LOSEC

País: Indonésia

Língua: indonésio

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

Ingredientes ativos:

OMEPRAZOLE

Disponível em:

ASTRAZENECA INDONESIA - Indonesia

DCI (Denominação Comum Internacional):

OMEPRAZOLE

Dosagem:

20 MG

Forma farmacêutica:

KAPSUL

Unidades em pacote:

DUS, 2 BLISTER @ 7 KAPSUL

Fabricado por:

ASTRAZENECA AB - Sweden

Data de autorização:

2019-09-18

Características técnicas

LOSEC® 20 MG
_Omeprazole _
CAPSULES
COMPOSITION
Each capsule contains: Omeprazole 20 mg
PHARMACEUTICAL FORM
LOSEC capsules 20 mg : hard gelatine capsules with an opaque pink
body, marked 20 and
an opaque reddish-brown cap marked A/OM. Each capsule contains
omeprazole 20 mg as
enteric coated pellets.
THEURAPEUTIC INDICATION
LOSEC is indicated for the treatment of
•
Duodenal ulcer
•
Gastric ulcer
•
NSAID associated gastric and duodenal ulcers or erosions
•
_Helicobacter pylori_ eradication in peptic ulcer disease
•
Reflux oesophagitis
•
Zollinger-Ellison syndrome
POSOLOGY AND METHOD OF ADMINISTRATION
LOSEC capsules are_ _recommended to be given_ _in the morning and
swallowed whole with
half a glass of water.
_Duodenal ulcer _
The recommended dosage in patients with an active duodenal ulcer is
LOSEC 20 mg_ _once
daily. Symptom resolution_ _is rapid and in most patients healing
occurs within 2 weeks. For
those patients who may not be fully healed after the initial course,
healing usually occurs
during a further 2 week treatment period.
In patients with poorly responsive duodenal ulcer LOSEC 40 mg once
daily is
recommended_ _and healing is usually achieved within 4 weeks.
For the prevention of relapse in patients with duodenal ulcer disease_
_the recommended dose
is LOSEC 10 mg once daily. If needed the dose can be increased to
LOSEC 20 mg once
daily.
_Gastric ulcer _
The recommended dosage is LOSEC 20 mg once daily. Symptom resolution
is rapid and in
most patients healing occurs within 4 weeks. For those patients who
may not be fully
DISETUJUI OLEH BPOM : 08/11/2021
ID : EREG10042212100083
2(10)
healed after the initial course, healing usually occurs during a
further 4 weeks treatment
period.
In patients with poorly responsive gastric ulcer LOSEC 40 mg once
daily is recommended
and healing is usually achieved within 8 weeks.
For the prevention of relapse in patients with poorly responsive
gastric ulcer the
recommended dose is LOSEC 20 mg once daily. If needed the dose can be
increased to
LOSEC 40 mg once