Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Finasteride
Organon Pharma (Ireland) Limited
G04CB; G04CB01
Finasteride
5 milligram(s)
Film-coated tablet
Testosterone-5-alpha reductase inhibitors; finasteride
Marketed
1992-08-10
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 • the need for Pročitajte cijeli dokument
Health Products Regulatory Authority 30 July 2021 CRN00C7P3 Page 1 of 7 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 of the active ingredient finasteride. Excipients with known effect: Each tablet contains 102mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet). Blue, apple‑shaped, film-coated tablets, marked 'PROSCAR' on one side and 'MSD 72' on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ‘Proscar’ is indicated for the treatment and control of benign prostatic hyperplasia (BPH) and for the prevention of urologic events to: - reduce the risk of acute urinary retention - reduce the risk of surgery including transurethral resection of the prostate (TURP) and prostatectomy. ‘Proscar’ causes regression of the enlarged prostate, improves urinary flow and improves the symptoms associated with BPH. Patients with an enlarged prostate are the appropriate candidates for therapy with ‘Proscar’. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dosage is one 5 mg tablet daily, with or without food. Method of administration 'Proscar' can be administered alone or in combination with the alpha-blocker doxazosin (see section 5.1 'Pharmacodynamic properties'). Although early improvement in symptoms may be seen, treatment for at least six months may be necessary to assess whether a beneficial response has been achieved. The risk of acute urinary retention is reduced within four months of treatment. _Use in renal insufficiency_ No adjustment in dosage is required in patients with varying degrees of renal insufficiency (creatinine clearances as low as 9 ml/min), as pharmacokinetic studies did not indicate any change in the disposition of finasteride. _Use in the elderly_ No dosage adjustment is required in elderly patients. 4.3 CONTRAINDICATIONS 'Proscar' is not indicated for use in women Pročitajte cijeli dokument