Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TELMISARTAN
HOVID BERHAD
TELMISARTAN
3x10 Tablets
Jubilant Generics Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ HOVID-TELMISARTAN TABLET Telmisartan 40mg and 80mg 1 WHAT IS IN THIS LEAFLET 1. What Telmisartan tablet is used for 2. How Telmisartan tablet works 3. Before you use Telmisartan tablet 4. How to use Telmisartan tablet 5. While you are using Telmisartan tablet 6. Side effects 7. Storage and Disposal of Telmisartan tablet 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT TELMISARTAN TABLET IS USED FOR Telmisartan tablet is used to treat essential hypertension (high blood pressure). ‘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. Telmisartan tablet is also used to reduce cardiovascular events (i.e. heart attack or stroke) in patients 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 TELMISARTAN TABLET WORKS Telmisartan tablet 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. Telmisartan tablet blocks the effect of angiotensin II so that the blood vessels relax, and thus the blood pressure is lowered. BEFORE YOU USE TELMISARTAN TABLET _- When you must not use it _ Do not take this medicine if you: are allergic to telmisartan or any of the excipients. are more than 3 months pregnant. (It is better to avoid telmisartan during pregnancy altogether) are lactating as it is not known whether telmisartan is excreted in hu Baca dokumen lengkap
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. CONTRAINDICATION • Hypersensitivity to the active substance or to any excipients used. • Second and third trimesters of pregnancy • Biliary obstructive disorders • Severe hepatic impairment • Concomitant use of telmisartan with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73m 2 ). • Telmisartan is contraindicated during lactation since it is not known whether it is excreted in human milk. Animal studies have shown excretion of telmisartan in breast milk. WARNINGS AND PRECAUTIONS PREGNANCY Angiotensin II receptor antagonists should not be initiated during pregnancy. Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started. HEPATIC IMPAIRMENT Telmisartan is not to be given to patients with cholestasis, biliary obstructive disorders or severe hepatic impairment since telmisartan is mostly eliminated with the bile. These patients can be expected to have reduced hepatic clearance for telmisartan. Telmisartan should be used only with caution in patients with mild to moderate hepatic impairment. RENOVASCULAR HYPERTENSION There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angio Baca dokumen lengkap