

Do not use after the expiration date.

Conditions for dispensing from pharmacies: On prescription Registration number: P N012240/01 Date of registration: 02.06.2010 / 07.11.2017 Expiration date: Perpetual Registration certificate holder: Bayer AG Germany Manufacturer: Representation: BAYER JSC Information update date: 28.05.2019 Illustrated Instructions

Both active ingredients that are part of Diane-35 have a positive effect on the state of hyperandrogenism. Cyproterone acetate is a competitive androgen receptor antagonist, it inhibits the synthesis of androgens and determines the decrease in the concentration of these hormones in the blood due to the antigonadotropic effect. This antigonadotropic effect is enhanced by ethinylestradiol, which also regulates the synthesis of sex steroid-binding globulin (SHBG) in plasma. With this in mind, the level of unbound biologically available androgen in the blood decreases.
When using the drug Diane-35 (usually after 4 months of therapy), acne is eliminated, excessive oiliness of hair and skin disappears even earlier. Hair loss, which often accompanies seborrhea, is also reduced. When using the drug by persons with mild forms of hirsutism (primarily with mild facial hair), the results of therapy should be expected only after a few months from its start.
The contraceptive effect of Diane-35 is based on the interaction of various factors, the most important of which are ovulation suppression and changes in cervical secretion. In addition to preventing pregnancy, the drug has a number of positive properties. The menstrual cycle becomes more regular, menstruation is less painful, blood loss is reduced. The latter helps to reduce the frequency of iron deficiency anemia.
The toxicity profile of ethinylestradiol is well understood. There are no preclinical data that supplement the information regarding the safety of ethinylestradiol indicated in the sections of the instructions for medical use of the drug.
Data from standard preclinical toxicity studies with repeated use of cyproterone acetate do not indicate the existence of any specific risk to the human body.
Available clinical experience does not suggest an increase in the incidence of liver tumors in humans. The results of studies of the carcinogenicity of cyproterone acetate, conducted in rodents, do not indicate the existence of any specific carcinogenic effect. However, it should be taken into account that sex steroids may promote the growth of certain pre-existing hormone-dependent tumors.
The available data do not give grounds to object to the use of the drug Diane-35 in humans when taken according to the directions provided and at the recommended dose.
Cyproterone acetate
After oral administration of cyproterone acetate is rapidly and completely absorbed. Its peak serum concentration is 15 ng / ml and is reached approximately 1.6 hours after a single dose. The bioavailability of cyproterone acetate is approximately 88%.
Cyproterone acetate is almost completely bound to serum albumin. Only 3.5-4% of the total concentration of the steroid remains in the unbound state. The increase in SHBG levels induced by ethinylestradiol does not affect protein binding of cyproterone acetate.
Cyproterone acetate is almost completely metabolized. The main metabolite in blood plasma is 15b-OH-CPA. The rate of clearance from blood serum is approximately 3.6 ml / min / kg.
The concentration of cyproterone acetate in serum decreases biphasically, with half-lives of 0.8 hours and 2.3-3.3 days. Some of the steroid is excreted unchanged. Metabolites are excreted in the urine and bile in a ratio of 1:2. The half-life of metabolites is 1.8 days.
Taking into account the long half-life of cyproterone acetate from the blood serum, its accumulation in the blood serum can be observed during one cycle of therapy with a coefficient of 2-2.5.
Ethinylestradiol
Adsorption
When taken orally, ethinylestradiol is rapidly and completely absorbed. The peak serum concentration of approximately 71 pg/mL is reached after 1.6 hours.
Distribution
Ethinylestradiol binds strongly, yet non-specifically, to serum albumin (approximately 98%) and induces an increase in serum SHBG concentration.
Ethinylestradiol is metabolized mainly by aromatic hydroxylation, with the formation of a large number of hydroxylated and methylated metabolites, among which there are both free metabolites and conjugates with glucuronides and sulfates. Clearance is 2.3-7 ml / min / kg.
The level of ethinylestradiol in the blood serum decreases in 2 phases with half-lives of approximately 1 and 10-20 hours, respectively. The substance is not excreted unchanged from the body, ethinylestradiol metabolites are excreted in the urine and bile in a ratio of 4:6. The half-life of metabolites is approximately 1 day.
Steady-state concentration is reached in the second half of the cycle of administration, when the level of the active substance in the blood serum is 60% higher compared to a single dose.

Indications for the use of the drug Diane-35

Treatment of androgen-dependent diseases in women, such as acne, especially pronounced forms and forms accompanied by seborrhea, inflammation or nodule formation (papular-pustular acne, nodular cystic acne), with androgenetic alopecia and mild forms of hirsutism.

