I take dimia pills, no periods. Contraceptive pills and menstruation: important nuances

Good afternoon Maria!

While taking oral hormonal contraceptives Indeed, the menstrual cycle returns to normal. Menstrual flow begins a few days after taking the last active tablet in the blister. Women with disabilities menstrual cycle, of course, they will appreciate this effect of contraceptives, because it is very convenient to know exactly when your period will come, not to suffer from prolonged and / or heavy bleeding and severe pain, etc. All this is painfully familiar to a good half of the female population of the planet. Of course, the onset of menstruation "like clockwork" is very relaxing, and any failure in the usual schedule can cause panic. And perhaps not in vain.

Pregnancy or failure?

As you know, there is not a single method of contraception in the world that would provide 100% protection against pregnancy, except, perhaps, complete sexual abstinence. Oral contraceptives, according to manufacturers, provide protection against unwanted pregnancy in 97 - 99% of cases. This is a high level of protection, and with the correct and regular intake of pills, indeed, pregnancy is practically impossible. Naturally, taking the pill late or skipping it, as well as a number of diseases, reduce the contraceptive effect of the drugs. A variety of food poisoning (vomiting, diarrhea) can also negatively affect the effect of the contraceptive.

However, a delay in menstruation can be caused by more than just pregnancy. The hormonal background of a woman is very sensitive to various kinds of internal and external influences. So, a delay in menstruation, even while taking oral contraceptives, can occur due to weight fluctuations when dieting, severe stress, climate change, etc. These factors can delay the onset of menstrual bleeding by a day or two. You will be surprised, but some foods can also affect a woman's menstrual cycle. So, the daily use of lemons can delay menstruation by 2 to 7 days, and a decoction of tansy or nettle, on the contrary, accelerate the onset of menstruation.

However, if you have had unprotected sex this cycle, the chance of pregnancy still prevails over all other causes of missed periods. Naturally, if you have conceived a child, you cannot start the next pack of pills. Therefore, you need to establish or disprove the fact of pregnancy as soon as possible.

Methods for determining pregnancy

The easiest and most affordable method for determining pregnancy at home is special test strips. Buy 2 - 3 test strips from the pharmacy different manufacturers(they will be needed in case of a controversial result) and test. To do this, collect the morning portion of urine (it is the most concentrated) and lower the test strip into it. After a few minutes, you can evaluate the result. One line on the test will mean no pregnancy, two strips - the presence of pregnancy.

An alternative to testing is a blood test to determine the level of human chorionic gonadotropin - the so-called "pregnancy hormone". The analysis can be taken now in any medical laboratory, and the result can be ready on the same day.

Sincerely, Xenia.

Dimia is one of the latest contraceptives designed for women with signs of hyperandrogenemia. This is an analogue of Yarina with a reduced concentration of estrogens in each tablet. Dimia is a monophasic oral contraceptive, which means that the hormone content in each serving is the same, with the exception of pacifiers (placebo).

But the functioning of the female reproductive system occurs according to cyclic modes. That is why cycle disorders often occur when using tablets. What to do if there is no menstruation while taking Dimia, when should you consult a doctor?

Read in this article

Reasons for the absence of menstruation

Ideally, when taking birth control pills, a girl should not have any problems or questions. But in practice, one has to face the opposite: various cycle failures are often noted, ranging from daubing to the absence of menstruation for several months.

In the first month of admission

Dimia, like most popular birth control pills, is a monophasic contraceptive. This has its pros and cons. The advantages include the fact that, due to the low concentration of hormones in each tablet, the frequency of development side effects below. But the body of a woman from the moment of puberty functions cyclically, it is thanks to these processes that the growth and maturation of the follicles, the release of the egg. At every minute, the level of hormones fluctuates in one direction or another. Therefore, it is so difficult to treat any violations of their production.

Taking Dimia, a woman's body enters new conditions when the same dose of the hormone is received daily. This inhibits the ovaries' own function. And it takes some time to get used to the new regime. For some, it proceeds without a trace, while others note that when taking Dimia, there are no periods.

A similar picture can develop in two cases:

While taking contraceptives, the girl had no complaints. But at the appointed time, menstruation did not come. You should not worry if the schedule for using the medicine has not been violated, such a reaction of the body is allowed. You should take a break of four days, as expected, and then start the next package. As a rule, next month everything is getting better.
It happens that against the background of taking hormonal contraceptives, a woman experiences periodic ones throughout the entire cycle. Sometimes they are quite plentiful and bring a lot of anxiety and discomfort. In this case, after taking Dimia, scanty periods occur at the right time, or they do not exist at all. The fact is that the endometrium does not have time to grow due to constant daubing. In most cases, everything returns to normal in the second month of admission. If it continues, you should definitely consult a doctor.

No dummy pills taken

Often girls want to change the length of their menstrual cycle. This can be done if you do not take all the placebo pills or skip them altogether. In this case, there will also be no periods until the placebo is taken.

Outta loop

You should be aware that menstrual-like bleeding occurs only on discontinuation of the drug. But some girls noticed that against the background of using Dimia, what ended all active pills. This is allowed.

It also happens that women, for some reason, do not finish drinking part of the package, after which they begin to daub. The beginning of such secretions should be considered the first day of a new cycle. Without knowing this, the girls are waiting for the next menstruation according to the "old" schedule, and they worry when they are not.

After complete discontinuation of the drug

Finishing the pack and deciding not to drink anymore hormonal pills, many people think that the cycle will be kept regular. However, this is not always the case. Own hormonal background recovers within 2 - 4 months, sometimes up to six months. Various failures may occur during this time.

