Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Norethisterone
DE Pharmaceuticals
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 Lees het volledige document
OBJECT 1 NORETHISTERONE 5MG TABLETS Summary of Product Characteristics Updated 21-Feb-2017 | Wockhardt UK Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 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 res Lees het volledige document