Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
telmisartan, Quantity: 40 mg
Sandoz Pty Ltd
Telmisartan
Tablet, uncoated
Excipient Ingredients: sodium hydroxide; meglumine; lactose; magnesium stearate; povidone; lactose monohydrate; crospovidone
Oral
7, 28, 56, and 98 tablets
(S4) Prescription Only Medicine
Telmisartan Sandoz 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, oblong, plain tablet scored on one side and debossed with 40 on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2013-07-01
TELMISARTAN SANDOZ ® 1 TELMISARTAN SANDOZ ® _Telmisartan Tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Telmisartan Sandoz ® . 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 TELMISARTAN SANDOZ ® IS USED FOR This medicine 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: Telmisartan Sandoz ® 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 TELMISARTAN SANDOZ _ _WORKS _ It contains the active ingredient, telmisartan which belongs to a group of medicines called angiotensin II receptor antagonist. It works by blocking the effect of angiotensin II. When the effect of angiotensin II is blocked, your blood vessels relax and yo Прочитать полный документ
220928-Telmisartan Sandoz-pi Page 1 of 22 AUSTRALIAN PRODUCT INFORMATION TELMISARTAN SANDOZ ® (TELMISARTAN) TABLETS 1 NAME OF THE MEDICINE telmisartan 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Telmisartan Sandoz ® 40 mg tablet contains 40 mg telmisartan. Each Telmisartan Sandoz ® 80 mg tablet contains 80 mg telmisartan. Excipients with known effect: Sugars as lactose For the full list of excipients, see Section 6.1 List of excipients 3 PHARMACEUTICAL FORM Telmisartan Sandoz® 40 mg tablets - white, oblong, plain tablet scored on one side and debossed with 40 on the other side. Telmisartan Sandoz® 80 mg tablets - white, oblong, plain tablet scored on one side and debossed with 80 on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Telmisartan Sandoz ® 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 Pharmacological properties/ Clinical trials) 4.2 D OSE 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. 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. Telmisartan may be used in combination with thiazide-type diuretics such as hydrochlorothiazide or calcium-channel blockers such as amlodipine, which has been shown to have an additive blood pressure lowering effect with telmisartan. 220928-Telmisartan Sandoz-pi Page 2 of 22 _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 Прочитать полный документ