Often after canceling Dimia, there is no menstruation for several months. This happens in the following cases:

If, before the appointment of hormonal drugs, a woman had irregular menstruation. After all, taking pills, the effect is fixed only for the period of treatment, a maximum of a month or two after the drug is discontinued. Then your own hormonal background is restored with the same violations that were before.
If a woman has been taking birth control for several years. The longer this method of contraception is used, the more difficult it is for the ovaries to restore their function. The same applies to age: in young girls, the cycle normalizes faster. You can meet with the fact that there is no menstruation for 3 - 6 months, sometimes longer. In such situations, it is always necessary to contact a gynecologist and be observed by him until menstruation is restored. Sometimes you have to prescribe additional treatment.

No periods while taking placebo

Some girls believe that as soon as the active pills in the package are finished and the placebo is started, they should start their period. And when they are gone for a day or two or even three, they begin to worry. It is assumed that menstruation will go within a week after the last active tablet. In this case, you should not worry, but after taking a placebo, you should immediately move on to a new package. Every girl should know the main situations while taking Dimia, when menstruation should begin normally. This way you can avoid unnecessary worries.

Ovarian exhaustion

Sometimes, against the background of taking hormonal drugs, there is a complete suppression of the own function of the ovaries, their depletion is noted. The risk of this increases with the following points:

with prolonged continuous use of hormonal pills;
if the woman is over 35 years old;
in the case when operations on the ovaries were previously performed;
if it is a multiparous woman.

With these risk factors, special attention should be paid to the restoration of menstruation. And if this does not happen within two months after discontinuation of the drug, you should consult a doctor as soon as possible.

Pregnancy

Hormonal contraceptives are one of the most effective methods of contraception. However, to achieve this effect, it is necessary to strictly follow the rules for taking pills. If you miss even one, the likelihood of an unplanned conception increases. Therefore, in all situations when, while taking oral contraceptives, there are no periods on time, pregnancy should be excluded. This can be done using a conventional urine test. But better and more reliable - which shows a valid 100% result from the 10th day after fertilization, if it occurred.

In the case when, against the background of use Dimia menstruation do not stop, it is also first necessary to exclude pregnancy, especially if the schedule for taking pills is violated.

Watch the video about hormonal contraception:

Why does bleeding start?

Menstruation with Dimia tablets in most cases is regular, mild, almost painless. They can even acquire a smearing character. But it happens that there are breakthrough bleeding or very. What is it connected with? There are several reasons:

After the abolition of Dimia, strong periods can be in the second or third month, when the body is fully restored from synthetic hormones. This is especially observed if, before the pills, a woman was disturbed by heavy menstruation.
If a girl skips dummy pills for several cycles in a row to remove critical days, then at any time she may experience breakthrough bleeding. This is due to the fact that the endometrium constantly grows under the influence of estrogens and progestins, but is not rejected - for this it is necessary to sharply reduce their level, for example, stop drinking or replace it with a placebo. In the end, it is so wide that it is removed on its own, this is manifested by profuse bleeding. Moreover, even a single pass of a placebo increases the risk of spotting and even heavy discharge in addition to critical days.
In the case when Dimia is prescribed not according to indications, and the woman may lack a dose of the hormone. In this case, the bleeding will be non-critical.
If a girl misses more than two tablets, then the risk of developing heavy discharge from her over the next five days increases dramatically. This is menstrual bleeding. In such a situation, it is better to stop taking the old pack and start the next one after a four-day break.
In the first month of admission, if the use of tablets is started after childbirth or termination of pregnancy at any time, breakthrough bleeding also occurs. As a rule, all violations disappear in the second or third month of admission.

What to do

What to do if the period after taking Dimia did not come on time? The algorithm of actions is as follows:

For reliability and reliability, you should first do a urine pregnancy test. But it is even better to take a blood test for hCG, it shows a reliable result from the 10th day after fertilization, if it has occurred. If all signs point to pregnancy, you should immediately make an appointment with a doctor.
If there is no menstruation for only a couple of days after the active pills, you should not worry, most likely they will go in a few days. Up to a week is allowed.
In the event that menstruation did not come in some month, especially at the beginning of the intake, and there are no signs of pregnancy, this is most likely an adaptation of the body to synthetic sex hormones. It is necessary to continue taking strictly according to the instructions. The absence of spotting for more than 2-3 cycles is a significant reason to see a doctor. Most likely, hormonal drugs will have to be canceled for a while to restore ovarian function.
If you didn't get your period when you skipped the placebo pills, that's how it should be. But when, after the complete cancellation of Dimia, the delay in menstruation is more than three months, especially in women after 35 years, you should immediately consult a doctor. There is a possibility that the ovarian reserve has been depleted. In such situations, it is sometimes necessary to take hormone replacement therapy until the age of menopause.

Dimia is one of the most popular and modern contraceptive drugs, an analogue of Yarina. With its help, it is possible to carry out not only protection from pregnancy, but also treatment - it has an antiandrogenic and mineralocorticoid effect. Against the background of taking the drug, various menstrual irregularities may occur, especially if there were errors in the application.

It happens that after Dimia there are no periods for more than one cycle, or there are various types of spotting, and sometimes abundant bloody issues. When any disorders appear, only a specialist can establish the true cause and prescribe an effective and safe treatment for a woman.

pharmachologic effect

Dimia ® is a combined monophasic oral contraceptive containing drospirenone and ethinyl estradiol. According to its pharmacological profile, drospirenone is close to natural progesterone: it does not have estrogenic, glucocorticoid and antiglucocorticoid activity and is characterized by a pronounced antiandrogenic and moderate antimineralocorticoid effect. The contraceptive effect is based on the interaction of various factors, the most important of which are the inhibition of ovulation, an increase in the viscosity of the cervical secretion and changes in the endometrium. Pearl index, an indicator that reflects the frequency of pregnancy in 100 women reproductive age during the year of contraceptive use, is less than 1.

