Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
trandolapril, Quantity: 4 mg
Alphapharm Pty Ltd
Trandolapril
Capsule, hard
Excipient Ingredients: dimeticone 350; microcrystalline cellulose; lactose monohydrate; pregelatinised maize starch; silicon dioxide; magnesium stearate; titanium dioxide; iron oxide yellow; iron oxide red; erythrosine; Gelatin; iron oxide black
Oral
28 capsules blister pack
(S4) Prescription Only Medicine
Treatment of hypertension. Data to support the usage of trandolapril in renovascular hypertension are, at present, not available. Trandolapril is also indicated for patients with left ventricular dysfunction post myocardial infarction (ejection fraction less than or equal to 35% or WMI (wall motion index) less than or equal to 1.2).
Visual Identification: Red- orange size 2 capsule; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2012-08-28
TRANALPHA _trandolapril_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Tranalpha. It does not contain all 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 Tranalpha against the benefits expected 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 TRANALPHA IS USED FOR Tranalpha is used to treat: • high blood pressure (hypertension) • some heart conditions 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. You may feel fine and have no symptoms, but eventually hypertension can lead to serious health problems, including stroke, heart disease and kidney failure. Tranalpha helps to lower your blood pressure. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY TRANALPHA HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Tranalpha for another purpose. _HOW TRANALPHA WORKS_ Tranalpha belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors. ACE inhibitors lower blood pressure by widening and relaxing your blood vessels, making it easier for the heart to pump blood around the body. Widening of the blood vessels also increases the supply of blood and oxygen to the heart. By increasing the supply of oxygen to your heart, your heart does not have to work as hard. Tranalpha is available only with a doctor's prescription. There is no evidence that Tranalpha is addictive. Tranalpha is not recommended for use in children as there have been no studies of its effects in children. BEFORE YOU TAKE TRANALPHA _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE TRANALPHA IF YOU: • are allergic (sensitive) reaction to t Preberite celoten dokument
AUSTRALIAN PRODUCT INFORMATION TRANALPHA _trandolapril _ 1 NAME OF THE MEDICINE Trandolapril 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Trandolapril is a long acting, highly lipophilic, non-peptide, angiotensin converting enzyme (ACE) inhibitor with a carboxyl group but without a sulphydryl group. Each Tranalpha capsule contains 0.5 mg, 1 mg, 2 mg or 4 mg of trandolapril as the active ingredient. Excipients with known effect: Contains sugars (as lactose) and sulfites. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Tranalpha 0.5 mg A hard capsule with a light scarlet body and a rich yellow cap Tranalpha 1 mg A hard capsule with a light scarlet body and a light orange cap Tranalpha 2 mg A hard capsule with a light scarlet body and a light scarlet cap Tranalpha 4 mg A hard capsules with a swedish orange body and a scarlet cap 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of hypertension. Data to support the usage of trandolapril in renovascular hypertension are, at present, not available. Trandolapril is also indicated for patients with left ventricular dysfunction post myocardial infarction (ejection fraction ≤35% or WMI (wall motion index) ≤1.2). 4.2 DOSE AND METHOD OF ADMINISTRATION Trandolapril has a duration of action greater than 24 hours and should not be administered at intervals of less than 24 hours. Monitoring of trough blood pressure should be done initially to ensure that control lasts over the dosing period. Should daily doses of more than one capsule be required, they should be administered together as a single daily dose. Since there is no clinically significant effect of food on the absorption of trandolapril, the capsules may be taken before, during or after a meal. HYPERTENSION The usual starting dose is one 1 mg capsule once daily. Maximum response is usually achieved within two to four weeks. Some patients not responding to 1 mg once daily may respond to 2 mg once daily. An alternative to increasing the dose is to add a calcium chann Preberite celoten dokument