Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
telmisartan, Quantity: 40 mg
AVALLON PHARMACEUTICALS PTY LTD
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
NOUMED 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 yellow, 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
Registered
2018-02-28
NOUMED TELMISARTAN 1 NOUMED TELMISARTAN _telmisartan tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about NOUMED TELMISARTAN. It does not contain all of 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 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. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT NOUMED TELMISARTAN IS USED FOR NOUMED TELMISARTAN tablets contain the active ingredient telmisartan, which belongs to a group of medicines called angiotensin II receptor antagonists or blockers (‘sartans’ or ARBs) that help relax blood vessels. It is used to: • lower high blood pressure (also called hypertension), • prevent cardiovascular complications (including death) in elderly patients 55 years or older with certain related conditions. HYPERTENSION Everyone alive has blood pressure. As your heart contracts and relaxes to pump blood into the arteries providing needed oxygen and nutrients around your body, the pressure goes from high (systolic) to low (diastolic) with each heartbeat. Your blood pressure may vary at different times of the day, depending on how busy, worried or relaxed you are. It may also change as you grow older, and the condition of your heart, arteries and health changes. There are usually no signs of hypertension. After regularly checking your blood pressure, your doctor may diagnose hypertension if your blood pressure stays higher than normal, even when you are calm or relaxed. Uncontrolled hypertension can lead to serious health problems, including stroke, heart disease and kidney failure. Telmisartan helps lower blood pressure either alone or with other medicines. CARDIOVASCULAR COMPLICATIONS Heart attack, stroke, diseases of the heart muscle and arteries, heart failure, death Read the complete document
Product Information - Australia Page 1 of 19 AUSTRALIAN PRODUCT INFORMATION - NOUMED TELMISARTAN (TELMISARTAN 40 MG & 80 MG TABLETS) 1. NAME OF THE MEDICINE Telmisartan 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each NOUMED TELMISARTAN tablet contains either 40 mg or 80 mg of the active ingredient telmisartan. Excipients with known effect: sugars (as lactose). For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM NOUMED TELMISARTAN 40mg tablets are white, oblong, plain tablets, scored on one side and debossed with 40 on the other side. NOUMED TELMISARTAN 80mg tablets are white, oblong, plain tablets, scored on one side and debossed with 80 on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NOUMED 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 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. Product Information - Australia Page 2 of 19 _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 mo Read the complete document