Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Norethisterone
Sandoz Ltd
G03AC01
Norethisterone
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06040102; GTIN: 5015915871015
CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Non-Regulatory Changes in detail: • New regulatory text PACKAGE LEAFLET: INFORMATION FOR THE USER NORETHISTERONE 5MG TABLETS NORETHISTERONE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. The name of your medicine is Norethisterone 5mg Tablets. In the rest of this leaflet it is called Norethisterone Tablets. WHAT IS IN THIS LEAFLET: 1. What Norethisterone Tablets are and what they are used for 2. What you need to know before you take Norethisterone Tablets 3. How to take Norethisterone Tablets 4. Possible side effects 5. How to store Norethisterone Tablets 6. Contents of the pack and other information 1. WHAT NORETHISTERONE TABLETS ARE AND WHAT THEY ARE USED FOR Norethisterone Tablets is one of a group of medicines called ‘Progestogens’. Progestogens are similar to the natural female hormone progesterone. Norethisterone Tablets contains the progestogen called norethisterone as the active ingredient. Norethisterone Tablets has many uses. You can take Norethisterone Tablets to treat or manage: • Heavy periods • Painful periods • Irregular periods or periods that are more frequent than normal • Premenstrual tension (PMT) • Endometriosis (where tissue from your womb is found outside your womb) • Breast cancer. Your doctor may also prescribe Norethisterone Tablets if you want to delay your next period. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORETHISTERONE TABLETS Norethisterone Tablets may not be suitable for all women. Please read t Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT NORETHISTERONE TABLETS BP 5mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5mg of Norethisterone. Excipients with known effect Each tablet contains 70.52mg of lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Metropathia haemorrhagica. • Premenstrual syndrome. • Postponement of menstruation. • Dysmenorrhoea. • Endometriosis. • Menorrhagia. • Disseminated Carcinoma of the breast. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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. Prophylaxis against recurrence of dysfunctional bleeding: If there are no signs of resumption of normal ovarian function (no rise of morning temperature in the second half of the cycle), recurrence must be anticipated. Cyclical bleeding can be established with 1 tablet twice daily from the 19th to the 26th day of the cycle. Premenstrual syndrome (including premenstrual mastalgia): Premenstrual symptoms such as headache, migraine, breast discomfort, water retention, tachycardia and psychic disturbances may be relieved by the administration of 2-3 tablets daily from the 19th to the 26th day of the cycle. Treatment should be repeated for several cycles. When treatment is stopped, the patient may remain symptom-free for a number of months. Postponement of menstruation: In cases of too frequent menstrual bleeding, and in special circumstances (eg operations, travel, sports) Dosage: 1 tablet three times daily, starting 3 days before the expected onset of menstruation. A normal period should occur 2-3 days after the patient has stopped taking tablets. Dysmenorrhoea: functional or primary dysmenorrhoea is almost invariably relieved by the suppression of ovulation. Lue koko asiakirja