Expiration date: 01/2025

Testimony

contraception

The dosage regimen

The drug is taken orally. Tablets should be taken in order, specified on the package every day at about the same time, squeezed small amounts of water. It should take 1 tab. continuously for 21 days. Taking pills from the next pack starts after a 7-day interval, during which usually occurs menstrualnopodobnoe bleeding (withdrawal bleeding). It usually starts on day 2-3 after the last tablet and may not end before you start taking pills from a new package.

The beginning of the drug Modell About

In the absence of any hormonal contraceptive use in previous month use of the drug Modell About to start the 1st day of the menstrual cycle (i.e., in the 1-St day menstrual bleeding). Allowed to start at the 2-5 day menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the pills from the first package.

The transition from other combined hormonal contraceptives (PDA, vaginal ring or contraceptive patch)

It is preferable to start taking the drug Modell About the next day after taking the last pill from the previous package, but in any case not later than the next day after the usual 7 day break. The drug Modell About to start on the day of removal of the vaginal ring or patch, but not later than the day when it should be introduced a new ring or apply a new patch.

The transition from contraceptives containing only progestogen ("mini-pili", injectable form, implant or intrauterine system (IUD) controlled release of progestogen)

You can go with the "mini-pill" for the drug Modell About any day (without a break), with implants or IUDs - the day of their removal, injectable contraceptive - on the day when should be made following injection. In all cases, you must use an additional barrier method of contraception during the first 7 days of taking the pills.

After abortion in the first trimester of pregnancy you can start taking the drug immediately - on the day of the abortion. Under this condition the woman needs no additional contraceptive methods.

After delivery or abortion in the II trimester of pregnancy

It is recommended to start taking the drug for 21-28 days after birth (with no breastfeeding) or abortion in the II trimester of pregnancy. If the reception is started later, you must use an additional barrier method of contraception during the first 7 days of taking the pills. If intercourse has taken place, prior to the receipt of Modell About the drug should be deleted pregnancy or must wait for first menstruation.

Receiving missed pills

If the delay in receiving the drug was less than 12 hours, contraceptive protection is not reduced. You should take the pill as soon as possible take the next pill at the usual time. If the delay in taking the drug was more than 12 hours, contraceptive protection may be reduced. The more missed tablets and the closer to the pass the 7-day break from the pill, the greater the chance of pregnancy. This can be guided by the following two basic rules:

• the drug should never be interrupted for more than 4 days;
  
•  to achieve adequate suppression of the hypothalamic-pituitary-ovarian system required 7 days of continuous pill-taking.
  

Accordingly, if the delay in the pill was more than 12 h (the interval since the last tablet, more 36 h), the woman should follow the recommendations given below.

The first week of the drug

You must take the last missed tablet as soon as possible, as soon as the woman remembers this (even if you just need to take two pills at the same time). Take the next pill at the usual time. Additionally, you should use a barrier method of contraception (e.g. condom) for the next 7 days. If intercourse took place during the week before skipping pills, you must take into account the probability of pregnancy.

The second week of the drug

You must take the last missed tablet as soon as possible, as soon as the woman remembers this (even if you just need to take two pills at the same time). Take the next pill at the usual time. Provided that the woman took the pills correctly during the 7 days preceding the first missed tablet, there is no need to use additional contraceptive measures. Otherwise, as well as the passage of two or more pills should also use a barrier method of contraception (e.g. condom) for 7 days.

Third week of using the drug

The risk of pregnancy increases due to the upcoming break in taking the pills. Should strictly adhere to one of the following two options. However, if during the 7 days preceding the first missed pill, all the pills are taken correctly, there is no need to use additional contraceptive methods. Otherwise, you must use the first of the following schemes and additionally use a barrier method of contraception (e.g. condom) for 7 days.

1. You must take the last missed tablet as soon as possible, as soon as the woman remembers this (even if you just need to take two pills at the same time). Next take the pills at the usual time until all the pills in the current pack. The next pack should be started immediately without a break. Withdrawal bleeding is unlikely until the end of the second pack, but may experience spotting and breakthrough bleeding while taking the pills.

