Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
hydrochlorothiazide, Quantity: 25 mg; telmisartan, Quantity: 80 mg
Arrotex Pharmaceuticals Pty Ltd
Hydrochlorothiazide,Telmisartan
Tablet, multilayer
Excipient Ingredients: meglumine; magnesium stearate; sodium stearylfumarate; povidone; mannitol; purified water; sodium hydroxide; lactose monohydrate; Colour
Oral
28
(S4) Prescription Only Medicine
Teltartan HCT 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 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
TELTARTAN HCT TABLETS _ _ _TELMISARTAN AND HYDROCHLOROTHIAZIDE _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about TELTARTAN HCT. It does not contain all available information. It does not take the place of talking to 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, or from www.medicines.org.au and may contain important information about the medicine and its use of which you should be aware. 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 TELTARTAN HCT IS USED FOR TELTARTAN HCT 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 TELTARTAN HCT WORKS _ _ _ TELTARTAN HCT 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 antagonists. Angiotensin II is a substance in the body which causes blood vessels to narrow, thus increasing blood pressure. Telmisartan works by blo Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION – TELTARTAN HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLETS 1 NAME OF THE MEDICINE Telmisartan and hydrochlorothiazide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION TELTARTAN HCT is available in three tablet strengths: • TELTARTAN HCT 40/12.5 mg containing telmisartan 40 mg/hydrochlorothiazide 12.5 mg • TELTARTAN HCT 80/12.5 mg containing telmisartan 80 mg/hydrochlorothiazide 12.5 mg • TELTARTAN HCT 80/25 mg containing telmisartan 80 mg/hydrochlorothiazide 25 mg EXCIPIENTS WITH KNOWN EFFECT The tablets also contains sugars as lactose monohydrate. For full list of excipients, see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM TELTARTAN HCT 40/12.5 mg and 80/12.5 mg tablets are pink mottled and white to off-white biconvex, oval shaped, two layer tablets. The white to off-white layer may contain pink specks. The pink mottled face of TELTARTAN HCT 40/12.5 mg tablets are marked with L199. The pink mottled face of TELTARTAN HCT 80/12.5 mg tablets are marked with L200. TELTARTAN HCT 80/25 mg tablets are yellow mottled and white to off-white biconvex, oval shaped, two layer tablets. The white to off-white layer may contain yellow specks. The yellow face of TELTARTAN HCT 80/25 mg tablets are marked with L201. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS TELTARTAN HCT is indicated for the treatment of hypertension. Treatment should not be initiated with these combinations. 4.2 D OSE AND METHOD OF ADMINISTRATION _Adults_: The recommended dose is one tablet once daily. 2 The dose of telmisartan can be increased before switching to TELTARTAN HCT. Direct change from monotherapy to the fixed combinations may be considered. TELTARTAN HCT 40/12.5 mg may be administered in patients whose blood pressure is not adequately controlled by telmisartan 40 mg or hydrochlorothiazide. TELTARTAN HCT 80/12.5 mg may be administered in patients whose blood pressure is not adequately controlled by telmisartan 80 mg or by TELTARTAN HCT 40/12.5 mg. TELTARTAN HCT 80/25 mg may be administered in p Read the complete document