Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Finasteride
DE Pharmaceuticals
D11AX10
Finasteride
1mg
Oral tablet
Oral
No Controlled Drug Status
Invalid to prescribe in NHS primary care
BNF: 13090000
PACKAGE LEAFLET: INFORMATION FOR THE USER FINASTERIDE 1MG FILM-COATED TABLETS 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 not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Finasteride 1mg Tablets are and what they are used for 2. What you need to know before you take Finasteride 1mg Tablets 3. How to take Finasteride 1mg Tablets 4. Possible side effects 5. How to store Finasteride 1mg Tablets 6. Contents of the pack and other information. 1. WHAT FINASTERIDE 1MG TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FINASTERIDE 1MG TABLETS Your doctor has prescribed these tablets because you have the early stages of male hair loss, which is also known as androgenetic alopecia (AGA). Finasteride 1mg Tablets are used to prevent hair loss and to encourage hair growth in men. The active substance (which makes this medicine work) is finasteride. Finasteride is a type of medicine called a 5-alpha-reductase inhibitor. DO NOT TAKE FINASTERIDE 1MG TABLETS IF YOU - are ALLERGIC to finasteride or any of the other ingredients in these tablets, listed in Section 6. - are a WOMAN (because this medicine is for men). It has been shown in clinical trials that Finasteride does not work in women with hair loss - are already taking finasteride or dutasteride used for a prostate problem called benign prostatic hyperplasia (BPH). Do not take Finasteride if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist. WARNING AND PRECAUTIONS TALK TO YOUR DOCTOR BEFORE TAKING FINASTERIDE 1MG TABLETS • if you are Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Finasteride 1mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1mg of finasteride. Excipient(s): Each tablet also contains 44mg of lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Light brown, round biconvex film-coated tablet debossed with “FIN” on one side and “1” on reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Early stages of androgenetic alopecia in men, Finasteride 1mg Film-coated Tablets stabilizes the process of androgenetic alopecia in men 18-41 years of age. Efficacy in bitemporal recession and end-stage hair loss has not been established. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: oral use. Men: 1mg once daily with or without food for 3-6 months before any noticeable difference is evident. There is no evidence that higher doses of finasteride result in increased efficacy. Efficacy and duration should be continuously assessed by the treating physician. Generally, continued treatment for 3-6 months is required before stabilisation of hair loss can be expected. Continued treatment is advised to sustain benefit. If treatment is stopped, the beneficial effects begin to reverse after about 6 months, and return to baseline after 9-12months. No data are available on the concomitant use of Finasteride with topical minoxidil for the treatment of male hair loss. _Dosage in the elderly. _ _No dosage adjustment is required in the elderly (see section _ _5.2)._ _Dosage in renal insufficiency._ _ Dosage adjustments are not necessary (see section _ _5.2)_ _Dosage in hepatic insufficiency._ There are no data available for the use of finasteride in patients with hepatic insufficiency (see section 4.4 and 5.2). _ _ _Children: _ This medicine should not be administered to children (see section 4.3). Finasteride 1 mg Film-coated Tablets is contraindicated in children (see section 4.3) 4.3 CONTRAINDICATIONS Contra-indicated in w Lugege kogu dokumenti