Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
telmisartan, Quantity: 40 mg
Arrotex Pharmaceuticals Pty Ltd
Telmisartan
Tablet
Excipient Ingredients: sodium hydroxide; mannitol; sodium stearylfumarate; meglumine; magnesium stearate; povidone
Oral
28
(S4) Prescription Only Medicine
APO-TELMISARTAN is indicated for:,Treatment of hypertension,Prevention of cardiovascular morbidity and mortality in patients 55 years or older with coronary artery disease, peripheral artery disease, previous stroke, transient ischaemic attack or high risk diabetes with evidence of end organ damage (see CLINICAL TRIALS)
Visual Identification: White to off-white color, oval shape, biconvex, uncoated tablets debossed with L203 on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2014-05-19
APO-TELMISARTAN TABLETS _Contains the active ingredient telmisartan_ 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 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 this medicine 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 THIS MEDICINE IS USED FOR Telmisartan is used to: • treat high blood pressure (also called hypertension) • prevent cardiovascular complications, including death due to cardiovascular causes, in patients aged 55 years of age or older with coronary artery disease, peripheral vascular disease, previous stroke, previous transient ischaemic attack (TIA) or high-risk diabetes with evidence of end organ damage 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 normal, 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. PREVENTION OF CARDIOVASCULAR COMPLICATIONS, INCLUDING DEATH DUE TO CARDIOVASCULAR CAUSES Patients who may be considered at a high risk of developing cardiovascular complications, or at a high risk of death due to cardiovascular causes, are those aged 55 or more who have problems such as coronary artery disease (a hear read_full_document
1 AUSTRALIAN PRODUCT INFORMATION APO- TELMISARTAN (TELMISARTAN) TABLET 1 NAME OF THE MEDICINE Telmisartan. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg or 80 mg telmisartan, as the active ingredient. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 40 MG TABLET: White to off-white colour, oval shape, biconvex, uncoated tablets debossed with L203 on one side and plain on other side. 80 MG TABLET: White to off-white colour, oval shape, biconvex, uncoated tablets debossed with L204 on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Telmisartan is indicated for: • Treatment of hypertension • Prevention of cardiovascular morbidity and mortality in patients 55 years or older with coronary artery disease, peripheral artery disease, previous stroke, transient ischaemic attack or high risk diabetes with evidence of end organ damage (see section 5.1 PHARMACODYNAMIC PROPERTIES – CLINICAL TRIALS). 4.2 DOSE AND METHOD OF ADMINISTRATION Telmisartan is available as tablets for oral administration. Telmisartan may be administered with or without food. DOSAGE TREATMENT OF HYPERTENSION _Adults_: The recommended dose is 40 mg once daily. In cases where the target blood pressure is not achieved, telmisartan dose can be increased to 80 mg once daily. Telmisartan may be used in combination with thiazide-type diuretics such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with telmisartan. When considering raising the dose, it must be borne in mind that, while reduction in blood pressure is achieved after the first dose, the maximum antihypertensive effect is generally attained four to eight weeks after the start of treatment. 2 PREVENTION OF CARDIOVASCULAR MORBIDITY AND MORTALITY The recommended dose is 80 mg once daily. It is not known whether doses lower than 80 mg of telmisartan are effective in preventing cardiovascular morbidity and mortality. When initiating telmisartan therap read_full_document