Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Ramipril
Rowex Ltd
C09AA; C09AA05
Ramipril
5 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
ACE inhibitors, plain; ramipril
Marketed
2004-09-10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RAMILO 1.25 MG TABLETS RAMILO 2.5 MG TABLETS RAMILO 5 MG TABLETS RAMILO 10 MG TABLETS 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 Ramilo is and what it is used for 2. What you need to know before you take Ramilo 3. How to take Ramilo 4. Possible side effects 5. How to store Ramilo 6. Contents of the pack and other information 1 WHAT RAMILO IS AND WHAT IT IS USED FOR Ramilo contains a medicine called ramipril. This belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors). Ramilo 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. Ramilo 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 RAMILO DO NOT TAKE RAMILO: - if you are allergic to ramipril, any other ACE inhibitor medicine or any of the other ingredients of this medicine (listed in section 6). signs of an allergic reaction may include a rash, swallowing or breathing problems, swelling of your lips, fa Прочитать полный документ
Health Products Regulatory Authority 18 September 2019 CRN008VRK Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ramilo 5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg ramipril. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet White, oblong, biplane with facet, both sides with breaking notch. Marking one-sided ‘R 5’. The tablet can be divided into equal doses. 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 Posology It is recommended that Ramilo is taken each day at the same time of the day. Ramilo can be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2). Ramilo has to be swallowed with liquid. It must not be chewed or crushed. _Adults _ Health Products Regulatory Authority 18 September 2019 CRN008VRK Page 2 of 16 Diuretic-Treated patients Hypotension may occur following initiation of therapy with Ramilo; this is more likely i Прочитать полный документ