Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
ramipril, Quantity: 10 mg
Sanofi-Aventis Australia Pty Ltd
Ramipril
Capsule, hard
Excipient Ingredients: erythrosine; Gelatin; indigo carmine; iron oxide black; titanium dioxide; pregelatinised maize starch
Oral
28 capsules, 14 capsules, 7 capsules (sample), 10 capsules, 30 capsules
(S4) Prescription Only Medicine
Treatment of hypertension. (Data are currently not available to support the use of RAMIPRIL WINTHROP 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 > 160 mmHg or diastolic blood pressure > 90 mmHg (or on antihypertensive treatment); total cholesterol > 5.2 mmol/L: HDL cholesterol < 0.9 mmol/L; current smoker; known microalbuminuria; any evidence of previous vascular disease.
Visual Identification: Hard gelatin capsules, size 4, blue opaque/white opaque, containing a white powder mixture.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2006-10-31
RAMIPRIL WINTHROP ® _Ramipril_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Ramipril Winthrop. It does not contain all the available information about this medicine. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Ramipril Winthrop against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT RAMIPRIL WINTHROP IS USED FOR Ramipril Winthrop belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors. Ramipril Winthrop is used to treat: • high blood pressure (hypertension) • some heart conditions such as heart failure after a heart attack • kidney problems in some patients Ramipril Winthrop 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 Ramipril Winthrop is used to lower high blood pressure (hypertension). Everyone has blood pressure. This pressure helps get your blood all around your body. Your blood pressure may be different at different times of the day and can be influenced by how busy or worried you are. You 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 that you have hypertension is to have your blood pressure checked on a regular basis. If high blood pressure is not treated it can lead to serious health problems, including stroke, heart disease and kidney failure. HEART FAILURE AFTER A HEART ATTACK Ramipril Winthrop 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 Olvassa el a teljes dokumentumot
ramipril-winthrop-ccdsv18-piv13-02sep19 Page 1 of 29 AUSTRALIAN PRODUCT INFORMATION – RAMIPRIL WINTHROP ® (RAMIPRIL) 1 NAME OF THE MEDICINE Ramipril 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ramipril Winthrop is available as tablets containing 1.25 mg, 2.5 mg, 5.0 mg and 10 mg ramipril and a capsule containing 10 mg ramipril. Ramipril is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°C and 112°C. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM The 1.25 mg tablets are white to almost white, oblong shaped tablets with score lines on both sides. Tablets are embossed 1.25/HMN on one side and 1.25/Hoechst logo on the other. The 2.5 mg tablets are yellowish to yellow, oblong shaped tablets with score lines on both sides. Tablets are embossed 2.5/HMR on one side and 2.5/Hoechst logo on the other. The 5.0 mg tablets are pale red, oblong shaped tablets with score lines on both sides. Tablets are embossed 5/HMP on one side and 5/Hoechst logo on the other. The 10 mg tablets are white to almost white, oblong shaped tablets with score lines on both sides. Tablets are embossed with HMO/HMO on one side only. The 10 mg capsules are two component, one half of opaque blue, the other of opaque white. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of hypertension. Data are currently not available to support the use of ramipril in renovascular hypertension. • Post MI heart failure. • Prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. ramipril-winthrop-ccdsv18-piv13-02sep19 Page 2 of 29 • For 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. • For reducing the risk of myocar Olvassa el a teljes dokumentumot