Nolpaza Gastro-Resistant Tablet 40mg

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Available from:

PAHANG PHARMACY SDN. BHD.

INN (International Name):

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Units in package:

28Tablet Tablets

Manufactured by:

KRKA

Summary of Product characteristics

1.3.1
Pantoprazole sodium sesquihydrate
SPC, Labeling and Package Leaflet
MY
SmPCPIL160254_3
10.11.2020 – Updated: 25.01.2021
Page 1 of 10
NOLPAZA
_Pantoprazole _
NAME OF THE MEDICINAL PRODUCT
Nolpaza gastro-resistant tablets 40 mg
PRODUCT DESCRIPTION AND COMPOSITION
Each gastro-resistant tablet contains 40 mg pantoprazole as
pantoprazole sodium sesquihydrate.
The tablets are light brownish yellow, oval, slightly biconvex,
film-coated tablets.
Each gastro-resistant tablet contains 36 mg sorbitol (E420).
DOSAGE FORM
Oral Gastro-resistant tablet.
THERAPEUTIC INDICATIONS
-
In combination with two appropriate antibiotics (see ,,Posology") for
the eradication of
Helicobacter pylori in patients with peptic ulcers with the objective
of reducing the recurrence
of duodenal and gastric ulcers caused by this microorganism
-
Duodenal ulcer
-
Gastric ulcer
-
Moderate and severe cases of inflammation of the esophagus (reflux
esophagitis).
-
Zollinger-Ellison-Syndrome and other pathological hypersecretory
conditions
POSOLOGY AND METHOD OF ADMINISTRATION
The following information applies unless Nolpaza 40 mg has been
otherwise prescribed by your
doctor. Please follow these instructions, as otherwise Nolpaza 40 mg
may not have the desired effect!
ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND ABOVE
Treatment of moderate and severe reflux oesophagitis_ _
One tablet of Nolpaza 40 mg per day. In individual cases the dose may
be doubled (increase to 2
tablets Nolpaza 40 mg daily) especially when there has been no
response to other treatment.
ADULTS
Eradication of H. pylori in combination with two appropriate
antibiotics
In cases of duodenal or gastric ulcer in which infection with
Helicobacter pylori has been confirmed,
the microorganism should be eradicated by combination treatment.
Depending on the resistance
pattern, the following combinations are recommended:
a) Twice daily one tablet Nolpaza 40 mg gastro-resistant tablet
+ twice daily 1000 mg amoxicillin
+ twice daily_ _500 mg clarithromycin
b) Twice daily one tablet Nolpaza 40 mg