The use of the drug Diane-35

The drug Diane-35 is intended for regular use in order to achieve a therapeutic effect and the necessary contraceptive protection. The use of other hormonal contraceptives should be discontinued. The method of using the drug Diane-35 does not differ from the usual regimen for taking most combined oral contraceptives. With this in mind, you should follow the same instructions regarding the method of application of the drug. Irregular intake of Diane-35 can cause intermenstrual bleeding and impair therapeutic and contraceptive efficacy.
If hormonal contraceptives were not used in the previous period (last month)
Reception of a dragee should be begun in the 1st day of a menstrual cycle. You can start taking it from the 2-5th day, however, in this case, during the first cycle, it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the drug.
Switching from another combined oral contraceptive (COC)
It is advisable to start taking Diane-35 the next day after taking the last active tablet of the previous COC, at least no later than the next day after the break in taking the tablets or after taking the placebo tablets of her previous COC.
Switching from a progestogen-only method (mini-pills, injections, implants) or a progestogen intrauterine system
You can start taking Diane-35 on any day after you stop taking the minipill (with an implant or intrauterine system - on the day of their removal; in the case of an injection - instead of the next injection). However, in all cases, it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the dragee.
After an abortion in the first trimester of pregnancy
You can start using Diane-35 immediately. In this case, she does not need to use additional contraceptives.
After childbirth or abortion in the second trimester of pregnancy
In case of breastfeeding, see subsection “ During pregnancy and breastfeeding".
It is necessary to recommend starting Diane-35 from 21-28 days after childbirth or abortion in the second trimester of pregnancy. With a later start of taking the dragee, you should additionally use a barrier method of contraception during the first 7 days of taking the drug. However, if sexual intercourse has already taken place, then before starting the use of COCs, it is necessary to exclude pregnancy or wait for menstruation.
What to do if you miss a pill
If the delay in taking the dragee does not exceed 12 hours, the contraceptive effect of the drug is not reduced. Missed tablets should be taken as soon as possible. The next dragee from this package is taken at the usual time.
If the delay in taking the missed tablet exceeds 12 hours, contraceptive protection may decrease. In this case, you can follow two basic rules:

a break in taking pills can never exceed 7 days;
adequate inhibition of the hypothalamus - pituitary - ovaries system is achieved by continuous intake of dragees for 7 days.

Accordingly, the following recommendations should be followed in everyday life:

1st week
You should take the last missed tablet as soon as possible, even if you have to take 2 tablets at the same time. After that, continue to take the pills at the usual time. In addition, for the next 7 days, you must use a barrier method of contraception, such as a condom. If sexual intercourse took place in the previous 7 days, the probability of pregnancy should be taken into account. The more pills missed and the closer the break in taking the drug, the higher the likelihood of pregnancy.
2nd week
You should take the last missed tablet as soon as possible, even if you have to take 2 tablets at the same time. After that, continue to take the pills at the usual time. Provided that the pills are taken correctly for 7 days before the first pass, there is no need to use additional contraceptives. In another case, or if more than 1 tablet is missed, it is recommended to additionally use a barrier method of contraception for 7 days.
3rd week
The risk of a decrease in reliability increases as a break in taking pills approaches. However, if the regimen of pills is followed, a decrease in contraceptive protection can be avoided. If one of the following options is followed, then there will be no need to use additional contraceptives, provided that the pills are taken correctly for 7 days before the pass. If this is not the case, the first of the following options should be followed and additional methods of contraception should be used for the next 7 days.

You should take the last missed tablet as soon as possible, even if you have to take 2 tablets at the same time. After that, continue to take the pills at the usual time. Dragees from the next package must be taken immediately after the end of the previous one, that is, there should be no breaks between packages. It is unlikely that menstrual-like bleeding will begin by the end of the second pack, although spotting or breakthrough bleeding is possible while taking the dragee.
You may also be advised to stop taking the pills from the current package. In this case, a break in taking the drug should be up to 7 days, including the days of skipping dragees; reception of a dragee needs to be begun from the following packing.
If the pills are missed and the patient does not have menstrual bleeding during the first usual break in taking the pills, the possibility of pregnancy should be excluded.
Recommendations for disorders of the gastrointestinal tract
In severe violations of the gastrointestinal tract, incomplete absorption of the drug is possible; in this case, additional contraception should be used.
If vomiting occurs within 3-4 hours after taking the pills, it is advisable to use the recommendations regarding skipping the pills. If a woman does not want to change her usual dosage regimen, she needs to take additional tablet(s) from another package.
How to change the time of your period or how to delay your period
To delay the onset of menstruation, you should continue to take Diane-35 pills from a new package and do not take a break in taking the drug. If desired, the reception period can be extended until the end of the second package. However, breakthrough bleeding or spotting cannot be ruled out. The usual intake of the drug is restored after a 7-day break in taking the dragee.
To shift the time of the onset of menstruation to another day of the week, it is recommended to shorten the break in taking pills by the desired number of days. It should be noted that the shorter the break, the more often the absence of menstrual-like bleeding and breakthrough bleeding or spotting during the reception of the dragee from the second package (as in the case of a delay in the onset of menstruation).