Pharmacokinetics

Drospirenone

Suction

When taken orally, drospirenone is rapidly and almost completely absorbed from the gastrointestinal tract. C max drospirenone in serum is about 38 ng / ml and is reached approximately 1-2 hours after a single dose.

Bioavailability - 76-85%. Simultaneous administration with food does not affect the bioavailability of drospirenone.

Distribution

After oral administration, plasma concentrations of drospirenone decreased with a final half-life of 31 hours. Drospirenone binds to serum albumin and does not bind to sex hormone-binding globulin (SHBG) or corticosteroid-binding globulin (transcortin). Only 3-5% of the total serum concentration of drospirenone exists as free steroids. The increase in SHBG induced by ethinylestradiol does not affect the binding of drospirenone to serum proteins. The average apparent V d of drospirenone is 3.7 ± 1.2 l / kg.

During the cycle of treatment C ss max drospirenone in plasma is about 70 ng / ml, it is achieved after 8 days of treatment. Serum concentrations of drospirenone increase approximately 3-fold due to the ratio of the final T 1/2 and dosing interval.

Metabolism

Drospirenone is extensively metabolized after oral administration. The main metabolites in blood plasma are the acidic forms of drospirenone, formed during the opening of the lactone ring, and 4,5-dihydro-drospirenone-3-sulfate, both are formed without the participation of the P450 system. Drospirenone is metabolized to a small extent by CYP3A4 and is able to inhibit this enzyme, as well as CYP1A1, CYP2C9 and CYP2C19 in vitro.

breeding

Renal clearance of drospirenone metabolites in serum is 1.5±0.2 ml/min/kg. Drospirenone is excreted only in trace amounts unchanged. Drospirenone metabolites are excreted by the kidneys and through the intestines with an excretion ratio of about 1.2:1.4. T1 / 2 metabolites by the kidneys and through the intestines is about 40 hours.

Ethinylestradiol

Suction

When taken orally, ethinylestradiol is absorbed rapidly and completely. C max in serum is about 33 pg / ml and is achieved within 1-2 hours after a single oral administration. Absolute bioavailability as a result of first-pass conjugation and first-pass metabolism is approximately 60%. Simultaneous food intake reduced the bioavailability of ethinylestradiol in approximately 25% of the examined patients; there were no other changes.

Distribution

Serum concentrations of ethinylestradiol decreased biphasically, in the final distribution phase T 1/2 is approximately 24 hours. Ethinylestradiol binds well, but nonspecifically, to serum albumin (approximately 98.5%) and induces an increase in SHBG serum concentrations. The apparent V d is about 5 l / kg.

C ss is achieved in the second half of the treatment cycle, and the serum concentration of ethinyl estradiol increases by 2-2.3 times.

Metabolism

Ethinylestradiol is a substrate for presystemic conjugation in the mucosa of the small intestine and in the liver. Ethinylestradiol is primarily metabolized by aromatic hydroxylation, producing a wide range of hydroxylated and methylated metabolites, which are present both in free form and as conjugates with glucuronic acid. The renal clearance of ethinylestradiol metabolites is approximately 5 ml/min/kg.

breeding

Unchanged ethinylestradiol is practically not excreted from the body. Metabolites of ethinylestradiol are excreted by the kidneys and through the intestines in a ratio of 4:6. T 1/2 metabolites is about 24 hours.

Pharmacokinetics in special clinical situations

In case of impaired renal function

C ss drospirenone in plasma in women with mild renal insufficiency (CC 50-80 ml / min) was comparable to the corresponding indicators in women with normal renal function (CC > 80 ml / min). In women with moderate renal insufficiency (CC from 30 ml / min to 50 ml / min), the plasma concentration of drospirenone was on average 37% higher than in women with normal renal function. Drospirenone was well tolerated in all groups. Drospirenone did not have a clinically significant effect on the content of potassium in the blood serum. Pharmacokinetics in severe renal failure has not been studied.

In violation of liver function

Drospirenone is well tolerated by patients with mild to moderate hepatic impairment (Child-Pugh class B). Pharmacokinetics in severe hepatic impairment has not been studied.

Indications

Oral contraception.

Dosing regimen

How to start taking Dimia ®

If hormonal contraceptives have not been used in the last month, Dimia ® is started on the first day of the menstrual cycle (i.e. on the first day of menstrual bleeding). It is also possible to start taking it on the 2nd-5th day of the menstrual cycle, in which case additional use of a barrier method of contraception is necessary during the first 7 days of taking the tablets from the first package.

Switching from other combined contraceptives (combined oral contraceptive pills, vaginal ring, or transdermal patch)

Dimia® should be started the next day after taking the last inactive tablet (for preparations containing 28 tablets) or the day after taking the last active tablet from the previous package (possibly the next day after the end of the usual 7-day break) - for preparations containing 21 tablets per pack. In the case of a woman using a vaginal ring or transdermal patch, it is preferable to start taking Dimia ® on the day they are removed or, at the latest, on the day when a new ring or patch is planned to be inserted.

Switching from progestogen-only contraceptives (mini-pills, injections, implants) or from an intrauterine system (IUD) that releases progestogens.

A woman can switch from taking a mini-pill to taking Dimia ® on any day (from an implant or from an IUD on the day they are removed, from injectable forms of drugs on the day the next injection was due), but in all cases it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills.

