Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
telmisartan, Quantity: 80 mg
Pharmacor Pty Ltd
Telmisartan
Tablet, uncoated
Excipient Ingredients: lactose monohydrate; crospovidone; povidone; sodium hydroxide; meglumine; colloidal anhydrous silica; magnesium stearate
Oral
28's (2 blisters of 14 tablets), 28's (4 blisters of 7 tablets), 10's (1 blister of 10 tablet)
(S4) Prescription Only Medicine
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.
Visual Identification: White to off white oblong shaped biconvex, uncoated tablets debossed with TEL on one side and 80 on other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2014-05-07
ALKEM TELMISARTAN Ver 03 1 ALKEM TELMISARTAN TABLETS Telmisartan CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Alkem Telmisartan. 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 TAKING THIS MEDICINE, ASK 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. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again WHAT ALKEM TELMISARTAN IS USED FOR Alkem Telmisartan 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 Alkem Telmisartan 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 kid Прочитать полный документ
ALKEM TELMISARTAN Ver 03 1 AUSTRALIAN PRODUCT INFORMATION – ALKEM TELMISARTAN (TELMISARTAN) 1. NAME OF THE MEDICINE Telmisartan 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Telmisartan is a specific angiotensin II receptor (type AT1) antagonist. Telmisartan is an white or slightly to yellowish crystalline powder. It is practically insoluble in water, very slightly soluble in ethanol, slightly soluble in methanol and soluble in a mixture of chloroform and methanol (1:1). ALKEM TELMISARTAN is available in 2 strengths as tablets for oral administration containing 40 mg and 80 mg of telmisartan. ALKEM TELMISARTAN 40: Each tablet contains Telmisartan 40 mg. ALKEM TELMISARTAN 80: Each tablet contains Telmisartan 80 mg. Excipients with known effect: lactose. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Tablets ALKEM TELMISARTAN 40 mg tablets: White to off-white, oblong shaped biconvex, uncoated tablets debossed with ‘TEL’ on one side and ‘40’ on other side. ALKEM TELMISARTAN 80 mg tablets: White to off-white, oblong shaped biconvex, uncoated tablets debossed with ‘TEL’ on one side and ‘80’ on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ALKEM 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). ALKEM TELMISARTAN Ver 03 2 4.2 DOSE AND METHOD OF ADMINISTRATION 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 telmi Прочитать полный документ