OLMETEC PLUS 20/12,5

Nazione: Indonesia

Lingua: indonesiano

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

Principio attivo:

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Commercializzato da:

PFIZER INDONESIA - Indonesia

INN (Nome Internazionale):

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Dosaggio:

20/12.5 MG

Forma farmaceutica:

TABLET SALUT SELAPUT

Confezione:

DUS, 3 BLISTER @ 10 TABLET SALUT SELAPUT

Prodotto da:

PFIZER MANUFACTURING DEUTSCHLAND Gmbh - Germany

Data dell'autorizzazione:

2020-02-06

Scheda tecnica

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