Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
Finasteride
PCO Manufacturing Ltd.
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
2003-01-10
_ _ _ _ _ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER PROSCAR ® 5 MG FILM-COATED TABLETS finasteride THIS MEDICINE IS FOR USE BY MEN ONLY READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE 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 Proscar is and what it is used for 2. What you need to know before you take Proscar 3. How to take Proscar 4. Possible side effects 5. How to store Proscar 6. Contents of the pack and other information 1. WHAT PROSCAR IS AND WHAT IT IS USED FOR WHAT PROSCAR IS Proscar contains the active substance finasteride. This belongs to a group of medicines called ‘5-alpha reductase inhibitors’. HOW PROSCAR WORKS Proscar shrinks the prostate gland in men when it is swollen. The prostate gland is found underneath the bladder (in men only). It produces the fluid found in semen. A swollen prostate gland can lead to a condition called ‘benign prostatic hyperplasia’ or BPH. 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 urine right away • finding it difficult to start passing urine • when you pass urine the flow of urine is weak • when you pass urine the flow stops and starts • feeling that you cannot empty your bladder completely. In some men, BPH can lead to more serious problems, such as: • urinary tract infections • a sudden inability to pass urine Կարդացեք ամբողջական փաստաթուղթը
Health Products Regulatory Authority 09 September 2022 CRN00D55T Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Proscar 5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 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 Greece, Spain and Poland;_ Blue, apple-shaped, film-coated tablets, marked 'Proscar' on one side and 'MSD 72' on the other. 4 CLINICAL PARTICULARS As per PA23198/007/001 5 PHARMACOLOGICAL PROPERTIES As per PA23198/007/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Microcrystalline cellulose (E460) Docusate sodium Lactose monohydrate Magnesium stearate (E572) Pregelatinised maize starch Sodium starch glycolate (Type A) Yellow iron oxide (E172) Hydroxypropylcellulose (E463) Indigo carmine aluminium lake (E132) Hypromellose (E464) Talc Titanium dioxide (E171) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the container and outer package of the product on the market in the country of origin. Health Products Regulatory Authority 09 September 2022 CRN00D55T Page 2 of 2 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30 °C. Store in the original package in order to protect from light and moisture. 6.5 NATURE AND CONTENTS OF CONTAINER Blister pack containing 14 or 28 tablets contained in an outer cardboard carton. Not all pack sizes may be marketed. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT Women should not handle crushed or broken 'Proscar' Tablets when they are or may potentially be pregnant (see section 4.3.'Contraindications', section 4.6.'Pregnancy and lactation', of SmPC PA23198/007/001, _Exposure to finasteride -risk to male _ _foetus)._ 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturin Կարդացեք ամբողջական փաստաթուղթը