Country: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TELMISARTAN
SYNERRV SDN BHD
TELMISARTAN
3 x 10 Tablets
Aurobindo Pharma Limited (Unit VII)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ AURO TELMISARTAN 40 (TELMISARTAN TABLETS 40MG) AURO TELMISARTAN 80 (TELMISARTAN TABLETS 80MG) Telmisartan 40mg & 80mg 1 WHAT IS IN THIS LEAFLET 1. What AURO TELMISARTAN is used for 2. How AURO TELMISARTAN works 3. Before you use AURO TELMISARTAN 4. How to use AURO TELMISARTAN 5. While you are using it 6. Side effects 7. Storage and Disposal of AURO TELMISARTAN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT IS AURO TELMISARTAN USED FOR AURO TELMISARTAN is used to treat high blood pressure. It is also used to reduce your risk of cardiovascular events such as a heart attack, stroke or death from cardiovascular causes in patients 55 years or older at high risk of developing major cardiovascular events who are unable to take a group of medicines called ACE inhibitors. AURO TELMISARTAN can be used in additional to other needed treatment such as for blood pressure, anti-blood clotting or cholesterol lowering therapy. HOW AURO TELMISARTAN WORKS AURO TELMISARTAN works by blocking a receptor called angiotensin II receptor. Angiotensin II is a substance produced in your body which causes your blood vessels to narrow, thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered. BEFORE YOU USE AURO TELMISARTAN _-When you must not use it _ Do not use AURO TELMISARTAN if you are allergic to Telmisartan or any other ingredients in this medication. If you are more than 3 months pregnant. It is best to avoid this medication in early pregnancy. If you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the liver and gall bladder) or any other severe liver disease. If you are diabetic or have renal (kidney) disease and are on a high blood pressure medication called Aliskiren. If you are breastfeeding. _-Before you start to use it _ Please tell your doctor if you are Lestu allt skjalið
1. NAME OF THE MEDICINAL PRODUCT Telmisartan Tablets 40mg Telmisartan Tablets 80mg TRADE NAME OF THE PRODUCT AURO TELMISARTAN 40 AURO TELMISARTAN 80 2. QUALITATIVE AND QUANTITATIVE COMPOSITION AURO TELMISARTAN 40mg Tablets Each Uncoated Tablet Contains Telmisartan Ph. Eur. 40mg AURO TELMISARTAN 80mg Tablets Each Uncoated Tablet Contains Telmisartan Ph. Eur. 80mg For the full list of excipients, see Section 6.1 3. PHARMACEUTICAL FORM AURO TELMISARTAN 40 White to off-white, oblong shaped, biconvex uncoated tablets, debossed with ‘N & 40’ on either side of the score line on one side and plain on the other side. AURO TELMISARTAN 80 White to off-white, oblong shaped, biconvex uncoated tablets, debossed with ‘N & 80’ on either side of the score line on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of essential hypertension. Cardiovascular risk reduction Telmisartan is indicated for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take ACE inhibitors. High risk of cardiovascular events can be evidenced by history of coronary artery disease, peripheral arterial disease, stroke, transient ischemic attack, or high-risk diabetes (insulin-dependent or non-insulin dependent) with evidence of end-organ damage. Telmisartan can be used in additional to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy). Studies of Telmisartan in this setting do not exclude that it may not preserve a meaningful fraction of the effect of the ACE inhibitor to which it was compared. Consider using the ACE inhibitor first, and, if it is stopped for cough only, consider re-trying the ACE inhibitor after the cough resolves. Use of telmisartan with an ACE inhibitor is not recommended. 4.2 DOSAGE AND ADMINISTRATION Adults TREATMENT OF ESSENTIAL HYPERTENSION The recommended dose is 40 mg once Lestu allt skjalið