País: Malásia
Língua: inglês
Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Irbesartan
Duopharma Marketing Sdn. Bhd.
Irbesartan
3 x10 Tablets
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
_ Consumer Medication Information Leaflet (RiMUP)_ 1 BEZARTAN TABLET ® Irbesartan (150 mg, 300 mg) WHAT IS IN THIS LEAFLET 1. What Bezartan Tablet is used for 2. How Bezartan Tablet works 3. Before you use Bezartan Tablet 4. How to use Bezartan Tablet 5. While you are using it 6. Side effects 7. Storage and Disposal of Bezartan Tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT BEZARTAN TABLET IS USED FOR Bezartan Tablet 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. HOW BEZARTAN TABLET WORKS _ _ Irbesartan 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 BEZARTAN TABLET _-When you must not use it _ • If you are allergic to irbesartan or any other ingredients of this medicine. • If you are more than 3 months pregnant. (it is also better to avoid Bezartan in early pregnancy- see pregnancy section) • If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren. - _Before you start to use it_ Bezartan contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine. _- Taking other medicines _ Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Bezartan Tablet does not usually interact with other med Leia o documento completo
BEZARTAN TABLET IRBESARTAN 150MG, 300MG DESCRIPTION Bezartan Tablet 150mg - White to off white, biconvex, oval-shaped, with marking ‘150’ on one side and film coated tablet Bezartan Tablet 300mg - White, oval shape, with scored on one side and film coated tablet CLINICAL PARTICULARS THERAPEUTIC INDICATIONS 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, Bezartan 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). POSOLOGY AND METHOD OF ADMINISTRATION The usual recommended initial and maintenance dose is 150 mg once daily, with or without food. Bezartan 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 Bezartan can be increased to 300 mg, or other antihypertensive agents can be added. In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect. In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg irbesartan once daily and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease. Special Populations _Renal impairment_: no dosage adjustment is necessary in patients with impaired renal function. A lower starting dose (75 mg) should be considered for patients undergoing haemodialysis. _Hepatic impairment_: no dosage adjustment is necessary in patients with mild to moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment. _Older people_: although consideration should be given to initiating therapy with 75 mg in Leia o documento completo