Riik: Malta
keel: inglise
Allikas: Medicines Authority
FINASTERIDE
Accord Healthcare Limited
D11AX10
FINASTERIDE
FILM-COATED TABLET
FINASTERIDE 1 mg
POM
OTHER DERMATOLOGICAL PREPARATIONS
Authorised
2011-04-01
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER FINASTERIDE 1 MG FILM-COATED TABLETS Finasteride Read all of this leaflet carefully before you start taking this medicine Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Finasteride 1 mg Tablets are and what they are used for 2. Before you take Finasteride 1 mg Tablets 3. How to take Finasteride 1 mg Tablets 4. Possible side effects 5. How to store Finasteride 1 mg Tablets 6. Further information 1. WHAT FINASTERIDE 1 MG TABLETS ARE AND WHAT THEY ARE USED FOR Finasteride 1 mg Tablets contain finasteride. Finasteride belongs to the group of medicines called 5- alpha reductase inhibitors. Your doctor has prescribed Finasteride 1 mg Tablets because you have male pattern hair loss (also known as androgenetic alopecia). Finasteride 1 mg Tablets prevent further hair loss in men. Men with mild to moderate, but not complete hair loss, can benefit from using Finasteride 1 mg Tablets. Finasteride 1 mg Tablets block an important enzyme (Type II 5α-reductase), which is involved in the regulation of the hair follicle. In the scalp, Finasteride 1 mg Tablets specifically lower the levels of DHT, a major cause of male pattern hair loss. In this way, Finasteride 1 mg Tablets help to reverse the balding process and prevent further hair loss. 2. BEFORE YOU TAKE FINASTERIDE 1 MG TABLETS DO NOT TAKE FINASTERIDE 1 MG TABLETS: If you are allergic (hypersensitive) to finasteride or any of the other ingredients of Finasteride 1 mg Tablets. If you are a child or adolescent. If you are a woman (see also under ‘Pregnancy and breast-feeding’). Finasteride 1 mg Tablets have been found t Lugege kogu dokumenti
Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Finasteride 1 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 1 mg of Finasteride. Excipient(s): Lactose monohydrate 95.58 mg. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. Reddish brown, round, biconvex, film coated tablets, marked ‘F1’ on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Finasteride 1 mg is indicated for treatment of the first stage of the hair loss (androgenetic alopecia) in males. Finasteride 1 mg stabilizes the process of the androgenetic alopecia in the 18-41 year old males. Its effectiveness in bitemporary recession nor in the loss of hair has not been determined. Finasteride is not indicated for use in women or children and adolescents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use only. The recommended dosage is one 1 mg tablet daily. Finasteride Accord 1mg may be taken with or without food. The tablet should be swallowed whole and must not be divided or crushed (See section 6.6). Page 2 of 10 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. 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 Lugege kogu dokumenti