Index of drugs

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

1 tabl contains 1500 μg levonorgestrel. The preparation contains lactose.

The exact mechanism of action of levonorgestrel as a contraceptive for emergency use is unknown. Levonorgestrel is thought to work primarily by preventing ovulation and fertilization, as long as sexual intercourse has occurred in the preovulatory period when the likelihood of conception is greatest. It can also cause changes in the endometrium that impede implantation. It is not effective if the implantation process has already begun. After oral administration, levonorgestrel is very quickly and almost completely absorbed. After accepting 1 tabl. The maximum serum concentration occurs after 2 hours. The course of biotransformation is typical for steroid metabolism. Levonorgestrel binds to serum albumin and sex hormone binding globulin (SHBG). Only about 1.5% of total serum concentration is an unbound fraction, while 65% of levonorgestrel is specifically bound to SHBG. The absolute bioavailability was determined to be almost 100% of the administered dose. Medium T_0,5 in the phase of elimination is about 26 h. Levonorgestrel is not excreted unchanged, only in the form of metabolites. Metabolites are excreted in almost equal amounts in urine and faeces.

Hypersensitivity to the active substance or to any of the excipients.

Emergency contraception is a sporadic method and should not replace other regular contraception. Emergency contraception does not always prevent unwanted pregnancy. If it is not completely certain that an unprotected sexual intercourse has been completed or if it has been more than 72 hours since the unprotected intercourse which occurred in the same menstrual cycle, fertilization may occur. Therefore, the use of levonorgestrel after the second sexual intercourse may not be effective in preventing pregnancy. If menstrual bleeding is delayed by more than 5 days or on the day of the expected menstruation, unusual bleeding or any other suspicion of pregnancy occurs, pregnancy should be ruled out. If pregnancy is found despite the use of levonorgestrel, the possibility of an ectopic pregnancy should be considered. Ectopic pregnancy may develop despite the occurrence of uterine bleeding. Levonorgestrel is not recommended in patients at risk of ectopic pregnancy (inflammation of the fallopian tube or ectopic pregnancy). Levonorgestrel is not recommended in patients with severe hepatic impairment. Severe malabsorption syndromes, e.g. in the course of Crohn's disease, may reduce the efficacy of levonorgestrel. After applying the preparation, menstrual bleeds are usually normal and occur within the prescribed period. Sometimes they may occur a few days earlier or later. In such cases, your doctor may recommend starting or changing the method of regular contraception. If, after the use of levonorgestrel by a woman using regular hormonal contraception, there is no withdrawal bleeding during the subsequent period of tablet interruption, pregnancy should be ruled out. Repeated use is not recommended in one menstrual cycle due to the risk of cycle disorders. The product is not recommended for use in children; There is very limited data on the use of the preparation in women under the age of 16. The preparation contains lactose - should not be used by patients suffering from hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

The preparation should not be given to pregnant women. The drug does not break the existing pregnancy. Levonorgestrel passes into breast milk.The potential exposure of the infant to the drug can be reduced if the nursing woman accepts the tablet. immediately after feeding and will not breastfeed immediately after taking the drug.

Very common: headache, nausea, abdominal pain, bleeding unrelated to menstruation (transient menstrual cycle disorders may occur, however, in most women, menstrual bleeding occurs within 7 days of the expected date), fatigue. Common: dizziness, diarrhea, vomiting, menstrual delay by more than 7 days (if menstrual bleeding occurs with a delay of more than 5 days, pregnancy should be excluded), irregular menstrual bleeding, breast tenderness. Very rare: abdominal pain, rash, urticaria, pruritus, pelvic pain, painful menstruation, and swelling of the face.

Orally. 1 tabl should be taken as soon as possible, preferably within 12 hours and not later than 72 hours after sexual intercourse without the use of effective protection. If vomiting occurs within 3 hours of taking the tablet, 1 more tablet should be taken immediately. The preparation can be used on any day of the menstrual cycle, provided that the menstrual period is not delayed. After using emergency contraception, it is recommended to use a local barrier method (eg condom, vaginal ring, spermicides, cervical cap) until the Next menstrual bleeding. The use of levonorgestrel is not a contraindication for the continued use of regular hormonal contraception.