국가: 몰타
언어: 영어
출처: Medicines Authority
FINASTERIDE
Laboratoires Bailleul S.A. 10-12 Avenue Pasteur L-2310 Luxembourg, Luxembourg
D11AX10
FINASTERIDE 1 mg
FILM-COATED TABLET
FINASTERIDE 1 mg
POM
OTHER DERMATOLOGICAL PREPARATIONS
Authorised
2017-04-05
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FINASTERIDE BIORGA 1 MG FILM-COATED TABLET 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 not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Finasteride Biorga is and what it is used for 2. What you need to know before you take Finasteride Biorga 3. How to take Finasteride Biorga 4. Possible side effects 5. How to store Finasteride Biorga 6. Contents of the pack and other information 1. WHAT FINASTERIDE BIORGA IS AND WHAT IT IS USED FOR Finasteride Biorga contains an active substance called finasteride. FINASTERIDE BIORGA IS FOR THE EXCLUSIVE USE IN MALES. Finasteride Biorga is used for the treatment at early stages of male pattern hair loss (also known as androgenetic alopecia) in men 18-41 years of age. If you have any questions about male hair loss after reading this package leaflet, ask your doctor. Male hair loss is a common disorder believed to be caused by a combination of genetic factors and one specific hormone called dihydrotestosterone (DHT). DHT helps to reduce the hair growth phase and makes hair finer. Finasteride specifically reduces DHT levels on the scalp, blocking an enzyme (II 5-alpha-reductase) that converts testosterone into DHT. Only males with mild to moderate, but not complete, hair loss can expect to benefit from the use of Finasteride Biorga. In many of the males treated with finasteride for 5 years, hair loss progression was slower and hair growth also improved in some way in at least half of those males. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FINA 전체 문서 읽기
1 1. NAME OF THE MEDICINAL PRODUCT Finasteride Biorga 1 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1 mg de finasteride. Excipient(s) with known effect: Each tablet contains 75.00 mg of lactose monohydrate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Round pink-orange film-coated tablet, with an “F1” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Finasteride Biorga is indicated in males between 18 and 41 years old for the treatment of the early phases of androgenetic alopecia. Finasteride Biorga stabilizes the process of androgenic alopecia. Its efficacy on bitemporal recession and loss of hair in the last stage 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 increased dose results in increased effects. Efficacy and duration of the treatment should be frequently evaluated by the doctor responsible for treatment. Three or six month’s daily treatment is usually necessary before any evidence of stabilisation of hair loss can be expected. Continued treatment is recommended to maintain the effect. 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 Crushed or broken tablets of Finasteride Biorga should not be handled by women when they are or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male foetus (see section 4.6 Fertility, pregnancy and lactation). Finasteride Biorga tablets are coated to prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed. Page 2 of 9 Patients with renal impairment No dosage adjustment is required in patients with renal insufficiency. 4.3 CONTRAINDICATIONS Contraindicated in women: see 4.6 ‘Fertility, pregnancy and lactation’ an 전체 문서 읽기