After an abortion in the first trimester of pregnancy

Taking the drug Dimia ® can be started on the doctor's prescription on the day of termination of pregnancy. In this case, the woman does not need to take additional contraceptive measures.

After childbirth or abortion in the second trimester of pregnancy.

A woman is recommended to start taking the drug on the 21-28th day after childbirth (provided that she is not breastfeeding) or abortion in the second trimester of pregnancy. If the reception is started later, the woman should use an additional barrier method of contraception during the first 7 days after starting Dimia ®. With the resumption of sexual activity (before taking the drug Dimia ®), pregnancy should be excluded.

Taking missed pills

Missing a placebo tablet from the last (4th) row of the blister can be ignored. However, they should be discarded to avoid inadvertently prolonging the placebo phase. The indications below apply only to missed tablets containing the active ingredients.

If the delay in taking the pill was less than 12 hours, contraceptive protection is not reduced. The woman should take the missed pill as soon as possible (as soon as she remembers) and the next pill at the usual time.

If late exceeds 12 hours, contraceptive protection may be reduced. In this case, you can be guided by two basic rules:

1. Taking pills should never be interrupted for more than 7 days;

2. To achieve adequate suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous tablet intake are required.

Accordingly, women can be given the following recommendations:

Days 1-7

Days 8-14

Days 15-24

1. A woman should take the last missed tablet as soon as she remembers, even if it means taking two tablets at the same time. Then she should take the tablets at the usual time until the active tablets run out. 4 placebo tablets from the last row should not be taken, you must immediately start taking the tablets from the next blister pack. Most likely, there will be no "withdrawal" bleeding until the end of the second pack, but there may be spotting or "withdrawal" bleeding on the days of taking the drug from the second pack.

If a woman misses a pill and does not subsequently experience "withdrawal" bleeding in the placebo pill phase, the possibility of pregnancy should be considered.

The use of the drug in gastrointestinal upset

In case of severe gastrointestinal disturbances (eg, vomiting or diarrhea), the absorption of the drug will be incomplete and additional contraceptive measures will be required. If vomiting occurs within 3-4 hours after taking the active tablet, a new (replacement) tablet should be taken as soon as possible. If possible, the next tablet should be taken within 12 hours of the usual tablet-taking time. If more than 12 hours have passed, it is recommended to proceed according to the instructions for skipping tablets. If a woman does not want to change her usual pill regimen, she should take an additional pill from another pack.

Postponement of menstrual bleeding "withdrawal"

To delay bleeding, the woman should skip taking the placebo tablets from the started package and start taking the drospirenone + ethinyl estradiol tablets from the new package. The delay can be extended until the active tablets in the second pack run out. During the delay, a woman may experience acyclic profuse or spotting bleeding from the vagina. Regular intake of Dimia ® is resumed after the placebo phase.

To shift bleeding to another day of the week, it is recommended to shorten the upcoming phase of taking placebo tablets by the desired number of days. When the cycle is shortened, it is more likely that a woman will not have menstrual-like "withdrawal" bleeding, but will have acyclic profuse or spotting bleeding from the vagina when taking the next pack (same as with lengthening the cycle).

Side effect

The following adverse events have been reported while taking Dimia ®:

Organ system class	Frequent (≥1/100 to	Less frequent (≥1/1000 to	Rare (≥ 1/10,000 to
Infections and infestations			candidiasis, incl. oral cavity
From the blood and lymphatic system			anemia, thrombocytopenia
From the side of the immune system			allergic reactions
From the side of metabolism and nutrition		weight gain	increased appetite, anorexia, hyperkalemia, hyponatremia, weight loss
From the side of the psyche	emotional lability	depression, decreased libido, nervousness, drowsiness	anorgasmia, insomnia
From the side of the nervous system	headache	dizziness, paresthesia	vertigo, tremor
From the organ of vision			conjunctivitis, dryness of the mucous membrane of the eye, visual impairment
From the side of the cardiovascular system		migraine, phlebeurysm, increase in blood pressure	tachycardia, phlebitis, vascular damage, nose bleed, fainting
From the digestive system	nausea, abdominal pain	vomit, diarrhea
From the side of the liver and biliary tract			pain in the gallbladder cholecystitis
From the skin and subcutaneous tissue		rash (including acne), itching	chloasma, eczema, alopecia, acne dermatitis, dry skin, erythema nodosum, hypertrichosis, skin lesions, skin striae, contact dermatitis, photodermatitis, skin nodules
From the musculoskeletal system		backache, limb pain, muscle cramps
From the reproductive system and mammary glands	chest pain, no withdrawal bleeding	vaginal candidiasis, pelvic pain, breast enlargement, fibrocystic breast, vaginal discharge, flushes of blood vaginitis, acyclic spotting, painful menstrual bleeding profuse bleeding "withdrawal", scanty menstrual bleeding, dryness of the vaginal mucosa, change in the cytological picture in a Pap smear	painful intercourse, vulvovaginitis, postcoital bleeding, breast cyst, breast hyperplasia, mammary cancer, cervical polyps, endometrial atrophy, ovarian cyst, uterine enlargement
Are common disorders		asthenia, increased sweating, edema (generalized edema, peripheral edema, facial edema)	feeling of discomfort

Women using combined oral contraceptives (COCs) have experienced the following serious adverse events:

Venous thromboembolic diseases;

Arterial thromboembolic diseases;

Tumors of the liver;

Occurrence or exacerbation of conditions for which the association with COC use has not been proven: Crohn's disease, ulcerative colitis, epilepsy, migraine, endometriosis, uterine fibroids, porphyria, systemic lupus erythematosus, herpes during a previous pregnancy, rheumatic chorea, hemolytic uremic syndrome, cholestatic jaundice;

Chloasma;

Acute or chronic liver disease may necessitate discontinuation of COCs until liver function tests return to normal;

In women with hereditary angioedema, exogenous estrogens may induce or exacerbate the symptoms of angioedema.

