Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TELMISARTAN
PAHANG PHARMACY SDN. BHD.
TELMISARTAN
30tablet Tablets; 28 Tablets
KRKA, d.d., Novo mesto
_CONSUMER MEDICATION INFORMATION LEAFLET_ _(RIMUP)_ 1 TOLURA TABLETS Telmisartan (40 mg, 80 mg) WHAT IS IN THIS LEAFLET 1. What Tolura is used for 2. How Tolura works 3. Before you use Tolura 4. How to use Tolura 5. While you are using it 6. Side effects 7. Storage and Disposal of Tolura 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT TOLURA IS USED FOR TOLURA IS USED TO treat essential hypertension (high blood pressure) in adults. ‘Essential’ means that the high blood pressure is not caused by any other condition. High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal range. TOLURA IS ALSO USED TO reduce cardiovascular events (i.e. heart attack or stroke) in adults 55 years of age or older who are at risk because they have a reduced or blocked blood supply to the heart or legs, or have had a stroke or have high risk diabetes. Your doctor can tell you if you are at high risk for such events. HOW TOLURA WORKS Tolura belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body which causes your blood vessels to narrow, thus increasing your blood pressure. Tolura blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered. BEFORE YOU USE TOLURA - _When you must not use_ _it_ if you are allergic to telmisartan or any other ingredients of this medicine. if you are more than 3 months pregnant. (It is also better to avoid Tolura in early pregnancy – see pregnancy section.) if you have severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of the bile from the liver and gall bladder) or any other severe liver disease. If any o Olvassa el a teljes dokumentumot
1.3.1 Telmisartan SPC, Labeling and Package Leaflet MY SmPCPIL115956_2 20.07.2018 – Updated: 17.09.2019 Page 1 of 12 TOLURA _Telmisartan_ NAME OF THE MEDICINAL PRODUCT Tolura 40 mg tablets Tolura 80 mg tablets COMPOSITION Each tablet contains 40 mg telmisartan. Each tablet contains 80 mg telmisartan. PRODUCT DESCRIPTION Tolura 40 mg tablets are presented as white to almost white, biconvex, oval tablets, thickness 4.0 mm – 5.2 mm. Tolura 80 mg tablets are presented as white to almost white, biconvex, capsule shaped tablets, thickness 4.8 mm – 6.2 mm. 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). 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. POSOLOGY AND METHOD OF ADMINISTRATION ADULTS Treatment of essential hypertension: The recommended dose is 40 mg once daily. In cases where the target blood pressure is not achieved, telmisartan dose can be increased to a maximum of 80 mg once daily. Alternatively, telmisartan may be used in combination with thiazide-type diuretics such as hydrochlorothiazide, which has been 1.3.1 Telmisartan SPC, Labeling and Package Leaflet MY SmPCPIL115956_2 20.07.2018 – Updated: 17.09.2019 Page 2 of 12 shown to have an additive blood pressure l Olvassa el a teljes dokumentumot