Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DUTASTERIDE
GoodScience Sdn. Bhd.
DUTASTERIDE
30 Capsules
Mega Lifesciences Public Company Limited
_Consumer Medication Information Leaflet (RiMUP)_ UROKA DUTASTERIDE SOFT GELATIN CAPSULES 0.5MG Dutasteride Soft Gelatin Capsules (0.5 mg) WHAT IS IN THIS LEAFLET 1. What UROKA is used for • if you are allergic to dutasteride, other 5-alpha reductase inhibitors, UROKA should have their PSA tested regularly. 2. How UROKA works or to any of the other ingredients 3. Before you use UROKA of this medicine. • In a clinical study of men at 4. How to use UROKA • if you have a severe liver disease. increased risk of prostate cancer, 5. While you are using UROKA • If you think any of these apply to men taking UROKA had a serious 6. Side effects you, don’t take this medicine until form of prostate cancer more often 7. Storage and disposal of UROKA you have checked with your than men who did not take UROKA. 8. Product description doctor. The effect of UROKA on this 9. Manufacturer serious form of prostate cancer is not 10. Product registration holder _Pregnancy and Lactation_ clear. WHAT UROKA IS USED FOR UROKA is used to treat men with an enlarged prostate (benign prostatic hyperplasia) - a non-cancerous growth of the prostate gland, caused by producing too much of a hormone called dihydrotestosterone. HOW UROKA WORKS The active ingredient is dutasteride. It belongs to a group of medicines called 5-alpha reductase inhibitors. As the prostate grows, it can lead to urinary problems, such as difficulty in passing urine and a need to go to the toilet frequently. It can also cause the flow of the urine to be slower and less forceful. If left untreated, there is a risk that your urine flow will be completely blocked _(acute _ _urinary _ _retention)_ . This requires immediate medical treatment. In some situations, surgery is necessary to remove or reduce the size of the prostate gland. UROKA lowers the production of dihydrotestosterone, which helps to shrink the prostate and relieve the symptoms. This will reduce the risk of acute urinary retention and the need for surgery. UROKA may also be used with another medicine ca Прочетете целия документ
(DUTASTERIDE SOFT GELATIN CAPSULES 0.5 MG) COMPOSITION: Each soft gelatin capsule contains dutasteride 0.5 mg DESCRIPTION OF THE CAPSULE: Colorless, oily liquid filled in 10 minim, oblong, opaque yellow, soft gelatin capsule. PHARMACODYNAMICS: Pharmacotherapeutic group: testosterone-5-alpha-reductase inhibitors. ATC code: G04C B02. Dutasteride reduces circulating levels of dihydrotestosterone (DHT) by inhibiting both type 1 and type 2, 5 α -reductase isoenzymes which are responsible for the conversion of testosterone to 5 α -DHT. EFFECT ON 5 ALPHA-DIHYDROTESTOSTERONE AND TESTOSTERONE Effect of daily doses of dutasteride on the reduction on DHT is dose dependant and is observed within 1-2 weeks (85% and 90% reduction, respectively). In patients with BPH treated with dutasteride 0.5 mg/day, the median decrease in serum DHT was 94% at 1 year and 93% at 2 years and the median increase in serum testosterone was 19% at both 1 and 2 years. EFFECT ON PROSTATE VOLUME: Significant reductions in prostate volume have been detected as early as one month after initiation of treatment and reductions continued through Month 24 (p<0.001). Dutasteride led to a mean reduction of total prostate volume of 23.6% (from 54.9 ml at baseline to 42.1 ml) at Month 12 compared with a mean reduction of 0.5% (from 54.0 ml to 53.7 ml) in the placebo group. Significant (p<0.001) reductions also occurred in prostate transitional zone volume as early as one month continuing through Month 24, with a mean reduction in prostate transitional zone volume of 17.8% (from 26.8 ml at baseline to 21.4 ml) in the dutasteride group compared to a mean increase of 7.9% (from 26.8ml to 27.5 ml) in the placebo group at Month 12. The reduction of the prostate volume seen during the first 2 years of double-blind treatment was maintained during an additional 2 years of open-label extension studies. PHARMACOKINETICS: ABSORPTION Following oral administration of a single 0.5 mg dutasteride dose, the time to peak serum concentrations of dutasteride is 1 to 3 hours. Th Прочетете целия документ