LACTOLAX Oral Solution 3350 MG/5ml

Summary of Product characteristics

                                PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lactolax
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of solution contains 3.35 g of lactulose.
3 PHARMACEUTICAL FORM
Oral solution.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
1.
In the treatment of hepatic encephalopathy.
2.
In the treatment of constipation.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
_Hepatic encephalopathy_
Adults  including  the  elderly:  Initially  30  -  50  ml  (6  -  10  x  5  ml  spoonfuls)  3  to  4  times  daily;  dosage  should  be 
subsequently adjusted to produce 2 to 3 soft stools daily and an
acidic faecal pH. 
_Constipation_: 
Adults including the elderly: Initially 15 ml (3 x 5ml spoonfuls) twice daily. Dosage can often be gradually reduced to 
10-20 ml a day or every other day.
Children 5 to 10 years
10 ml (2 x 5ml spoonfuls) twice daily
Children under 5 years
5 ml (1 x 5ml spoonful) twice daily
Each dose may, if necessary be taken with water, milk
or fruit juices to increase palatability.
4.3 CONTRAINDICATIONS
1.
Use in patients who require a galactose-free diet
2.
Use in patients with evidence of gastrointestinal obstruction.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
1.
In the event of diarrhoea adequate fluid intake should be maintained during treatment, and the dosage reduced to 
avoid loss of fluid and potassium and exacerbation
of encephalopathy.
2.
Long
term use of this product is inadvisable except under medical supervision.
3.
A dose of 30ml provides 116 KJ (28 Kcals), and is unlikely to
adversely affect diabetics.
4.
Lactolax should be administered with care to patients who are intolerant to lactose. (It contains 0.3g Lactose per 
5ml).
IRISH MEDICINES BOARD
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