Country: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
telmisartan, Quantity: 40 mg
Arrotex Pharmaceuticals Pty Ltd
Telmisartan
Tablet
Excipient Ingredients: sodium stearylfumarate; povidone; magnesium stearate; meglumine; mannitol; sodium hydroxide
Oral
28
(S4) Prescription Only Medicine
TELTARTAN 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
Registered
2014-05-19
1 TELTARTAN TABLETS _Telmisartan _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Teltartan. 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 or doctor 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 IS USED FOR Teltartan is used to: • treat high blood pressure (also called hypertension) • prevent cardiovascular complications, including death due to cardiovascular causes, in patients older than 55 years of age with coronary artery disease, peripheral vascular disease, previous stroke, previous transient ischaemic attack (TIA) or high risk diabetes with evidence of end organ damage TREATMENT OF HYPERTENSION Teltartan 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 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. _ _ _HOW TELTARTAN WORKS _ Teltartan contains telmisartan. Telmisartan belongs to Прочитајте комплетан документ
1 AUSTRALIAN PRODUCT INFORMATION – TELTARTAN (TELMISARTAN) TABLET 1 NAME OF THE MEDICINE Telmisartan 2 QUALITATIVE AND QUANTITATIVE COMPOSITION TELTARTAN contains the active ingredient telmisartan. Tablets containing 40 mg and 80 mg of telmisartan are available. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM TELTARTAN is available as tablets for oral administration. TELTARTAN tablets are white to off-white, biconvex, oval-shaped, uncoatedtablets. TELTARTAN 40 mg tablets have one face marked with L203 and plain on the other side. TELTARTAN 80 mg tablets have one face marked with L204 and plain on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS TELTARTAN 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 D OSE AND METHOD OF ADMINISTRATION 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. 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. 2 When initiating telmisartan therapy for the prevention of cardiovascular morbidi Прочитајте комплетан документ