Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
ramipril, Quantity: 2.5 mg
Amneal Pharma Australia Pty Ltd
Ramipril
Tablet, uncoated
Excipient Ingredients: sodium stearylfumarate; iron oxide yellow; sodium bicarbonate; pregelatinised maize starch; croscarmellose sodium; lactose monohydrate
Oral
30
(S4) Prescription Only Medicine
? 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. ,? 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 myocardial infarction, stroke, cardiovascular death or revascularization procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure >160mmHg or diastolic blood pressure >90mmHg (or on antihypertensive treatment); total cholesterol >5.2mmol/L; HDL cholesterol <0.9mmol/L; current smoker; known microalbuminuria; any evidence of previous vascular disease.
Visual Identification: Light yellow to yellow coloured flat faced bevel edged, round uncoated tablet debossed with 'H' & '18' separated by score line on one side and plain on other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2011-10-06
_Ramipril AN – Consumer Medicine Information _ _ _ _Doc ID: 93.AN.M.2.0 _ _ _ _ Page 1 _ RAMIPRIL AN TABLETS _Ramipril _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Ramipril AN. It does not contain all the available information. 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 AN against the benefits it is expected to 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 AN IS USED FOR Ramipril AN belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors. Ramipril AN 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 AN 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 AN 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 AN 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 r Olvassa el a teljes dokumentumot
_Ramipril AN tablets Product Information _ _ _ _ _ _ _ _ Amneal Pharma Australia Pty Ltd _ Doc ID:94.AN.P.4.0 Page 1 RAMIPRIL AN _ _ _(RAMIPRIL TABLETS) _ _ _ PRODUCT INFORMATION _ _ NAME OF THE MEDICINE The name of the medicine is ramipril. CHEMICAL NAME: (2S,3aS,6aS)-1-[(S)-2-[[(S)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino] propanoyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid MOLECULAR FORMULA: C 23 H 32 N 2 O 5 MOLECULAR WEIGHT: 416.5 CAS REGISTRY NUMBER: [ _87333-19-5_ ] DESCRIPTION Ramipril is a white or almost white, crystalline powder. It is sparingly soluble in water, freely soluble in methanol. RAMIPRIL is available as tablets containing 1.25 mg, 2.5 mg, 5 mg & 10 mg of ramipril. RAMIPRIL AN tablets contains following inactive ingredients: pregelatinised maize starch, lactose monohydrate, sodium bicarbonate, croscarmellose sodium and sodium stearylfumarate. The 2.5 mg tablet also contains iron oxide yellow. The 5mg tablet also contains iron oxide red. PHARMACOLOGY MECHANISM OF ACTION Ramipril is a prodrug which, after absorption from the gastrointestinal tract, is hydrolysed in the liver to form the active moiety, ramiprilat. Ramipril and ramiprilat inhibit angiotensin-converting enzyme (ACE) which is identical to KININASE II. This converting enzyme (ACE) is a peptidyl dipeptidase that catalyses the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex, thus inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion. The latter decrease may result in a small increase in serum potassium. KININASE II is one of the enzymes responsible for the degradation of bradykinin, a potent _Ramipril AN tablets Product Information _ _ _ _ _ _ _ _ Amneal Pharma Australia Pty Ltd _ Doc ID:94.AN.P.4.0 Page 2 vasodepressor peptide. The inhibition of KININASE II activity by ramipril prevents the degradation of bradykinin thus leading to i Olvassa el a teljes dokumentumot