Nazione: Indonesia
Lingua: indonesiano
Fonte: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
PFIZER INDONESIA - Indonesia
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
40/12.5 MG
TABLET SALUT SELAPUT
DUS, 3 BLISTER @ 10 TABLET SALUT SELAPUT
DAICHI SANKYO EUROPE GmbH - Germany
2020-04-08
PT. PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Olmesartan medoxomil, Hydrochlorothiazide Trade Name: OLMETEC PLUS CDS Effective Date: June, 2020 Supersedes: May, 2016 1. NAME OF THE MEDICINAL PRODUCT Olmetec Plus 20/12.5 mg Olmetec Plus 40/12.5 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Olmetec Plus 20/12.5 mg tablet contains 20 mg olmesartan medoxomil and 12.5 mg hydrochlorothiazide Each Olmetec Plus 40/12.5 mg tablet contains 40 mg olmesartan medoxomil and 12.5 mg hydrochlorothiazide For excipients, see section 6.1 - LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Film-coated tablet. Olmetec Plus 20/12.5 mg tablet: Reddish-yellow, round, film-coated tablet with C22 debossed on one side. Olmetec Plus 40/12.5 mg tablet: Reddish-yellow, oval, film-coated tablet with C23 debossed on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Olmetec Plus fixed dose combination is indicated in patients whose blood pressure is not adequately controlled on olmesartan medoxomil or hydrochlorothiazide alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults _ Olmetec Plus is administered once daily, with or without food, in patients whose blood pressure is not adequately controlled by olmesartan medoxomil or hydrochlorothiazide alone. DISETUJUI OLEH BPOM: 08/06/2021 ID REG: EREG10024112000482 - EREG10024112000483 When clinically appropriate, direct change from monotherapy to the fixed combination may be considered. Dose titration of the individual components is recommended: Olmetec Plus 20/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide 12.5 or 25 mg monotherapy, or Olmetec 20 mg alone. If additional blood pressure lowering is required, the dose of each monocomponent may be titrated to the strength of Olmetec Plus 40/12.5 mg and subsequently, if required to 40/25 mg. Olmetec Plus 40/12.5 mg and Olmetec Plus 40/25 mg may be administered in patients whose blood pressure is not adequately controlled by O Leggi il documento completo