Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
captopril, Quantity: 50 mg
Arrow Pharma Pty Ltd
Tablet, uncoated
Excipient Ingredients: microcrystalline cellulose; stearic acid; maize starch; lactose monohydrate
Oral
100 tablets, 90 tablets
Medicine Registered
(S4) Prescription Only Medicine
1.HYPERTENSION: Capoten (captopril) is indicated for the treatment of hypertension. In using Capoten, consideration should be given to the risk of neutropenia/agranulocytosis (see PRECAUTIONS). Capoten is effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive. 2. MYOCARDIAL INFARCTION: Capoten is indicated to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction less than or equal to 40%, and to reduce the incidence of overt heart failure and subsequent hospitalisations for congestive heart failure in these patients. The efficacy data for the use of captopril following myocardial infarction are strongest for initiation of therapy beyond 3 days post-infarct. 3. HEART FAILURE: Capoten (captopril) is indicated for the treatment of heart failure. In symptomatic patients it is recom
Visual Identification: Oval, bi-convex, slightly mottled white tablet, with one beveled edge face. One side is scored and the other side plain. Dimensions 5.8 mm x 11.3 mm.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1991-09-30
CAPOTEN- Consumer Medicine Information Page 1 of 4 CAPOTEN _captopril _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET Read this leaflet carefully before taking Capoten. This leaflet answers some common questions about Capoten. It does not contain all the available information. Some of the information it contains may not apply to you. It does not take the place of talking to your doctor or pharmacist. ALWAYS FOLLOW THE INSTRUCTIONS THAT YOUR DOCTOR AND PHARMACIST GIVE YOU ABOUT CAPOTEN. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT TAKING CAPOTEN. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again WHAT CAPOTEN IS USED FOR Capoten is used for treating high blood pressure (hypertension), certain heart conditions, and certain kidney conditions associated with diabetes. These are long term (chronic diseases) so it is important that you continue to take your Capoten every day. Capoten contains captopril. Captopril belongs to a class of medicines known as ACE inhibitors. ACE inhibitors work to lower your blood pressure to normal levels if it is too high. Capoten also acts to help your heart or kidneys to work better. Your doctor will tell you why you need to take Capoten. Never let anyone else take your medicine. There is no evidence that it is addictive or habit forming. This medicine is only_ _available only with a doctor’s prescription. Capoten is not recommended for use in children as there have been not enough studies of its effects in children. However it may be necessary for a child with hypertension and kidney problems to take this medicine, if this is the case your doctor will discuss all the possible risks and benefits to the child before starting therapy. BEFORE YOU TAKE CAPOTEN _ _ _WHEN YOU MUST NOT TAKE _ _IT _ • YOU MUST NOT TAKE CAPOTEN IF YOU ARE PREGNANT OR MAY BECOME PREGNANT • MEDICAL CONDITIONS KNOW AS IDIOPATHIC ANGIOEDEMA OR HEREDITARY ANGIOEDEMA • YOU MUST NOT TAKE CAPOTEN IF YOU HAVE EVER HAD AN ALLERGY TO CAPOTEN OR ANY OF THE INGREDIENTS Read the complete document
1 AUSTRALIAN PI – CAPOTEN (CAPTOPRIL) 1 NAME OF THE MEDICINE Captopril. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION CAPOTEN tablets come in three strengths and contain either 12.5 mg, 25 mg or 50 mg of captopril. CAPOTEN oral solution comes in one strength and contains 5 mg of captopril per mL of solution. Excipients with known effect: sodium benzoate and lactose For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM CAPOTEN 12.5 MG TABLET contains captopril 12.5mg, white, scored, capsule-shaped tablet marked SQUIBB 450. CAPOTEN 25 MG TABLET contains captopril 25mg, white, square, double scored. CAPOTEN 50 MG TABLET contains captopril 50mg, white, oval, scored. CAPOTEN ORAL SOLUTION contains captopril 5 mg/mL, clear, colourless, unsweetened, flavour free. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS HYPERTENSION: CAPOTEN (captopril) is indicated for the treatment of hypertension. 2 In using CAPOTEN, consideration should be given to the risk of neutropenia/agranulocytosis (see section 4.4 Special warnings and precautions for use). CAPOTEN is effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive. MYOCARDIAL INFARCTION: CAPOTEN is indicated to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction, manifested as an ejection fraction less than or equal to 40% and to reduce the incidence of overt heart failure, and subsequent hospitalisations for congestive heart failure in these patients. The efficacy data for the use of CAPOTEN following myocardial infarction are strongest for initiation of therapy beyond 3 days post-infarct. HEART FAILURE: CAPOTEN (captopril) is indicated for the treatment of heart failure. In symptomatic patients it is recommended that CAPOTEN be administered together with a diuretic. DIABETIC NEPHROPATHY: CAPOTEN is indicated for the treatment of diabetic Read the complete document