Modell Pure, 2 mg+0.035 mg 63 pcs

A combined contraceptive (estrogen+antiandrogen).

A combined low-dose monophasic contraceptive with antiandrogenic activity. The mechanism of action is due to its constituent antiandrogenic agent of steroid structure – cyproterone acetate and oral estrogen – ethinyl estradiol. It blocks androgen receptors, inhibits the secretion of gonadotropic hormones by the pituitary gland.

Cyproterone has the ability to competitively bind to natural androgens receptors (including testosterone, dihydroepiandrosterone, androstenedione) generated in small quantities in women, mainly in the adrenal glands, ovaries and skin. By blocking androgen receptors in target organs it reduces androgenization phenomena in women (due to disruption of processes mediated by hormone-receptor complexes at the level of main intracellular mechanisms).

In addition to antiandrogenic properties, it has gestagenic activity mimicking the properties of corpus luteum hormone. It inhibits the secretion of gonadotropic hormones by the pituitary gland and inhibits ovulation, which accounts for its contraceptive effect.

Ethinylestradiol enhances the central and peripheral effects of cyproterone on ovulation and maintains the high viscosity of cervical mucus, which makes it difficult for sperm to penetrate the uterine cavity and helps provide a reliable contraceptive effect.

Indications

– contraception in women with phenomena of androgenization;

– treatment of androgen-dependent diseases/conditions in women (“vulgar acne” (acne papulopustulosa, acne nodulocystica).p> – treatment of androgen-dependent diseases/conditions in women (“vulgar” acne (acne papulopustulosa, acne nodulocystica); seborrhea; androgenic alopecia; hirsutism).

Active ingredient

Composition

1 tablet

ethinylestradiol micronized 35 mcg

ciproterone acetate micronized 2 mg

Auxiliary substances:

Lactose monohydrate – 29.115 mg,

Corn starch – 20 mg,

Povidone K25 – 2.1 mg,

talc – 1.65 mg,

magnesium stearate – 100 µg.

Shell composition:

sucrose – 19.637 mg, calcium carbonate – 8.402 mg, talc – 4.095 mg, titanium dioxide – 278 µg, povidone K90 – 200 µg, macrogol 6000 – 2.178 mg, glycerol 85% – 139 µg, iron oxide dye – 27 µg, mountain glycol wax – 44 µg.

How to take, the dosage

The drug is only prescribed for the treatment of adrogenia, but because it has contraceptive properties, no other hormonal contraceptive drugs should be taken during treatment.

Modelle Pure is taken orally, 1 tablet a day. The tablet is taken without chewing and with a small amount of liquid. The timing of the medication is not important, but subsequent dosing should be done at the same chosen hour, preferably after breakfast or dinner.

The administration of Modell Pure begins on day 1 of the cycle, using the tablet of the corresponding day of the week from the calendar package.

The daily intake of the drug is done using the tablets from the calendar pack in the direction of the arrow on the foil until all the tablets have been taken. After all 21 yellow-orange tablets in the calendar pack have been taken, the remaining white tablets must be taken for the next 7 days. Menstruation should occur during the last 7 days of your cycle (28 days). Menstruation usually begins 2-3 days after the 21st day of the cycle of treatment with Modell Pure. The next pack should be started the day after taking the pills from the previous pack is completely finished, whether bleeding continues or not.

When switching from combined oral contraceptives, Modell Pure should be started the day after taking the last tablet with the active ingredients of the previous drug, but in no case later than the day after the usual 7-day break in intake (for products containing 21 pills). Then according to the scheme described above. If the patient has taken the previous contraceptive daily for 28 days, Modell Pure should be started after taking the last inactive pill.
If switching from contraceptives containing only gestagens (“mini-pills”), Modell Pure can be started without a break. When using injectable forms of contraceptives, Modell Pure can be started on the day the next injection is due. If you change from an implant, on the day it is removed. In all cases, it is necessary to use an additional barrier method of contraception during the first seven days of taking the drug.

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

After childbirth or a second trimester abortion, the drug should be started on days 21-28. If intake is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the drug. If a woman was sexually active between childbirth or abortion and the start of Modell Pure, pregnancy should be ruled out first or the first menstruation should be waited.

A woman should take a missed pill as soon as possible, the next pill is taken at the usual time. A delay of less than 12 hours does not reduce the reliability of contraception. If the delay in taking the pill is more than 12 hours, the reliability of contraception may be reduced.

If pills are taken more than 12 hours late (the interval since the last pill was taken is more than 36 hours) during the first and second weeks of the drug, the woman should take the last missed pill as soon as she can remember (even if this means taking two pills at once). The next pill is taken at the usual time. Additionally, a barrier method of contraception should be used for the next 7 days.

