SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Lactugal.

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient:

Lactulose Solution BP 99.897 % v/v (Equivalent to 62.0-74.0% w/v of Lactulose).

3.    PHARMACEUTICAL FORM

Oral solution.

4    CLINICAL PARTICULARS

4.1.    Therapeutic Indications

Constipation; Hepatic encephalopathy (Portal systemic encephalopathy).

4.2 Posology and method of administration

For oral administration.

Adults:

Constipation:

Hepatic encephalopathy:

Children:

Constipation:

Hepatic encephalopathy:

Elderly:

The normal adult dosage is appropriate.

All dosages should be adjusted to the needs of the individual. Each dose may, if necessary, be taken with water or fruit juices etc.

4.3 Contraindications

Lactugal is contra-indicated in patients with:

•    galactosaemia

•    gastro-intestinal obstruction, digestive perforation or risk of digestive perforation

•    hypersensitivity to the active substance or any of the excipients.

4.4 Special warnings and precautions for use

Consultation of a physician is advised in case of:

-    Painful abdominal symptoms of undetermined cause before the treatment is started.

-    Insufficient therapeutic effect after several days.

Lactulose should be administered with care to patients who are intolerant to lactose (see section 'List of excipients').

The dose normally used in constipation should not pose a problem for diabetics.

The dose used in the treatment of hepatic encephalopathy is usually much higher and may need to be taken into consideration for diabetics.

Chronic use of unadjusted doses and misuse can lead to diarrhoea and disturbance of the electrolyte balance.

This product contains lactose, galactose and small amounts of fructose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Paediatric population

Use of laxatives in children should be exceptional and under medical supervision.

It should be taken into account that the defaecation reflex could be disturbed during the treatment.

4.5. Interactions with other Medicinal Products and other Forms of Interaction

There are no known interactions with lactulose.

4.6 Fertility, pregnancy and lactation

Wide clinical experience in combination with data from animal production studies has not revealed any embryotoxic hazards to the foetus if used in the recommended dosage during pregnancy. If drug therapy is required during pregnancy or for lactating mothers, the use of this drug is acceptable.

Due to the negligible systemic absorption of lactulose, no effects on breast fed infants are anticipated and Lactugal can be used during breast feeding.

4.7. Effects on Ability to Drive and Use Machines

There is no evidence to show that lactulose affects driving ability.

4.8 Undesirable effects

A normal dosage of lactulose may cause mild abdominal pain and flatulence which will disappear spontaneously after a few days. High doses may provoke nausea in some patients and this can be minimised by administration with water, fruit juice or meals. Administration of higher doses than those instructed can result in abdominal pain and diarrhoea, in this instance the dose should be decreased.

Higher doses, such as those associated with the treatment of portosystemic encephalopathy, used for extended periods of time can result in electrolyte imbalance due to diarrhoea. The dose should be adjusted to obtain two to three formed stools per day.

Gastro-intestinal disorders:

Flatulence, abdominal pain, nausea and vomiting. If the dose is too high, diarrhoea will occur.

Investigations:

Electrolyte imbalance due to diarrhoea.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

If elevated doses are given diarrhoea and abdominal pain may occur. A dose reduction or cessation of therapy should be considered. Excessive fluid loss due to diarrhoea may result in clinically important electrolyte disturbances and suitable corrective measures should be taken.

There is no specific antidote in the case of an overdose and supportive, symptomatic treatment should be given.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Lactulose is a synthetic disaccharide which is metabolised by gastro-intestinal bacterial flora to low molecular weight acids (chiefly lactic and acetic acids). There is no endogenous metabolising enzyme in the human gut.

Its mode of action in constipation is as an osmotic agent producing soft stools.

A dual mode of action is proposed for the efficacy of lactulose in Portal System Encephalopathy, relating to the metabolism of ammonia and subsequent nitrogenous toxins. The reduction in gastro-intestinal pH results in a net entrapment of ammonia in the gut lumen. Lactulose has also been shown to alter ammonia metabolism by microbial flora.

5.2. Pharmacokinetic Properties

Lactulose is absorbed from the gastro-intestinal tract to 0.4 - 2% and is excreted unchanged with the urine. There are no human lactulose disaccharide enzymes; metabolism of lactulose to lactic acid occurs via gastro-intestinal microbial flora only. Due to its poor bioavailability, plasma lactulose concentrations are negligible.

There are no known changes in kinetic properties in patients with organic diseases which may alter drug disposition.

5.3 Preclinical safety data

The results of acute, sub-chronic and chronic toxicity studies in various species indicate that the compound has very low toxicity. The effects observed, appear to be more related to the effect of bulk in the gastrointestinal tract than to a more specific toxic activity. In reproduction and teratology experiments in rabbits, rats or mice, no adverse effects were found.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Banana Flavour (17.41.0042)

Quinoline Yellow (E104)

6.2.    Incompatibilities

There are no known incompatibilities.

6.3.    Shelf Life

36 months from the date of manufacture.

6.4.    Special Precautions for Storage

Store at a temperature not exceeding 20°C. Do not freeze

6.5 Nature and contents of container

Amber glass winchesters with polypropylene caps as closures: pack sizes 300 ml, 500 ml, 1000 ml and 2000 ml.

Polyethylene containers with polypropylene caps as closures: pack sizes 250 ml, 300 ml, 500 ml, 1000 ml and 2000 ml.

Not all pack sizes may be marketed.

6.6. Instructions for Use, Handling and Disposal

There are no special storage or handling instructions for this product.

MARKETING AUTHORISATION HOLDER

Intrapharm Laboratories Ltd The Courtyard Barns Choke Lane Maidenhead Berkshire SL6 6PT United Kingdom

8. MARKETING AUTHORISATION NUMBER

PL 17509/0011

9. DATE OF FIRST AUTHORISATION/RENEWAL AUTHORISATION

24^th November 2004

10 DATE OF REVISION OF THE TEXT

23/01/2015