Contraindications to the use of Diane-35

COC should not be used in the presence of at least one of the following conditions or diseases. If any of these conditions or diseases occur for the first time during the use of COCs, the drug should be stopped immediately.
Venous or arterial thrombotic/thromboembolic events (e.g. deep vein thrombosis, pulmonary embolism, myocardial infarction) or cerebrovascular disorders at present or in history.
The presence or history of prodromal symptoms of thrombosis (transient cerebrovascular accident, angina pectoris).
Migraine with a history of focal neurological symptoms.
Diabetes mellitus with vascular damage.
The presence of severe or multiple risk factors for venous or arterial thrombosis may also be a contraindication (see).
Current pancreatitis or history of pancreatitis if associated with severe hypertriglyceridemia.
Current or history of severe liver disease until liver function tests return to normal.
Liver tumors (benign or malignant) - diagnosed or present in history.
Diagnosed or suspected malignant tumors (for example, genital or mammary glands), dependent on sex hormones.
Vaginal bleeding of unknown etiology.
Diagnosed or suspected pregnancy.
Hypersensitivity to the active substances or to any of the components of the drug.
The drug Diane-35 is not prescribed to men.

Side effects of Diane-35

Side effects have been reported with the use of Diane-35, but their relationship with the use of the drug has not been confirmed or refuted:

Organs and systems	Frequent (≥1/100)	Uncommon (≥1/1000 and ≤/100)	Single (≤1/1000)
			contact lens intolerance
	Nausea, abdominal pain	Vomiting, diarrhea
The immune system			Hypersensitivity
Study	Weight gain		Weight loss
Metabolism and malnutrition		Fluid retention

Mental disorders	Depression, mood disorder	Decreased libido	Increased libido
Reproductive system and mammary glands			Changes in vaginal secretion, the appearance of secretion from the mammary glands
Skin and subcutaneous tissues		Skin rashes, urticaria	Erythema nodosum, exudative erythema multiforme

Special instructions for the use of the drug Diane-35

Clinical data regarding estrogen/progestogen combinations such as Diane-35 are based on experience with COCs. With this in mind, the following cautions regarding the use of COCs also apply to this drug.
In the presence of any of the following conditions / risk factors, it is necessary to evaluate the benefits of using Diane-35 and the possible risk, taking into account the individual characteristics of each patient, and discuss this with her before she decides to take the drug. If any of the conditions or risk factors listed below worsen, worsen, or occur for the first time, it is recommended to consult a doctor. The doctor must decide whether to stop the use of Diane-35.
Circulatory disorders
Based on the results of epidemiological studies, there is an association between COC use and an increased risk of venous and arterial thrombotic and thromboembolic diseases such as myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism. These conditions rarely occur.
Venous thromboembolism (VTE), manifested as venous thrombosis and/or pulmonary embolism, may occur with any COC. The risk of venous thromboembolism is highest during the 1st year of COC use. The incidence of VTE in patients taking oral contraceptives with a low dose of estrogen (≤0.05 mg ethinylestradiol) is up to 4 cases per 10,000 women/year compared with 0.5-3 cases per 10,000 women/year in women not using oral contraceptives. The frequency of VTE associated with pregnancy is 6 cases per 10,000 women/year.
Thrombosis of other blood vessels, such as arteries and veins of the liver, kidneys, mesenteric vessels, vessels of the brain or retina, has been extremely rarely reported in women using COCs. There is no consensus regarding the relationship of these complications with the use of COCs.
Symptoms of venous or arterial thrombotic / thromboembolic events or stroke can be: unilateral pain in the lower extremities or their swelling; sudden severe chest pain radiating to the left arm; sudden shortness of breath; sudden onset cough; any unusual, severe, prolonged headache; sudden decrease or complete loss of vision; diplopia; speech disorder or aphasia; vertigo; collapse with or without partial epileptic seizure; weakness or very pronounced sudden numbness of one side or one part of the body; dysmotility; symptoms of an acute abdomen.
Factors that increase the risk of venous or arterial thrombotic/thromboembolic events or stroke:

