Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Finasteride
Aurobindo Pharma (Malta) Limited
G04CB; G04CB01
Finasteride
5 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Testosterone-5-alpha reductase inhibitors; finasteride
Not marketed
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. It binds to the enzyme 5-alpha reductase, thereby inhibiting the formation of the substance that plays a role in the enlargement of the prostate. As a result of this inhibition, further enlargement of the prostate is prevented. With longer term use, the enlarged prostate becomes smaller in most cases. This medicine is intended for use with men only. WHY HAS YOUR DOCTOR PRESCRIBED FINTRID? Finasteride is a specific enzyme inhibitor that is used to treat men with benign prostatic enlargement (benign prostatic hyperplasia, BPH). Fintrid reduces the enlarged prostate and relieves urinary tract symptoms. This medicine reduces the risk of suddenly being unable to urinate (acute urinary retention) and having to undergo 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. The condition for which Fintrid is prescribed only affects men. Women who a Leggi il documento completo
Health Products Regulatory Authority 12 October 2020 CRN009K13 Page 1 of 8 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 Dosage The recommended dose is one Fintrid5 mg tablet daily (equivalent to 5 mg finasteride). Fintrid can be given alone or in combination with the alpha-blocker doxazosin (see section 5.1Pharmacodynamic properties). Posology Dosage in adults 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 Leggi il documento completo