Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
finasteride
Accord Healthcare Limited
G04CB01
finasteride
5mg
tablets film-coated
(28/2x14/) in blister
Prescription
Registered
2016-09-19
PACKAGE LEAFLET: INFORMATION FOR THE USER FINASTERIDE 5 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 any further questions, ask your doctor, pharmacist or nurse. − 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 of the side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Finasteride 5 mg Tablets are and what they are used for 2. What you need to know before you take Finasteride 5 mg Tablets 3. How to take Finasteride 5 mg Tablets 4. Possible side effects 5. How to store Finasteride 5 mg Tablets 6. Contents of the pack and other information 1. WHAT FINASTERIDE 5 MG TABLETS ARE AND WHAT THEY ARE USED FOR Finasteride belongs to the group of medicines called 5-alpha reductase inhibitors. They act by reducing the size of the prostate gland in men. Finasteride shrinks the prostate gland in men when it is swollen. Finasteride is used in the treatment and control of benign (i.e., non-cancerous) enlargement of the prostate (benign prostatic hyperplasia - BPH). The prostate gland is found underneath the bladder (but only in man). It produces the fluid found in semen. A swollen prostate gland can lead to a condition called ‘benign prostatic hyperplasia (BPH). Finasteride causes shrinkage of the enlarged prostate, improves urinary flow and symptoms caused by BPH, and reduces the risk of you developing a sudden inability to pass urine (known as acute urinary retention) and the need for surgery. WHAT IS BPH? If you have BPH it means that your prostate gland is swollen. It can press on the tube that urine passes through, on its way out of your body. This can lead to problems such as - Feeling like you need to Прочитать полный документ
FINASTERIDE 5 MG FILM-COATED TABLETS 1. Name of the medicinal product Finasteride 5 mg Film-coated Tablets 2. Qualitative and quantitative composition One film-coated tablet contains 5 mg finasteride Excipient(s) with known effect: lactose monohydrate (90.95 mg) For the full list of excipients, see section 6.1 3. Pharmaceutical form Film-coated tablet. Blue, round biconvex, film-coated tablet with "F5" marking on one side and plain on other side. 4. Clinical particulars 4.1 Therapeutic indications Finasteride 5 mg Tablets are indicated for the treatment and control of benign prostatic hyperplasia (BPH) to: - cause regression of the enlarged prostate, improve urinary flow and improve the symptoms associated with BPH, - reduce the incidence of acute urinary retention and reduce need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride 5 mg tablets should be administered in patients with an enlarged prostate (prostate volume above ca. 40 ml). 4.2 Posology and method of administration For oral use only. The recommended dosage is one 5 mg tablet daily with or without food. The tablet should be swallowed whole and must not be divided or crushed (See section 6.6). Even though improvement can be seen within a short time, treatment for at least 6 months may be necessary in order to determine objectively whether a satisfactory response to treatment has been achieved. Dosage in the elderly Dosage adjustments are not necessary although pharmacokinetic studies have shown that the elimination rate of finasteride is slightly decreased in patients over the age of 70. Dosage in hepatic insufficiency The effect of hepatic insufficiency on the pharmacokinetics of finasteride has not been studied. (See section 4.4). Dosage in renal insufficiency Dosage adjustments are not necessary in patients with varying degrees of renal insufficiency (starting from creatinine clearance as low as 9 ml/min) as in pharmacokinetic studies renal insufficiency was not found to affect the elimination of fin Прочитать полный документ