Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Ramipril
Pinewood Laboratories Ltd,
C09AA; C09AA05
Ramipril
2.5 milligram(s)
Capsule, hard
Product subject to prescription which may be renewed (B)
ACE inhibitors, plain; ramipril
Not marketed
2005-06-10
PACKAGE LEAFLET: INFORMATION FOR THE USER RAMIC 2.5 MG HARD CAPSULES, RAMIC 5 MG HARD CAPSULES RAMIC 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 or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms 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 Ramic capsules are and what they are used for 2. What you need to know before you take Ramic capsules 3. How to take Ramic capsules 4. Possible side effects 5. How to store Ramic capsules 6. Contents of the pack and other information 1. WHAT RAMIC CAPSULES ARE AND WHAT THEY ARE USED FOR Ramic capsules contain the active ingredient ramipril (belongs to a group of medicines called ACE inhibitors [Angiotensin Converting Enzyme inhibitors]) which: decrease the body’s production of substances that could raise blood pressure relax and widen blood vessels make it easier for the heart to pump blood around the body. You have been prescribed Ramic capsules for one or more of the following reasons: to treat high blood pressure (hypertension) to help treat your heart when it cannot pump enough blood to the rest of your body (heart failure) to help reduce the risk of having a heart attack or stroke to help prevent further weakening of your heart if it has been weakened by a heart attack to treat or prevent worsening of some kidney diseases including those caused by diabetes. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAMIC CAPSULES DO NOT TAKE RAMIC CAPSULES: If you are ALLERGIC (hypersensitive) to ramipril or any of the other ingredients in the product (see Section 6). Signs of allergic reaction may inc Belgenin tamamını okuyun
Health Products Regulatory Authority 04 February 2020 CRN008JZW Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ramic 2.5 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 2.5 mg of ramipril. Excipients with known effect: Sunset yellow: 0.063mg Ponceau 4R: 0.13mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard Capsule Orange opaque body and orange opaque cap. Dimensions 14.3 x 5 mm. The body has 'RP 2.5' printed in black, 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 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 Oral administration. It is recommended that Ramic is taken each day at the same time of the day. Ramic capsules should be taken with plenty of liquid. It must not be chewed or crushed. The absorption of Ramic is not affected by food. Ramic can be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2). _Adults_ Hypertension: The dose should Belgenin tamamını okuyun