Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Finasteride
Ennogen Healthcare Ltd
D11AX10
Finasteride
1mg
Oral tablet
Oral
No Controlled Drug Status
Invalid to prescribe in NHS primary care
BNF: 13090000
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 Đọc toàn bộ tài liệu