国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ramipril
Bristol Laboratories Ltd
C09AA05
Ramipril
1.25mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050501; GTIN: 5060013942525
PACKAGE LEAFLET: INFORMATION FOR USER RAMIPRIL 1.25 MG CAPSULES RAMIPRIL 2.5 MG CAPSULES RAMIPRIL 5 MG CAPSULES RAMIPRIL 10 MG CAPSULES 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 ARE AND WHAT THEY ARE 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 ARE AND WHAT THEY ARE USED FOR The name of your medicine is Ramipril 1.25 mg or 2.5 mg or 5 mg or 10 mg capsules. The active substance is Ramipril and belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme inhibitors). Ramipril 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 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 medi 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ramipril 1.25 mg capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 1.25mg of Ramipril Excipients with known effect: Also contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsule, Hard Yellow/ white coloured gelatin capsules of size "4" 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 ; 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 (see section 4.4). In hypertensive patients in whom the diuretic is not discontinued, therapy with Ramipril should be initiated with a 1.25 mg dose. Rena 阅读完整的文件