País: Indonesia
Idioma: indonesio
Fuente: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
OLMESARTAN MEDOXOMIL
PFIZER INDONESIA - Indonesia
OLMESARTAN MEDOXOMIL
40 MG
TABLET SALUT SELAPUT
DUS, 3 BLISTER @ 10 TABLET SALUT SELAPUT
DAICHI SANKYO EUROPE GmbH - Germany
2019-07-15
Generic Name: Olmesartan medoxomil Trade Name: Olmetec ® CDS Effective Date: April 2020 Supersedes: May 2016 Approved by BPOM: 2020-0060223 Page 1 of 13 PT. PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Olmesartan medoxomil Trade Name: Olmetec ® CDS Effective Date: April 2020 Supersedes: May 2016 NAME OF THE MEDICINAL PRODUCT Olmetec ® 20 mg film-coated tablet Olmetec ® 40 mg film-coated tablet QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg of olmesartan medoxomil Each tablet contains 40 mg of olmesartan medoxomil For excipients, see section LIST OF EXCIPIENTS PHARMACEUTICAL FORM Film-coated tablet. Olmetec ® 20 mg tablets: White, circular, film-coated tablets with C14 respectively debossed on one side. Olmetec ® 40 mg tablets: White, oval, film-coated tablets with C15 debossed on one side. CLINICAL PARTICULARS THERAPEUTIC INDICATION Treatment of essential hypertension. POSOLOGY AND METHOD OF ADMINISTRATION ADULTS The recommended starting dose of olmesartan medoxomil is 10 mg once daily. In patients whose blood pressure is not adequately controlled at this dose, the dose of olmesartan medoxomil may be increased to 20 mg once daily as the optimal dose. If additional blood pressure reduction is required, olmesartan medoxomil dose may be increased to a maximum of 40 mg daily or hydrochlorothiazide therapy may be added. DISETUJUI OLEH BPOM: 21/04/2021 ID REG: EREG10024112000528 - EREG10024112000529 Generic Name: Olmesartan medoxomil Trade Name: Olmetec ® CDS Effective Date: April 2020 Supersedes: May 2016 Approved by BPOM: 2020-0060223 Page 2 of 13 The antihypertensive effect of olmesartan medoxomil is substantially present within 2 weeks of initiating therapy and is maximal by about 8 weeks after initiating therapy. This should be borne in mind when considering changing the dose regimen for any patient. In order to assist compliance, it is recommended that Olmetec ® tablets be taken at about the same time each day, with or without food, for example at breakfast time. ELDERLY The Leer el documento completo