Država: Indonezija
Jezik: indonezijščina
Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 2 ALU-BLISTER @ 10 TABLET
2022-09-24
Red font: Proposed CCDS 0252-13; Blue F on t: Editorial; Y e llow mark: Additional from BPOM DISETUJUI OLEH BPOM : 15/10/2021 EREG10036412000538 - 39 M I C A R D I S P LUS C OM P OS I T I ON 1 tablet c on ta i ns : [ 1 , 1 ’ - b iph e n yl] - 2 - car b o xyl i caci d , 4 ’ - [ (1 , 4 ’ d i m e t h yl - 2 ’ - p ro p yl[ 2 , 6 - bi - 1 H - b en z i m i d a z ol e] - 1 ’ - yl)methyl] (= telmisartan) 40 or 80 m g Hydrochlorothiazide 12.5 m g Excipients: ** povidone, meglumine, sodium hydroxide, sorbitol, magnesium stearate, microcristalline c e ll u l ose , ferric oxide red (E172), sodium starch glycolate, lactose monohydrate, maize st a rc h Sodium MIC A R D IS ® PLUS t a b l e t s 40/12.5 mg contain less than 1 mmol sodium (23 mg) per tablet, that is to sa y essentially ‘ s o di um - f ree’. Sodium M I C A R D I S ® PLUS tablets 80/12.5 mg contain less than 1 mmol sodium (23 mg) per tablet, that is to sa y essentially ‘ s o di um - f ree’. I ND I CAT I O NS T r ea t m en t of essen t i a l h y p er t ens i on . As fixed dose combination MICARDIS PLUS is indicated in patients whose blood pressure is not adequately controlled on telmisartan or hydrochlorothiazide a l on e. DOSAGE AND A D M IN IST R A T IO N MICARDIS PLUS may be taken with or without f ood . Ad u l ts MICARDIS PLUS should be taken once daily. The dose of telmisartan could be up-titrated b ef or e switching to MICARDIS PLUS. Direct change from monotherapy to the fixed combinations may be c ons i d er ed . • MICARDIS PLUS 40/12.5 mg may be administered in patients whose blood pressure is no t adequately controlled by MICARDIS 40 mg or hy dr o chl o r o t hi a z i de . • MICARDIS PLUS 80/12.5 mg may be administered in patients whose blood pressure is no t adequately controlled by MICARDIS 80 mg or by MICARDIS PLUS 40/12.5 m g . Sodium or volume d ep l e t i on should be corrected before treatment commencement with Mi c a r d i s P lu s . The maximum antihypertensive effect is generally attained with MICARDIS P L U S 4 – 8 weeks Preberite celoten dokument