Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TELMISARTAN
GENPHARMA SDN. BHD
TELMISARTAN
3 x 10s Tablets; 10 x 10s Tablets
Alembic Pharmaceuticals Limited (Formulation Division)
_ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ TELMIDIP TABLETS Telmisartan (40 mg and 80 mg) 1 WHAT IS IN THIS LEAFLET 1. What _TELMIDIP_ is used for 2. How _TELMIDIP_ works 3. Before you use _TELMIDIP_ 4. How to use _TELMIDIP_ 5. While you are using it 6. Side effects 7. Storage and disposal of _TELMIDIP_ 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _TELMIDIP_ IS USED FOR Telmisartan belongs to a group of medicines used: ▪ To treat essential hypertension (high blood pressure). ‘Essential’ means that the high blood pressure is not caused by any other condition. ▪ 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 a stroke or have high risk of diabetes. HOW _TELMIDIP _WORKS _TELMIDIP_ 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. _TELMIDIP_ blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered. BEFORE YOU USE _TELMIDIP _ - _When you must not take it _ Do not take _TELMIDIP_ if: ▪ you are allergic (hypersensitive) to telmisartan or any other ingredients included in the tablets (see section _Product description _ for a list of other ingredients) ▪ you are pregnant (when pregnancy is detected, _TELMIDIP_ should be discontinued as soon as possible) ▪ you are breastfeeding ▪ you have biliary obstructive disorders (problem with the damage of the bile from the liver and gall bladder) ▪ you have severe liver problems If any of the above applies to you, tell your doctor or pharmacist before taking _TELMIDIP_ . - _Before you start to take it _ Please tell your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses: ▪ Kidney disease or kidney transplant ▪ Renal artery st Baca dokumen lengkapnya
1 1. NAME OF THE MEDICINAL PRODUCT TELMIDIP 40 mg Tablets TELMIDIP 80 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TELMIDIP 40 mg Tablets Each tablet contains 40 mg telmisartan. TELMIDIP 80 mg Tablets Each tablet contains 80 mg telmisartan. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet TELMIDIP 40 mg Tablets White to off-white color, oval shape, biconvex, uncoated tablets debossed with 'L203' on one side and plain on other side. Dimension: Thickness 3.90 mm to 4.70 mm Length 11.80 mm to 12.20 mm Width 5.70 mm to 6.10 mm TELMIDIP 80 mg Tablets White to off-white color, oval shape, biconvex, uncoated tablets debossed with 'L204' on one side and plain on other side. Dimension: Thickness 4.80 mm to 5.60 mm Length 16.00 mm to 16.40 mm Width 7.70 mm to 8.10 mm 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of essential hypertension in adults. 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. 2 Use of telmisartan with an ACE inhibitor is not recommended. 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ _Treatment of essential hype Baca dokumen lengkapnya