Contraindications for use

Dimia ® , like other combined oral contraceptives, is contraindicated in any of the following conditions:

Thrombosis (arterial and venous) and thromboembolism at present or in history (including thrombosis, deep vein thrombophlebitis; pulmonary embolism, myocardial infarction, stroke, cerebrovascular disorders);

Conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history;

Multiple or pronounced risk factors for venous or arterial thrombosis, incl. complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of the cerebral vessels or coronary arteries; uncontrolled arterial hypertension, major surgery with prolonged immobilization, smoking over the age of 35, obesity with a BMI >30 kg/m 2 ;

Hereditary or acquired predisposition to venous or arterial thrombosis, for example, resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antibodies against phospholipids (presence of antibodies to phospholipids - antibodies to cardiolipin, lupus anticoagulant);

Pancreatitis with severe hypertriglyceridemia at present or in history;

Severe chronic or acute renal failure;

Liver tumor (benign or malignant) at present or in history;

Hormone-dependent malignant neoplasms of the genital organs or breast at present or in history;

Bleeding from the vagina of unknown origin;

Migraine with a history of focal neurological symptoms;

Lactase deficiency, lactose intolerance, glucose-galactose malabsorption, lapp lactase deficiency (lactase deficiency in some peoples of the North);

Pregnancy and suspicion of it;

lactation period;

Hypersensitivity to the drug or any of the components of the drug.

WITH caution

Risk factors for thrombosis and thromboembolism: smoking before the age of 35, obesity, dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated valvular heart disease, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the next of kin);

Diseases in which peripheral circulatory disorders can occur: diabetes mellitus without vascular complications, systemic lupus erythematosus (SLE), hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, phlebitis of superficial veins;

Hereditary angioedema;

Hypertriglyceridemia;

Severe liver disease (before normalization of liver function tests);

Diseases that first appeared or worsened during pregnancy or against the background of a previous intake of sex hormones (including jaundice and / or itching associated with cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, herpes during pregnancy in history, minor chorea (illness Sydenham), chloasma);

postpartum period.

Use during pregnancy and lactation

The drug Dimia ® is contraindicated in pregnancy.

If pregnancy occurs during the use of the drug Dimia ® , it should be stopped immediately. Extended epidemiological studies have found neither an increased risk of birth defects in children born to women who took COCs before pregnancy, nor a teratogenic effect of COCs when they were inadvertently taken during pregnancy.

According to preclinical studies, undesirable effects that affect the course of pregnancy and fetal development due to the hormonal action of the active components cannot be ruled out.

The drug Dimia ® can affect lactation: reduce the amount of milk and change its composition. Small amounts of contraceptive steroids and/or their metabolites may be excreted in milk during COC use. These amounts may affect the child. The use of Dimia ® during breastfeeding contraindicated.

Application for violations of liver function

Contraindicated:

Existing (or history of) severe liver disease, provided that liver function is not currently normal;

Liver tumor (benign or malignant) at present or in history.

Application for violations of kidney function

Contraindicated:

Severe chronic or acute renal failure

Use in children

The use of the drug before the establishment of menarche is not indicated.

special instructions

If there are any of the conditions/risk factors mentioned below, the benefits of taking COCs should be assessed individually for each woman and discussed with her before starting use. If an adverse event worsens or if any of these conditions or risk factors appear, the woman should contact her doctor. The doctor must decide whether to stop taking the COC.

Circulatory disorders

Taking any combined oral contraceptive increases the risk of venous thromboembolism (VTE). The increased risk of VTE is most pronounced in the first year of a woman's use of a combined oral contraceptive.

Epidemiological studies have shown that the incidence of VTE in women with no risk factors who took low doses of estrogen (
Data from a large, prospective, 3-arm study showed that the incidence of VTE in women with or without other risk factors for venous thromboembolism who used the combination of ethinylestradiol and drospirenone, 0.03 mg + 3 mg, coincided with the frequency of VTE in women who used levonorgestrel-containing oral contraceptives and other handhelds. The degree of risk of venous thromboembolism when taking Dimia ® has not yet been established.

Epidemiological studies have also found an association between COC use and an increased risk of arterial thromboembolism (myocardial infarction, transient ischemic disorders).

Very rarely, thrombosis of other blood vessels, such as veins and arteries of the liver, mesentery, kidneys, brain or retina, has occurred in women taking oral contraceptives. There is no consensus regarding the relationship of these phenomena with the use of hormonal contraceptives.

Symptoms of venous or arterial thrombotic / thromboembolic events or acute disorders of cerebral circulation:

Unusual unilateral pain and/or swelling lower extremities;

Sudden severe chest pain, whether or not it radiates left hand or not;

sudden shortness of breath;

Sudden onset of cough;

any unusual severe prolonged headache;

Sudden partial or complete loss of vision;

Diplopia;

Impaired speech or aphasia;

Vertigo;

Collapse with or without partial epileptic seizures;

Weakness or very noticeable numbness, suddenly affecting one side or one part of the body;

Movement disorders;

Symptom complex "acute" abdomen.

A woman should consult with a specialist before taking COCs.

