Lactulose Liquid Ph Eur

Lactulose Liquid EP

Lactulose 67.0% w/v

Oral Solution

A. Chronic constipation.

B. Chronic portal systemic encephalopathy.

Adults

Children

Dosage does not appear to be related to the age or weight of the child and should be adjusted to produce the required response.

Chronic portal systemic encephalopathy

Initially 30-50ml three times daily according to the requirements of the patient for adequate acidification of the colonic contents.

Use in the elderly

No evidence exists that elderly patients require different dosages or show different side-effects from younger patients.

In common with other preparations used for the treatment of constipation, Lactulose solution should not be used in patients with gastrointestinal obstruction. Lactulose solution should not be given to patients with galactosaemia or lactose intolerance.

Prolonged use of Lactulose in children may contribute to the development of dental caries. Patients should be instructed to pay careful attention to dental hygiene.

There are no known interactions involving Lactulose.

Lactulose solution should be used with caution during the first trimester of pregnancy.

There is no evidence that Lactulose affects driving ability.

Side-effects rarely occur after the administration of Lactulose solution. Mild transient effects such as abdominal distension or cramps and flatulence, which subside after the initial stages of treatment, have occasionally been reported. High doses may provoke nausea in some patients.

This can be minimised by administration with water, fruit juice or with meals.

No cases of intoxication due to deliberate or accidental overdosage with Lactulose solution have been reported to the company.

The active principle of Lactulose solution, lactulose, is neither broken down nor absorbed in the stomach and small intestine. In the colon it acts as a substrate for and promotes the growth of naturally occurring glycolytic micro-organisms, and is broken down to lactic acid. The pH of the intestinal contents is lowered, the growth of acidophilic flora is promoted and the putrefactive micro-organisms are suppressed. This reduces the formation of ammonia and amines and their absorption from the gut, thus leading to a fall in blood ammonia levels (responsible for hepatic encephalopathy). By normalising the intestinal flora Lactulose solution ensures the passage of normal stools, without excessive peristalsis.

Not appropriate.

There are no preclinical data of relevance to the prescriber which are additional to those already included in other sections of the Summary of Product Characteristics.

Other sugars (lactose, galactose, tagatose and other ketoses)

Purified water

Not applicable.

36 months.

Do not store above 25°C.

Amber glass bottles, plastic bottles (HDPE), PET bottles with polyethylene closure (polyethylene wad faced with PP. PVDC or PET lining), containing 200 ml, 300 ml, 500 ml or 1 litre of Lactulose solution.

Not applicable.

Novartis Consumer Health UK Limited

Trading as Novartis Consumer Health

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UK

PL 00030/0175

10 April 2000

4^th January 2006

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