Kraj: Izrael
Język: angielski
Źródło: Ministry of Health
NORETHISTERONE ACETATE
BAYER ISRAEL LTD
G03DC02
TABLETS
NORETHISTERONE ACETATE 5 MG
PER OS
Required
BAYER WEIMAR GMBH UND CO.KG, GERMANY
NORETHISTERONE
NORETHISTERONE
Oral progestron for: Dysfunctional bleeding, primary and secondary amenorrhea, premenstrual syndrome, timing of mensturation and endometriosis.
2021-03-31
PACKAGING TECHNOLOGY BERLIN SGQCL page 2 Bayer AG client: JS86 material-no.: 87205878 PZ: 2589W-3B code-no.: name: LF-INS-PRIMOLUT NOR 5MG TAB IL country: IL/-/BAG colors: BLACK version: 21.05.2020/01 Restricted Document dimension: 297 X 594 MM PRIMOLUT®-NOR TABLETS Each tablet contains: Norethisterone acetate 5 mg Inactive and allergenic ingredients: see section 6 “Further Information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. 1) WHAT IS THE MEDICINE INTENDED FOR? Primolut-Nor is intended for use in several circumstances: Progestogenic treatment of dysfunctional menstrual cycles, primary and secondary amenorrhea, pre-menstrual syndrome, menstrual cycle regulation and inflammation of the endometrium (endometriosis). THERAPEUTIC GROUP: Primolut-Nor belongs to a group of medicines called progestogens, which are female hormones. 2) BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive (allergic) to norethisterone acetate or to any of the additional ingredients contained in the medicine. For the list of inactive ingredients, see section 6 “Further Information”. • You are pregnant or think you may be pregnant. • You are breastfeeding. • You have ever suffered from a blood circulation problem, including a blood clot (thrombosis) in the legs (deep vein thrombosis), in the lungs (pulmonary embolism), in the heart (heart attack), in the brain (stroke), or any other part of your body. • You have any symptoms of a blood clot, such as chest pain, shortness of breath and/or sudden, unexplained cough. • You have any condition which raises your risk for a blood clot (thrombosis). • You have ever suffered from a migraine with visual disturbances. • You are suffering (or recoveri Przeczytaj cały dokument
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Primolut-Nor 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 milligrams of norethisterone acetate. Excipient with known effect Lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM. Tablets. White tablets with cross-score on one side and "AP" in regular hexagon on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dysfunctional bleeding, primary and secondary amenorrhea, premenstrual syndrome, timing of menstruation and endometriosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The following dosage schemes are recommended: • DYSFUNCTIONAL BLEEDING The administration of 1 tablet Primolut Nor 5 mg twice daily over 10 days leads to the arrest of uterine bleeding not associated with organic lesions within 1-4 days. In individual cases, bleeding diminishes during the first few days after the commencement of tablet-taking and does not stop until about 5-7 days later. For the treatment to be successful, Primolut Nor administration must be continued regularly even after arrest of bleeding (up to a total of 20 tablets Primolut Nor 5 mg). About 2-4 days after discontinuation of treatment a withdrawal bleeding will occur resembling a normal menstruation in intensity and duration. • SLIGHT BLEEDING DURING TABLET-TAKING Occasionally slight bleeding may occur after initial arrest of bleeding. In these cases tablet- taking must not be interrupted. • MISSING ARREST OF HAEMORRHAGE, HEAVY BREAKTHROUGH BLEEDING If the bleeding does not stop in spite of regular tablet-taking, an organic cause or an extra- genital factor (e.g. polyps, high-situated carcinoma of the cervix uteri or endometrium, myoma, residua of abortion, extra-uterine pregnancy, thrombopenia, thrombasthenia) must be assumed, so that other measures are called for. This applies also in cases where, after initial arrest of haemorrhage, fairly heavy bleeding recurs within a few days even during tablet-taki Przeczytaj cały dokument