Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
hydrochlorothiazide, Quantity: 12.5 mg; telmisartan, Quantity: 40 mg
Sandoz Pty Ltd
Hydrochlorothiazide,Telmisartan
Tablet, film coated
Excipient Ingredients: iron oxide red; povidone; meglumine; magnesium stearate; sodium hydroxide; lactose; iron oxide yellow; macrogol poly(vinyl alcohol) grafted polymer; citric acid monohydrate; colloidal anhydrous silica; lactose monohydrate; crospovidone
Oral
7, 14, 28, 56 and 98 tablets
(S4) Prescription Only Medicine
Telmisartan/HCT Sandoz? is indicated for the treatment of hypertension. Treatment should not be initiated with these combinations.
Visual Identification: Red, oval, biconvex film-coated tablet debossed with 40 on one side and with 12.5 on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2014-01-31
TELMISARTAN/HCT SANDOZ ® 1 TELMISARTAN/HCT SANDOZ ® TABLETS _Telmisartan and Hydrochlorothiazide _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Telmisartan/HCT Sandoz. 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 TELMISARTAN/HCT SANDOZ IS USED FOR This medicine 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 _ _SANDOZ WORKS _ This medicine contains the active ingredients telmisartan and hydrochlorothiazide. 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 exc Read the complete document
210826-Telmisartan/HCT Sandoz-pi Page 1 of 24 AUSTRALIAN PRODUCT INFORMATION TELMISARTAN/HCT SANDOZ ® (TELMISARTAN HYDROCHLOROTHIAZIDE) TABLETS 1 NAME OF THE MEDICINE Telmisartan/Hydrochlorothiazide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Telmisartan/HCT Sandoz ® 40 mg/12.5 mg tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide . Each Telmisartan/HCT Sandoz ® 80 mg/12.5 mg tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide . Each Telmisartan/HCT Sandoz ® 80 mg/25 mg tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide . _List of excipients with known effect:_ Sugars as lactose anhydrous. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Telmisartan/HCT Sandoz ® 40 mg/12.5 mg tablet - red, oval, biconvex film-coated tablet debossed with 40 on one side and with 12.5 on the other side Telmisartan/HCT Sandoz ® 80 mg/12.5 mg tablet - white to white off, oval, biconvex film- coated tablet debossed with 80 on one side and with 12.5 on the other side Telmisartan/HCT Sandoz ® 80 mg/25 mg tablet - yellow, oval, biconvex film-coated tablet debossed with 80 on one side and with 25 on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Telmisartan/HCT Sandoz is indicated for the treatment of hypertension. Treatment should not be initiated with these combinations. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE _Adults_ The recommended dose is one tablet once daily. The dose of telmisartan can be increased before switching to Telmisartan/HCT Sandoz. Direct change from monotherapy to the fixed combinations may be considered. Telmisartan/HCT Sandoz 40/12.5 mg may be administered in patients whose blood pressure is not adequately controlled by telmisartan 40 mg or hydrochlorothiazide. Telmisartan/HCT Sandoz 80/12.5 mg may be administered in patients whose blood pressure is not adequately controlled by Telmisartan 80 mg or by Telmisartan/HCT Sandoz 40/12.5 mg. 210826-Telmisartan/HCT Sandoz-pi Page 2 of 24 Telmisartan/HCT S Read the complete document