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:

2021-04-16

Summary of Product characteristics

PI_Text001952_1
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Page 1 of 11
1.
NAME OF THE MEDICINAL PRODUCT
Nolpaza
®
20 mg gastro-resistant tablets
Nolpaza
®
40 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20 mg gastro-resistant tablet contains 20 mg pantoprazole as
22.55 mg pantoprazole sodium
sesquihydrate.
Each 40 mg gastro-resistant tablet contains 40 mg pantoprazole as
45.10 mg pantoprazole sodium
sesquihydrate.
Excipient:
Each 20 mg gastro-resistant tablet contains 18 mg sorbitol (E420).
Each 40 mg 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_
-
Symptomatic gastro-oesophageal reflux disease.
-
For long-term management and prevention of relapse in reflux
oesophagitis.
-
Reflux oesophagitis
_Adults_
-
Prevention of gastroduodenal ulcers induced by non-selective
non-steroidal anti-inflammatory
drugs (NSAIDs) in patients at high risk with a need for continuous
NSAID treatment (see
section 4.4).
-
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
The tablets should not be chewed or crushed, and should be swallowed
whole 1 hour before a meal
with some water.
_RECOMMENDED DOSE_
_ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND ABOVE_
CONFIDENTIAL
Nolpaza gastro-resistant tablets 20 mg, 40 mg
VOL: 1; P: 30 / 64
PI_Text001952_1
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Symptomatic gastro-oesophageal reflux disease
The recommended oral dose is one Nolpaza 20 mg gastro-resistant tablet
per day. Symptom relief is
generally accomplished within 2–4 weeks. If this is not sufficient,
symptom relief will normally be
achieve