देश: माल्टा
भाषा: अंग्रेज़ी
स्रोत: Medicines Authority
FINASTERIDE
Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland
D11AX10
FINASTERIDE 1 mg
FILM-COATED TABLET
FINASTERIDE 1 mg
POM
OTHER DERMATOLOGICAL PREPARATIONS
Withdrawn
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 BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have 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. WHAT IS IN THIS LEAFLET 1. What Finasteride 1 mg Tablets are and what they are used for 2. What you need to know 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. Contents of the pack and other 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FINASTERIDE 1 MG TABLETS DO NOT TAKE FINASTERIDE 1 MG TABLETS: • If you are allergic to finasteride or any of the other ingredients of this medicine (listed in Section 6). • If you are a child or adole पूरा दस्तावेज़ पढ़ें
Page 1 of 9 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 Posology 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). 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 months. Method of administration Page 2 of 9 For oral use only. _DOSAGE IN RENAL INSUFFICIENCY _ No dosage adjustment is required in patients with renal insufficiency. _DOSAGE IN HEPATIC INSUFFICIENCY _ There are no data available in patients with hepatic insufficiency 4.3 CONTRAINDICATIONS Finasteride should not be used in children / adolescents. Contraindicated in women and children (see section 4.4 ‘special warning पूरा दस्तावेज़ पढ़ें