Pajjiż: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
trandolapril, Quantity: 4 mg
Medis Pharma Pty Ltd
Trandolapril
Capsule
Excipient Ingredients: povidone; lactose monohydrate; sodium stearylfumarate; maize starch; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; titanium dioxide; iron oxide red; Gelatin
Oral
28 capsules
(S4) Prescription Only Medicine
Trandolapril is indicated for the 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: "Size 2" Flesh coloured cap imprinted with 'TR' in black ink and flesh coloured body imprinted with '4' in black ink; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2008-06-13
TRANDOLAPRIL-GA _TRANDOLAPRIL _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Trandolapril-GA. 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 Trandolapril-GA 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 TRANDOLAPRIL-GA IS USED FOR Trandolapril-GA is used to treat high blood pressure, which doctors call hypertension and also to treat 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. Trandolapril-GA helps to lower your blood pressure. Trandolapril-GA belongs to a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors. It works by relaxing your blood vessels, making it easier for blood to move around your body. This helps lower blood pressure and increase the supply of blood and oxygen to the heart. Your doctor may prescribe Trandolapril-GA for another reason. Ask your doctor if you have any questions about why Trandolapril-GA has been prescribed for you. Trandolapril-GA is only available with a doctor's prescription. Trandolapril-GA is not addictive. Trandolapril-GA is not recommended for use in children as there have been no studies of its effects in children. BEFORE YOU TAKE TRANDOLAPRIL-GA _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE TRANDOLAPRIL-GA IF YOU HAVE HAD AN ALLERGIC REACTION TO TRANDOLAPRIL OR TO ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Aqra d-dokument sħiħ
PRODUCT INFORMATION TRANDOLAPRIL-GA CAPSULES NAME OF THE MEDICINE Trandolapril The chemical name is (2S,3aR,7aS)-1-[(2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino] propanoyl]octahydro-1H-indole-2- carboxylic acid. CH 3 N N O O O CH 3 HOOC H H H Trandolapril Molecular weight: 430.54 Molecular formula: C 24 H 34 N 2 O 5 CAS number: 87679-37-6 DESCRIPTION Trandolapril-GA Capsules is trandolapril, a long acting, highly lipophilic, non-peptide, angiotensin converting enzyme (ACE) inhibitor with a carboxyl group but without a sulphydryl group. Trandolapril is a colourless, crystalline substance that is soluble in chloroform, dichloromethane and methanol. It is practically insoluble in water and sparingly soluble in hydrochloric acid. Each Trandolapril-GA capsule contains 0.5 mg, 1 mg, 2 mg or 4mg of trandolapril. Each capsule also contains the following inactive ingredients: Lactose, starch-maize, povidone, sodium stearylfumarate. In addition the 0.5mg and 2mg capsule contains the following inactive ingredients: gelatin, titanium dioxide (E171), erythrosine – FD & C red 3 (E127) yellow iron oxide (E172) and black ink (SW- 9008). The 1 mg capsule contains: gelatin, titanium dioxide (E171), erythrosine – FD & C red 3 (E127), yellow iron oxide (E172) red iron oxide (E172) and black ink (SW-9008). The 4mg capsule contains: gelatin, titanium dioxide (E171), red iron oxide (E172) and black ink (SW-9008 / SW-9009). PHARMACOLOGY Trandolapril-GA PI v2 110603 Page 1 of 17 Product Information Page 2 of 17 MECHANISM OF ACTION Trandolapril is an orally active angiotensin converting enzyme (ACE) inhibitor. It is administered as a pro-drug (trandolapril) which is rapidly converted to its biologically active metabolite trandolaprilat: a compound which binds tightly to, and dissociates slowly from, ACE. There is evidence that trandolapril itself has a marked affinity for angiotensin converting enzyme, and may therefore have n antihypertensive effect. ldosterone secretion and an crease in plasma renin activity by suppressing Aqra d-dokument sħiħ