国: シンガポール
言語: 英語
ソース: HSA (Health Sciences Authority)
HYDROCHLOROTHIAZIDE; TELMISARTAN
BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
C09DA07
12.5 mg
TABLET
HYDROCHLOROTHIAZIDE 12.5 mg; TELMISARTAN 80 mg
ORAL
Prescription Only
BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG
ACTIVE
2003-08-20
1 Abcd PACKAGE LEAFLET: INFORMATION FOR THE USER MICARDIS PLUS 40/12.5 MG TABLETS MICARDIS PLUS 80/12.5 MG TABLETS Telmisartan/hydrochlorothiazide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What MICARDIS PLUS is and what it is used for 2. What you need to know before you take MICARDIS PLUS 3. How to take MICARDIS PLUS 4. Possible side effects 5. How to store MICARDIS PLUS 6. Contents of the pack and other information 1. WHAT MICARDIS PLUS IS AND WHAT IT IS USED FOR MICARDIS PLUS 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. MICARDIS PLUS is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet. Both of these substances help to control high blood pressure. • Telmisartan belongs to a group of medicines called angiotensin II receptor blocker. 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 blindne 完全なドキュメントを読む
Page 1 of 15 MICARDIS ® PLUS abcd 1. NAME OF THE MEDICINAL PRODUCT MICARDIS PLUS 40/12.5 mg MICARDIS PLUS 80/12.5 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 tablet contains: [1,1’-biphenyl]-2-carboxylic acid, 4’-[(1,4’dimethyl-2’-propyl[2,6-bi-1H-benzimidazole]-1’-yl)methyl] (= telmisartan) 40 or 80 mg and hydrochlorothiazide 12.5 mg 3. PHARMACEUTICAL FORM 40/12.5mg: Oblong, white-red, Biconvex two-layer tablets. The white face is marked with “H4” and the Boehringer Ingelheim company symbol 80/12.5mg: Oblong, white-red, Biconvex two-layer tablets. The white face is marked with “H8” and the Boehringer Ingelheim company symbol 4. CLINICAL PARTICULARS 4.1 INDICATIONS Treatment of essential hypertension. As fixed dose combination MICARDIS PLUS is indicated in patients whose blood pressure is not adequately controlled on telmisartan or hydrochlorothiazide alone. 4.2 DOSAGE AND ADMINISTRATION Adults MICARDIS PLUS should be taken once daily. The dose of telmisartan could be up-titrated before switching to MICARDIS PLUS. Direct change from monotherapy to the fixed combinations may be considered. • MICARDIS PLUS 40/12.5 mg may be administered in patients whose blood pressure is not adequately controlled by MICARDIS 40 mg or hydrochlorothiazide. • MICARDIS PLUS 80/12.5 mg may be administered in patients whose blood pressure is not adequately controlled by MICARDIS 80 mg or by MICARDIS PLUS 40/12.5 mg. Sodium or volume depletion should be corrected before treatment commencement with MICARDIS PLUS. The maximum antihypertensive effect is generally attained with MICARDIS PLUS 4 – 8 weeks after the start of treatment. When necessary, MICARDIS PLUS may be administered with another antihypertensive drug. In patients with severe hypertension treatment with telmisartan at doses up to 160 mg alone and in combination with hydrochlorothiazide 12.5 - 25 mg daily was well tolerated and effective. _Special populations: _ Geriatric patients No dose adjustment is necessary for geriatric patients. Paediatric p 完全なドキュメントを読む