Model puree pills 2mg + 0,035mg №21

Indications

- contraception in women with androgenization phenomena.

- treatment of androgen-dependent diseases / conditions in women ("vulgar" acne (acne papulopustulosa, acne nodulocystica); seborrhea; androgenic alopecia; hirsutism).

Dosing regimen

The drug is taken orally, 1 tab. / Day, every day at the same time, preferably after breakfast or dinner. The pill should be swallowed whole, without chewing and washing down with a small amount of liquid.

Taking the drug Modelle Pure begin on the 1st day of the menstrual cycle (ie, on the 1st day of menstrual bleeding), using a pill of the corresponding day of the week from the calendar package.

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

After 28 days from the start of taking the drug (21 days of intake 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.

At the transition from 21-day combined oral contraceptives (CPC) taking the drug Modell Pure should begin the day after taking the last pill of the previous drug,but in no case later than the next day after the usual 7-day break in reception. Further, as described above. The use of additional contraception is not required.

At transition from 28-day PDAs taking the drug Modell Pure should start the day after taking the last active pill. Further, as described above. The use of additional contraception is not required.

At transition from contraceptives containing only gestagens ("mini-pili"), Modell Pure should be used without interruption. Further, as described above. The use of additional contraception is not required.

At use of injectable contraceptives Modell Pure drug start taking from the day when the next injection should be done. At transition from implant - on the day of its removal. In all cases, you must use an additional barrier method of contraception (condom) during the first 7 days of taking pills.

After abortion in the first 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 II trimester of pregnancy taking the drug should be started on the 21-28th day. If reception is started later, it is necessary to use an additional barrier method of contraception (condom) during the first 7 days of taking the pills. If a woman lived sexually between the birth or abortion and the start of the drug Modell Pure, then pregnancy should be excluded first or you should wait for the first menstruation.

Missed pill should be taken as soon as possible, the next pill is taken at the usual time. If late less than 12 hours the reliability of contraception is not reduced. If the delay in taking the pill was more than 12 hours, contraceptive reliability can be reduced.

It should be borne in mind that taking the pill should never be interrupted for more than 7 days, and that 7 days of continuous taking the pill is 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 1st and 2nd week of taking the drugthen the woman should take the last missed pill as soon as possible as soon as she remembers (even if it means taking two pills at the same time). The next pill is taken at the usual time. Additionally, you should use a barrier method of contraception (condom) 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 3rd week of taking the drugthen the woman should take the missed pill as soon as possible, as soon as she remembers (even if it means taking two pills at the same time). The next pill is taken at the usual time. In addition, taking the pill from a new pack should be started as soon as the current pack is finished, i.e. without a 7-day break.Additionally, you should use a barrier method of contraception (condom) for the next 7 days. Most likely, the woman will not experience withdrawal bleeding until the end of the second package, but there may be spotting or breakthrough uterine bleeding on the days of taking the pills.

If you skip taking 3 or more tablets, you should contact your doctor.

If a woman had vomiting or diarrhea within 3 to 4 hours after taking the drug Modell Pure, the absorption of active substances may be incomplete. In this case, you need to focus on the recommendations when skipping the pill. If a woman does not want to change the usual mode of taking the drug, if necessary take an extra pill (or several pills) from another package.

In order to delay the onset of menstruation, the woman should continue taking the pills from the new package of the drug Modelle Pure immediately after all the pills from the previous one are taken, without interruption in the intake. pills from this new package can be taken as long as the woman wants (until the package is finished). While taking the drug from the second package, a woman may have spotting or breakthrough uterine bleeding. To resume taking the drug Modell Pure from the new package should be after the usual 7-day break.

In order to postpone the beginning of menstruation to another day of the weekA woman should shorten the next pause in the pill for as many days as she wants. The shorter the interval, the higher the risk that no withdrawal bleeding will occur, and there will be a spotting and breakthrough bleeding during the second package (just as if she would like to delay the onset of menstruation).

At treatment of hyperandrogenic conditions the duration of treatment is determined by the severity of the disease. After the disappearance of symptoms, it is recommended to take the drug Modell Pure for at least another 3-4 months. In the event of a relapse within a few weeks or months after completion of the course, it is possible to carry out repeated therapy with Modell Pure.

