Nchi: Malta
Lugha: Kiingereza
Chanzo: Malta Medicines Authority
FINASTERIDE
Merck Sharp & Dohme B.V. Waarderweg 39, Haarlem Noord-Holland, 2031 BN, Netherlands
D11AX10
FINASTERIDE
FILM-COATED TABLET
FINASTERIDE 1 milligram(s)
POM
OTHER DERMATOLOGICAL PREPARATIONS
Authorised
2005-08-25
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PROPECIA 1 MG FILM-COATED TABLETS Finasteride 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 no listed in this leaflet. 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 other information 1. WHAT PROPECIA IS AND WHAT IT IS USED FOR Propecia contains the active substance finasteride. PROPECIA IS FOR USE IN MEN ONLY. Propecia is used for the treatment of male pattern hair loss (also known as androgenetic alopecia) in men aged 18-41. If after reading this leaflet, you have any questions about male pattern hair loss, ask your doctor. Male pattern hair loss is a common condition thought to be caused by a combination of genetic factors and a particular hormone, called dihydrotestosterone (DHT). DHT contributes to shortening of the growth phase of the hair and to thinning of the hair. In the scalp, Propecia specifically lowers the levels of DHT by blocking an enzyme (Type II 5-alpha reductase) that converts testosterone to DHT. Only men with mild to moderate, but not complete hair loss can expect to benefit from the use of Propecia. In most of the men treated with Propecia for 5 years, the progression of hair loss was slowed, and at least half of these men also had some kind of improved hair growth. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROPECIA DO NOT TAKE PROPECIA: • if you are a woman (because this medicine is for men, see Pregnancy). Soma hati kamili
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Propecia 1 mg, film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg of finasteride. Excipients with known effect Each tablet contains 110.4 mg of lactose monohydrate. This medicinal product contains 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 tablet embossed with ‘P’ logo on one side and ‘ Propecia’ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Propecia is indicated in men 18-41 years of age for the early stages of androgenetic alopecia. Propecia stabilizes the process of androgenetic alopecia. Efficacy in bitemporal recession and end-stage hair loss has not been established. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 1 tablet (1 mg) daily 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 stabilization of hair loss can be expected. Continued use is recommended to sustain benefit. If treatment is stopped, the beneficial effects begin to reverse by 6 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 subsequent potential risk to a male foetus (see 4.6 Fertility, pregnancy and lactation). Propecia tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed. _Patients with renal impairment _ 2 No dosage adjustment is required in patients with renal insufficiency. 4.3 CONTRAINDICATIONS Contraindicated in women: see 4.6 Fertility, pregnancy and Soma hati kamili