Kraj: Izrael
Język: angielski
Źródło: Ministry of Health
FINASTERIDE
MERCK SHARP & DOHME ISRAEL LTD
G04CB01
TABLETS
FINASTERIDE 5 MG
PER OS
Required
MERCK SHARP & DOHME UK LTD
FINASTERIDE
FINASTERIDE
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. Pro-cure causes regression of the enlarged prostate, improves urinary flow and improves the symptoms assocciated with BPH. Patients with an enlarged prostate are the appropriate candidates for therapy with Pro-cure.
2015-02-28
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) 1986 This medicine can be sold under doctor's prescription only PRO-CURE ® 5 MG TABLETS Each tablet contains: Finasteride 5 mg For a list of inactive ingredients see section 6.1 "What PRO-CURE 5 MG contains". See also section 2.6 “IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF PRO-CURE 5 MG. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. This leaflet contains concise information about PRO-CURE 5 MG. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their ailment seems similar to yours. The condition which PRO-CURE 5 MG is prescribed occurs only in men. This medicine is not intended for women or children. 1. WHAT PRO-CURE 5 MG IS AND WHAT IT IS USED FOR? THERAPEUTIC GROUP: 5α-reductase inhibitor For the treatment and control of benign prostatic hyperplasia (BPH) to cause regression of the enlarged prostate, and by this improve urinary flow and improve symptoms associated with BPH. PRO-CURE 5 MG reduces the risk of acute urinary retention and the need for prostate surgery. 2. BEFORE YOU TAKE PRO-CURE 5 MG 2.1 DO NOT TAKE PRO-CURE 5 MG IF YOU: are a woman and you are or may potentially be pregnant. Women should also not handle crushed or broken tablets of PRO- CURE 5 MG (see also section 2.5 "pregnancy"). This medicine is not intended for women or children. are hypersensitive (allergic) to finasteride or any of the other ingredients of PRO-CURE 5 MG (for a list of inactive ingredients, see section 6.1). 2.2 SPECIAL WARNINGS CONCERNING USE OF PRO-CURE 5 MG BEFORE STARTING TREATMENT WITH PRO-CURE 5 MG, TELL YOUR DOCTOR IF: you are suffering, or have suffered in the past, from impaired function of the liver. PRO-CURE 5 MG can affect a blood test called PSA. If you have a PSA test done, tell your doctor that you are taking PRO-CURE 5 MG. you are sensi Przeczytaj cały dokument
1 HIGHLIGHTS OF PRESCRIBING INFORMATIONTHESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PRO- CURE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PRO- CURE. PRO-CURE (FINASTERIDE) TABLETS --------------------------- RECENT MAJOR CHANGES --------------------------- ----------------------------INDICATIONS AND USAGE ---------------------------- PRO-CURE, is a 5α-reductase inhibitor, indicated for the treatment and control of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to (1.1): Reduce the risk of acute urinary retention Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. LIMITATIONS OF USE: PRO-CURE is not approved for the prevention of prostate cancer (1.3). ----------------------- DOSAGE AND ADMINISTRATION ----------------------- PRO-CURE may be administered with or without meals (2). Monotherapy: One tablet (5 mg) taken once a day (2.1). Combination with Doxazosin: One tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin_ _(2.2). --------------------- DOSAGE FORMS AND STRENGTHS --------------------- 5-mg film-coated tablets (3). ------------------------------ CONTRAINDICATIONS ------------------------------- Hypersensitivity to any components of this product (4). Women who are or may potentially be pregnant (4, 5.4, 8.1, 16). ----------------------- WARNINGS AND PRECAUTIONS ----------------------- PRO-CURE reduces serum prostate specific antigen (PSA) levels by approximately 50%. However, any confirmed increase in PSA while on PRO-CURE may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for men not taking a 5α-reductase inhibitor (5.1). PRO-CURE may increase the risk of high-grade prostate cancer (5.2, 6.1). Women should not handle crushed or broken PRO-CURE tablets when they are pregnant or may potentially be pregnant due to potential risk to a male fetus (5.3, 8.1, 1 Przeczytaj cały dokument