País: Malasia
Idioma: inglés
Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TELMISARTAN; HYDROCHLOROTHIAZIDE
PAHANG PHARMACY SDN. BHD.
TELMISARTAN; HYDROCHLOROTHIAZIDE
30 Tablets; 60 Tablets; 100 Tablets; 30 Tablets; 60 Tablets; 100 Tablets
CADILA PHARMACEUTICALS LIMITED
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ TELI H TABLETS 40MG/12.5MG Telmisartan BP 40mg, Hydrochlorothiazide BP 12.5mg 1 WHAT IS IN THIS LEAFLET 1. What _Teli H _ is used for 2. How _Teli H _ works 3. Before you use _Teli H_ 4. How to use _Teli H_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Teli H_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _TELI H _ IS USED FOR _Teli H _ is a combination of two active substances, Telmisartan and Hydrochlorothiazide in one tablet. Both of these substances help to control high blood pressure. _Teli _ _H _ is used to treat high blood pressure (essential hypertension) in patients whose blood pressure is not controlled enough when either telmisartan or hydrochlorothiazide is used alone. HOW _TELI H _ WORKS • Telmisartan belongs to a group of medicines called 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 blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered. • Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which cause your urine output to increase, leading to a lowering of your blood pressure. 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. BEFORE YOU USE _TELI H_ - _When you must not use it_ • if you are allergic (hypersensitive) to telmisartan or any other ingredients included in _Teli _ _H_ _ _ tablets (see “Product Description” for a list of other ingredients). • if you are allergic (hypersensitive) to hydrochlorothiazide or to any other sulfonamide-derived medicines. • if Leer el documento completo
For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory NAME OF THE MEDICINAL PRODUCT Teli H 40 mg/12.5 mg tablets QUALITATIVE AND QUANTITATIVE COMPOSITION Each bi-layered tablet contains 40 mg telmisartan BP and 12.5 mg hydrochlorothiazide BP PHARMACEUTICAL FORM Tablet PRODUCT DESCRIPTION Biconvex, bilayered, oval shaped, uncoated tablets. One layer is pink and other layer is white and may contain pink specks. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Treatment of essential hypertension. Telmisartan 40 mg+hydrochlorothiazide 12.5mg is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone. POSOLOGY AND METHOD OF ADMINISTRATION ADULTS Telmisartan+hydrochlorothiazide should be taken in patients whose blood pressure is not adequately controlled by telmisartan alone. Individual dose titration with each of the two components is recommended before changing to the fixed dose combination. When clinically appropriate, direct change from monotherapy to the fixed combination may be considered. Telmisartan 40 mg+hydrochlorothiazide 12.5mg may be administered in patients whose blood pressure is not adequately controlled by telmisartan monotherapy or hydrochlorothiazide monotherapy. SPECIAL POPULATIONS RENAL IMPAIRMENT : Due to the hydrochlorothiazide component, Teli H should not be used in patients with severe renal dysfunction (creatinine clearance <30 mL/min). Loop diuretics are preferred to thiazides in this population. Experience in patients with mild to moderate renal impairment is modest but has not suggested adverse renal effects and dose adjustment is not considered necessary. Periodic monitoring of renal function is advised. HEPATIC IMPAIRMENT : In patients with mild to moderate hepatic impairment the posology should not exceed telmisartan 40mg + hydrochlorothiazide 12.5mg once daily. Telmisartan + hydrochlorothiazide is not indicated in patients with severe hepatic impairment. Thiazides should be used with caution in patients with impaired hepatic Leer el documento completo