Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Captopril
JensonR+ (Ireland) Limited
C09AA; C09AA01
Captopril
25/5 milligram(s)/millilitre
Oral solution
Product subject to prescription which may be renewed (B)
ACE inhibitors, plain; captopril
Not marketed
2018-07-06
PACKAGE LEAFLET: INFORMATION FOR THE USER Captopril 5 mg/5 ml Oral Solution Captopril 25 mg/5 ml Oral Solution 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 Captopril Oral Solution is and what it is used for 2. What you need to know before you take Captopril Oral Solution 3. How to take Captopril Oral Solution 4. Possible side effects 5. How to store Captopril Oral Solution 6. Contents of the pack and other information 1. WHAT CAPTOPRIL ORAL SOLUTION IS AND WHAT IT IS USED FOR Captopril Oral Solution contains the active substance captopril which 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. Captopril is used to treat the following in adults, the elderly and children: • High blood pressure and certain heart conditions. If high blood pressure is left uncontrolled it can increase the risk of heart disease or stroke. Captopril works by lowering your blood pressure which reduces this risk. • People whose heart no longer pumps blood as well as it once did. This condition is known as heart failure. • People who have recently suffered a heart attack. A heart attack happens once one of the major blood vessels supplying blood to the heart muscle becomes blocked. This means that the heart does not receive the oxygen it needs and the heart muscle becomes damaged. • Kidney disease in people with diabetes. 2. WHAT YOU NE Read the complete document
Health Products Regulatory Authority 12 April 2021 CRN00C76W Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Captopril 25mg/5ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of Captopril 25 mg/5 ml Oral Solution contains 5 mg captopril. Each 5 ml of Captopril 25 mg/5 ml Oral Solution contains 25 mg captopril. Excipient(s) with known effects: This medicinal product contains 0.192 mmol (or 4.40 mg) sodium per 5 mL. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral solution Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Captopril oral solution is indicated for: _Hypertension: _the treatment of essential hypertension. _Heart Failure: _for the treatment of chronic heart failure. _Myocardial Infarction:_ - _short-term (4 weeks) treatment:_ Captopril Oral Solution is indicated in any clinically stable patient within the first 24 hours of an infarction. - _long-term prevention of symptomatic heart failure:_ indicated in clinically stable patients with asymptomatic left ventricular dysfunction. _Type I Diabetic Nephropathy: _indicated for the treatment of macroproteinuric diabetic nephropathy in patients with type I diabetes. (See section 5.1). Captopril oral solution can be used alone or in combination with other antihypertensive agents (see sections 4.3, 4.4, 4.5 and 5.1). 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. Captopril oral solution may be taken before, during and after meals. _Hypertension:_ the recommended starting dose is 25-50 mg daily in two divided doses. The dose may be increased incrementally, with intervals of at least 2 weeks, to 100-150 mg/day in two divided doses as needed to reach target blood pressure. Captopril oral solution may be used alone or with other antihypertensive agents, especially thiazide diuretics. A once-daily dosing re Read the complete document