Adverse Effects

All women taking PDA are at increased risk of thrombosis and thromboembolism, a slight increase in the risk of the onset and worsening of other diseases. When taking a PDA, irregular (acyclic) vaginal bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use.

Determination of the frequency of unwanted reactions: often (> 1/100 and <1/10); infrequently (> 1/1000 and <1/100); rarely (> 1/10 000 and <1/1000).

Nervous system: often - headache, depression, mood swings; infrequently - migraine, decreased libido; rarely - increased libido.

Gastrointestinal: often - nausea, abdominal pain; infrequently - vomiting, diarrhea.

On the part of the reproductive system and the breast: often - pain in the mammary glands, engorgement of the mammary glands; infrequently - breast hypertrophy; rarely - intermenstrual bleeding, oligomenorrhea.

Other: often - weight gain; infrequently - fluid retention, rash, urticaria; rarely - allergic reactions, erythema nodosum, erythema multiforme, weight loss, deterioration of the tolerance of contact lenses, with long-term use - chloasma.

Contraindications

- thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, thromboembolism of the pulmonary artery), coronary artery disease, stroke;

- conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) now or in history;

- complicated lesions of the valvular apparatus of the heart (pulmonary hypertension, atrial fibrillation, history of subacute bacterial endocarditis);

- uncontrolled arterial hypertension (systolic blood pressure above 160 mm Hg or diastolic blood pressure above 100 mm Hg);

- serious surgical intervention with prolonged immobilization;

- diabetes with vascular complications;

- multiple or pronounced risk factors of venous or arterial thrombosis, including diseases of cerebral vessels or coronary arteries, arterial hypertension, middle age;

- liver failure and severe liver disease (until normalization of liver tests);

- active viral hepatitis, liver cirrhosis in the stage of decompensation;

- idiopathic jaundice or itching during a former pregnancy;

- congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes);

- liver tumors (benign or malignant) now or in history;

- migraine with focal neurological symptoms at present or in history;

- pancreatitis with severe hypertriglyceridemia now or in history;

- identified hormone-dependent malignant diseases (including breast cancer and endometrium) or suspicion of them;

- bleeding from the vagina of unknown origin;

- sickle cell anemia;

- otosclerosis with worsening during pregnancy;

- Herpes during pregnancy in history;

- Smoking over the age of 35;

- pregnancy;

- lactation period;

- Hypersensitivity to any of the components of the drug.

Carefully

The potential risk and the expected benefit of using a PDA in each particular case should be carefully weighed with the following diseases / conditions and risk factors.

- thrombosis risk factors: smoking, obesity, dislipoproteinemia, hypertension, migraine, valvular disease, prolonged immobilization, major surgery, major trauma, genetic predisposition to thrombosis (thrombosis, blood coagulation disorders, myocardial infarction or cerebrovascular accident at a young age of any of the next of kin);

- diseases in which there may be violations of the peripheral circulation: diabetes mellitus (or predisposition, for example, unexplained glucosuria), SLE, renal dysfunction, hemolytic-uremic syndrome, Crohn's disease and UC, varicose veins, phlebitis of superficial veins;

- hypertriglyceridemia;

- liver disease;

- A family history of breast cancer or a benign breast tumor in a personal history;

- a history of diagnosed depression;

- uterine fibroids;

- cholelithiasis;

- intolerance to contact lenses;

- Diseases that first arose or aggravated during pregnancy or against the background of previous intake of sex hormones (for example, jaundice and / or itching associated with cholestasis , cholelithiasis, porphyria, Sydenhem chorea, chloasma).

Use during pregnancy and lactation

The use of the drug is contraindicated in pregnancy and lactation.

Application for violations of the liver

The use of the drug is contraindicated in liver failure and severe liver disease (before normalization of liver samples), active viral hepatitis, liver cirrhosis in the stage of decompensation, liver tumors (benign or malignant) now or in history.

Precautions should be prescribed the drug for liver disease.

