Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
RAMIPRIL
Actavis Group PTC ehf
C09AA05
RAMIPRIL
10 Milligram
Capsule
Product subject to prescription which may be renewed (B)
ACE inhibitors, plain
Authorised
2007-12-14
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Ramipril Actavis 2.5 mg hard Capsules Ramipril Actavis 5 mg hard Capsules Ramipril Actavis 10 mg hard Capsules Ramipril 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, pharmacist or nurse. • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET: 1. What Ramipril Actavis is and what it is used for 2. What you need to know before you take Ramipril Actavis 3. How to take Ramipril Actavis 4. Possible side effects 5. How to store Rampril Actavis 6. Contents of the pack and other information 1. WHAT RAMIPRIL ACTAVIS IS AND WHAT IT IS USED FOR Ramipril Actavis contains a medicine called ramipril. This belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors). Ramipril Actavis works by: • Decreasing your body’s production of substances that could raise your blood pressure • Making your blood vessels relax and widen • Making it easier for your heart to pump blood around your body. Ramipril Actavis can be used: • To treat high blood pressure (hypertension) • To reduce the risk of you having a heart attack or stroke • To reduce the risk or delay the worsening of kidney problems (whether or not you have diabetes) • To treat your heart when it cannot pump enough blood to the rest of your body (heart failure) • As treatment following heart attack (myocardial infarction) complicated with heart failure. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAMIPRIL ACTAVIS DO NOT TAKE RAMIPRIL ACTAVIS: • If you are allergic to ramipril, any other ACE inhibitor medicine or any of the other ing Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ramipril Actavis 10 mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 10 mg of ramipril. Excipient(s) with known effect For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. Size 4, light grey capsule body and dark green capsule cap, marked R on cap and 10 on body, containing a white or almost white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of hypertension. Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with: - manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or - diabetes with at least one cardiovascular risk factor (see section 5.1). Treatment of renal disease. - Incipient glomerular diabetic nephropathy as defined by presence of microalbuminuria. - Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1), - Manifest glomerular non diabetic nephropathy as defined by macroproteinuria 3 g/day (see section 5.1). Treatment of symptomatic heart failure. Secondary prevention after acute myocardial infraction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure when started > 48 hours following acute myocardial infarction. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of Administration Oral use. It is recommended that Ramipril is taken each day at the same time of the day. Ramipril can be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2). Ramipril has to be swallowed with liquid. It must not be chewed or crushed. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Læs hele dokumentet