Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
SODIUM PICOSULFATE
Ferring Ireland Ltd
5 Milligram
Tablets
2011-11-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sodium Picosulfate Ferring 5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg sodium picosulfate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off-white round tablets, 6 mm in diameter, debossed with 5. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short term relief of functional constipation. Sodium Picosulfate Ferring is indicated in adults and in children aged from 10 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and children from 10 years of age_ One to two tablets (5 – 10mg) swallowed whole at bedtime. Dosage can be titrated individually. Once regularity has re-started dosage should be reduced and can usually be stopped. SODIUM PICOSULFATE FERRING SHOULD NOT BE TAKEN EVERY DAY FOR MORE THAN FIVE DAYS WITHOUT INVESTIGATING THE CAUSE OF CONSTIPATION. _Paediatric population_ Sodium Picosulfate Ferring should not be used in children below 10 years of age. The safety and efficacy of Sodium Picosulfate Ferring in children below 10 years of age have not been established. No data are available. Method of administration The tablet should be swallowed whole with adequate fluid. The maintenance of an adequate fluid intake during treatment is essential, especially for younger patients and the elderly who are more susceptible to the effects of dehydration. 4.3 CONTRAINDICATIONS Sodium Picosulfate Ferring is contraindicated in patients with ileus, gastrointestinal obstruction, gastrointestinal ulceration or perforation, acute abdominal surgical conditions including appendicitis, acute inflammatory bowel IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date P Aqra d-dokument sħiħ