Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CANDESARTAN CILEXETIL
ASTRAZENECA SDN. BHD.
CANDESARTAN CILEXETIL
30 Tablet Tablets
ASTRAZENECA AB
ATACAND ® TABLET CANDESARTAN CILEXETIL (8 MG & 16 MG) _CONSUMER MEDICATION INFORMATION LEAFLET _ _(RIMUP)_ 1 WHAT IS IN THIS LEAFLET 1. What Atacand is used for 2. How Atacand works 3. Before you use Atacand 4. How to use Atacand 5. While you are using it 6. Side effects 7. Storage and disposal of Atacand 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 12. Serial Number WHAT ATACAND IS USED FOR Atacand is used for treating high blood pressure (hypertension) in adults. It is also taken for treating a heart condition known as heart failure in adults where the heart does not pump your blood around your body as well as it should. HOW ATACAND WORKS Atacand is a type of medicine called an angiotensin II receptor antagonist, which by blocking the effects of the hormone angiotensin II causes the blood vessels to relax and widen. This results in a lowering of your blood pressure, and makes it easier for your heart to pump blood to all parts of your body. BEFORE YOU USE ATACAND Do not take Atacand if you are pregnant, think you might be pregnant or considering becoming pregnant. You must tell your doctor if you think you are (or might become) pregnant. Atacand may cause serious harm or even death to your baby if used during pregnancy (see heading on “Pregnancy”). _ _ - _When you must not use it _ _ _ • If you are breast-feeding. • If you are allergic to any of the ingredients in Atacand. • If you have diabetes or impaired kidney function and you are treated with a blood pressure medicine containing aliskiren. Important: You should not take Atacand if you have had problems in the past when taking medicines containing candesartan cilexetil. _Use in children _ The safety and efficacy of Atacand have not been established in children and adolescents (under 18 years). - _Before you start to use it _ Please talk to your doctor or pharmacist before taking this medicine: • If you are taking other medicines to help lower your blood pressure, particularly: o diuretics; o an ACE Прочетете целия документ
1 Atacand 8 mg and 16 mg Candesartan Cilexetil Tablets Composition Each tablet contains 8 mg and 16 mg candesartan cilexetil. Pharmaceutical form Atacand 8 mg: A light pink, circular, biconvex tablet, with a score and engraved A/CG on one side and 008 on the other side. Atacand 16 mg: A pink, circular, biconvex tablet, with a score and engraved A/CH on one side and 016 on the other side. Therapeutic indication Treatment of hypertension. Treatment of patients with heart failure and impaired left ventricle systolic function (left ventricular ejection fraction 40%) as add -on therapy to ACE inhibitors or when ACE inhibi tors are not tolerated. Posology and method of administration Dosage in Hypertension The recommended initial dose and usual maintenance dose is 8 mg once daily. The dose may be increased to 16 mg once daily. If blood pressure is not sufficiently control led after 4 weeks of treatment with 16 mg once daily, the dose may be further increased to a maximum of 32 mg once daily (see Pharmacodynamic properties). If blood pressure control is not achieved with this dose, alternative strategies should be considered . Therapy should be adjusted according to blood pressure response. Most of the antihypertensive effect is attained within 4 weeks of initiation of treatment. Use in the elderly No initial dosage adjustment is necessary in elderly patients. Use in patie nts with intravascular volume depletion An initial dose of 4 mg may be considered in patients at risk for hypotension, such as patients with possible volume depletion (see Special warnings and special precautions for use). Use in impaired renal function No initial dosage adjustment is necessary in patients with mild to moderate renal impairment (i.e. creatinine clearance 30-80 ml/min/1.73 m 2 BSA). In patients with severe renal impairment (i.e. creatinine clearance Прочетете целия документ