Lactulose Solution (Novartis Consumer Health)

1. Name Of The Medicinal Product

Lactulose Liquid Ph Eur

Lactulose Liquid EP

2. Qualitative And Quantitative Composition

Lactulose 67.0% w/v

3. Pharmaceutical Form

Oral Solution

4. Clinical Particulars

4.1 Therapeutic Indications

A. Chronic constipation.

B. Chronic portal systemic encephalopathy.

4.2 Posology And Method Of Administration

Adults

Initially:	15-30ml daily for first 2-3 days (45ml may be given in obstinate cases).
Maintenance:	10-15ml daily or according to the need of the patient

Children

Initially:	10-25ml daily for first 2-3 days.
Maintenance:	5-15ml daily or according to the need of the patient.

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.

4.3 Contraindications

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.

4.4 Special Warnings And Precautions For Use

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There are no known interactions involving Lactulose.

4.6 Pregnancy And Lactation

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

4.7 Effects On Ability To Drive And Use Machines

There is no evidence that Lactulose affects driving ability.

4.8 Undesirable Effects

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.

4.9 Overdose

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

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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.

5.2 Pharmacokinetic Properties

Not appropriate.

5.3 Preclinical Safety Data

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.

6. Pharmaceutical Particulars

6.1 List Of Excipients

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

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

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.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

Administrative Data

7. Marketing Authorisation Holder

Novartis Consumer Health UK Limited

Trading as Novartis Consumer Health

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UK

8. Marketing Authorisation Number(S)

PL 00030/0175

9. Date Of First Authorisation/Renewal Of The Authorisation

10 April 2000

10. Date Of Revision Of The Text

4^th January 2006

Legal category

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