If the delay in taking the pill was more than 12 hours (the interval from taking the last pill is more than 36 hours) during the third week of taking the drug, the woman should take the last missed pill as soon as she can remember (even if it means taking two pills at the same time) as soon as possible. The next pill is taken at the usual time. In addition, taking a pill from a new pack should be started as soon as the current pack is finished, i.e., without interruption.

The woman most likely will not have a bleeding withdrawal until the end of the second pack, but she may have a mucous bloody discharge or breakthrough uterine bleeding on the days she takes the pills. If the woman had vomiting within 3 to 4 h after taking the drug, absorption of the active ingredients may be incomplete. In this case it is necessary to be guided by the recommendations for skipping the pill. In order to delay the onset of menstruation, a woman should continue taking pills from a new package of the drug immediately after taking all pills from the previous one, without interruption.

The pills in this new pack can be taken as long as the woman wishes (until the pack runs out). While taking the pills in the second package, a woman may experience menses or breakthrough uterine bleeding. The pills in the next package should be started after all 28 pills have been taken.

In order to postpone the day her period starts to another day of the week, a woman should shorten the nearest interval between pills by as many days as she wants. The shorter the interval, the higher the risk that she won’t have a bleeding withdrawal and, subsequently, will have spotting and breakthrough bleeding while taking her second pack (just like when she would like to delay the start of her period).

In the treatment of hyperandrogenic conditions, the duration of intake is determined by the severity of the disease. After the disappearance of symptoms it is recommended to take the drug for at least another 3-4 months. If there is a relapse in a few weeks or months after completion of the course, Modell Pure may be retreated.

Interaction

The effect on hepatic metabolism of drugs that induce microsomal liver enzymes may lead to increased clearance of sex hormones, which in turn may lead to breakthrough bleeding or decrease the reliability of contraception. These medications include: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, rifabutin, possibly also oxcarbazepine, topiramate, felbamate, griseofulvin and St. John’s wort medications.

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

While using drugs that affect microsomal enzymes and for 28 days after their withdrawal, an additional barrier method of contraception should be used.

Some antibiotics (e.g., penicillins and tetracyclines) may reduce intestinal hepatic circulation of estrogen, thereby lowering the concentration of ethinyl estradiol. During the use of antibiotics (such as penicillins and tetracyclines) and for 7 days after their withdrawal, an additional barrier method of contraception should be used. If the period of using a barrier method of contraception ends later than the pills in the package, you should proceed to the next package of MODEL PURE without the usual interruption of taking the pills.

PDAs may affect the metabolism of other drugs, resulting in an increase (e.g., cyclosporine) or decrease (e.g., lamotrigine) in their plasma and tissue concentrations. It may be necessary to adjust the dosing regimen of the drugs.

Special Instructions

Medical examinations

Before starting or resuming use of MODELL PURE, a woman should have a thorough general medical (including BP, HR, BMI) and gynecological exam, including breast examination and cytology of cervical scrape (Papanicolaou test), to rule out pregnancy.

The scope of additional examinations and the frequency of follow-up examinations are determined on an individual basis. Generally, follow-up examinations should be performed at least twice a year.

Warn women that MODELL PIER does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

If any of the conditions, diseases, and risk factors listed below are currently present, the potential risks and expected benefits of PDA should be carefully weighed on a case-by-case basis and discussed with the woman before she decides to start taking the drug. If any of these conditions, diseases, or risk factors aggravate, worsen, or first appear, the woman should consult with her physician, who may decide if the drug should be discontinued.

Cardiovascular disease

There is evidence of an increased incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke) with CPK. These diseases are rare. The risk of venous thromboembolism is maximal in the first year of taking these drugs. The risk of thrombosis (venous and/or arterial) and thromboembolism increases:

– with age;

– in smokers (with more cigarettes or increased age, the risk subsequently increases, especially in women over 35);

In the presence of:

– a history of a history of a history of a family (e.g., venous or arterial thromboembolism ever in a close relative or parent at a relatively young age). If there is a hereditary predisposition, the woman should be referred to an appropriate specialist to decide whether or not she should receive CPK;

– obesity (BMI > 30 kg/m2);

– dyslipoproteinemia;

– arterial hypertension;

– migraine;

– heart valve disease;

– atrial fibrillation;

– prolonged immobilization, major surgery, any lower extremity surgery, or extensive trauma. In these situations, the use of CPC should be stopped (if surgery is planned, at least 4 weeks before) and should not be resumed for 2 weeks after the end of immobilization.

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

The increased risk of thromboembolism in the postpartum period should be considered.

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

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

Tumors

Papillomavirus persistence is an important risk factor for cervical cancer. Some epidemiological studies suggest an additional increase in this risk with long-term PDA use, but this statement remains controversial because it is not definitively clear to what extent the results take into account associated risk factors such as cervical screening and sexual behaviors, including less frequent use of barrier methods of contraception.

