País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DUTASTERIDE
Intega Sdn. Bhd.
DUTASTERIDE
2 x 15 Capsules; 6 x 15 Capsules
Laboratorios Leon Farma S.A.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ INTASTERIDE SOFT GELATIN CAPSULES _Dutasteride 0.5mg_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 1 WHAT IS IN THIS LEAFLET 1. What inTASTERIDE is used for 2. How inTASTERIDE works 3. Before you use inTASTERIDE 4. How to use inTASTERIDE 5. While you are using it 6. Side effects 7. Storage and disposal of inTASTERIDE 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT INTASTERIDE IS USED FOR inTASTERIDE 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 DHT (dihydrotestosterone). HOW INTASTERIDE 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 the need to go to the toilet more 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. InTASTERIDE helps to shrink the prostate and relieve symptoms, by reducing the amount of DHT your body produces. BEFORE YOU USE INTASTERIDE _ _ _When you must not use it _ You must not use inTASTERIDE if you: • are allergic to dutasteride or any of the other ingredients of inTASTERIDE, or to similar medicines known as 5-alpha reductase inhibitors. • if you are female, children and adolescents. This medicine is for adult men only. • if you have severe liver impairment If any of these apply to you, do not take inTASTERIDE until you have checked with your doctor. Women who are pregnant (or may be) must not handle leaking capsules. Dutasteride is absorbed through the skin and can affect the normal development of a male baby. Contact your doctor for advice if a pregnant woman has come into contact with the contents of inTASTERIDE. _ _ _Before you start to use it _ If Llegiu el document complet
LEÓN CODE FRONT SIDE / PLEASE, INCLUDE YOUR DESIGN ON THIS KEYLINE 10 mm 10 mm 490 mm 510 mm 10 mm 202 mm 222 mm 10 mm 340 mm 170 mm 148 mm LAETUS CENTERED WITHIN FINAL FOLDED LAETUS CENTERED WITHIN FINAL FOLDED 37 mm 37 mm BACK SIDE / PLEASE, INCLUDE YOUR DESIGN ON THIS KEYLINE 10 mm 10 mm 490 mm 510 mm 10 mm 202 mm 222 mm 10 mm ONLY FOR POSITION ONLY FOR POSITION 1. NAME OF THE MEDICINAL PRODUCT inTASTERIDE (Dutasteride) 0.5 mg soft gelatin capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 0.5 mg dutasteride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Soft capsule Dutasteride 0.5 mg soft capsules are oblong soft gelatin capsules (approximately 16.5 x 6.5 mm) of light yellow colour, filled with transparent liquid. 4. CLINICAL PARTICULARS ▪ 4.1 Therapeutic indications Monotherapy inTASTERIDE is indicated for the treatment and control of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery. Combination with Alpha-Blocker inTASTERIDE in combination with the alpha-blocker tamslosin is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. ▪ 4.2 Posology and method of administration _Adult males (including elderly)_ Capsules should be swallowed whole and not chewed or opened, as contact with the capsule contents may result in irritation of the oropharyngeal mucosa. inTASTERIDE may be taken with or without food. The recommended dose of inTASTERIDE is one capsule (0.5 mg) taken orally once a day. Although an improvement may be observed at an early stage, treatment for at least 6 months may be necessary in order to assess objectively whether a satisfactory response to the treatment can be achieved. For the treatment of BPH, inTASTERIDE can be administered alone or in combination with the alpha-blocker tamsulosin (0.4mg). _Renal impairment_ The effect of renal impairment on dutasteride pharm Llegiu el document complet