Country: Malta
Language: English
Source: Medicines Authority
CAPTOPRIL
Syri Pharma Limited Floor 0 1 WML, 1 Windmill Lane Dublin 2, D02 F206, Ireland
C09AA01
CAPTOPRIL 25 mg/5ml
ORAL SOLUTION
CAPTOPRIL 25 mg/5ml
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2019-03-14
MRP/Renewal Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER CAPTOPRIL THAME 25MG/5ML SUGAR FREE ORAL SOLUTION 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. The name of your medicine is Captopril Thame 25mg/5ml Sugar Free Oral Solution but it will be referred to as 'Captopril' throughout this leaflet. WHAT IS IN THIS LEAFLET: 1. What Captopril is and what it is used for 2. What you need to know before you take Captopril 3. How to take Captopril 4. Possible side effects 5. How to store Captopril 6. Contents of the pack and other information 1. WHAT CAPTOPRIL IS AND WHAT IT IS USED FOR This medicine contains the active substance Captopril. Captopril 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 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. Captopril can also help people whose heart no longer pumps blood as well as it once did. This condition is known as heart failure. Captopril may also be used to treat patients who 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 become Read the complete document
MRP/Renewal/RFI-I Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Captopril Thame 25mg/5ml Sugar Free Oral Solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml of oral solution contains 25mg captopril Each ml of oral solution contains 5mg captopril _Excipients with known effect:_ Each 5ml of oral solution contains 1.25mg sodium benzoate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral Solution A clear, colourless solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Hypertension:_ Captopril is indicated for the treatment of essential hypertension. _Heart Failure:_ Captopril is indicated for the treatment of chronic heart failure. _Myocardial Infarction:_ • _Short-term (4 weeks) treatment: _ Captopril is indicated in any clinically stable patient within the first 24 hours of an infraction. • _Long-term prevention of symptomatic heart failure: _ Captopril is indicated in clinically stable patients with asymptomatic left ventricular dysfunction. _Type I Diabetic Nephropathy:_ Captopril 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 150mg. Captopril may be taken before, during and after meals. HYPERTENSION: The recommended starting dose is 25-50mg daily in two divided doses. The dose may be increased incrementally, with intervals of at least 2 weeks, to 100-150mg/day in two divided doses as needed to reach target blood pressure. Captopril may be used alone or with other antihypertensive agents, especially thiazide diuretics (see sections 4.3, 4.4, 4.5 and 5.1). A MRP/Renewal/RFI-I Page 2 of 15 once-daily dosing regimen may be appropriate when concomitant antihypertensive medication such as thiazide diuretics is added. In patients with a strongly active renin-angiotensin-aldosterone s Read the complete document