Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
CAPTOPRIL
Bristol-Myers Squibb Pharmaceuticals uc
C09AA01
CAPTOPRIL
25 Milligram
Tablets
Product subject to prescription which may be renewed (B)
ACE inhibitors, plain
Authorised
1981-04-02
PACKAGE LEAFLET: INFORMATION FOR THE USER CAPOTEN™ 25 MG TABLETS Captopril READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Capoten is and what it is used for 2. What you need to know before you take Capoten 3. How to take Capoten 4. Possible side effects 5. How to store Capoten 6. Contents of the pack and other information 1. WHAT CAPOTEN IS AND WHAT IT IS USED FOR The name of this medicine is Capoten. Each tablet contains 25 mg captopril as the active ingredient. Capoten belongs to the group of medicines called Angiotensin Converting Enzyme (ACE) Inhibitors. ACE inhibitors work by helping to widen your blood vessels, which then make it easier for your heart to pump blood through them. Capoten is used to treat high blood pressure and certain heart conditions. If high blood pressure is left uncontrolled it can increase the risk of heart disease or stroke. Capoten works by lowering your blood pressure which reduces this risk. Capoten can also help people whose heart no longer pumps blood as well as it once did. This condition is known as heart failure. Capoten may also be used to treat patients who recently suffered a heart attack. A heart attack happens once one of the ma Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Capoten 25 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg captopril. Excipients with known effect: Lactose monohydrate 25 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, square, biconvex tablets, with '25' embossed on one side and cross scored on the other side. The score line is to facilitate breaking for ease of swallowing and to divide into equal doses of 12.5 mg (half tablet) or 6.25 mg (quarter tablet). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension: Capoten is indicated for the treatment of essential hypertension. Heart Failure: Capoten is indicated for the treatment of chronic heart failure with reduction of systolic ventricular function in combination with diuretics and, when appropriate, digitalis and beta-blockers. Myocardial Infarction: - _Short-term (4 weeks) treatment: _Capoten is indicated in any clinically stable patients within the first 24 hours of an infarction. - _Long term prevention of symptomatic heart failure: _Capoten is indicated in clinically stable patients with asymptomatic left ventricular dysfunction (ejection fraction 40%). Type I Diabetic Nephropathy: Capoten is indicated for the treatment of macroproteinuric diabetic nephropathy in patients with Type I diabetes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: Dose should be individualised according to patient’s profile (see section 4.4) and blood pressure response. The recommended maximum daily dose is 150 mg. Capoten may be taken before, during and after meals. Method of administration: For oral use only. HEALTH PRODUCTS REGULATORY AUTHORITY ______________________________________________________________________________________________________________________ Прочетете целия документ