Application for violations of kidney function

With caution should use the drug in violation of the kidneys.

special instructions

Medical examinations

Before starting or resuming use of the drug Modelure Pure, a woman needs to conduct a thorough general medical (including measurement of ADD, heart rate, BMI determination) and gynecological examination, including the examination of the mammary glands and a cytological examination of a scraping from the cervix (Pap test), to eliminate pregnancy.

The amount of additional research and the frequency of control examinations is determined individually. Usually control tests should be carried out at least 2 times a year.

A woman should be warned that the drug Model Pure does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

If any of the conditions, diseases and risk factors listed below are present, then the potential risk and the expected benefits of using a PDA in each case should be carefully weighed and discussed with the woman before she decides to start taking the drug. In the event of a worsening, aggravation, or first manifestation of any of these conditions, diseases, or risk factors, the woman should consult with her doctor, who may decide to discontinue the drug.

Diseases of the cardiovascular system

There is evidence of an increase in the incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary thromboembolism, myocardial infarction, stroke) when using CPC.These diseases are rare. The risk of venous thromboembolism is maximum in the first year of taking such drugs. The risk of thrombosis (venous and / or arterial) and thromboembolism increases:

- with age;

- in 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:

- burdened family history (for example, venous or arterial thromboembolism ever with close relatives or parents at a relatively young age). In case of hereditary predisposition, a woman should be referred to the appropriate specialist to decide on the possibility of using a PDA;

- obesity (BMI> than 30 kg / m²);

- dyslipoproteinemia;

- arterial hypertension;

- migraine;

- valvular heart disease;

- Atrial fibrillation;

- prolonged immobilization, serious surgical intervention, any operation on the lower limbs or extensive trauma. In these situations, it is necessary to discontinue the use of PDA (in the case of the planned operation, at least 4 weeks before it) and not to resume reception within 2 weeks after the end of immobilization.

The question of the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial.

You should consider the increased risk of thromboembolism in the postpartum period.

Peripheral circulatory disorders may also occur in diabetes mellitus, SLE, tetany, hemolytic-uremic syndrome,chronic inflammatory bowel disease (Crohn's disease or NUC) and sickle cell anemia.

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

Tumors

An important risk factor for cervical cancer is the persistence of papillomavirus. The results of some epidemiological studies indicate an additional increase in this risk with long-term use of PDA, however, this statement remains controversial, because it is not fully established how the results of studies take into account associated risk factors, such as screening for cervical conditions and sexual behavior, including rarer use barrier contraceptive methods.

The relationship between the use of PDA and breast cancer has not been proven. There is a slightly increased relative risk of developing breast cancer diagnosed in women who are currently taking CCP. Increased risk gradually disappears within 10 years after discontinuation of these drugs. The observed increase in risk may be the result of careful observation and earlier diagnosis of breast cancer in women using PDA. In women who have ever used CCP, earlier stages of breast cancer and
clinically, it is less pronounced than in women who have never used a PDA.

In isolated cases, against the background of the use of PDA, the development of benign and, in extremely rare cases, malignant tumors of the liver, which in some cases led to life-threatening intra-abdominal bleeding, was observed. In the event of severe abdominal pain, enlargement of the liver or signs of intra-abdominal bleeding, differential diagnosis should take into account the possibility of a liver tumor in patients taking CPC.

Other states

Women with hypertriglyceridemia (or the presence of this condition in the family history) may increase the risk of pancreatitis during the use of PDA.

Despite the fact that a slight increase in blood pressure has been described in many women taking CPC, a clinically significant increase in blood pressure was rarely observed. However, if a persistent develops during the use of PDA, a clinically significant increase in blood pressure should be abolished by these drugs and treatment of hypertension should begin. Reception of PDA can be continued if normal blood pressure values ​​are achieved with the help of antihypertensive therapy.

The following conditions have been reported to develop or worsen both during pregnancy and when taking PDA, but their relationship with taking PDA has not been proven: jaundice and / or itching associated with cholestasis; the formation of gallstones; porphyria; SLE; hemolytic uremic syndrome; Chorea Sydenham; herpes pregnant; hearing loss associated with otosclerosis. It also describes cases of Crohn's disease and NUC with PDA.

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

Acute or chronic abnormal liver function may require the abolition of the PDA until the liver function returns to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires the discontinuation of PDC.

