País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
RAMIPRIL
Accord Healthcare Limited
C09AA05
RAMIPRIL
10 Milligram
Capsules Hard
Product subject to prescription which may be renewed (B)
ramipril
Marketed
2013-03-15
PACKAGE LEAFLET: INFORMATION FOR THE USER RAMIPRIL 1.25 MG CAPSULES, HARD RAMIPRIL 2.5 MG CAPSULES, HARD RAMIPRIL 5 MG CAPSULES, HARD RAMIPRIL 10 MG CAPSULES, HARD 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 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 Ramipril capsules is and what it is used for 2. What you need to know before you take Ramipril capsules 3. How to take Ramipril capsules 4. Possible side effects 5. How to store Ramipril capsules 6. Contents of the pack and other information 1. WHAT RAMIPRIL CAPSULES IS AND WHAT IT IS ARE USED FOR Ramipril capsules contain a medicine called ramipril. This belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors). Ramipril capsules 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 capsules 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 CAPSULES DO NOT TAKE RAMIPRIL CAPSULES: If you are allergic to Ramipril, any other ACE inhibitor medicine or any o Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ramipril 10 mg capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ramipril 10 mg, capsule, hard contains 10.0 mg of ramipril For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Blue/White, size ‘4’ hard gelatin capsules, imprinted ‘R’ on cap & ‘10’ on body with black ink, containing white to off 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 the 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 infarction: 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 capsules is taken each day at the same time of the day. Ramipril capsules may be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2). Ramipril capsules has to be swallowed with liquid. It must not be chewed or crushed. POSOLOGY 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Llegiu el document complet