2. You can also stop taking tablets from the current package, starting, thus, the 7-day break (including the day skipping pills) and then start taking pills from a new package.

If a woman misses a pill, and then during a break in the reception she has no withdrawal bleeding, pregnancy must be excluded.

Recommendations in case of any disorders of the gastrointestinal tract

In case of severe gastrointestinal disorders (vomiting, diarrhea), the absorption may be incomplete, so you should use additional methods of contraception. If within 4 hours after taking the pill will occur vomiting, should focus on the recommendations when skipping pills.

Change the start date of the menstrual cycle

In order to delay the onset of menstruation, it is necessary to continue reception of tablets from new packing Modell About no 7-day break. Pills from a new package can be made as long as necessary, i.e. as long as the package is over. On the background of the drug from the second package possible spotting from the vagina or breakthrough uterine bleeding. To resume regular use Modell Pro from another package follows the usual 7-day break. In order to postpone the start of menstruation to another day of the week, the woman should shorten the nearest break in the pill on the desired number of days. The shorter the interval, the higher the risk that it will not have withdrawal bleeding, and may continue to experience spotting and breakthrough bleeding while taking the second packaging (as in the case when she would like to delay the onset of menstruation).

Additional information for special categories of patients

The efficacy and safety of the drug as a contraceptive method were studied in women of reproductive age. It is assumed that the efficacy and safety of the drug in postpubertatne to 18 years are similar to those in women after the age of 18. The use of the drug before the onset of menarche is not indicated.

After menopause the drug Modell About is not shown.

Do not use this drug if you have currently or a history of severe liver disease (up to normalization of liver samples), availability now or history of benign or malignant tumors of the liver.

The drug is contraindicated in acute renal failure and kidney failure, severe.

Side effects

Frequency of adverse reactions identified using the drug, as follows: often (?1/100-<1/10); infrequently (?1/1000-<1/100); rare (?1/10 000 to<1/1000).

The immune system: rarely - asthma, hypersensitivity reactions.

From the nervous system: often - headache.

Mental disorders: often - depression; rarely, change in libido.

On the part of the organ of hearing: rarely is hearing loss.

Of the cardiovascular system: often-headache; infrequently - increase in blood pressure, decrease in blood pressure; rarely - thromboembolism.

From the digestive system: often - nausea; rare - vomiting, diarrhea.

The skin and subcutaneous tissue: often - acne, eczema, itching; rare - erythema nodosum, erythema multiforme.

From the reproductive system and mammary gland: often - violation of the menstrual cycle, acyclic bleeding, breast tenderness, increased sensitivity of the breast, leukorrhea, Candida vulvovaginitis; rarely, increase breast, vaginitis; rare - discharge from the breast.

Other: infrequently - fluid retention, weight changes.

The following serious adverse events have been reported in women taking BCP: venous thromboembolism; arterial thromboembolism; increased blood pressure; liver tumours; occurrence or deterioration of conditions whose connection with the admission of the CCP is not completely installed (Crohn's disease, ulcerative colitis, epilepsy, migraine, uterine myoma, porphyria, SLE, herpes during pregnancy, Sydenham chorea, haemolytic uremic syndrome, cholestatic jaundice); chloasma.

In women with hereditary angioedema, the use of estrogen may cause or exacerbate its symptoms.

Contraindications

• thrombosis (venous and arterial) now or in history (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
  
• state prior thrombosis (including transient ischemic attack, atrial fibrillation, angina pectoris) now or in history;
  
• migraine with focal neurological symptoms in the present or in history;
  
• diabetes with vascular complications;
  
• multiple or severe risk factors for venous or arterial thrombosis (including complicated lesions valvular apparatus of the heart, atrial fibrillation, vascular diseases of the brain or coronary arteries; uncontrolled hypertension, prolonged immobilization, extensive surgery, surgery on the lower extremities, extensive trauma, Smoking age 35 years, obesity with BMI >30 kg/m2);
  
• pancreatitis with severe hypertriglyceridemia in the present or in history;
  
• hepatic failure and severe liver disease (up to the normalization of indicators of liver function);
  
• liver tumors (benign or malignant) currently or in history;
  
• acute renal failure and renal failure severe;
  
• identification of hormone-dependent malignant diseases (including genital or mammary glands) or suspicion on them;
  
• vaginal bleeding ambiguous Genesis;
  
• pregnancy or suspicion on it;
  
• lactation (breastfeeding);
  
• hereditary lactose intolerance, lactase deficiency or malabsorption syndrome glucose-galactose;
  
• hypersensitivity to the drug.
  

