Country: Malasja
Lingwa: Ingliż
Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FINASTERIDE
ORGANON MALAYSIA SDN. BHD.
FINASTERIDE
30Tablet Tablets; 15 Tablet Tablets
AIAC International Pharma, LLC
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ PROSCAR ® TABLET Finasteride (5 mg) 1 Copyright 2023 Organon group of companies. All rights reserved. WHAT IS IN THIS LEAFLET 1. What Proscar is taken for 2. How Proscar works 3. Before you take Proscar 4. How to take Proscar 5. While you are taking Proscar 6. Side effects 7. Storage and Disposal of Proscar 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT PROSCAR IS TAKEN FOR Why your doctor prescribed Proscar? Your doctor has prescribed Proscar because you have a benign prostatic hyperplasia or BPH. Your prostate gland, which is near your bladder, has become bigger and is making it more difficult for you to pass urine. What is the prostate? The prostate is a walnut-sized gland found only in men. It is located below the bladder and it surrounds the urethra, a tube that carries urine from the bladder out through the tip of the penis (see diagram). The prostate's main function is to produce fluid for semen, the fluid that carries sperm. HOW PROSCAR WORKS Proscar is a 5-alpha reductase inhibitor. It shrinks the enlarged prostate gland and relieves urinary symptoms. Proscar will help reduce the risk of developing a sudden inability to pass urine (acute urinary retention) and the need for surgery. BEFORE YOU TAKE PROSCAR What is BPH? BPH is a benign enlargement of the prostate gland which is common in men over 50 years old. Because the prostate is close to the bladder and surrounds part of the urethra, its enlargement may affect your ability to urinate. You may experience symptoms such as a need to urinate often, especially at night, a feeling that you must urinate right away, difficulty in starting to urinate, a weak or interrupted urinary stream, or a feeling that you cannot empty your bladder completely. In some men, BPH can lead to serious problems, including urinary tract infections, a sudden inability to pass urine, as well as the need for surgery. For this reason, a man with symptoms of BPH should see his physici Aqra d-dokument sħiħ
Copyright 2023 Organon group of companies. All rights reserved. PROSCAR LPC-OG0906-5T-072023-Malaysia (finasteride) LOCAL PRODUCT CIRCULAR TABLETS PROSCAR ® (FINASTERIDE) PROSCAR ® (finasteride), a synthetic 4-azasteroid compound is a specific inhibitor of Type II 5 α - reductase, an intracellular enzyme which metabolizes testosterone into the more potent androgen dihydrotestosterone (DHT). In benign prostatic hyperplasia (BPH), enlargement of the prostate gland is dependent upon the conversion of testosterone to DHT within the prostate. PROSCAR is highly effective in reducing circulating and intraprostatic DHT. Finasteride has no affinity for the androgen receptor. In the PROSCAR Long-Term Efficacy and Safety Study (PLESS), the effect of therapy with PROSCAR on BPH-related urologic events (surgical intervention [e.g., transurethal resection of the prostate and prostatectomy] or acute urinary retention requiring catheterization) was assessed over a 4-year period in 3016 patients with moderate to severe symptoms of BPH. In this double- blind, randomized, placebo-controlled multicenter study, treatment with PROSCAR reduced the risk of total urologic events by 51% and was also associated with a marked and sustained regression in prostate volume, and a sustained increase in maximum urinary flow rate and improvement in symptoms. 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. Copyright 2023 Organon group of companies. All rights reserved. Patients with an enlarged prostate are the appropriate candidates for therapy with PROSCAR. PROSCAR administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic Aqra d-dokument sħiħ