Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
ASTRAZENECA SDN. BHD.
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
30Tablet Tablets
ASTRAZENECA AB
ATACAND PLUS ® TABLET _ _ Candesartan cilexetil 16mg _ _ Hydrochlorothiazide 12.5mg _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 WHAT IS IN THIS LEAFLET 1. What Atacand Plus is used for 2. How Atacand Plus works 3. Before you use Atacand Plus 4. How to use Atacand Plus 5. While you are using it 6. Side effects 7. Storage and Disposal of Atacand Plus 8. Product Description 9. Manufacturer & Product Registration Holder 10. Date of revision 11. Serial Number WHAT ATACAND PLUS IS USED FOR Atacand Plus is used for treating hypertension (high blood pressure), where a monotherapy is not sufficiently effective. HOW ATACAND PLUS WORKS Candesartan cilexetil is a type of medicine called an angiotensin II receptor antagonist, which by blocking the effects of the hormone angiotensin II, causes relaxation of the blood vessels and results in a lowering of the blood pressure. Hydrochlorothiazide belongs to a class of drugs called diuretics. Its effects promote the urinary excretion of sodium, chloride and water and results in a lowering of the blood pressure. BEFORE YOU USE ATACAND PLUS Do not take Atacand Plus if you are pregnant, think you might be pregnant or considering becoming pregnant. Atacand Plus may cause serious harm or even death to your baby if used during pregnancy (see Pregnancy section). _When you must not use it _ • If you are breast feeding. • If you are allergic to any of the ingredients in Atacand Plus or to drugs closely related to hydrochlorothiazide. • If you have severe liver disease. • If you have severe kidney disease. • If you have had gout. • 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 Plus if you have had problems in the past when taking medicines containing candesartan cilexetil or hydrochlorothiazide. Atacand Plus is not recommended for children. _Before you start to use it_ Please talk to your doctor or pharmacist before taking this medicine: • If you are taki Soma hati kamili
ATACAND PLUS ® 16/12.5 MG _candesartan cilexetil and hydrochlorothiazide _ TABLET FERTILITY, PREGNANCY AND LACTATION _Use in pregnancy _ The use of Atacand Plus is contraindicated during pregnancy (see ‘Contraindications’). Patients receiving Atacand Plus should be made aware of that before contemplating a possibility of becoming pregnant so that they can discuss appropriate options with their treating physician. When pregnancy is diagnosed, treatment with Atacand Plus must be stopped immediately and if appropriate, alternative therapy should be started. When used in pregnancy, drugs that act directly on the renin-angiotensin system can cause foetal and neonatal injury and death. Exposure to angiotensin II receptor antagonist therapy is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see ‘Preclinical safety data’) . There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester. Animal studies are insufficient. Hydrochlorothiazide crosses the placenta. Based on the pharmacological mechanism of action of hydrochlorothiazide, its use during pregnancy may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia. _ _ _Use in lactation_ It is not known whether candesartan is excreted in human milk. However, candesartan is excreted in the milk of lactating rats. Hydrochlorothiazide passes int o mother’s milk. Because of the potential for adverse effects on the nursing infant, breast feeding should be discontinued if the use of Atacand Plus is considered essential (see ‘ Contraindications ’ ). COMPOSITION One tablet contains 16 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide. PHARMACEUTICAL FORM Tablets. Atacand Plus 16 mg/12.5 mg are peach, oval, biconvex tablets with a score on both sides and engraved A/CS. THERAPEUTIC INDICATIONS Soma hati kamili