Nazione: Malesia
Lingua: inglese
Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DUTASTERIDE
SYNERRV SDN BHD
DUTASTERIDE
30 Capsules
Aurobindo Pharma Limited (Unit VII)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 DUTABIT 0.5 (DUTASTERIDE SOFT CAPSULE 0.5MG) DUTASTERIDE (0.5MG) WHAT IS IN THIS LEAFLET 1. What DUTABIT is used for 2. How DUTABIT works 3. Before you use DUTABIT 4. How to use DUTABIT 5. While you are using it 6. Side Effects 7. Storage and Disposal of DUTABIT 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT DUTABIT IS USED FOR DUTABIT 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 DUTABIT 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 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. DUTABIT helps to shrink the prostate and relieve symptoms, by reducing the amount of DHT your body produces. BEFORE YOU USE DUTABIT - _When you must not use it _ if you are allergic (hypersensitive) to dutasteride or to any of the other ingredients of DUTABIT, or to other 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 DUTABIT 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 DUTABIT capsule. - _Before you start to use it _ If you have liver disease, check with your doctor that DUTABIT is suitable for you. You may need extra check-ups while you are t Leggi il documento completo
NAME OF THE MEDICINAL PRODUCT: Dutasteride Soft Capsules 0.5 mg (TRADE) NAME OF PRODUCT: DUTABIT 0.5 STRENGTH : 0.5 mg. PHARMACEUTICAL DOSAGE FORM: Soft Capsules. QUALITATIVE AND QUANTITATIVE COMPOSITION Dutasteride Soft Capsules 0.5 mg: Each Capsule contains Dutasteride Ph. Eur. 0.5 mg. PHARMACEUTICAL FORM: Dull yellow, opaque, oblong shaped, size ‘6’ soft gelatin capsule containing clear colorless to pale yellow viscous oil. CLINICAL PARTICULARS Therapeutic indications _Monotherapy:_ Dutasteride 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:_ Dutasteride in combination with the alpha-blocker tamsulosin is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. POSOLOGY AND METHOD OF ADMINISTRATION Adult Males (Including Elderly): Recommended Dose: 1 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. Treatment of BPH: Dutasteride can be administered alone or in combination with the α-blocker, tamsulosin (0.4 mg). RENAL IMPAIRMENT: The effect of renal impairment on dutasteride pharmacokinetics has not been studied. However, no adjustment in dosage is anticipated for patients with renal impairment. HEPATIC IMPAIRMENT: The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied so caution should be used in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the use of dutasteride is contraindicated.. Administration: Capsules should be swallowed whole and not chewed or opened, as contact with the capsule contents may result in irritation of the oropharyngeal mucosa. Dutasteride may be taken with o Leggi il documento completo