age;
tobacco smoking (in combination with heavy smoking and with age, the risk increases, especially in women over the age of 35);
family history (for example, cases of venous or arterial thromboembolism in siblings or parents at a relatively early age). If a hereditary predisposition is suspected, before a decision is made on the use of any PDA, the patient should be referred for a consultation with an appropriate specialist;
obesity (body mass index - more than 30 kg / m2);
dyslipoproteinemia;
AG (arterial hypertension);
pathology of the heart valves;
atrial fibrillation;
prolonged immobilization, radical surgery, any surgery on the lower extremities, significant trauma. In these cases, it is recommended to stop the use of COCs (for elective operations at least 4 weeks before they are carried out) and not to restore it earlier than 2 weeks after complete remobilization.

There is no consensus on the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism.
It is necessary to take into account the increased risk of thromboembolism in the postpartum period.
Other diseases that may be associated with serious circulatory disorders include: diabetes mellitus; systemic lupus erythematosus; hemolytic uremic syndrome; chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.
An increase in the incidence of migraine or its exacerbation during the period of COC use (which may be a precursor to cerebrovascular accident) requires an urgent cessation of COC use.
Biochemical parameters characteristic of a hereditary or acquired tendency to venous or arterial thrombosis include: resistance to activated protein C (APC), hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies).
When analyzing the risk/benefit ratio, the physician should take into account that adequate treatment for the conditions mentioned above can reduce the risk of thrombosis associated with them, as well as the fact that the risk of pregnancy-associated thrombosis is higher than with COCs. at low doses (≤0.05 mg ethinyl estradiol).
Tumors
The most important risk factor for developing cervical cancer is the persistence of papillomavirus. The results of some epidemiological studies suggest an additional increase in this risk with long-term use of COCs, however, this statement is controversial, since it is not completely clear how the results of studies take into account concomitant risk factors, such as taking a cervical smear and sexual behavior, including the use of barrier methods of contraception .
The results of a meta-analysis based on data obtained in 54 epidemiological studies indicate a slight increase in the relative risk (RR = 1.24) of developing breast cancer in women using COCs. This increased risk gradually disappears within 10 years after the end of COC use. Because breast cancer is rare in women under 40 years of age, the increase in breast cancer diagnoses in current or recent COC users is small relative to the overall risk of developing breast cancer. The results of these studies do not provide evidence for the existence of a causal relationship. The increased risk may be due to both the earlier diagnosis of breast cancer in women using COCs, the biological effect of COCs, or a combination of both factors. A trend has been noted that breast cancer detected in women who have ever taken COCs is clinically less pronounced than in those who have never taken COCs.
In isolated cases, benign, and even less often, malignant liver tumors were noted in women using COCs, which sometimes led to life-threatening intra-abdominal bleeding. If there are complaints of severe pain in the epigastric region, liver enlargement or signs of intra-abdominal bleeding in differential diagnosis, the possibility of a liver tumor in women taking COCs should be considered.
Other states
Women with hypertriglyceridemia or a family history of this disorder are at risk of developing pancreatitis when taking COCs.
Although a slight increase in blood pressure has been reported in many women taking COCs, a clinically significant increase in blood pressure is a single occurrence. However, if prolonged clinically significant hypertension (arterial hypertension) occurs while taking a COC, then it is sometimes advisable to stop the COC and direct treatment to hypertension (arterial hypertension).
The occurrence or exacerbation of the following diseases during pregnancy and with the use of COCs has been reported, but their relationship with the use of COCs is not conclusively established: jaundice and / or itching associated with cholestasis, formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic-uremic syndrome, Sydenham's chorea, herpes of pregnancy, hearing loss associated with otosclerosis.
In acute or chronic liver dysfunction, it may be necessary to stop taking COCs until liver function tests return to normal. In case of recurrence of cholestatic jaundice, which first occurred during pregnancy or previous use of sex hormones, COC should be discontinued.
Although COCs may affect peripheral insulin resistance and glucose tolerance, there is no evidence of the need to change the therapeutic regimen in women with diabetes taking low doses of COCs (containing ≤0.05 mg of ethinyl estradiol). However, diabetic women should be closely monitored while taking COCs.
Crohn's disease and ulcerative colitis may be associated with COC use.
Occasionally, chloasma may occur, especially in women with a history of chloasma of pregnancy. Women who are prone to chloasma should avoid exposure to direct sunlight or ultraviolet radiation while taking COCs.
medical examination
Before starting or restoring Diane-35 intake, a complete medical examination should be carried out and the patient's history should be studied in detail, taking into account contraindications (see) and warnings (see). When using COCs, it is recommended to conduct periodic examinations, which is very important, since contraindications (for example, transient circulatory disorders, etc.) or risk factors (for example, a family history of venous or arterial thrombosis) may first occur while taking the drug.
The frequency and nature of these examinations should be based on existing norms of medical practice, taking into account the individual characteristics of each woman, however, special attention is paid to the examination of the pelvic organs, including the standard analysis of the cytology of the cervix, abdominal organs, mammary glands, determination of blood pressure.
It is necessary to warn a woman that Diane-35, like other oral contraceptives, does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Reduced efficiency
The effectiveness of Diane-35 may decrease if a tablet is missed, gastrointestinal dysfunction or the use of other drugs.
Cycle control
When taking oral contraceptives, intermenstrual bleeding (spotting or breakthrough bleeding) may occur, especially during the first few months of treatment. With this in mind, the examination with the appearance of any intermenstrual bleeding should be carried out only after a period of adaptation of the body to the drug, which is approximately 3 cycles.
If cycle disturbances continue or recur after several normal cycles, non-hormonal causes of bleeding should be considered and appropriate investigations carried out to exclude the presence of a tumor or pregnancy. Diagnostic measures can include curettage.
In some women, menstrual-like bleeding may not occur during a break in taking the drug. When taking COCs as directed, pregnancy is unlikely. However, if the contraceptive is taken irregularly or if menstrual bleeding is absent for 2 cycles, pregnancy must be excluded before continuing to take the COC.
During pregnancy and breastfeeding
The drug is contraindicated for use during pregnancy. In the event of pregnancy during the use of Diane-35, the drug should be discontinued. However, according to the results of embryotoxicity studies using a combination of two active components of the drug, no confirmation of the teratogenic effect of the drug during organogenesis was found. Although the use of cyproterone acetate in high doses during the hormone-sensitive phase of differentiation of the genital organs causes the appearance of female sexual characteristics in male fetuses, during the observation of newborn boys whose mothers took cyproterone acetate during pregnancy, no female sexual characteristics were detected.
The use of Diane-35 is contraindicated during lactation. Cyproterone acetate passes into breast milk. About 0.25% of the dose of cyproterone acetate taken by the mother enters the child's body with milk, which corresponds to 1 μg / kg of body weight and 0.2% of the daily dose of ethinyl estradiol.
Influence on the ability to drive vehicles and work with mechanisms
No influence noted.

