Nolpaza tablets gastro-resistant

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

pantoprazole (pantoprazole sodium sesquihydrate)

Available from:

KRKA d.d.

ATC code:

A02BC02

INN (International Name):

pantoprazole (pantoprazole sodium sesquihydrate)

Dosage:

40mg

Pharmaceutical form:

tablets gastro-resistant

Units in package:

(14/1x14/) in blister, (28/2x14/) in blister, (56/4x14/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-08-24

Summary of Product characteristics

PI_Text018840_1
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Page 1 of 11
1.
NAME OF THE MEDICINAL PRODUCT
Nolpaza
®
40 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 40 mg pantoprazole as 45.10 mg
pantoprazole sodium
sesquihydrate.
Excipient:
Each gastro-resistant tablet contains 36 mg sorbitol (E420).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet
Light yellowish brown, oval, slightly biconvex film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults and adolescents 12 years of age and above_
-
Reflux oesophagitis
_ _
_Adults_
-
Eradication of _Helicobacter pylori _(_H. pylori_) in combination with
appropriate antibiotic therapy
in patients with _H. pylori _associated ulcers.
-
Gastric and duodenal ulcers.
-
Zollinger-Ellison syndrome and other pathological hypersecretory
conditions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND ABOVE_
Reflux oesophagitis
One Nolpaza 40 mg gastro-resistant tablet per day. In individual
cases, the dose may be doubled
(increase to 2 Nolpaza 40 mg gastro-resistant tablets daily),
especially when there has been no
response to other treatment. A 4-week period is usually required for
the treatment of reflux
oesophagitis. If this is not sufficient, healing will usually be
achieved within a further 4 weeks.
PI_Text018840_1
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Page 2 of 11
_ADULTS_
Eradication of _H. pylori_ in combination with two appropriate
antibiotics
In _H. pylori _positive patients with gastric and duodenal ulcers,
eradication of the germ by a
combination therapy should be achieved. Considerations should be given
to official local guidance
(e.g. national recommendations) regarding bacterial resistance and the
appropriate use and prescription
of antibacterial agents. Depending upon the resistance pattern, the
following combinations can be
recommended for the eradication of _H. pylori_:
a)
twice daily one Nolpaza 40 mg gastro-resistant tablet
+ twice da