Index of drugs

Emergency contraception for use within 72 hours after sexual intercourse without the use of an effective contraceptive, also in the case of failure of the contraceptive method used.

1 tabl contains 750 μg levonorgestrel. The preparation contains lactose.

The exact mechanism of action of the preparation is not known. It is believed that levonorgestrel used as recommended works mainly by inhibiting ovulation and fertilization, as long as sexual intercourse occurred in the preovulatory period when the likelihood of conception is greatest. The preparation may also cause changes in the endometrium, which reduce the possibility of implantation. The preparation is not effective if the implantation process has already begun. It is estimated that the effectiveness of the preparation decreases over time from unprotected intercourse (95% after intake within 24 h, 85% after admission within 24-48 h and 58% after admission within 48-72 h). Levonorgestrel used as prescribed does not significantly affect blood coagulation factors or lipid or carbohydrate metabolism. After oral administration, the preparation is absorbed quickly and almost completely. After the adoption of 2 tabl. within 12 h maximum blood concentration occurs after 2 h. T_0,5 is 26 h. Levonorgestrel is excreted as metabolites in almost equal amounts in urine and faeces. Levonorgestrel is associated with plasma albumin and sex hormone binding globulin (SHBG). Only about 1.5% of the total concentration of levonorgestrel in the blood is free and 65% is specifically bound to SHBG. The absolute bioavailability of levonorgestrel was determined to be almost 100% of the administered dose.

Hypersensitivity to levonorgestrel or other ingredients of the preparation.

Emergency contraception is a sporadic method and in no case can replace a routine method of contraception and does not always prevent unwanted pregnancy. If there is no absolute certainty about the exact time of sexual intercourse without an effective contraceptive or if the preparation is used later than 72 h after the intercourse has been completed in the same menstrual cycle, fertilization may occur. Use of the preparation after the second sexual intercourse may also not ensure effective contraception. If menstrual bleeding is delayed for more than 5 days or if there is abnormal bleeding on the day of the expected menstruation, or if there is any other suspicion of pregnancy, pregnancy should be ruled out. If pregnancy is detected despite the use of the preparation, the risk of an ectopic pregnancy should be considered. Ectopic pregnancy may develop despite uterine bleeding. It is not recommended for use in women with severe hepatic impairment. Malabsorption syndromes, e.g. in the course of Crohn's disease, may reduce the effectiveness of the preparation. After the use of the drug, menstrual bleeding is usually normal and occurs within the prescribed period; sometimes it may occur a few days earlier or later. In such cases, the patient should be advised to start or change the method of regular contraception. If a woman regularly uses hormonal contraception and no menstruation occurs in the Next period of not taking birth control pills, pregnancy should be ruled out. Repeated use of the preparation in the same menstrual cycle is not recommended due to the possibility of menstrual cycle disorders. The product is not intended for use in children; data on use in girls under 16 are very limited. The product contains lactose - should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

The preparation should not be used during pregnancy. The preparation does not break the existing pregnancy. Epidemiological studies show that if the preparation turned out to be ineffective and pregnancy occurred, it does not adversely affect the fetus.Levonorgestrel passes into breast milk. Exposure of an infant to levonorgestrel can be reduced if the woman takes the tablets immediately after breastfeeding and will not breast-feed immediately after taking the tablets.

Very common: bleeding unrelated to menses, headache, nausea, abdominal pain, tiredness. Common: menstrual delay by more than 7 days, irregular bleeding and menstrual staining, breast tenderness, dizziness, diarrhea, vomiting. Very rare: rash, hives, pruritus, swelling of the face. Transient menstrual cycle disorders may occur, however in most women the next menstrual bleeding occurs in the expected time. If subsequent menstrual bleeding occurs with a delay of more than 5 days, pregnancy should be ruled out.

Orally. In order to achieve the greatest contraceptive effectiveness, 2 tables should be taken: first as soon as possible after sexual intercourse without the use of an effective contraceptive (no later than 72 hours); the second - after 12 hours from the first dose. If you vomit within 3 hours of taking the tablet, you should take one more tablet immediately. The preparation can be used on any day of the menstrual cycle, provided that the menstrual period is not delayed. After applying the preparation, it is recommended to use a local barrier method (a condom, an intrauterine disc or a cervical cap) until the next menstrual period. The use of the preparation is not a contraindication for the continued use of another hormonal contraceptive.