Diane-35 drug interactions

The interaction of drugs containing a combination of estrogen / progestogen (such as Diane-35) and other drugs can lead to breakthrough bleeding and / or loss of contraceptive effectiveness. The following interactions are reported in the literature.
Hepatic metabolism: interactions with drugs that induce microsomal enzymes may occur, which may cause increased clearance of sex hormones (eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, and drugs containing St. John's wort) .
Interaction with enterohepatic circulation: the results of some clinical studies suggest that the enterohepatic circulation of estrogens may be reduced when taking certain antibiotics that reduce the concentration of ethinylestradiol (for example, antibiotics of the penicillin and tetracycline series).
When treated with any of the above drugs, a woman should temporarily use a barrier method in addition to taking Diane-35 or choose another method of contraception. When treating with drugs that induce microsomal enzymes, the barrier method should be used throughout the entire period of treatment with the corresponding drug and for another 28 days after stopping its use. When treated with antibiotics (excluding rifampicin and griseofulvin), the barrier method should be used for another 7 days after antibiotic withdrawal. If the barrier method is still being used, and the pills in the Diane-35 package have already run out, taking the pills from the next package should be started without the usual break.
Oral contraceptives containing estrogen/progestogen (such as Diane-35) may interfere with the metabolism of other drugs. Therefore, the concentrations of active substances in blood plasma and tissues (for example, cyclosporine) may change.
Note. To establish the potential for interaction with drugs that are prescribed simultaneously with Diane-35, it is recommended that you read the instructions for the medical use of these drugs.
Impact on laboratory results
Taking contraceptives such as Diane-35 may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, plasma levels of proteins (carriers) such as sex-binding globulin hormones and lipid/lipoprotein fractions, parameters of carbohydrate metabolism, as well as parameters of coagulation and fibrinolysis.

Diane-35 overdose, symptoms and treatment

No serious adverse effects due to overdose have been reported. Overdose symptoms are possible: nausea, vomiting, and in young girls - slight bleeding from the vagina. There are no specific antidotes treatment should be symptomatic.

Storage conditions for Diane-35