NEXIUM MUPS

País: Indonesia

Idioma: indonesio

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

Ingredientes activos:

ESOMEPRAZOLE MAGNESIUM

Disponible desde:

ASTRAZENECA INDONESIA - Indonesia

Designación común internacional (DCI):

ESOMEPRAZOLE MAGNESIUM

Dosis:

20 MG

formulario farmacéutico:

TABLET SALUT SELAPUT

Unidades en paquete:

DUS, 2 BLISTER @ 15 TABLET SALUT SELAPUT

Fabricado por:

ASTRAZENECA Pharmaceuticals - Sweden

Fecha de autorización:

2018-10-23

Ficha técnica

1
NEXIUM
® MUPS 20 & 40 MG
_esomeprazole _
FILM-COATED TABLETS
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg or 40 mg esomeprazole (as magnesium
trihydrate).
For excipients see _List of excipients_.
PHARMACEUTICAL FORM
Gastro-resistant tablets
20 mg: A light pink, oblong, biconvex, film-coated tablet engraved 20
mg on one side and
A
EH
on the other
side.
40 mg: A pink, oblong, biconvex, film-coated tablet engraved 40 mg on
one side and
A
EI
on the other side.
THERAPEUTIC INDICATION
NEXIUM MUPS tablets are indicated for:
_Gastroesophageal Reflux Disease (GERD) _
-
Treatment of erosive reflux esophagitis
-
Long-term management of patients with healed esophagitis to prevent
relapse
-
Symptomatic treatment of gastroesophageal reflux disease (GERD).
_In combination with an appropriate antibacterial therapeutic regimen
for the eradication of Helicobacter _
_pylori and _
-
Healing of _Helicobacter pylori_ associated duodenal ulcer.
_Patients requiring continued non-steroidal anti-inflammatory (NSAID)_
_therapy _
-
Healing of gastric ulcers associated with NSAID therapy.
-
Prevention of gastric and duodenal ulcers associated with continuous
NSAID therapy in patient at risk.
Patients are considered to be at risk due to their age (>60) and
documented history of peptic ulcer.
Controlled studies do not extend beyond 6 months.
_Maintenance of haemostasis and prevention of rebleeding of gastric or
duodenal ulcers following treatment _
_with NEXIUM for solution for infusion. _
_Treatment of Zollinger Ellison Syndrome. _
POSOLOGY AND METHOD OF ADMINISTRATION
The tablets should be swallowed whole with liquid. They should not be
chewed or crushed.
For patients who have difficulty in swallowing the tablets can also be
dispersed in half a glass of non-
carbonated water. No other liquids should be used as the enteric
coating may be dissolved. Stir until the
tablets disintegrate and drink the liquid with the pellets immediately
or within 30 minutes. Rinse the glass
with half a glass of water and drink. The pelle