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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pantoprazole Niche 20 mg Gastro-Resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20 mg pantoprazole (as pantoprazole sodium sesquihydrate).
Excipient:
Each Pantoprazole Niche 20 mg Gastro-Resistant Tablet contains 18 mg sorbitol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
A light brownish yellow, oval, slightly biconvex tablet.
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.
_Adults_
Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in
patients at risk with a need for continuous NSAID treatment (see section 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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
_Symptomatic gastro-oesophageal reflux disease_
The recommended oral dose is one gastro-resistant tablet Pantoprazole Niche 20 mg per day. Symptom relief is
generally accomplished within 2-4 weeks. If this is not sufficient, symptom relief will normally be achieved within a
further 4 weeks. When symptom relief has been achieved, reoccurring symptoms can be controlled using an on-demand
regimen of 20 mg once daily, when required. A switch to continuous therapy may be considered in case satisfactory
symptom control cannot be maintained with on-demand treatment.
Long-term management and prevention of relapse in reflux oesophagitis
For long-term management, a maintenance dose of
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