OLMETEC

Nazione: Indonesia

Lingua: indonesiano

Fonte: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Principio attivo:

OLMESARTAN MEDOXOMIL

Commercializzato da:

PFIZER INDONESIA - Indonesia

INN (Nome Internazionale):

OLMESARTAN MEDOXOMIL

Dosaggio:

20 MG

Forma farmaceutica:

TABLET SALUT SELAPUT

Confezione:

DUS, 3 BLISTER @ 10 TABLET SALUT SELAPUT

Prodotto da:

DAICHI SANKYO EUROPE GmbH - Germany

Data dell'autorizzazione:

2019-11-04

Scheda tecnica

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