Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PANTOPRAZOLE SODIUM SESQUIHYDRATE
Sanofi-Aventis Ireland Limited
20 Milligram
Tablets Gastro-Resistant
2011-07-08
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Freestom 20 mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 20 mg pantoprazole (as sodium sesquihydrate). Excipient: 38.425 mg Maltitol and 0.345 mg Lecithin (derived from soya oil) (see section 4.4) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet Yellow, oval tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 20 mg pantoprazole (one tablet) per day. It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms. Once complete relief of symptoms has occurred, treatment should be discontinued. The treatment should not exceed 4 weeks without consulting a doctor. If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor. _Special populations_ No dose adjustment is necessary in elderly patients or in those with impaired renal or liver function. _Paediatric use_ _PANTOPRAZOLE _is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy. Method of administration _PANTOPRAZOLE _20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance, substituted benzimidazoles, lecithin (derived from soya oil) or to any of the excipients. Co-administration with atazanavir (see section 4.5). IRISH MEDICINES BOARD _______________________________________________________________________________ Read the complete document