Risk venous thromboembolic disorders

Increasing age;

Hereditary predisposition (venous thromboembolism ever happened to siblings or parents at a relatively early age);

Prolonged immobilization, advanced surgery, any surgical intervention on the lower extremities or major trauma. In such situations, it is recommended to stop taking the drug (in the case of a planned surgical intervention, at least four weeks in advance) and not resume until two weeks after the full restoration of mobility. If the drug has not been discontinued in advance, anticoagulant treatment should be considered;

Absence consensus about the possible role of varicose veins and superficial thrombophlebitis in the appearance or exacerbation of venous thrombosis.

Risk arterial thromboembolic complications or acute cerebrovascular accident when taking COC increases with:

Increasing age;

Smoking (women over 35 are strongly advised to stop smoking if they want to take COCs);

Dyslipoproteinemia;

arterial hypertension;

Migraines without focal neurological symptoms;

Obesity (BMI over 30 kg/m2);

Hereditary predisposition (arterial thromboembolism ever in siblings or parents at a relatively early age). If a hereditary predisposition is possible, a woman should consult a specialist before taking COCs;

Damage to the heart valves;

Atrial fibrillation.

The presence of one major risk factor for venous disease or multiple risk factors for arterial disease may also be a contraindication. Anticoagulant therapy should also be considered. Women taking COCs should be properly instructed to inform their physician if symptoms of thrombosis are suspected. If thrombosis is suspected or confirmed, COC use should be discontinued. It is necessary to start adequate alternative contraception due to the teratogenicity of anticoagulant therapy (indirect anticoagulants - coumarin derivatives).

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

Other medical conditions associated with adverse vascular events 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 frequency or severity of migraine while taking COCs may be an indication for the immediate abolition of combined oral contraceptives.

Tumors

The most significant risk factor for developing cervical cancer is infection with the human papillomavirus. Some epidemiological studies have reported an increased risk of developing cervical cancer in long-term use combined oral contraceptives, however, conflicting opinions remain as to the extent to which these findings are attributable to concomitant factors, such as testing for cervical cancer or the use of barrier methods of contraception.

A meta-analysis of 54 epidemiological studies found a slight increase in the relative risk (RR = 1.24) of breast cancer in women who currently take COCs. The risk gradually decreases over 10 years after stopping COCs. Because breast cancer rarely develops in women under 40 years of age, an increase in the number of diagnosed cases of breast cancer in COC users has little effect on the overall likelihood of breast cancer. These studies did not find sufficient evidence of a causal relationship. The increased risk may be due to earlier diagnosis of breast cancer in COC users, the biological effects of COCs, or a combination of both. Diagnosed breast cancer in women who have ever taken COCs was clinically less severe, due to the early diagnosis of the disease.

Rarely, benign liver tumors and, even more rarely, malignant liver tumors have occurred in women taking COCs. In some cases, these tumors were life-threatening due to 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.

Other states

The progestogen component of Dimia ® is an aldosterone antagonist that retains potassium in the body. In most cases, an increase in potassium content is not expected. However, in a clinical study in some patients with mild or moderate kidney disease who were taking potassium-sparing drugs, serum potassium levels increased slightly while taking drospirenone. Therefore, it is recommended to monitor serum potassium levels during the first cycle of treatment in patients with renal insufficiency in whom serum potassium levels were at the upper limit of normal before treatment and, especially, while taking potassium-sparing drugs.

In women with hypertriglyceridemia or a hereditary predisposition to it, the risk of pancreatitis may be increased when taking COCs.

Although a slight increase in blood pressure has been observed in many women taking COCs, a clinically significant increase was rare. Only in these rare cases is immediate discontinuation of COCs warranted. If, when taking COCs in patients with concomitant arterial hypertension, blood pressure constantly increases or

Overdose

There have been no cases of overdose of Dimia ® yet. Based on the general experience with the use of combined oral contraceptives, potential symptoms overdose can be: nausea, vomiting, slightly pronounced bleeding from the vagina.

Treatment: there are no antidotes. Treatment should be symptomatic.

drug interaction

Influence of others medicines for Dimia ®

Interactions between oral contraceptives and other medicinal products may result in acyclic bleeding and/or contraceptive failure. The interactions described below are reflected in the scientific literature.

The mechanism of interaction with hydantoin, barbiturates, primidone, carbamazepine and rifampicin; oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and preparations of St. John's wort (Hypericum perforatum) is based on the ability of these active substances to induce microsomal liver enzymes. The maximum induction of microsomal liver enzymes is not achieved within 2-3 weeks, but after that it persists for at least 4 weeks after discontinuation of drug therapy.

Contraceptive failure has also been reported with antibiotics such as ampicillin and tetracycline. The mechanism of this phenomenon is not clear.

Women with short-term treatment (up to one week) with any of the above groups of drugs or single drugs should temporarily use (during the period of simultaneous use of other drugs and for another 7 days after its completion), in addition to PDA, barrier methods of contraception.

Women receiving rifampicin therapy, in addition to taking COCs, should use a barrier method of contraception and continue to use it for 28 days after stopping treatment with rifampicin. If concomitant medications last longer than the expiration date of the active tablets in the package, the inactive tablets should be stopped and immediately start taking the drospirenone + ethinylestradiol tablets from the next package.

If a woman is constantly taking drugs - inducers of microsomal liver enzymes, she should use other reliable non-hormonal methods of contraception.

The main metabolites of drospirenone in human plasma are formed without the participation of the cytochrome P450 system. Cytochrome P450 inhibitors are therefore unlikely to interfere with the metabolism of drospirenone.

Effect of Dimia ® on other medicinal products

Oral contraceptives may affect the metabolism of some other active substances. Accordingly, plasma or tissue concentrations of these substances may either increase (eg, cyclosporine) or decrease (eg, lamotrigine).