If any of the above diseases or conditions develop for the first time while taking the drug, it should be discontinued immediately.

With caution

To evaluate the relation of potential risk and expected benefit of the drug Modell About each individual case in the presence of the following diseases/conditions and risk factors:

• risk factors for thrombosis and thromboembolism: Smoking, obesity (BMI <30 kg/m2), dislipoproteinemia, controlled hypertension, migraine without focal neurologic symptoms, uncomplicated heart valve disease, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age any of the next of kin);
  
• other diseases which may include peripheral circulatory disorders: diabetes mellitus without diabetic angiopathy, SLE, hemolytic uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia, flebit superficial veins;
  
• hereditary angioedema;
  
• hypertriglyceridemia;
  
• liver disease not related to contraindications;
  
•  the disease was first incurred or aggravated by the pregnancy or on the background of the previous reception of sex hormones (e.g., jaundice and/or itchy, associated with cholestasis, cholelithiasis, otosclerosis with deterioration of hearing, porphyria, herpes pregnant, chorea Sydenham);
  
• postpartum period.
  

Application of pregnancy and breastfeeding

Pregnancy

If pregnancy is detected during the reception Modell About, the drug should immediately cancel. Extensive epidemiological studies have not identified an increased risk of developmental defects in children born to women treated with sex hormones before pregnancy, or teratogenic effects in cases when sex hormones were taken inadvertently in early pregnancy. In animal studies, the effects of drospirenone and ethinyl estradiol were associated with their pharmacological effects. In particular, in reproductive toxicity studies in animals revealed embryotoxic and fetotoksi?eskoe effect, but these effects were considered as associated with specific animal species. At levels of exposure in animals greater than corresponding levels in women taking drospirenone and ethinyl estradiol, was observed the influence on the sex differentiation of rat embryos, which was absent from the small monkeys. According to the data obtained in animal studies cannot exclude the possibility of development of undesirable effects caused by the hormonal activity of active substances, the person. However, the cumulative experience of using a PDA during pregnancy did not provide evidence of adverse effects in humans. Data on the results of the drug Modell About during pregnancy is limited, which does not allow to draw any conclusions about the negative impact of the drug on pregnancy, health of the fetus and newborn. Currently, any significant epidemiological data are not available.

Lactation

The drug is contraindicated during breastfeeding. Can reduce the amount of breast milk and change its composition, so the drug is not recommended until the cessation of breastfeeding. A small amount of sex hormones and/or their metabolites may be excreted with breast milk, but there is no confirmation of their negative impact on the health of the child.

Application for violations of liver function

Do not use this drug if you have currently or a history of severe liver disease (up to normalization of liver samples), availability now or history of benign or malignant tumors of the liver.

Application for violations of renal function

The drug is contraindicated in acute renal failure and kidney failure, severe.

The children

It is assumed that the efficacy and safety of the drug in postpubertatne the age of 18 latinlegacy so in women after the age of 18. The use of the drug before the onset of menarche is not indicated.

Use in elderly patients

After menopause the drug Modell About is not shown.

Special instructions

Before the start or resumption of the use of the drug Modell About, you should read the life history, family history of women, a thorough General medical (including measurement of blood pressure, heart rate, determination of BMI) and gynecological examination, including examination of the mammary glands and cytological examination of scraping from the cervix (Papanicolaou test), to exclude pregnancy. The amount of additional research and the frequency of control examinations are set individually. Typically, control examinations should be conducted at least 1 time in 6 months.

A woman should be informed that Modell About does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

If any of the conditions, diseases and risk factors mentioned below are present, you should carefully weigh the potential risks and expected benefits of the application of the PDA in each individual case and to discuss it with the woman before she decides to start taking the drug. With weighting, strengthening or at the first sign of risk factors may require removal of the drug.