The association between PDA use and breast cancer has not been proven. There is a slightly increased relative risk of breast cancer diagnosed in women currently taking CRPS. The increased risk gradually disappears within 10 years of stopping the use of these drugs. The increased risk observed may be a consequence of close monitoring and earlier diagnosis of breast cancer in women using PDAs. Women who have ever used PDAs show earlier stages of breast cancer and
clinically less breast cancer than women who have never used PDAs.

In a handful of cases, there have been benign, and in extremely rare cases, malignant liver tumors, which in some cases have led to life-threatening intra-abdominal bleeding. If severe abdominal pain, liver enlargement, or signs of intra-abdominal bleeding occur, the possibility of a liver tumor in patients taking CRP should be considered in the differential diagnosis.

Contraindications

– thrombosis (venous and arterial) and thromboembolism (including deep vein thrombosis, pulmonary embolism), CHD, stroke;

– conditions preceding thrombosis (including transient ischemic attacks, angina pectoris), current or past history;

– complicated valvular heart disease (pulmonary hypertension, atrial fibrillation, history of subacute bacterial endocarditis);

– uncontrolled arterial hypertension (systolic BP greater than 160 mm Hg orBP greater than 160 mmHg or diastolic BP greater than 100 mmHg.

– major surgical intervention with prolonged immobilization;

– diabetes mellitus with vascular complications;

– multiple or significant risk factors for venous or arterial thrombosis, including cerebrovascular or coronary artery disease, arterial hypertension, advanced age;

– hepatic impairment and severe liver disease (until normal liver function tests);

– active viral hepatitis, decompensated cirrhosis of the liver;

– idiopathic jaundice or pruritus in a former pregnancy;

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

– current or history of liver tumors (benign or malignant);

– migraine with focal neurologic symptoms, current or history;

– pancreatitis with significant hypertriglyceridemia, current or history;

– identified hormone-dependent malignancies (includingч. Breast and endometrial cancer) or suspected;

– vaginal bleeding of unclear genesis;

– sickle cell anemia;

– otosclerosis with worsening in pregnancy;

– herpes in a history of pregnancy;

– smoking over 35 years of age;

– pregnancy;

– lactation period;

– hypersensitivity to any of the components of the drug.

With caution

The potential risks and expected benefits of PDA use should be carefully weighed on a case-by-case basis if the following diseases/conditions and risk factors are present.

Risk factors for thrombosis: Smoking, obesity, dyslipoproteinemia, arterial hypertension, migraine, heart valve defects, prolonged immobilization, major surgery, extensive trauma, hereditary predisposition to thrombosis (thrombosis, blood clotting disorders, myocardial infarction or stroke at a young age in any immediate family member);

Diseases in which peripheral circulatory disorders may be noted: diabetes mellitus (or predisposition, such as unexplained glucosuria), SLE, impaired renal function, hemolytic-uremic syndrome, Crohn’s disease and NCD, varicose veins, superficial vein phlebitis;

– hypertriglyceridemia;

– liver disease;

– family history of breast cancer or personal history of benign breast tumor;

– a history of diagnosed depression;

– uterine myoma;

p> – cholelithiasis;

– contact lens intolerance;

– conditions that first appeared or worsened during pregnancy or on previous use of sex hormones (e.g., jaundice and/or pruritus associated with cholestasis, cholelithiasis, porphyria, Sydenham’s chorea, chloasma).

Side effects

Often: headache, depressed mood, mood changes, nausea, abdominal pain, weight gain, soreness and tightness in the mammary glands.
Infrequent: migraine, vomiting, diarrhea, fluid retention in the body, increased mammary glands, rash, urticaria, decreased libido.
Rare: hypersensitivity reactions, poor tolerance of contact lenses, decreased body weight, increased libido, vaginal discharge, mammary discharge, rash, erythema nodosum, erythema multiforme, pigment spots on the face (chloasma).
The following serious side effects have been reported in women using combined oral contraceptives:
– venous thromboembolic disorders;
– arterial thromboembolic disorders;
– cerebrovascular disorders;
– arterial hypertension;
– hypertriglyceridemia;
– glucose tolerance disorders or effects of peripheral insulin resistance;
– liver tumors (benign and malignant);
– liver function disorders;
– chloasma;
– in women with hereditary angioedema provocation or exacerbation of disease symptoms under the influence of exogenous estrogens;
– occurrence or worsening of the following conditions, the connection of which with taking combined oral contraceptives is not proved: jaundice and/or pruritus associated with cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; Sydingham’s chorea; herpes of pregnancy; hearing loss associated with otosclerosis, Crohn’s disease and nonspecific ulcerative colitis, cervical cancer.

Overdose

Symptoms: nausea, vomiting, bleeding when discontinuing the drug.

Treatment: symptomatic therapy; no specific antidote.

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