Based on in vitro inhibition and in vivo interaction studies in female volunteers treated with omeprazole, simvastatin and midazolam as a substrate, an effect of drospirenone at a dose of 3 mg on the metabolism of other active substances is unlikely.

Other interactions

In patients without renal insufficiency, the simultaneous use of drospirenone and ACE inhibitors or NSAIDs does not significantly affect the content of potassium in the blood serum. But still, the simultaneous use of the drug Dimia ® with aldosterone antagonists or potassium-sparing diuretics has not been studied. In this case, during the first cycle of treatment, it is necessary to control the concentration of serum potassium.

Laboratory tests

Taking contraceptive steroids may affect the results of some laboratory tests, including the determination of biochemical indicators of liver function, thyroid gland, adrenals and kidneys, plasma protein (carrier) concentrations, such as corticosteroid-binding proteins and lipid/lipoprotein fractions, parameters of carbohydrate metabolism, and parameters of blood coagulation and fibrinolysis. In general, the changes remain within the range of normal values. Drospirenone is the cause of an increase in plasma renin activity and - due to a small antimineralocorticoid activity - reduces the concentration of aldosterone in plasma.

Terms and conditions of storage

The drug should be stored out of the reach of children, protected from light at a temperature not exceeding 25°C. Shelf life - 2 years.

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

In addition, as auxiliary compounds in the composition of the drug there are such substances as: corn starch (16.6 mg.), including pregelatinized (9.6 mg.), magnesium stearate (0.8 mg.) and polyvinyl alcohol copolymer (1.45 mg.).

The drug shell contains a complex of compounds Opadry II 85G18490, which in turn includes substances such as talc, titanium dioxide, as well as soy and macrogol.

As part of the second tablet (so-called placebo ), coated with a green shell contains 37.26 mg. lactose , 42.39 mg. MCC, 0.9 mg. magnesium stearate , 0.45 mg. colloidal silicon dioxide , as well as 9 mg. pregelatinized cornstarch .

film sheath placebo pills contains a complex of compounds under the name Opadry II 85F21389 , whose chemical composition is macrogol ,polyvinyl alcohol , talc, quinoline yellow dye , indigo carmine , as well as the Sunset dye.

Release form

Dimia tablets containing active substances drospirenone and ethinylestradione have a round biconvex shape. On one side of the tableted medicinal product, the marking “G73” is embossed.

The same round and biconvex shape placebo pills are distinguished by the green color of the shell. One package of the drug contains 28 tablets, which can be packaged in 1 or 3 blisters.

pharmachologic effect

Dimia is a combined drug, which is monophasic contraceptive .

Pharmacodynamics and pharmacokinetics

This medicinal product contains ethinylestradiol , as well as drospirenone (substance close to natural origin). The active substances that make up this contraceptive do not have antiglucocorticoid, estrogenic, glucocorticoid abilities , as well as a pronounced moderate antimineralocorticoid and antiandrogenic action .

Its effectiveness contraceptive Dimia achieves through several factors, for example, due to inhibition of ovulation , changes endometrium and raising secretion viscosity located in cervix .

When taken orally drospirenone almost completely and fairly quickly absorbed in the stomach. The maximum concentration of the substance in the blood (Cmax) is reached a maximum of two hours after ingestion contraceptive . After the stage of distribution and metabolism drospirenone be excreted from the body kidneys , a small part of the drug is excreted with the help of intestines .

Active ingredient ethinylestradiol, included in contraceptive, just like drospirenone is rapidly absorbed and reaches its maximum concentration in the blood after two hours. The compound is excreted from the body intestines and kidneys .

Indications for use

Dimia is used as a contraceptive.

Contraindications

This contraceptive is contraindicated in such conditions as:

hypersensitivity to any of the active components of the drug;
venous or arterial ;
heart attack ;
cerebrovascular disorders ;
some diseases of cardio-vascular system e.g. damage heart valve or atrial fibrillation ;
stroke ;
cerebrovascular disease ;
hypertension ;
smoking, provided that the woman has reached the age of 35 years or more;
, including suspicions of her;
period lactation ;
kidney failure ;
, including benign ones;
causeless vaginal bleeding ;
lactase deficiency ;
Lapp's insufficiency .

Dimia contraceptives should be used with caution when , otorosclerosis, porphyria, chorea minor, thromboembolism, cholelithiasis, as well as in diseases that are accompanied by disorders blood circulation , For example, Crohn's disease , phlebitis , other.

Side effects of Dimia

Side effects Dimia can be expressed in the following ailments from the side genitourinary, nervous, digestive and cardiovascular systems :

vaginal bleeding spotting or breakthrough acyclic character ;
engorgement of the mammary glands;
rare but can develop hypertrophy mammary glands, as well as the composition of secretions vagina ;
increase or decrease libido ;
migraine ;
mood changes;
extremely rare, but may occur arterial , as well as ;
nausea ;
hyperkalemia ;
vomit .

In addition, while taking the drug, there may be allergic reactions and expressed in , skin rashes, and . It should be remembered that when using contraceptive , including the drug Dimia, body weight may increase, as well as intolerance to contact lenses, develops chloasma (hyperpigmentation) .

Dimia tablets, instructions for use (Method and dosage)

You can read about how to take the drug correctly in the instructions for Dimia. These contraceptives should be taken every day without skipping. Doctors recommend doing this at the same time, always in the order that is usually indicated on the blister. TOcontraceptives Dimia, as well as other similar drugs, should be used continuously for 28 days.

new packaging birth control pills Dimia should be opened only after the end of the previous one. Approximately from the third day from the start of taking the last row of tablets in a blister (placebo period), mild bleeding . If the packaging contraceptive did not end by the end of the month, then they start taking the pills again on the first day menses .

