Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
telmisartan, Quantity: 80 mg; hydrochlorothiazide, Quantity: 12.5 mg
Arrotex Pharmaceuticals Pty Ltd
Hydrochlorothiazide,Telmisartan
Tablet, multilayer
Excipient Ingredients: lactose monohydrate; magnesium stearate; povidone; sodium hydroxide; mannitol; meglumine; sodium stearylfumarate; purified water; iron oxide red
Oral
28
(S4) Prescription Only Medicine
APO TELMISARTAN HCTZ is indicated for the treatment of hypertension. Treatment should not be initiated with these combinations.
Visual Identification: Oblong biconvex bilayered uncoated tablets with one white/off white color layer and one pink colour mottled layer debossed with L200; 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
APO-TELMISARTAN HCTZ 1 APO-TELMISARTAN/HCTZ TABLETS _Telmisartan and Hydrochlorothiazide _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. 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 THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR APO-Telmisartan HCTZ 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 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. Untreated hypertension can lead to serious health problems, including stroke, heart disease and kidney failure. APO-Telmisartan HCTZ contains both telmisartan and hydrochlorothiazide (HCTZ) 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 antagonists. Angiotensin II is a substance in the body which causes blood vessels to narrow, thus increasing blood pressure. Telmisartan works by blocking the effect of angiotensin II. When the effect of angiotensin II is blocked, your blood vessels relax, and your blood pressure goes down • Hydrochlorothiazide belongs to the group of medicines called diuretics. Diuretics help to reduce the amount of excess fluid in the body by in Прочетете целия документ
AUSTRALIAN PRODUCT INFORMATION APO-TELMISARTAN HCTZ (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLETS 1 NAME OF THE MEDICINE Telmisartan and Hydrochlorothiazide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains telmisartan and hydrochlorothiazide as the active ingredients. APO-TELMISARTAN HCTZ 40/12.5 MG: Each tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide. APO-TELMISARTAN HCTZ 80/12.5 MG: Each tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide. APO-TELMISARTAN HCTZ 80/25 MG: Each tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide. EXCIPIENTS WITH KNOWN EFFECT Contains sugars as lactose For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM APO-TELMISARTAN HCTZ 40/12.5 MG: Each tablet is a pink mottled and white to off-white biconvex, oval shaped, two layer tablet. The white to off-white layer may contain pink specks. The pink mottled face of tablets are marked with L199. APO-TELMISARTAN HCTZ 80/12.5 MG: Each tablet is a pink mottled and white to off-white biconvex, oval shaped, two layer tablet. The white to off-white layer may contain pink specks. The pink mottled face of tablet is marked with L200. APO-TELMISARTAN HCTZ 80/25 MG: Each tablet is a yellow mottled and white to off-white biconvex, oval shaped, two layer tablet. The white to off-white layer may contain yellow specks. The white face of tablets are marked with L201. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS APO-Telmisartan HCTZ is indicated for the treatment of hypertension. Treatment should not be initiated with these combinations. 4.2 DOSE AND METHOD OF ADMINISTRATION APO-Telmisartan HCTZ is intended for oral administration. DOSAGE Adults: The recommended dose is one tablet once daily. The dose of telmisartan can be increased before switching to APO-Telmisartan HCTZ. Direct change from monotherapy to the fixed combinations may be considered. APO-Telmisartan HCTZ 40/12.5 mg may be administered in patients whose blood pressure is not a Прочетете целия документ