Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
SODIUM PHOSPHATE DIBASIC DODECAHYDRATE SODIUM PHOSPHATE DIBASIC DIHYDRATE
Laboratorios Casen-Fleet S.L.U.
24.4/10.8 Grams
Oral Solution
2007-10-19
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fleet Phospho-soda 24.4g/10.8g Oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 45ml bottle contains 5.0 g sodium. Fleet Phospho-soda contains a very small amount of ethanol. Less than 100 mg per dose For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Oral solution Clear colourless solution with a ginger-lemon odour, free from precipitation and turbidity. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a bowel cleanser in preparing the patient for colon surgery, or for preparing the colon for x-ray or for endoscopic examination. Bowel cleansing agents are not to be considered as treatments for constipation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults Only: Not to be given to children under the age of 18 years. Elderly patients: As for Adults. The taking of Fleet Phospho-soda 24.4g/10.8g Oral solution should be started the day before the hospital appointment. For hospital appointments before 12 noon the dosage instructions for morning appointments should be followed and for appointments after 12 noon the dosage instructions for an afternoon appointment should be followed. M ORNING A PPOINTMENT : Day before appointment 7am – In place of breakfast drink at least one full glass of “clear liquid” or water, more if desired. “Clear liquids” include water, clear soup, strained fruit juices without pulp, black tea or black coffee, clear carbonated and non-carbonated soft drinks. 1 st Dose – Straight afterwards, dilute 45ml in half a glass (120ml) cold water. Drink this solution followed by one full glass (240ml) cold water, more if desired. per 45ml dose per 1ml Sodium dihydrogen phosphate dihydrate 24.4 g 0.542 g Disodium phosphate dodecahydrate 10.8 g 0.24 g IRISH ME Read the complete document