מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
CAPTOPRIL, HYDROCHLOROTHIAZIDE
Bristol-Myers Squibb Pharmaceuticals uc
C09BA01
CAPTOPRIL, HYDROCHLOROTHIAZIDE
50/25 Milligram
Tablets
Product subject to prescription which may be renewed (B)
ACE inhibitors and diuretics
Authorised
1986-05-16
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CAPOZIDE TABLETS 50 mg captopril/ 25 mg hydrochlorothiazide 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 Capozide is and what it is used for 2. What you need to know before you take Capozide 3. How to take Capozide 4. Possible side effects 5. How to store Capozide 6. Contents of the pack and other information 1. WHAT CAPOZIDE IS AND WHAT IT IS USED FOR Capozide is a combination of two active substances, captopril and hydrochlorothiazide. Captopril belongs to a group of medicinal products called Angiotensin Converting Enzyme (ACE) Inhibitors. ACE inhibitors cause blood vessels to relax and the blood pressure to lower. Hydrochlorothiazide is one of a group of medicinal products called thiazide diuretics (also known as water tablets). They increase urine output and hence decrease blood pressure. The two active substances in Capozide work together to decrease blood pressure further than if either was given alone. Capozide is used in the treatment of high blood pressure (essential hypertension), if treatment with captopril or hydrochlorothiazide alone has not led to a sufficient decrease in blood pressure. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPOZIDE Please read the following section attentively. It contains important information which you and your doctor should observe prior to taking of Capozide. DO NOT TAKE CAPOZIDE if you are allergic to captopril or to any other ACE inhibitors or to any of the other ingredients of this medicine (li קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Capozide (Captopril 50mg/ Hydrochlorothiazide 25mg) Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg captopril and 25 mg hydrochlorothiazide. Excipient with known effect: Each tablet contains 70.20 mg lactose-monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off-white, oval, biconvex tablet; with a breakbar on one side and engraved with "C H" on the other side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled by captopril alone or hydrochlorothiazide alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Capozide can be administered in a single or two divided doses/day with or without food in patients whose blood pressure is not adequately controlled by captopril alone or hydrochlorothiazide alone. A maximum daily dose of 50 mg captopril/25 mg hydrochlorothiazide should not be exceeded. If satisfactory reduction of blood pressure has not been achieved, additional antihypertensive medication may be added (see sections 4.3, 4.4,4.5 and 5.1). _Adults_: the administration of the fixed combination of captopril and hydrochlorothiazide is usually recommended after dosage titration with the individual components. The usual maintenance dose is 50 mg/25 mg, once a day, in the morning. When clinically appropriate a direct change from monotherapy to the fixed combination may be considered. _Special populations:_ in salt/volume depleted patients, elderly patients, and diabetic patients, the usual starting dose is 25 mg/12.5 mg once a day. _Paediatric population:_ There is no relevant indication for use of Capozide in children. Method of administration For oral use. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ קרא את המסמך השלם