Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
FINASTERIDE
Aurobindo Pharma Limited
G04CB01
FINASTERIDE
5 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Testosterone-5-alpha reductase inhibitors
Transfer Pending
2008-06-20
PACKAGE LEAFLET: INFORMATIONFOR THE USER FINTRID 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 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 Fintrid is and what it is used for 2. What you need to know before you take Fintrid 3. How to take Fintrid 4. Possible side effects 5. How to store Fintrid 6. Contents of the pack and other information 1. WHAT FINTRID IS AND WHAT IT IS USED FOR Fintrid belongs to the group of medicines, called 5-alpha reductase inhibitors. They act by reducing the size of the prostate gland in men. Fintrid is used in the treatment and control of benign enlargement of the prostate (benign prostatic hyperplasia - BPH). It causes regression of the enlarged prostate, improves urinary flow and symptoms caused by BPH, and reduces the risk of acute urinary retention and the need for surgery. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FINTRID DO NOT TAKE FINTRID - if you are allergic to finasteride or any of the other ingredients of this medicine (listed in section 6) - if you are a woman (because this medicine is for men) - if you are a child. _ _ WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Fintrid. − if you have a large amount of residual urine and/or severely reduced urinary flow. If this is the case, you should be closely monitored for narrowing of the urinary tract. − if you have a PSA test (test used to detect prostate cancer). Tell your doctor that you are taking finasteride. Finasteride can affect the blood levels of the substance being tested, PSA. Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fintrid 5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg finasteride. Excipient with known effect: lactose monohydrate (97.5 mg). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Blue coloured, circular, biconvex, beveled edged film-coated tablets debossed with ‘E’ on one side and ‘61’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fintrid 5 mg is 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. Fintrid should be administered in patients with an enlarged prostate (prostate volume above ca. 40ml). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Fintrid is for oral use only. Posology DOSAGE IN ADULTS 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 There is no data available in patients with hepatic insufficiency (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 H E A Lugege kogu dokumenti