Cardiovascular disease

The results of epidemiological studies indicate a relationship between use of PDAs and increasing the incidence of venous and arterial thrombosis and thromboembolism such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disease. These diseases are rare. The risk of developing venous thromboembolism (VTE) is maximal in the first year of taking these drugs. Increased risk is present after initial CPC application or renewal application of the same or different PC (after the break between doses of the drug in the 4 weeks or more). Data from a large prospective study involving 3 groups of patients show that this increased risk is present primarily during the first 3 months.

The overall risk of VTE in patients receiving low-dose PDA (containing <50 µg of ethinyl estradiol), 2-3 times higher than in nonpregnant patients who do not accept the CCP, however, this risk remains lower than the risk of VTE during pregnancy and childbirth. VTE can lead to death (1-2% of cases).

VTE, manifested as deep vein thrombosis or pulmonary embolism may develop in the application of any PDA.

Extremely rare in the application of the CCP occurs thrombosis other blood vessels, e.g. hepatic, mesenteric, renal, cerebral veins and arteries or vessels of the retina. A unified view on the relationship between the occurrence of these events and the use of PDA is missing.

Symptoms of deep vein thrombosis (DVT) include: unilateral swelling of the lower limbs along the veins on the lower limbs, pain or discomfort in the lower limbs in an upright position or during walking, the local temperature increase in the affected lower limbs, redness, or discoloration of the skin on the lower limbs.

Symptoms of pulmonary embolism (PE): difficulty or rapid breathing; sudden cough, including coughing up blood; sharp chest pain which may increase with deep breathing; sense of anxiety; severe dizziness; fast or irregular heartbeat. Some of these symptoms (e.g., dyspnea, cough) are nonspecific and may be misinterpreted as symptoms of other more or less severe events (e.g. respiratory infection).

Arterial thromboembolism may lead to stroke, vascular occlusion or myocardial infarction. Symptoms of a stroke: sudden weakness or loss of sensation of the face, limbs, especially on one side of the body sudden confusion, trouble speaking and understanding; sudden uni - or bilateral loss of vision; sudden gait disturbance, dizziness, loss of balance or coordination; sudden, severe or prolonged headache with no apparent cause; loss of consciousness or fainting with seizure. Other signs of vascular occlusion: sudden pain, swelling and mild bruising of the limbs, simptomokomplex "acute" abdomen.

The symptoms of a heart attack include: pain; discomfort; a feeling of pressure, heaviness; a feeling of pressure or fullness in the chest, in the arm or behind the breastbone; discomfort in the left side of the chest radiating to the back, jaw, throat, arm, epigastric area; cold sweat, nausea, vomiting or dizziness, pronounced weakness, anxiety or shortness of breath; fast or irregular heartbeat.

Arterial embolism can lead to death.

The risk of thrombosis (venous and/or arterial) and thromboembolism is increased:

• with age;
  
• smokers (with the increase in the number of cigarettes or increasing age the risk increases, especially in women older than 35 years);
  
• obesity (BMI > 30 kg/m2);
  
• if there is a positive family history (eg, venous or arterial thromboembolism ever have close relatives or parents at a relatively young age). In the case of hereditary or acquired predisposition, the woman should be referred to the appropriate specialist to address the question about the possibility of using PDAs;
  
• prolonged immobilization, major surgery, any surgery on the lower limbs or major trauma. In these situations, it is desirable to stop the use of PDA (in the case of the planned operation, at least 4 weeks in advance) and not to resume reception during 2 weeks after immobilization;
  
• with dyslipoproteinemia;
  
• hypertension;
  
• migraine;
  
• in diseases of the heart valves;
  
• in atrial fibrillation.
  

The question of the possible role of varicose veins and superficial thrombophlebitis in venous thromboembolism remains controversial. You should consider the increased risk of thromboembolism in the postpartum period.

Peripheral circulatory disorders also may occur with diabetes, SLE, hemolytic uremic syndrome, chronic inflammatory bowel diseases (Crohn's disease or ulcerative colitis) and sickle cell anemia.

