Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LACTULOSE
Resolution Chemicals Limited
3.3 g/5ml
Oral Solution
2009-11-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lactulose Resolution 3.3g /5ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 5ml of Lactulose solution contains 3.3 g of Lactulose For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Oral Solution. Clear, colourless or pale brownish yellow liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS (1) In the treatment of constipation. (2) In the treatment of hepatic encephalopathy (portal systemic encephalopathy); hepatic coma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral The recommended dosage has to be adapted to the need of the patient. Lactulose may be taken with water or fruit juice. Initial dosage for constipation: Adults – 15ml twice daily Children 5 to 10 years –10ml twice daily Children 2 to 5 years –5ml twice daily Babies 1 -2 year – 2.5 – 5ml twice daily Babies 1 month - 1 year. 2.5ml twice daily Initial dosage for hepatic encephalopathy: Adults (including the elderly) – 30 to 50ml three times daily Children: The safety and efficacy in children aged 0 - 18 years has not been established. No data are available. In elderly patients and patients with renal or hepatic insufficiency no special dosage recommendations exist. Subsequently adjust the dose to produce two or three soft stools each day. Because of the physiological mode of action of Lactulose Liquid Ph. Eur. it may take up to 48 hours before effects are obtained. As treatment takes effect it may be possible for the patient to reduce the effective dose gradually over a period of time. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/04/2011_ _CRN 2077524_ _page number: 1_ 4.3 CONTRAI Read the complete document