Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
DANTRON POLOXALCOL
Mundipharma Pharmaceuticals Limited
1000mg/75mg
Oral Suspension
2011-01-07
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Codalax Forte 1000mg/75mg per 5ml suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 5ml of suspension contains 1000mg Poloxmer 188 and 75mg Dantron. Excipients: Each 5ml also contain: 1000mg Sorbitol liquid (non-crystallising), 0.2ml 96% ethanol and 10mg Niasept sodium containing sodium ethyl, methyl and propyl parahydroxybenzoate (E 215, E 219 and E 217) _For a full list of excipients, see section 6.1_ 3 PHARMACEUTICAL FORM Oral suspension. Orange-yellow coloured oral suspension, with an odour of peach and a sweet taste. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Use only in the treatment of analgesic induced constipation in the terminally ill patient. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral Adults and Elderly One 5 ml spoonfuls at bedtime. Children Not recommended for children under twelve years of age. 4.3 CONTRAINDICATIONS ○ In common with other gastro-intestinal evacuants, CODALAX and CODALAX Forte suspensions should not be given when acute or painful conditions of the abdomen are present or when the cause of constipation is suspected to be intestinal obstruction. ○ Pregnancy. ○ Hypersensitivity to any of the constituents of the products. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE ○ Oral administration of dantron has been reported to cause intestinal tumours in rats and mice. It has also been reported to be hepatocarcinogenic in rats as well as in mice. There is no sound evidence to conclude a no effect dose and therefore there may be a risk of such effects in humans. ○ In babies, children and patients wearing nappies, there may be staining of the buttocks. This may lead to superficial IRISH MEDICINES BOARD __________________________________________________________________________ Læs hele dokumentet