产品特点
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pantoprazole Ranbaxy 20 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20 mg pantoprazole (as pantoprazole sodium sesquihydrate 22.6 mg).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
Yellow enteric coated oval shaped, biconvex tablets imprinted with ‘II’ on one side and plain on other side.
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 Ranbaxy 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 one gastro-resistant
阅读完整的文件
产品特点 