Expiration date: 12/2025

Structure and Composition:

Tablets, film-coated. 1 tablet contains:

0.02 mg ethinylestradiol

0.15 mg of desogestrel

Excipients: kinolin Yellow (E104), alpha-tocopherol, magnesium stearate, anhydrous colloidal silica, stearic acid, povidone, lactose monohydrate potato starch in the tablet core propylene glycol, macrogol 6000, hypromellose film coated

in blister 21 pcs. in box 1 or 3 blisters.

Description pharmaceutical form:

Biconvex tablets pale yellow shaped disk labeled "P9" - on one side, «RG» - on the other side.

Pharmacokinetics:

Both components are rapidly and almost completely absorbed from the gastrointestinal tract. Ethinylestradiol undergoes first-pass metabolism and its conjugates with sulfuric acid and glucuronic - enterohepatic circulation. Ethinylestradiol excreted in urine (40%) and the feces (60%). T1 / 2 -. 26 hours Desogestrel biotransformed in the liver to form the active metabolite - 3-ketodesogestrel. T1 / 2 - 38 hours.

Description of the pharmacological actions:

Inhibits the release of FSH and LH, it prevents ovulation, increases the viscosity of cervical mucus and inhibits implantation of a fertilized egg.

Indications:

Oral contraception.

Contraindications:

• hypersensitivity
  
• hypertension, moderate or severe
  
• hyperlipidemia (familial forms)
  
• arterial thromboembolic disease, including history (myocardial infarction, cerebrovascular disease)
  
• there is a risk of arterial or venous thromboembolism
  
• venous thromboembolism in a personal or family history
  
• diabetic angiopathy
  
• the presence or indication of a history of severe liver disease, cholestatic jaundice, hepatitis, jaundice during pregnancy, Dubin-Johnson syndrome and Rotor, liver cancer, porphyria, intake of drugs containing steroids
  
• hepatitis (until the restoration of laboratory parameters and for 3 months after normalization)
  
• cholelithiasis
  
• estrogen-dependent tumors (including suspected them), breast and endometrial cancer, endometrial hyperplasia, endometriosis, breast fibroadenoma, genital bleeding of unknown etiology
  
• systemic lupus erythematosus (including history)
  
• severe itching, genital herpes, otosclerosis, or deterioration of otosclerosis during a previous pregnancy or steroids
  
• pregnancy (including suspected it).
  

Relative contraindications: disorders of hemostasis system, heart failure (including history), renal failure (including history), epilepsy, migraines, the risk of estrogen-dependent tumors, diabetes, sickle cell anemia (the period infections or conditions reception estrogensoderjath drug hypoxia can provoke thromboembolism), a severe form of depression (including history), if depression is associated with impaired tryptophan exchange, with a view to the correction can be used vitamin B6. In the appointment of a contraceptive for patients with these diseases should be carefully weighed and discussed with the patient the expected benefits of therapy with possible adverse effects.

Application of pregnancy and breastfeeding:

Contraindicated during pregnancy. It is not recommended during breast-feeding, because may decrease the release of milk.

Side effect:

From the nervous system and sensory organs: headache, migraine, mood changes, depression, Sydenham's chorea.

Cardio-vascular system and blood (blood, hemostasis): very rarely - increased risk of arterial and venous thromboembolic disease (eg myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary thromboembolism) hypertension.

From the digestive tract: nausea, vomiting, cholelithiasis, cholestatic jaundice.

With the genitourinary system: intermenstrual bleeding, amenorrhea, changes in vaginal mucus, candidiasis, change in size of uterine fibroids, endometriosis symptoms worsening.

For the skin: nodular erythema, rash, chloasma.

Allergic reactions: very rarely - worsening reactive systemic lupus erythematosus.

Other: tension, pain, and increase the flow of milk from the mammary glands increase in the sensitivity of the cornea with contact lens fluid retention, changes in body weight, decreased carbohydrate tolerance.

Drug Interactions:

When used together antispasmodics, barbiturates, antibiotics (tetracycline, ampicillin, rifampicin), griseofulvin, laxatives, active complexes of certain medicinal plants, including St. John's wort, change the character of menstrual reactions or reduce the effectiveness.

Dosage and administration:

Orally (possible in one and the same time of day) to prevent pregnancy - Table 1. per day, beginning with 1-5 days of menstruation for 21 days, then - break 7 days (menstrualnopodobnoe bleeding), then - pills of the next pack (even if the bleeding has not stopped) after delivery - non-breastfeeding women - 21 days after abortion - 1 day after surgery.

Precautionary measures:

If between taking tablets has been more than 36 hours, the contraceptive reliability of this cycle can not be guaranteed. Omitting Table 1. the first or second week of the cycle should take 2 tablets. the next day and then - regularly. Omitting Table 2. a row in first or second week cycle - 2 tablets. in the next 2 days and then - regular intake of using additional methods of contraception until the end of the cycle when skipping pills on the third week of the cycle - further ruled 7-day break.

With caution used in the non-ischemic etiology of heart disease, hypertension, diabetes mellitus complicated by vascular lesions, renal dysfunction, epilepsy, chorea Sydenham, bronchial asthma.

Note that oral contraceptives reduced tolerance to carbohydrates and increase the need for insulin or oral antidiabetic agents.

While receiving required medical examination at least every 6 months. After suffering a viral hepatitis application is possible not earlier than 6 months (with normalization of liver function). In the case of vomiting or diarrhea, you must use additional mechanical contraceptive method. During the reception, should stop smoking (increases the frequency of thromboembolic events of various localization, especially in women older than 35 years).

Admission should be discontinued 3 months before the planned pregnancy for 4 weeks before the planned surgery and during prolonged immobilization (eg after injuries), as well as immediately upon creation or strengthening of migraine or unusually severe headache, sudden worsening of vision, suspected thrombosis or heart attack brain sharp rise in blood pressure, jaundice or hepatitis without jaundice, generalized itching, appearance or shortness of epileptic seizures.