Index of drugs

Oral contraception in women.

1 package contains 21 tables with a fixed composition: 250 μg of norgestimate and 35 μg of ethinylestradiol.

Single-phase oral contraceptive. Ethinylestradiol and norgestimate - synthetic gestagen with specific progestagenic effect and minimal androgenic effect were used in the preparation. Norgestimate has anti-estrogenic and anti-gonadotropic effects. The properties of gestagen and the balance of doses of the estrogenic and progestagen components cause a number of positive metabolic effects. The preparation may have a beneficial effect on the lipid metabolism of the body - its use increases the concentration of HDL fraction. It reduces the incidence of functional ovarian cysts, fibroids, mastopathy, acute inflammatory pelvic diseases, endometrial cancer and ovarian cancer. It increases the regularity of the menstrual cycle, reduces blood loss, the incidence of iron deficiency anemia and reduces the incidence of dysmenorrhea. After oral administration, norgestimate and ethinylestradiol are rapidly absorbed. Norgestimate is rapidly metabolised during the "first pass" through the intestine and liver to the 17-deacetylergestimate and norgestrel, which are pharmacologically active progestagens. Ethinyl estradiol is metabolised to various hydroxyl metabolites and their conjugated compounds. 17-deacetylergestimat is albumin-bound and not associated with SHBG, while norgestrel is mainly associated with SHBG. Ethinylestradiol is extensively bound to blood albumin. Metabolites of both active substances are excreted in urine and faeces. T_0,5 are respectively: for ethinyl estradiol - 10-15 h, 17-deacetylergestimate - 24.9 h, norgestrel - 45 h.

Hypersensitivity to the active substances or to any of the excipients. Presence or history of thrombophlebitis or other thromboembolic events. Current or previous history of venous thrombosis (deep vein thrombosis, pulmonary embolism). Presence or history of arterial thrombosis (myocardial infarction, cerebral circulation disorders) or prodromal states (eg transient ischemic attack, angina pectoris). The occurrence of severe or complex risk factors for venous thrombosis or arteries. Migraine with focal neurological symptoms. Predispositions for thrombosis (thrombophilia). Valvular heart disease with complications. Severe hypertension (persistent systolic blood pressure ≥160 mmHg or persistent diastolic blood pressure ≥100 mmHg). Diabetes with vascular complications. Current or previous history of acute liver disease until the liver parameters return to normal. Current or previous liver cancer (benign or malignant). Probable or recognized estrogen-dependent cancer of the genital or breast organs. Endometrial hyperplasia. Undiagnosed bleeding from the genital tract. Cholestatic jaundice during pregnancy or jaundice when using oral contraception. Pregnancy or suspected pregnancy.

The risk / benefit ratio of oral contraceptives should be determined for the following disorders: disorders that increase the risk of developing venous thromboembolic events (eg long-term immobilization or major surgical procedures); risk factors for arterial diseases (e.g., smoking, hyperlipidemia, hypertension or obesity); hypertension (constant systolic blood pressure 140-159 mmHg and diastolic blood pressure 90-99 mmHg); diabetes; severe depression now or in the past; smoking tobacco. The oral contraceptive can be used no earlier than 3 months after the return of liver function parameters to normal values ​​after hepatitis; in the case of severe hepatitis, this period is not less than 6 months.In case of first or worsening of migraine or headache with atypical course, recurrent, persistent or severe, the oral contraceptive should be discontinued.

Safety in pregnancy - cat. X. The preparation is contraindicated in pregnancy. It should not be used during breast-feeding.

During the use of the preparation may occur: slight increase in blood pressure, edema; intermenstrual bleeding, spotting, amenorrhea, no withdrawal bleeding, changes in menstrual bleeding, increased uterine fibroids, vaginal candidiasis, exacerbation of cervical erosion and secretion by the cervical glands; breast tenderness, milkworm, breast pain, breast enlargement, reduction of milk secretion (when used immediately after delivery); nausea, vomiting, abdominal cramps, flatulence, colitis; erythema nodosum, skin rash, chloasma, erythema multiforme, acne, seborrhea, alopecia, hirsutism, hypertrichosis, herpes of pregnant women, hyperpigmentation (which may not subside after discontinuation), haemorrhagic effusions; cholestatic jaundice, Budd-Chiari syndrome; change in corneal curvature, intolerance of contact lenses, cataracts; headache, mood changes, depression, irritability, chorea; fluid retention, changes in body weight, impaired Glucose tolerance, changes in appetite; libido changes, premenstrual syndrome; impaired renal function, haemolytic-uremic syndrome. Rarely were hypertension, myocardial infarction, cerebral circulation disorders, deep vein thrombosis, thromboembolic conditions of the arteries, pulmonary embolism and other congestion; benign or malignant liver tumors, cervical cancer, breast cancer; intrahepatic cholestasis, cholelithiasis; severe headache, migraine, damage to the optic nerve.