Although KPC may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose KPC (<0.05 mg of ethinyl estradiol). However, women with diabetes should be carefully monitored while using PDA.

Chloasma can sometimes develop, especially in women with a history of pregnant chloasma. Women with a tendency to chloasma while using PDA should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.

Treatment (contraception) should be immediately stopped when pregnancy occurs, the development of migraine-like headaches (if they were not there before), the appearance of early signs of phlebitis or phlebothrombosis (unusual pain or distension of the veins on the lower limbs), with the appearance of jaundice, visual disturbances, cerebrovascular disorders, stitching pains of unclear etiology when breathing or coughing, pain and chest tightness, with an increase in blood pressure.

Admission is also stopped 3 months before the planned pregnancy, 6 weeks before the planned surgical intervention and with prolonged immobilization.

In case of diarrhea and vomiting, the contraceptive effect is reduced, therefore, without stopping taking the drug Modell Pure, it is necessary to use additional non-hormonal methods of contraception.

Laboratory tests

Acceptance of CPC may affect the results of some laboratory tests, including indicators of liver function, kidney, thyroid, adrenal glands, plasma protein content, carbohydrate metabolism, coagulation parameters and fibrinolysis.

Laboratory staff should be warned about taking oral contraceptives.

You may change the results of skin allergy tests, reducing the concentration of LH and FSH.

Due to the fact that the contraceptive effect is fully manifested by the 14th day from the beginning of the reception, in the first 2 weeks it is recommended to additionally use non-hormonal (barrier) methods of contraception.

The drug Model Pure does not affect the course of puberty during the formation of a normal menstrual cycle.

Appointment after childbirth is recommended not earlier than the first normal after childbirth menstruation.

In the case of the appearance of acyclic bleeding during the first 3 weeks of hormonal contraception, it is possible to continue taking the drug, as a rule, bleeding stops independently.In the absence of bleeding during the 7-day interval between taking the drug, taking pills should be discontinued until pregnancy is excluded.

Effect on the menstrual cycle

With the use of PDA, irregular (acyclic) bleeding / vaginal bleeding (spotting bleeding or breakthrough bleeding) may occur, especially during the first months of use. Therefore, any irregular bleeding should be assessed after an adaptation period of approximately three cycles.

If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be performed to rule out malignant tumors or pregnancy.

Some women may not develop withdrawal bleeding during a break in the pill. If the CCP was taken as recommended, it is unlikely that the woman is pregnant. However, with the irregular use of PDA and the absence of two consecutive bleeding withdrawals, the drug can not be continued until pregnancy is excluded.

Influence on ability to drive motor transport and control mechanisms

Not found.

Overdose

Symptoms: nausea, vomiting, bleeding with drug withdrawal.

Treatment: symptomatic therapy; there is no specific antidote.

Drug interaction

Effect on liver metabolism of drugs that induce microsomal liver enzymes,can lead to an increase in the clearance of sex hormones, which in turn can lead to breakthrough bleeding or decrease the reliability of contraception. Such drugs include: phenytoin, barbiturates, primidone, Carbamazepine , rifampicin, rifabutin, possibly also oxcarbazepine, topiramate , felbamate, Griseofulvin , and preparations containing St. John's wort.

HIV protease inhibitors (eg, ritonavir) and non-nucleoside reverse transcriptase inhibitors (eg, nevirapine), and combinations thereof, also have the potential to affect hepatic metabolism.

During the use of drugs that affect microsomal enzymes, and within 28 days after their cancellation, a barrier method of contraception should be additionally used.

Some antibiotics (for example, penicillins and tetracyclines) can reduce the enterohepatic circulation of estrogen, thereby lowering the concentration of ethinyl estradiol. During the use of antibiotics (such as penicillins and tetracyclines) and within 7 days after their cancellation, an additional method of contraception should be used. If the period of use of the barrier method of protection ends later than the pills in the package, you need to proceed to the next package of the drug Modell Pure without the usual interruption in taking the tablets.

PDA may affect the metabolism of other drugs, which leads to an increase (for example, cyclosporine) or a decrease (for example, lamotrigine) in plasma and tissue concentrations.May require correction dosage regimen of drugs.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not higher than 30 ° C.