Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Ramipril
KRKA, d.d., Novo mesto
C09AA; C09AA05
Ramipril
2.5 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
ACE inhibitors, plain; ramipril
Marketed
2010-11-26
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RAMIPRIL KRKA 1.25 MG TABLETS RAMIPRIL KRKA 2.5 MG TABLETS RAMIPRIL KRKA 5 MG TABLETS RAMIPRIL KRKA 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 Ramipril Krka is and what it is used for 2. What you need to know before you take Ramipril Krka 3. How to take Ramipril Krka 4. Possible side effects 5. How to store Ramipril Krka 6. Contents of the pack and other information 1. WHAT RAMIPRIL KRKA IS AND WHAT IT IS USED FOR Ramipril Krka contains a medicine called ramipril. This belongs to a group of medicines called ACE inhibitors. Ramipril Krka 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 Krka 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 KRKA DO NOT TAKE RAMIPRIL KRKA: - if you are allergic to ramipril, any other ACE inhibitor medicine, or any of the other ingredients of Ramipril Krka listed in section 6. Signs of an allergic reaction may include a ras Soma hati kamili
Health Products Regulatory Authority 10 October 2019 CRN009D7D Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ramipril Krka 2.5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg ramipril. Excipient with known effect: Lactose: 150.86 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Yellow oblong flat tablets, dimensions 10.0 x 5.00 mm. 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 _Adults_ Diuretic-Treated patients Hypotension may occur following initiation of therapy with Ramipril Krka; this is more likely in patients who are being treated concurrently with diuretics. Caution is therefore recommended since these patients may be volume and/or salt depleted. If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with Ramipril Krka (see section 4.4). Health Products Regulatory Authority 10 October 2019 CRN009D7D Page 2 of 15 In hypertensive patients in who Soma hati kamili