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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Duphalac 3.335g/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lactulose solution containing 3.335 g of lactulose per 5 ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Clear, colourless to pale brownish – yellow viscous liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
(1) In the treatment of constipation.
(2) In the treatment of hepatic encephalopathy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Hepatic Encephalopathy
Initially 30 to 50 ml three times daily; dosage should be subsequently adjusted to produce 2 to 3 soft stools daily and an
acidic faecal pH.
4.3 CONTRAINDICATIONS
1. Use in patients who require a galactose-free diet.
2. Use in patients with evidence of gastrointestinal obstruction.
3. Hypersensitivity to any of the components of the product.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
1. Long term use of this product is inadvisable except under medical supervision.
2. A dose of 30 ml provides 116 KJ (28 kcals) and is unlikely to adversely affect diabetics.
3. Duphalac should be administered with care to patients who are intolerant to lactose.
4. Use of laxatives in children should be under medical supervision.
Constipation
Adults:
15 ml twice daily.
Children 5-10 years:
10 ml twice daily.
Children 2-5 years:
5 ml twice daily.
Babies 1-2 years:
2.5 ml- 5 ml twice daily.
Babies 1 month-1 year:
2.5 ml twice daily.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 10/05/2011_
_CRN 2099107_
_page number: 1_
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
The product should not be taken with enteric coated mesalazine (5-ASA) as
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