Oral: 1 tablet once a day at the same time for 21 consecutive days. Over the Next 7 days, no tablets are taken and during this time, usually after 2-4 days, withdrawal bleeding should occur. Taking the tablets from the next pack should begin after a 7-day break, even if the withdrawal bleed is still ongoing, even if the bleeding does not occur.Beginning of the preparation. If during the last month the patient did not use any hormonal contraceptive method, the preparation should be started on day 1 of the cycle (ie on day 1 of menstrual bleeding). In case of switching from another combined oral contraceptive, the preparation should ideally be started on the first day after the last tablet used in the previous cycle of contraceptive, but no later than the first day after the standard 7 day break in taking tablets or taking placebo tablets . When switching from a contraceptive that contains only progestogen, the preparation should be started on the first day after the last tablet of the previous contraceptive. Familiarize yourself with the recommendations for changing the medicine in women who use other types of hormonal contraception (eg transdermal patch, contraceptive injection, etc.).Use after childbirth or miscarriage. After giving birth, women who have decided not to breastfeed can start using the product on the first day of the first spontaneous menstrual bleeding or 3 weeks after delivery, whichever comes first. After an abortion or miscarriage that occurred before the 20th week of pregnancy, oral contraceptives can be started immediately; it is not necessary to use an additional method of contraception; it should be noted that ovulation may occur within 10 days of abortion or miscarriage. After a stimulated or idiopathic miscarriage that occurred in the 20th week of pregnancy or later, the use of hormonal contraceptives may be started on day 21 after a miscarriage or on the first day of the first spontaneous menstrual bleeding, whichever comes first; during the first 7 days of the first cycle of application of the preparation, non-hormonal contraception should be used at the same time.Proceeding if you miss a tablet. If less than 12 hours have passed since the tablet was missed, the contraceptive effectiveness is maintained; omit the tablet should be taken as soon as possible, and the next - at the usual time. If more than 12 hours have passed since the tablet was missed, the effectiveness may be reduced. The procedure in the case of not accepting tablets is based on two basic principles: taking tablets can not be interrupted for more than 7 days; 7 days of uninterrupted tablet intake is necessary to achieve sufficient blockage of the hypothalamo-pituitary-ovary axis. According to these rules, you should proceed in the manner described below. If you miss a tablet in the first week, take it as soon as possible, even if it means taking two tablets at the same time, take your next tablet at the usual time. For the next 7 days an additional non-hormonal contraceptive method should be used. If sexual intercourse was maintained within the 7 days preceding the omission of the tablet, it is possible to become pregnant. The more tablets are missed and the closer the 7-day break in the use of the preparation, the greater the risk of getting pregnant. If you miss a tablet in the second week, take it as soon as possible, even if it means taking two tablets at the same time, take your next tablet at the usual time. If the preparation was taken correctly within 7 days preceding skipping the tablet, no additional contraceptive methods are required. If, however, more than one tablet is omitted, an additional non-hormonal contraceptive method should be used for 7 days. If you miss the tablet in the third week, there are two options for the procedure. If during the 7 days preceding the missed tablet the preparation was used correctly, you can choose one of the following recommendations, without the need for any additional contraceptive methods; otherwise, you should choose option A and use additional methods of contraception for 7 days. A - Skip the tablet as soon as possible, even if it means taking two tablets at the same time, take the next tablets at the usual time, and take the tablets from the next packet immediately after completing the current one without taking a 7-day break (withdrawal bleeding occurs after the completion of the second pack, spotting or intra-cyclic bleeding may occur while taking the tablets). B - You can stop taking the tablets from the current packaging, take 7 days (including the day you missed the tablet), after which you should start taking the tablets from the next pack. Consider the possibility of pregnancy if tablets are missed and subsequent withdrawal bleeding occurs during the first normal interruption of the use of the tablets.Proceedings in the case of gastrointestinal disorders. If vomiting occurs within 3 hours of taking the tablet, and in the case of severe diarrhea persisting for more than 24 hours, the contraceptive effectiveness of the preparation may not be sufficient. You should then take 1 tablet per day continuously for 7 days and at the same time use additional non-hormonal methods of contraception. If vomiting and / or diarrhea will persist, the effectiveness of oral contraceptives can be reduced.Procedure to delay bleeding. To delay the onset of the withdrawal bleed, start the next pack without a 7-day tablet interval and take the tablets from the next pack for the number of days needed. You can take the preparation until the second packet is depleted, and then, after maintaining the 7-day break, start the regular use again.