SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Lactuflave cherry

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Each five ml of the oral solution contains 3.35 g lactulose and less than 1.27 g of other sugars (lactose, galactose, tagatose and other keto-sugars).

For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Oral solution

Clear, colourless to yellow brownish solution

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

-    Treatment of chronic constipation.

-    Treatment and maintenance therapy of hepatic encephalopathy (portal-systemic encephalopathy), hepatic coma.

4.2    Posology and method of administration

Constipation:

Initially:

Adults (including the elderly): Children 5 to 10 years: Children under 5 years:

Babies under 1 year:

Maintenance:

The dose should be adjusted to the needs of the individual.

Hepatic encephalopathy:

Adults (including the elderly): Initially 30 - 50 ml 3 times a day. Subsequently this dose should be adjusted to produce two or three soft stools each day.

Contraindications

Hypersensitivity to the active substance or to any of the excipients Gastrointestinal obstruction Lactose intolerance Galactosaemia

4.4    Special warnings and precautions for use

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Patients with rare hereditary problems of galactose intolerance e.g. galacotosaemia, or glucose-galactose malabsorption should not take this medicine.

Patients with the Lapp lactase deficiency should not take this medicine.

Because of its low content of available calories of less than 5 kcal (21kJ) per 5ml, Lactulose solution is unlikely to adversely affect diabetics.

4.5    Interaction with other medicinal products and other forms of interaction

Long term use of high of lactulose, provoking diarrhea, may enhance potassium depletion induced by other drugs.

4.6    Pregnancy and lactation

If a laxative therapy is needed in pregnancy and lactation, the use of lactulose solution is acceptable.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

Gastrointestinal disorders:

Mild side-effects, e.g. bloating, flatulence and abdominal cramps occur rarely and usually subside after the initial stages of the treatment. High doses may provoke nausea in some patients.

4.9 Overdose

No cases of intoxication or a specific antidote are known.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Osmotically acting laxatives ATC code: A06AD11

The disaccharide lactulose is not absorbed or metabolized in man. Ingested lactulose therefore passes through the gastrointestinal tract until it reaches the large bowel where it provides the natural substrate for the saccharolytic bacterial flora. The resulting break-down products, the monosaccharides galactose and fructose and subsequently acetic and lactic acid, increase stool volume by drawing water into the bowel and also lower the colonic pH. Both increased faecal bulk and acidification lead to the formation of a soft stool and stimulate peristalsis.

In patients with hepatic encephalopathy, the lowered stool pH results in a markedly reduced formation of ammonia and other nitrogenous toxins in the colon, and a markedly reduced absorption of these toxins.

Due to Lactulose’s physiological mode of action it may take up to 48 hours before the onset of full effects of treatment.

5.2 Pharmacokinetic properties

See above.

5.3 Preclinical safety data

There is no proof of any relevant acute toxicity, chronic toxicity, mutagenic or carcinogenic potential or toxicity in the reproduction.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Citric acid, cherry flavour, purified water.

6.2 Incompatibilities

No incompatibilities are known.

6.3    Shelf life

2 years unopened.

6 months after first opening.

6.4    Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

Amber PET bottles with PP screw-caps of 100, 200, 500 and 1000 ml solution.