国家: 马耳他
语言: 英文
来源: Medicines Authority
FINASTERIDE
Merck Sharp & Dohme Limited
D11AX10
FINASTERIDE
FILM-COATED TABLET
FINASTERIDE 1 mg
POM
OTHER DERMATOLOGICAL PREPARATIONS
Authorised
2005-08-25
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PROPECIA 1 MG FILM-COATED TABLETS FINASTERIDE This medicine is for use in men only READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may want 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, please tell your doctor or pharmacist. See section 4 WHAT IS IN THIS LEAFLET: 1. What Propecia is and what it is used for 2. What you need to know before you take Propecia 3. How to take Propecia 4. Possible side effects 5. How to store Propecia 6. Contents of the pack and information. 1. WHAT PROPECIA IS AND WHAT IT IS USED FOR Propecia contains a medicine called finasteride. This belongs to a group of medicines called Type II ‘5- alpha reductase inhibitors’. Propecia is used for the treatment of male pattern hair loss (also known as androgenetic alopecia) in men 18-41. Propecia increases hair growth on the scalp and prevents further hair loss in men. Men with mild to moderate, but not complete hair loss, can benefit from using Propecia. HOW DOES THE HAIR ON YOUR HEAD GROW? On average your hair grows about 1 centimetre (half an inch) each month. Hair grows from hair follicles, which are located under your skin. A single scalp hair grows continuously for 2-4 years (growth phase) and then stops growing for 2-4 mon 阅读完整的文件
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Propecia 1 mg Film-Coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of ‘Propecia’ contains 1 mg of finasteride as the active ingredient. Excipients with known effect; Each tablet contains 110.4 mg of lactose monohydrate. This medicinal product contain less than 1 mmol of sodium per tablet. For a full list of excipients, see section 6.1/ 3. PHARMACEUTICAL FORM Film-coated tablets. Tan octagonal, film-coated, convex tablets, marked with a ‘P’ logo on one side and ‘PROPECIA’ on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ‘Propecia’ is indicated in men 18-41 years of age for the treatment of male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss. ‘Propecia’ is NOT indicated for use in women or children and adolescents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dosage is one 1 mg tablet daily. ‘Propecia’ may be taken with or without food. There is no evidence that an increase in dosage will result in increased efficacy. Efficacy and duration of treatment should continuously be assessed by the treating physician. Generally, three to six months of once daily treatment are required before evidence of stabilisation of hair loss can be expected. Continuous use is recommended to sustain benefit. If treatment is stopped, the beneficial effects begin to reverse by six months and return to baseline by 9 to 12 months. Method of administration Crushed or broken tablets of ‘Propecia’ should not be handled by women when they are or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male foetus (see section 4.6 Fertility, pregnancy and lactation). Page 2 of 9 ‘Propecia’ tablets are coated to prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed. Patients with renal impairment N 阅读完整的文件