国家: 新西兰
语言: 英文
来源: Medsafe (Medicines Safety Authority)
Carvedilol 12.5mg
Viatris Limited
Carvedilol 12.5 mg
12.5 mg
Film coated tablet
Active: Carvedilol 12.5mg Excipient: Colloidal silicon dioxide Crospovidone Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry white YS-22-18096 Povidone
Blister pack, PVC/aluminium blister strip - 90 tablets, 90 tablets
Prescription
Prescription
Moehs Catalana SL
Hypertension Dicarz 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/aluminium blister strip - 60 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/aluminium blister strip - 90 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE bottle, PP cap with permaseal liner - 90 tablets - 12 months from date of manufacture stored at or below 25°C
2004-04-29
Page 1 of 5 NEW ZEALAND CONSUMER MEDICINE INFORMATION DICARZ _CARVEDILOL FILM-COATED TABLETS _ _6.25 MG, 12.5 MG & 25 MG _ _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Dicarz. 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 Dicarz 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 DICARZ IS USED FOR Dicarz is used to treat: • high blood pressure. • angina (a type of severe chest pain). • heart failure. • heart failure following a recent heart attack. It may be used in combination with other heart medications. Dicarz contains the active ingredient carvedilol_._ It belongs to a group of medicines called beta blockers. These medicines work by relaxing tightened blood vessels and slowing the rate of your heart beat. Dicarz is different from conventional beta blockers as it has additional effects of being an alpha blocker and an antioxidant. This means your heart does not have to pump as hard to move the blood around the body. When you place extra demands on your heart, such as during exercise, the heart may cope better so you may not get short of breath as easily. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor’s prescription. There is not enough information to recommend the use of this medicine for people under the age of 18 years. BEFORE YOU TAKE DICARZ _WHEN YOU MUST NOT TAKE _ _IT _ DO NOT TAKE DICARZ IF YOU HAVE AN ALLERGY TO: • any medicine containing carvedilol. • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: shortness of breath; wheezing 阅读完整的文件
Page 1 of 15 NEW ZEALAND DATA SHEET DICARZ _CARVEDILOL FILM-COATED TABLETS _ _3.125 MG, 6.25 MG, 12.5 MG AND 25 MG _ _ _ PRESENTATION DICARZ 3.125 mg: White, oval shaped, film-coated tablet, plain on both sides. DICARZ 6.25 mg: White, oval shaped, film-coated tablet with a breakline on both sides, imprinted “6.25” on one side. DICARZ 12.5 mg: White, oval shaped, film-coated tablet, with a breakline on both sides, imprinted “12.5” on one side. DICARZ 25 mg: White, oval shaped, film-coated tablet, with a breakline on both sides, imprinted “25” on one side. INDICATIONS HYPERTENSION DICARZ 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 DICARZ is efficacious in the treatment of chronic stable angina and unstable angina. CHRONIC HEART FAILURE (CHF) Unless a contraindication exists, DICARZ 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. DOSAGE AND 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, DICARZ should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects. Page 2 of 15 _DURATION OF TREATMENT _ Treatment with DICARZ is a long-term therapy. As with all β -blockers, tre 阅读完整的文件