Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
candesartan cilexetil
Lupin Australia Pty Limited
Candesartan cilexetil
Registered
CONSUMER MEDICINE INFORMATION CANDESARTAN GH (CANDESARTAN CILEXETIL) UNCOATED TABLET WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Candesartan GH. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking Candesartan GH against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT CANDESARTAN GH IS USED FOR Candesartan GH belongs to a group of medicines known as angiotensin-II receptor antagonists. Candesartan GH is used to treat: • high blood pressure, also called hypertension; • heart failure, usually in combination with other medicines. _HYPERTENSION _ Everyone has blood pressure. This pressure helps get your blood all around your body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) which means your blood pressure stays high, even when you are calm and relaxed. Regular blood pressure checks are the only way of knowing that you have hypertension. There are no symptoms of hypertension and you may feel fine. If hypertension is not treated, serious health problems such as stroke or heart attack and heart or kidney failure may occur. Candesartan GH lowers blood pressure by dilating (expanding) small blood vessels from the heart, letting the blood be pumped around the body more easily. _HEART FAILURE _ Heart failure means that the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body. Heart failure is not the same as heart attack and does not mean that the heart stops working. Heart failure may start off with no symptoms, but as the condition progresses, patients may feel short of breath or may get tired easily after light physical activ Đọc toàn bộ tài liệu
AUSTRALIAN PRODUCT INFORMATION – CANDESARTAN GH (CANDESARTAN CILEXETIL) UNCOATED TABLET 1 NAME OF THE MEDICINE Candesartan cilexetil. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Candesartan GH tablets come in four strengths and contain 4 mg, 8 mg, 16 mg or 32 mg of candesartan cilexetil. List of excipients with known effects: lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM CANDESARTAN GH Candesartan cilexetil 4 mg tablet; Light pink, mottled, round biconvex uncoated tablet with ‘291’ on one side and a scoreline on the other side. CANDESARTAN GH Candesartan cilexetil 8 mg tablet; Light pink, mottled, round biconvex uncoated tablet with ‘292’ on one side and a scoreline on the other side. CANDESARTAN GH Candesartan cilexetil 16 mg tablet; Light pink, mottled, round biconvex uncoated tablet with ‘L293’ on one side and a scoreline on the other side. CANDESARTAN GH Candesartan cilexetil 32 mg tablet; Light pink, mottled, round biconvex uncoated tablet with ‘L294’ on one side and a scoreline on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of hypertension. Treatment of patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction ≤ 40%) as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated. 4.2 DOSE AND METHOD OF ADMINISTRATION Candesartan GH should be taken once daily with or without food. Candesartan GH v6.0 Page 2 of 17 (candesartan cilexetil) uncoated tablet PAEDIATRICS The safety and efficacy of candesartan have not been established in children. HYPERTENSION The recommended maintenance dose of candesartan is 8 mg or 16 mg once daily. The maximal antihypertensive effect is attained within 4 weeks following initiation of treatment. For those patients who start on 8 mg and require further blood pressure reduction, a dose increase to 16 mg is recommended. An initial dose of 16 mg is also well tolerated. Some patients may receive an ad Đọc toàn bộ tài liệu