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Lactulose Solution

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Lactulose Solution BP

Lactulose

3.3 g

Galactose

0.4 g

Lactose

04g

Tagatose

0.05 g

2 QUALITATIVE AND QUANTITATIVE COMPOSITION


3    PHARMACEUTICAL FORM

Solution

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

In constipation and hepatic encephalopathy.

4.2    Posology and method of administration

Oral administration

Dose: expressed in twice of the syrup containing 3.3g/5ml In Constipation:

Adults: Initially 15m1 twice daily, gradually reducing according to patients needs.

Children:

Under 1 year:

2.5ml

1 to 5 years:

5.0ml

5 to 12 years:

10.0ml twice daily gradually reduced.

No special recommendations in the elderly.

In Hepatic Encephalopathy:

30 to 50ml 3 times daily, subsequently adjusted to produce 2 to 3 soft stools daily.

No special recommendations. Doses should be taken with liquids or food.

4.3 Contraindications

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

Intestinal obstruction.

Contains lactose: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

It must be used cautiously in diabetics.

The product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. (See Section 4.3)

4.5 Interaction with other medicinal products and other forms of interaction

No known interactions.

4.6 Fertility, Pregnancy and lactation

There is no evidence to suggest that Lactulose cannot be used in pregnancy or in lactation.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

Flatulence, cramps, abdominal discomfort have occurred seldomly especially when therapy is initiated. (These symptoms occur in about 20% of patients receiving full doses of the drug). Nausea and vomiting have also been reported particularly with higher dosage.

4.9 Overdose

Excessive dosage can cause diarrhoea, loss of fluid and potassium and exacerbation of hepatic encephalopathy. Lost fluid and electrolytes must be replaced and dosage reduced.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Lactulose is an osmotic laxative. Its laxative action is due to a non-specific response to the acidity of the bowel contents which occur when Lactulose is metabolised by saccharolytic enzymes of the colon flora into organic acid such as lactic acids.

5.2 Pharmacokinetic properties

Lactulose is not absorbed or metabolised in the small intestine and is only partially absorbed upon reaching the colon. It is metabolised in the colon by the action of the colon flora i.e. saccharolytic enzymes of the flora degrade Lactulose into organic acids such as lactic acid.

The amount of unmodified Lactulose in the urine is very slight and even more remote in the faeces or bile.

5.3 Preclinical safety data

None stated.

6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients

Purified Water

6.2 Incompatibilities

None stated.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Keep tightly closed. Store in a cool dry place below 20°C.

6.5 Nature and contents of container

White plastic/PVC containers and caps 1000ml, 500ml, 300ml and 200ml.


6.6 Special precautions for disposal

None stated.

7    MARKETING AUTHORISATION HOLDER

Sterling Pharmaceuticals Ltd

288 Upper Balsall Heath Road

Moseley

Birmingham

B12 9DR

8    MARKETING AUTHORISATION NUMBER(S)

PL32515/0055

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

30th September 1996

10    DATE OF REVISION OF THE TEXT

11/08/2012