Valsts: Malaizija
Valoda: angļu
Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IRBESARTAN
SANOFI-AVENTIS (MALAYSIA) SDN. BHD.
IRBESARTAN
14 Tablet Tablets; 28Tablet Tablets
SANOFI WINTHROP INDUSTRIE
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ APROVEL ® FILM-COATED TABLET _ _ Irbesartan (150 mg & 300 mg) 1 WHAT IS IN THIS LEAFLET: 1. What Aprovel is used for 2. How Aprovel works 3. Before you use Aprovel 4. How to use Aprovel 5. While you are using it 6. Side effects 7. Storage and Disposal of Aprovel 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT APROVEL IS USED FOR Aprovel 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 APROVEL WORKS Aprovel 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. Aprovel prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Aprovel slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. BEFORE YOU USE APROVEL _- When you must not use it _ • if you are ALLERGIC (hypersensitive) to irbesartan or any other ingredients of Aprovel • if you are MORE THAN 3 MONTHS PREGNANT . (It is also better to avoid Aprovel 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 Aprovel should not be given to children and adolescents (under 18 years). _- Before you start to use it _ APROVEL 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. APROVEL CONTAINS SODIUM. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. _- Taking other medicines _ Please tell your doctor or pharmacist if you are Izlasiet visu dokumentu
MY/APR/0521/SmPC0421 1 APROVEL 150 MG FILM-COATED TABLETS APROVEL 300 MG FILM-COATED TABLETS QUALITATIVE AND QUANTITATIVE COMPOSITION APROVEL 150 MG FILM-COATED TABLETS. Each tablet contains 150 mg of irbesartan. APROVEL 300 MG FILM-COATED TABLETS. Each tablet contains 300 mg of irbesartan. PHARMACEUTICAL FORM APROVEL 150 MG FILM-COATED TABLETS. White to off-white, biconvex, oval-shaped film-coated tablet, engraved with a heart on one side and the number ‘2872’ on the other side. APROVEL 300 MG FILM-COATED TABLETS. White to off-white, biconvex, oval-shaped film-coated tablet, engraved with a heart on one side and the number ‘2873’ on the other side. 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, Aprovel 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 Posology The usual recommended initial and maintenance dose is 150 mg once daily, with or without food. Aprovel 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 Aprovel 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 with Aprovel (_see Interaction with _ _other medicinal products and other forms of interaction). _ 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 treatmen Izlasiet visu dokumentu