The increase in the frequency and severity of migraine attacks during the use of PDAs (which may precede cerebrovascular disorders) should be grounds for immediate discontinuation of these drugs.

For biochemical parameters, indicating hereditary or acquired predisposition for venous or arterial thrombosis include resistance to activated protein C, hyperhomocysteinemia, deficiency of antitrombina III, protein deficiency, deficiency of protein S, the presence of antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant).

In assessing the balance of risks and benefits should take into account that adequate treatment of the condition may reduce the associated risk of thrombosis. You should also consider that the risk of thrombosis and embolism in pregnancy above, than when receiving the low-dose MMR (containing less than 50 µg ethinyl estradiol).

Pharmaceutical preparations containing levonorgestrel, norgestimate or norethindrone, have a low risk of venous thromboembolism. The drugs, including drospirenone, the risk of thromboembolic complications in 2 times above, therefore it should warn the woman about this increased risk before prescribing the drug Modell About.

Tumors

The most significant risk factor for cervical cancer is persistent papillomavirus infection. There are reports of some increase in the risk of cervical cancer with prolonged use of PDAs. However, the connection with the reception of the CCP is not proven. Stored conflicting evidence as to the extent to which these data are associated with screening to identify cervical pathology or with features of sexual behaviour (a rare use of barrier methods of contraception).

A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of breast cancer diagnosed in women taking the BCP now (relative risk 1.24). The increased risk gradually disappears during the 10 years after stopping these drugs. Due to the fact that breast cancer is rarely noted in women under 40, increased number of diagnoses of breast cancer in women taking the BCP currently or recently took, is small relative to the total risk of this disease. The relationship between breast cancer and PDAs are not proven. The observed increase in risk may also be the result of careful observation and early diagnosis of breast cancer in women who use PDAs. Women have ever used a PDA, detected more early stage breast cancer, than women, never let them to apply.

In rare cases, application of the PDA was observed the development of benign, but in extremely rare cases, malignant liver tumours, which in some cases led to life threatening intra-abdominal hemorrhage. In case of severe pain in the abdomen, liver enlargement or signs of intra-abdominal bleeding, this should be considered in the differential diagnosis.

Other States

Clinical studies have shown no effect of drospirenone on the concentration of potassium in the serum of patients with renal insufficiency mild to moderate severity. Theoretically there is a risk of hyperkalemia in patients with impaired renal function and the initial potassium level ULN or in patients receiving medicinal products, resulting in a delay of potassium in the body.

In women with hypertriglyceridemia (or in the presence of this condition in the family history) may increase the risk of developing pancreatitis while receiving PDA. Despite the fact that a small increase in blood pressure have been reported in many women taking PDA clinically significant hypertension occurred rarely. However, if during the application of the CCP develops persistent, clinically significant increase in blood pressure, you should undo these drugs and treatment of hypertension. Welcome PDA may be continued, if using a hypertensive therapy achieved normal values of HELL.

The following status, as reported, develop or worsen as pregnancy, or when taking the PDA, but their relationship with the receiving CCP not proven: jaundice and/or itchy, associated with cholestasis; formation of gallstones; porphyria; SLE; hemolytic-uremic syndrome; Sydenham chorea; herpes pregnancy; hearing loss, associated with otosclerosis. Also describes cases of Crohn's disease or ulcerative colitis with application of the PDA.

In women with hereditary forms of angioedema exogenous estrogens may induce or worsen symptoms of angioedema.

When acute or chronic disturbances of liver function may require removal of the drug as long as liver function tests have not returned to normal. Recurrent cholestatic jaundice, which develops first during pregnancy or previous admission of sex hormones, requires discontinuation of PDA.

Although PDAs can impact on insulin resistance and glucose tolerance, there is no need to change the therapeutic regime in patients with diabetes using low-dose MMR (containing less than 50 mcg ethinyl estradiol). However, women with diabetes need careful monitoring of glucose concentration in the blood during treatment.

In applying the drug may develop chloasma, especially in women with a history of chloasma pregnant. Women with a tendency to chloasma during the reception CCP should avoid prolonged sun exposure and UV radiation.