During sexual intercourse during the first seven days of using the drug, additional methods must be used. contraception (barrier). When switching to the use of Dimia after other complex contraceptives , For example, transdermal patch , tablets , vaginal rings and so on, you should start taking this drug immediately the next day after using the previous method contraception .

When switching to Dimia after using contraceptive , which contain exclusively ( injections, implants, ) or after you can take this drug on any convenient day. However, before using the tablets, you should apply barrier methods of contraception.

As prescribed by the doctor, a woman can start taking these pills on the day after the interruption. pregnancy (, vacuum) . After childbirth it is recommended to wait 28 days and only then resume taking the drug. It is important to note that a missed appointment placebo pills (from the 4th row of the blister) is an insignificant factor.

However, this rule does not apply to tablets containing active substances in their composition. ethinylestradiol and drospirenone . If 12 hours have not passed since the last pill, then the level of contraceptive protection does not decrease. The missed tablet should be taken as soon as possible and the next one at the usual time.

You should not take a break in taking pills for more than 7 days, since this is the amount of time needed to suppress hypothalamic-pituitary ovarian system . For correct use contraceptive you should adhere to the following recommendations:

if you miss taking a pill during the first week of using the drug, a woman should resume use as soon as possible contraceptive , and also in order to avoid the risk of becoming pregnant, be sure to resort to additional methods barrier contraception over the next seven days;
if you miss taking the drug from 8 to 14 days of its use, you should also resume using Dimia as soon as possible, and then return to the usual schedule, while there is no need for additional contraception if the woman did not forget to take birth control pills in the previous seven days;
efficiency and reliability of this method contraception is significantly reduced if the missed dose of the drug fell on the period from 15 to 24 days of its use, since at this time the woman needs to switch to placebo pills .

To avoid unwanted pregnancy if the last of the described situations of skipping the drug occurs, the woman should take the pill as soon as possible to replace the missed one. Next, you should stick to your usual schedule of taking the drug until the active pills run out. As a result of mixing the intake schedule contraceptive , designed for 28 days, will remain in the blister placebo pills which do not need to be accepted.

Most likely, with this variant of normal withdrawal bleeding there will be no contraceptive until the end of the next package, however, I may appear spotting . If you miss taking the drug between 15 and 24 days of the start of its use, the woman may not return to the usual schedule of use contraceptives and take 4 days (including missed days) placebo pills and then proceed with a new package.

If with this option did not come "withdrawal" bleeding then the possibility of pregnancy should be considered. In the presence of gastrointestinal disorder the effectiveness of the drug is reduced, since the active compounds will not be completely absorbed by the stomach. If, after 4 hours after taking the contraceptive pill, the woman vomited, it is worth immediately taking the second one, i.e. replacement tablet.

If not monthly when taking Dimia, this may signal the onset of pregnancy . It is worth noting that spotting "cancellation" a woman can correct, for example, delay it on her own by changing the schedule for taking the drug.

For this you can skip placebo pills and immediately start taking tablets containing the active compound from the new package. It is noteworthy that when postponing or shifting withdrawal bleeding may appear acyclic spotting or profuse bleeding .

Overdose

At the moment, there is no information about cases of overdose of Dimia. However, based on experience with complex contraceptives similar to this drug in case of overdose, symptoms such as nausea, vaginal bleeding, as well as vomit . If these symptoms occur, stop using the drug and consult a doctor for advice.

Interaction

To avoid weakening the effectiveness of contraceptives, you should not use Dimia in conjunction with drugs that affect liver enzymes , For example, , Primidone, Phenytoin, Oxcarbazepine, Felbamate, barbiturates and others, as well as medicinal products containing in their chemical composition St. John's wort.

On the hepatic metabolism drugs can have a negative effect HIV protease inhibitors and non-nucleoside , as well as their combinations. downgrade estrogen circulation , and consequently, the effectiveness of Dimia occurs while taking and .

For 28 and 7 days (respectively) after taking drugs that affect induction of liver enzymes, as well as antibiotics you should stop using this drug. Contraceptives can affect the effect of some drugs, so before using Dimia, you should carefully read the instructions.

Terms of sale

Available by prescription only.

Storage conditions

Contraceptives are stored out of the reach of children, at a temperature not exceeding 25 C.

Best before date

special instructions

Constant use contraceptives may increase the risk of development. Moreover, this risk is highest in the first year of using a contraceptive. If the following symptoms occur while taking Dimia, you should immediately stop using the drug:

swelling of the lower extremities and strong pain ;
suddenvision loss ;
cough ;
causeless severe headache;
diplopia ;
vertigo ;
speech disorder ;
acute abdomen ;
collapse ;
numbness ;
weakness ;
movement disorders .

During the use of Dimia, the risk of dangerous thromboembolic disorders occurs significantly when:

hereditary disposition;
after the age of 30;
immobilization and after emergency surgery;
smoking;
hypertension ;
dyslipoproteinemia ;
diseases heart valves.

When using a contraceptive, be sure to take into account the risk of thromboembolism especially after childbirth , as well as the development of other adverse effects when diabetes, Crohn's disease, colitis, anemia etc. Women should not start taking the drug without the advice of a doctor, as well as a preliminary medical examination.

It is important to exclude pregnancy . During use of the contraceptive, "withdrawal" bleeding may occur, so the assessment of the normality of such secretions can be carried out after three months (adaptation period) since the start of the use of birth control pills.