Lactulose Solution BP.

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

For a full list of excipients see section 6.1

Liquid for oral use.

Constipation; hepatic encephalopathy (portal systemic encephalopathy).

Constipation:

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.

Hepatic encephalopathy:

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

Method of administration: Oral.

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

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.

Not applicable.

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

Not applicable.

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.

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

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 is 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 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.

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

Not required.

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

Not applicable

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

HDPE bottles: 24 months unopened and 24

months after opening.

The product should be stored at a temperature not exceeding 25^OC. Do not freeze.

(i) Amber glass winchesters, with polypropylene caps as closures.

Pack sizes: 300ml and 1,000ml;

or

(ii) Opaque, high density polyethylene bottles.

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

(Square cross section OR Circular cross section)

Not applicable.

Sandoz Ltd

Woolmer Way

Bordon

Hampshire

GU35 9QE

PL 04416/0218

21 April 1992 / 10 July 1997

06^th December 2007