Страна: Нова Зеландия
Език: английски
Източник: Medsafe (Medicines Safety Authority)
Carvedilol 25mg;
Sandoz New Zealand Limited
Carvedilol 25 mg
25 mg
Tablet
Active: Carvedilol 25mg Excipient: Colloidal silicon dioxide Crospovidone Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone
Prescription
Zhejiang Huahai Pharmaceutical Co Ltd
Carvedilol Sandoz is indicated for the management of essential hypertension. It can be used alone or in combination with other antihypertensive agents (e.g. calcium channel blockers, diuretics).
Package - Contents - Shelf Life: Blister pack, PVC/Al - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVC/Al - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture
2013-12-13
Carvedilol Sandoz 1 CONSUMER MEDICINE INFORMATION CARVEDILOL SANDOZ CARVEDILOL 6.25MG, 12.5MG AND 25MG TABLETS, UNCOATED_ _ _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Carvedilol Sandoz. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CARVEDILOL SANDOZ IS USED FOR Carvedilol Sandoz is used to treat: • high blood pressure • angina (a type of severe chest pain) • heart failure • heart failure following a recent heart attack Carvedilol Sandoz may be used in combination with other “heart” medicines. Carvedilol Sandoz is a long-term treatment. Carvedilol Sandoz belongs to a group of medicines called beta blockers. These medicines work by relaxing tightened blood vessels and slowing the rate of heart beat. Carvedilol Sandoz is different from conventional beta blockers as it has additional effects of being an alpha blocker (which also relaxes and widens your blood vessels) and an antioxidant. Heart failure occurs when the heart can no longer pump blood strongly enough for the body’s needs. Often the heart gets bigger to try to improve the blood flow, but this can make the heart failure worse. Symptoms of heart failure include shortness of breath and swelling of the feet and/or legs due to fluid build-up. Carvedilol Sandoz, when used with other “heart” medicines, reduces the pressure that the heart has to pump against as well as controlling the heart rate. Over time this will reduce the size of an oversized heart and increase its efficiency. Carvedilol Sandoz helps to stop heart failure getting worse and reduces the chances of you being admitted to hospital and/or dying from this diseas Прочетете целия документ
NEW ZEALAND DATA SHEET Page 1 of 17 1 PRODUCT NAME CARVEDILOL SANDOZ, tablets, uncoated, 6.25 mg, 12.5 mg and 25 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains carvedilol 6.25 mg, 12.5 mg or 25 mg. Excipients with known effect: Lactose For the full list of excipients, See section 6.1 3 PHARMACEUTICAL FORM Carvedilol Sandoz 6.25 mg: yellow, round, convex, scored uncoated tablet, coded 'C2' on one side. Carvedilol Sandoz 12.5 mg: red/brown, round, convex, scored uncoated tablet, coded 'C3' on one side. Carvedilol Sandoz 25 mg: white to almost white, round, convex, scored uncoated tablet, coded 'C4' on one side. Tablets can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERTENSION: Carvedilol Sandoz is indicated for the management of essential hypertension. It can be used alone or in combination with other antihypertensive agents (e.g. calcium channel blockers, diuretics). TREATMENT OF ANGINA PECTORIS: Carvedilol Sandoz is efficacious in the treatment of chronic stable angina and unstable angina. CHRONIC HEART FAILURE (CHF): Unless a contraindication exists, Carvedilol Sandoz is indicated for the treatment of all patients with stable and symptomatic mild, moderate and severe chronic heart failure of ischaemic or non-ischaemic aetiology in combination with standard therapy (including ACE inhibitors and diuretics with or without digitalis). LEFT VENTRICULAR DYSFUNCTION FOLLOWING ACUTE MYOCARDIAL INFARCTION: Long term treatment following myocardial infarction complicated by left ventricular dysfunction (LVEF < 40% or wall motion index < 1.3), including well controlled heart failure, in combination with ACE inhibitors and other treatments recommended in the management of patients after myocardial infarction. NEW ZEALAND DATA SHEET Page 2 of 17 4.2 DOSE AND METHOD OF ADMINISTRATION METHOD OF ADMINISTRATION The tablets are to be swallowed with sufficient fluid. It is not necessary to take the dose in relation to meals, however for chronic heart failure patients, Carve Прочетете целия документ