País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IRBESARTAN
KOMEDIC SDN BHD
IRBESARTAN
14tablet Tablets; 28tablet Tablets; 30tablet Tablets; 60tablet Tablets; 100tablet Tablets
MEDOCHEMIE LTD
_Consumer Medication Information Leaflet (RiMUP) _ CONVERIUM Irbesartan (150mg, 300mg) 1 WHAT IS IN THIS LEAFLET 1. What CONVERIUM is used for 2. How CONVERIUM works 3. Before you use CONVERIUM 4. How to use CONVERIUM 5. While you are using it 6. Side effects 7. Storage and disposal of CONVERIUM 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT CONVERIUM IS USED FOR CONVERIUM is used - To treat high blood pressure (_essential hypertension_) - To protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function - Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (>300 mg/day) in patients with type 2 diabetes and hypertension. In this population, Converium reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation). HOW CONVERIUM WORKS CONVERIUM belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. BEFORE YOU USE CONVERIUM _When you must not use it _ DO NOT TAKE CONVERIUM: - If you are allergic (hypersensitive) to irbesartan or any other ingredients of CONVERIUM - If you are more than 3 months pregnant (it is also better to avoid CONVERIUM in early pregnancy – see pregnancy section) Converium should not be given to children and adolescents (under 18 years) _Pregnancy and Lactation _ You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking Converium before yo Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Converium 150mg tablets Converium 300mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Converium tablets 150mg: each tablet contains 150mg irbesartan Converium tablets 300mg: each tablet contains 300mg irbesartan Excipients: 31.0mg of lactose monohydrate per Converium 150mg tablet 62.0mg of lactose monohydrate per Converium 300mg tablet For full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet Converium tablets 150mg: White, round flat, scored tablets having a diameter of 10.5mm Converium tablets 300mg: White, round flat, scored tablets having a diameter of 12.7mm Converium 150mg and 300mg tablets can be divided into equal halves 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION Treatment of essential hypertension. Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (>300 mg/day) in patients with type 2 diabetes and hypertension. In this population, Converium reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end- stage renal disease (need for dialysis or renal transplantation). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The usual recommended initial and maintenance dose is 150mg once daily, with or without food. Converium at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg. However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years. In patients insufficiently controlled with 150 mg once daily, the dose of Converium can be increased to 300 mg, or other anti-hypertensive agents can be added. In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Converium (see section 4.5). In hypertensive type 2 diabetic patients therapy should be initiated at 150mg irbesartan once daily and titrated up to 300mg once daily as the preferred maintenance dose for treatm Llegiu el document complet