Gedeon Richter


Pharmline Marketing
Full Prescribing Info
Premenstruation syndrome, postponement of menstruation, mastodynia, dysfunctional uterine bleeding, endometriosis. Dysfunctional disturbances in bleeding during the menopause.
Dosage/Direction for Use
Premenstrual syndrome, mastodynia: 5-10 mg (1-2 tablets) daily from the 16-25 day of the cycle, possibly with oestrogen.
Dysfunctional uterine bleeding (provided the functional nature of the bleeding was confirmed by a histological test within 6 months): 6-12 days daily 5-10 mg (1-2 tablets). To prevent any relapse daily 5-10 mg (1-2 tablets) from the 16 to the 25 day of the cycle, in general combined with oestrogen.
Endometriosis: 5 mg (1 tablet) daily from the 5th to 25th day of the cycle for 6 months, or if taken continuously, it should be begun with 2.5 mg (half a tablet) daily from the 5th day of the cycle and to prevent intermenstrual bleedings the dose should be increased by half a tablet every 2-3 weeks for as long as 4-6 months.
Postponement of menstruation: In cases of too frequent menstrual bleeding, and in special circumstances (e.g. operations, travel, sports) the postponement of menstruation is possible. Take 1 tablet of Norcolut three times daily for no longer than 10 to 14 days, starting 3 days before the expected onset of menstruation. A normal period should occur 2-3 days after the patient has stopped taking tablets.
Dysfunctional disturbances during the menopause: A daily dose of 5 mg (1 tablet) is recommended as a cure, for a longer period of time. Provided this therapy should be prove unsuccessful, it is necessary to complete same by daily 25-50 μg ethinyloestradiol (Mikrofollin tablet).
Puberty, pregnancy, mammary and genital carcinoma. Especially if the drug has to be taken permanently, the following cases should be judged separately: cardiac and renal diseases, asthma bronchiale, epilepsy, predisposition for thrombosis, hepatitis, disturbances in liver function.
Lactation, history of migraine with focal symptoms, diabetes with vascular involvement, presence or history of liver tumours (benign or malignant), hypersensitivity, Dublin Johnson syndrome, history during pregnancy of idiopathic jaundice, severe pruritis or herpes gestations.
Malignancy should be excluded before Norcolut treatment. Oncological control is necessary before the administration. Venous thromboembolism, diabetes, chloasma, depression and conditions where the immediate discontinuation of the norethisterone is necessary.
Use In Pregnancy & Lactation
This drug is contraindicated in pregnancy.
Side Effects
Headache, nausea, vomiting, breast tension, gastrointestinal complaints, intermenstrual bleeding, fluid retention, paraesthesia, a change in body weight, fatigability occuring rarely and generally ceasing during the later cycles.
Drug Interactions
It should be administered with caution together with enzyme inducers (they may accelerate its metabolism).
ATC Classification
G03DC02 - norethisterone ; Belongs to the class of estren derivative progestogens used in progestogenic hormone preparations.
Tab 5 mg x 20's.
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Sign up for free
Already a member? Sign in