Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Norethisterone
Bayer Plc
G03AC01
Norethisterone
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06040102; GTIN: 5016703003762
v013_0 Page 1 of 9 Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes. If you have any doubts or queries about your medication, please contact your doctor or pharmacist. PACKAGE LEAFLET: INFORMATION FOR THE USER PRIMOLUT N 5 mg tablets (norethisterone) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Primolut N is and what it is used for 2. What you need to know before you take Primolut N 3. How to take Primolut N 4. Possible side effects 5. How to store Primolut N 6. Contents of the pack and other information 1. WHAT PRIMOLUT N IS AND WHAT IT IS USED FOR Primolut N contains norethisterone, which belongs to a group of medicines called _ progestogens_, which are female hormones_._ Primolut N can be used in several different circumstances: to treat irregular, painful or heavy periods to treat endometriosis (where tissue from the lining of the womb is present in places where it is not normally found) v013_0 Page 2 of 9 to treat premenstrual syndrome (also known as premenstrual tension, PMS or PMT) to delay periods 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRIMOLUT N _ _ Your doctor will discuss your medical and family history with you. Your doctor will also need to check your blood pressure and make sure you are not pregnant. You may also need additional checks, Lesen Sie das vollständige Dokument
OBJECT 1 PRIMOLUT N Summary of Product Characteristics Updated 10-Oct-2017 | Bayer plc 1. Name of the medicinal product Primolut N ® 2. Qualitative and quantitative composition Each tablet contains 5 milligrams of norethisterone BP. Excipient with known effect Lactose For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet. White, uncoated tablets impressed with 'AN' in a regular hexagon on one side. 4. Clinical particulars 4.1 Therapeutic indications Metropathia haemorrhagica. Premenstrual syndrome. Postponement of menstruation. Endometriosis. Menorrhagia. Dysmenorrhoea. 4.2 Posology and method of administration Posology Not intended for use in children. _Metropathia haemorrhagica (dysfunctional uterine bleeding): _1 tablet 3 times daily for 10 days. Bleeding is arrested usually within 1-3 days. A withdrawal bleeding resembling normal menstruation occurs within 2-4 days after discontinuing treatment. One tablet twice daily from the 19 th to the 26 th day of the two subsequent cycles should be given to prevent recurrence of the condition. To ensure treatment success, Primolut N must be taken for the full 10 days. Occasionally, slight bleeding may occur after the initial suspension of bleeding. Treatment should not be interrupted or suspended in these cases. If vaginal bleeding does not stop, despite correct tablet intake, an organic cause or an extra-genital factor (e.g. polyps, carcinoma of the cervix uteri or endometrium, myoma, residua of abortion, extra-uterine pregnancy, or coagulation disorders) must be considered so that other measures are then mostly required. This also applies to cases where after an initial suspension of bleeding, fairly heavy bleeding reoccurs during tablet intake. _Premenstrual syndrome (including premenstrual mastalgia): _Premenstrual symptoms such as headache, migraine, breast discomfort, water retention, tachycardia, and psychological disturbances may be relieved by the administration of 1-3 tablets daily from the 19 th to the 26 th day of the cycle. Treatm Lesen Sie das vollständige Dokument