Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Finasteride
LTT Pharma 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
Authorised
2016-09-16
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 What Finasteride 5 mg Tablets is and what it is used for What you need to know before you take Finasteride 5 mg Tablets How to take Finasteride 5 mg Tablets Possible side effects How to store Finasteride 5 mg Tablets Contents of the pack and other information WHAT FINASTERIDE 5 MG TABLETS IS AND WHAT IT IS 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 pass urine more often, especially at night * Feeling that you must pass u Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 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 For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from the UK_ Blue, round biconvex, film-coated tablet with "F5" marking on one side and plain on other side. 4 CLINICAL PARTICULARS As per PA1390/013/002 5 PHARMACOLOGICAL PROPERTIES As per PA1390/013/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS _TABLET CORE:_ Lactose monohydrate, Cellulose microcrystalline (E460), Starch pregelatinised (maize) Lauroyl macrogolglycerides, Sodium starch glycolate (type-A), Magnesium stearate (E572) _FILM COATING:_ Hypromellose (E464) Titanium dioxide (E171) Indigo carmine (E132) Macrogol 6000 6.2 INCOMPATIBILITIES Not applicable. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _1_ _/_ _0_ _5_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _6_ _2_ _8_ _8_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the blister and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special storage conditions. 6.5 NATURE AND CONTENTS OF CONTAINER An opaque white (PVC-PVdC /Aluminium) Blister The finasteride 5mg Lue koko asiakirja