Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Norethisterone
Sigma Pharmaceuticals Plc
G03AC01
Norethisterone
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06040102
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 Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Norethisterone 5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Norethisterone 5.0mg. _ _ For the full list of_ _excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. Norethisterone 5mg Tablets are 6.5mm, round, white, uncoated tablets with “NE 5” on one side and a break line on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _At low dose: _ Dysfuntional uterine bleeding Polymenorrhoea Menorrhagia Metropathia Haemorrhagia Pre-menstrual syndrome Postponement of menstruation _At high dose: _ Disseminated carcinoma of the breast._ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology _Low dose _ DYSFUNCTIONAL UTERINE BLEEDING, POLYMENORRHOEA, MENORRHAGIA, DYSMENORRHOEA AND METROPATHIA HAEMORRHAGIA: 1 tablet three times daily for 10 days; bleeding usually stops within 48 hours. Withdrawal bleeding resembling true menstruation occurs a few days after the end of treatment. One tablet twice daily, from days 19 to 26 of the two subsequent cycles, should be given to prevent recurrence of the condition. ENDOMETRIOSIS: 1 tablet three times daily for a minimum treatment period of six months. The dosage should be increased to 4 or 5 tablets a day if spotting occurs. The initial dosage should be resumed when bleeding or spotting stops. POSTPONEMENT OF MENSTRUATION: 1 tablet three times daily, starting three days before the expected onset of menstruation. Menstruation usually follows within three days of finishing the treatment. PRE-MENSTRUAL SYNDROME: 1 tablet daily from days 16 to 25 of the menstrual cycle. _ _ _High dose _ For disseminated breast carcinoma the starting dose is 8 tablets (40mg) per day increasing to 12 tablets (60mg) if no regression is noted._ _ Method of administration Oral Administration 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or any of the excipients listed in section 6.1 Pregnancy Previous idiopathic or current venous thromboembolism (deep vein thrombosis, pulmonary embolism) Active or Прочитайте повний документ