Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
telmisartan, Quantity: 80 mg; hydrochlorothiazide, Quantity: 25 mg
Generic Health Pty Ltd
Hydrochlorothiazide,Telmisartan
Tablet, multilayer
Excipient Ingredients: mannitol; povidone; magnesium stearate; purified water; sodium hydroxide; sodium stearylfumarate; meglumine; lactose monohydrate; Colour
Oral
28
(S4) Prescription Only Medicine
TELMISARTAN HCT GH is indicated for the treatment of hypertension. Treatment should not be initiated with these combinations.
Visual Identification: Oblong shaped biconvex, bilayered, uncoated tablets with one white/off white color layer and one yellow colour mottled layer debossed with L201; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2014-04-08
CONSUMER MEDICINE INFORMATION TELMISARTAN HCT GH (TELMISARTAN AND HYDROCHLOROTHIAZIDE) MULTILAYER TABLET WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Telmisartan HCT GH. It does not contain all 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 this medicine against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from your pharmacist, doctor, and may contain important information about the medicine and its use of which you should be aware. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT TELMISARTAN HCT GH IS USED FOR Telmisartan HCT GH is used to lower high blood pressure (hypertension). Everyone has blood pressure. This pressure helps your blood move around your body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm or relaxed. There are usually no signs 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. _HOW TELMISARTAN HCT GH _ _WORKS _ _ _ Telmisartan HCT GH contains telmisartan and hydrochlorothiazide in one single tablet. These two active ingredients help to reduce blood pressure in different ways: • Telmisartan belongs to a group of medicines called angiotensin II receptor blockers. Angiotensin II is a substance in the body which causes blood vessels to narrow, thus increasing blood pressure. Telmisartan Прочитать полный документ
AUSTRALIAN PRODUCT INFORMATION – TELMISARTAN HCT GH (TELMISARTAN AND HYDROCHLOROTHIAZIDE) MULTILAYER TABLET 1 NAME OF THE MEDICINE Telmisartan and hydrochlorothiazide. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Telmisartan HCT GH is available in three tablet strengths: • Telmisartan HCT GH 40/12.5 mg containing telmisartan 40 mg/hydrochlorothiazide 12.5 mg; • Telmisartan HCT GH 80/12.5 mg containing telmisartan 80 mg/hydrochlorothiazide 12.5 mg; and • Telmisartan HCT GH 80/25 mg containing telmisartan 80 mg/hydrochlorothiazide 25 mg. List of excipients with known effects: sugars as lactose, and mannitol. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Telmisartan HCT GH 40/12.5 mg tablets are oblong biconvex bilayered uncoated tablets with one white/off white color layer and one pink colour mottled layer debossed with L199. Telmisartan HCT GH 80/12.5mg tablets are oblong biconvex bilayered uncoated tablets with one white/off white color layer and one pink colour mottled layer debossed with L200. Telmisartan HCT GH 80/25 mg tablets are oblong shaped biconvex, bilayered, uncoated tablets with one white/off white color layer and one yellow colour mottled layer debossed with L201. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Telmisartan HCT GH is indicated for the treatment of hypertension. Treatment should not be initiated with these combinations. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS The recommended dose is one tablet once daily. The dose of telmisartan can be increased before switching to Telmisartan HCT GH. Direct change from monotherapy to the fixed combinations may be considered. Telmisartan HCT GH 40/12.5 mg may be administered in patients whose blood pressure is not adequately controlled by Telmisartan GH 40 mg or hydrochlorothiazide. Telmisartan HCT GH v7 Page 2 of 26 (telmisartan and hydrochlorothiazide) multilayer tablet Telmisartan HCT GH 80/12.5 mg may be administered in patients whose blood pressure is not adequately controlled by Telmisart Прочитать полный документ