SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Lactulose Solution BP.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml of Lactulose Solution contains 3.4g of lactulose.

For a full list of excipients see section 6.1

3    PHARMACEUTICAL FORM

Liquid for oral use.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Constipation; hepatic encephalopathy (portal systemic encephalopathy).

4.2    Posology and method of administration Constipation:

Adults:    Initially 15ml twice daily.

Children:    1 to 5 years - 5ml twice daily.

5 to 10 years - 10ml twice daily.

Dosage may vary depending on the condition. The above dosage serves as a

guide. Eventually the dose should be adjusted, usually reduced to meet the needs of the individual.

Initially 30ml to 50ml, 3 times daily; adjust dose to produce 2 or 3 soft stools daily.

Method of administration: Oral.

4.3 Contraindications

Contraindicated where there is evidence of gastrointestinal obstruction and in patients who require a galactose-free diet.

4.4 Special warnings and precautions for use

The product should be administered with care to patients who are intolerant to lactose.

Due to the product’s physiological mode of action it may take up to 48 hours before effects are obtained, however the product does exhibit a “carry-over” effect which may enable the patient to reduce the dose gradually over a period of time.

4.5 Interaction with other medicinal products and other forms of interaction

Not applicable.

4.6 Pregnancy and lactation

The product should only be administered on the advice of a physician during pregnancy or lactation.

4.7 Effects on ability to drive and use machines

Not applicable.

Undesirable effects

In the event of diarrhoea, adequate fluid intake should be maintained during treatment and the dosage reduced to prevent loss of fluid and potassium and exacerbation of encephalopathy. The product may give rise temporarily to flatulence and abdominal cramping.

4.9 Overdose

Patients should be given plenty of fluids. An anticholinergic preparation such as atropine methonitrate would help to offset the excessive intestinal motility.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

The action of lactulose in treating constipation depends on the inability of the enzymes in the small intestine to hydrolyse the synthetic disaccharide, lactulose, into its component molecules of fructose and galactose. Therefore, as lactulose in virtually unabsorbed, it passes into the large bowel chemically unchanged and forms a substrate for commensal saccharolytic bacteria.

The resulting breakdown products, simple organic compounds like lactic and acetic acid, give rise to increased intra-colonic osmotic pressure, with consequent increased faecal bulk, and stimulate peristalsis. The growth of the saccharolytic bacteria is favoured and the normal colonic flora restored.

A soft stool is formed and normal bowel action encouraged without irritation or direct interference with the gut mucosa.

In patients with hepatic encephalopathy larger doses of lactulose are used; a significant reduction in the pH of the colonic contents results, which reduces markedly the formation and absorption of ammonium ions and other nitrogenous toxins into the portal circulation. Rapid decrements in blood ammonia concentration have been reported following lactulose treatment.

5.2    Pharmacokinetic properties

No pharmacokinetic particulars are presented as lactulose is not absorbed by the body.

5.3    Preclinical safety data

Not required.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Lactose, D-galactose, fructose, D-tagatose and epilactose.

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

Glass bottles: 36 months unopened and 36 months after opening.

HDPE bottles: 24 months unopened and 24 months after opening.

6.4    Special precautions for storage

Glass bottles: Store below 20^oC. Do not freeze.

HDPE bottles: Store below 25°C. Do not freeze.

Nature and contents of container

Amber glass Winchesters, with polypropylene caps as closures. Pack sizes: 300ml and 1,000ml;

or

Opaque, high density polyethylene bottles (square cross section or circular cross section).

Pack sizes: 200ml, 300ml, 500ml and 1,000ml.

6.6 Special precautions for disposal

Not applicable.

7    MARKETING AUTHORISATION HOLDER

Sandoz Limited Frimley Business Park,

Frimley,

Camberley,

Surrey,

GU16 7SR,

United Kingdom.

8    MARKETING AUTHORISATION NUMBER(S)

PL 04416/0218

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

21/04/1992 / 30/04/2003 04/08/2011