The effectiveness of CPC can be reduced by skipping pills, vomiting or diarrhea or as a result of drug interactions.

The effect on the menstrual cycle

Application of the PDA may experience irregular (acyclic) bleeding (spotting or breakthrough bleeding), especially during the first months of use. Therefore, evaluation of any irregular bleeding should only be undertaken after a period of adaptation of approximately 3 cycles.

If irregular bleeding recur or develop after previous regular cycles, you should conduct a thorough examination to exclude malignant neoplasms or pregnancy.

Some women during a break in the pill may not develop withdrawal bleeding. If the reception of the PDA was conducted in accordance with the instructions, the pregnancy is unlikely. However, if the receiving PDA was carried out irregularly, or if you do not have two consecutive withdrawal bleeding, to continue receiving the drug should be deleted pregnancy.

Effect on laboratory tests

Welcome PDA can affect the results of certain lab tests, including liver function tests, kidneys, thyroid gland, adrenal glands, the content of transport proteins in the blood plasma, indicators of carbohydrate metabolism and parameters of coagulation and fibrinolysis. Changes do not usually go beyond the normal values. Drospirenone increases plasma renin activity and aldosterone, because of its effect antimineralokortikoidnym.

Effects on ability to drive vehicles and management mechanisms

Studies on the influence of the drug on the ability to drive vehicles and mechanisms was conducted. There was no effect of CPC on the ability to drive vehicles and mechanisms.

Overdose

About serious violations in cases of overdose were reported.

Symptoms: on the basis of the experience of using PDAs in case of overdose may include nausea, vomiting, spotting from the vagina or metrorrhagia.

Treatment: symptomatic therapy; no specific antidote.

Drug interactions

The interaction of oral contraceptives with other drugs may lead to breakthrough bleeding and/or reduce the contraceptive reliability. Women taking such drugs should temporarily use a barrier method of contraception in addition to the drug Modell About or choose another method of contraception.

Interactions leading to reduced efficacy of the agent Modell About

The use of drugs, inducing microsomal liver enzymes may lead to increased clearance of sex hormones, which in turn may lead to breakthrough bleeding or reduce the reliability of contraception. Such drugs include phenytoin, barbiturates, primidon, carbamazepine, rifampicin, rifabutin, and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin and products containing St. John's wort.

While taking drugs that affect hepatic microsomal enzymes, and for 28 days after their cancellation should additionally use a barrier method of contraception.

The HIV protease inhibitors (eg, ritonavir) and non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine) and combinations thereof may also potentially affect hepatic metabolism.

Some antibiotics (e.g., penicillin and tetracycline) may reduce enterohepatic circulation of estrogens, thereby lowering the concentration of ethinyl estradiol. During the use of antibiotics (such as penicillins and tetracycline) and for 7 days after their cancellation should additionally use a barrier method of contraception. If the period of use of barrier method of protection ends later than the tablets in a package, you need to go to the next package of the drug Modell About without the usual break from the pill.

Other interactions

The main metabolites of drospirenone are generated in the plasma without the participation of cytochrome P450. Therefore, it is unlikely the effect of inhibitors of cytochrome P450 on the metabolism of drospirenone.

PDA can affect the metabolism of other drugs, which leads to an increase (e.g. ciclosporin) or decrease (e.g. lamotrigine) their concentration in plasma and tissues.

Based on the studies of interactions in vitro and studies in female volunteers taking omeprazole, simvastatin and midazolam revealed that the effect of drospirenone in a dose of 3 mg on the metabolism of other drugs is unlikely.

There is a theoretical possibility of increasing serum potassium concentration in women receiving Modell About simultaneously with other drugs that may increase serum potassium concentration. These drugs include ACE inhibitors, antagonists of angiotensin II receptor some anti-inflammatory drugs, potassium-sparing diuretics and aldosterone antagonists. However, research evaluating the interaction of drospirenone with ACE inhibitors or indomethacin, there were no significant differences between serum potassium concentrations compared to placebo.

Terms and conditions storage

The drug should be stored out of reach of children at temperature not exceeding 25°C.