国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
ramipril, Quantity: 5 mg
Arrotex Pharmaceuticals Pty Ltd
Ramipril
Tablet, uncoated
Excipient Ingredients: sodium stearylfumarate; calcium sulfate dihydrate; sodium bicarbonate; pregelatinised maize starch
Oral
30 tablets
(S4) Prescription Only Medicine
Treatment of hypertension. Data are currently not available to support the use of ramipril in renovascular hypertension. Postmyocardial infarction heart failure. Prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. Reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke or peripheral vascular disease. Reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure above 160 mmHg or diastolic blood pressure above 90 mmHg (or on antihypertensive treatment); total cholesterol above 5.2mmol/L: HDL cholesterol less than 0.9mmol/L; current smoker; known microalbuminuria; any evidence of previous vascular disease.
Visual Identification: White to off-white, oval shaped tablet, with scoreline on one side and "RP5" on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2007-03-06
PRILACE - Consumer Medicine Information Page 1 of 5 PRILACE ramipril CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PRILACE. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking PRILACE against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT PRILACE IS USED FOR PRILACE contains ramipril, which belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. PRILACE is used to treat: • high blood pressure (hypertension) • some heart conditions such as heart failure after a heart attack • kidney problems in some patients. PRILACE is also used to reduce the risk of cardiovascular problems and complications in patients aged 55 years or more with heart or blood vessel disease, or diabetes. HYPERTENSION PRILACE is used to lower high blood pressure (hypertension). Everyone has blood pressure. This pressure helps circulating your blood around your body. Your blood pressure is different at different times of the day and can be affected by how busy or worried you are. You would have hypertension when your blood pressure stays higher than is needed, even when you are calm and relaxed. There are usually no symptoms of hypertension. The only way of knowing you have hypertension is to have your blood pressure checked on a regular basis. If hypertension is not treated, it can lead to serious health problems, including stroke, heart disease and kidney failure. HEART FAILURE AFTER A HEART ATTACK PRILACE may be used after a heart attack. A heart attack occurs when one of the major blood vessels supplying blood to your heart becomes blocked. This means that your heart muscle cannot receive the oxygen it needs and becomes damaged. Th 阅读完整的文件
1 AUSTRALIAN PRODUCT INFORMATION – PRILACE (RAMIPRIL) TABLETS AND CAPSULES 1 NAME OF THE MEDICINE Ramipril. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Prilace tablets come in four strengths and contain 1.25 mg, 2.5 mg, 5 mg and 10 mg* of ramipril. Prilace capsules contain 10 mg of ramipril. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Prilace 1.25 mg tablets are white to off-white, oval-shaped tablet marked “RP 1” on one side. Prilace 2.5 mg tablets are white to off-white, oval-shaped tablet marked “RP 2” on one side and scoreline on other side. Prilace 5 mg tablets are white to off-white, oval-shaped tablet marked “RP 5” on one side and scoreline on other side. Prilace 10 mg tablets are white to off-white, oval-shaped tablet marked “RP 10” on one side and scoreline on other side. Prilace 10 mg capsules are white and blue opaque capsule with “RP 10” printed in black. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Treatment of hypertension. Data are currently not available to support the use of ramipril in renovascular hypertension. Post-myocardial infarction heart failure. Prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. 2 Reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke or peripheral vascular disease. Reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure >160 mmHg or diastolic blood pressure > 90 mmHg (or on antihypertensive treatment); total cholesterol >5.2 mmol/L or HDL cholesterol <0.9 mmol/L; current smoker; known microalbuminuria; any evidence of previous vascular disease. 4.2 D OSE AND METHOD OF ADMINISTRATION Prilace tablets and capsules should be swallowed w 阅读完整的文件