Lactulose Liquid Ph Eur
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lactulose Liquid Ph Eur Lactulose Liquid EP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lactulose 67.0% w/v
3 PHARMACEUTICAL FORM
Solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
a. Chronic constipation.
b. Chronic portal systemic encephalopathy.
4.2 Posology and method of administration
Adults
Initially: 15-3 0ml daily for first 2-3 days (45ml may be given in obstinate
cases).
Maintenance: 10-15ml daily or according to the need of the patient.
Children
Initially: 10-25ml daily for first 2-3 days
Maintenance: 5-15ml daily or according to the need of the patient.
Dosage does not appear to be related to the age or weight of the child and should be adjusted to produce the required response.
Chronic portal systemic encephalopathy
Initially 30-50ml three times daily according to the requirements of the patient for adequate acidification of the colonic contents.
Use in the elderly
No evidence exists that elderly patients require different dosages or show different side-effects from younger patients.
4.3 Contraindications
In common with other preparations used for the treatment of constipation, Lactulose solution should not be used in patients with gastrointestinal
obstruction. Lactulose solution should not be given to patients with galactosaemia or lactose intolerance.
4.4 Special warnings and precautions for use
Prolonged use of Lactulose in children may contribute to the development of dental caries. Patients should be instructed to pay careful attention to dental hygiene.
4.5 Interaction with other medicinal products and other forms of interaction
There are no known interactions involving Lactulose.
4.6 Pregnancy and lactation
Lactulose solution should be used with caution during the first trimester of pregnancy.
4.7 Effects on ability to drive and use machines
There is no evidence that Lactulose affects driving ability.
4.8 Undesirable effects
Side-effects rarely occur after the administration of Lactulose solution. Mild transient effects such as abdominal distension or cramps and flatulence, which subside after the initial stages of treatment, have occasionally been reported. High doses may provoke nausea in some patients.
This can be minimised by administration with water, fruit juice or with meals.
4.9 Overdose
No cases of intoxication due to deliberate or accidental overdosage with Lactulose solution have been reported to the company.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
The active principle of Lactulose solution, lactulose, is neither broken down nor absorbed in the stomach and small intestine. In the colon it acts as a substrate for and promotes the growth of naturally occurring glycolytic microorganisms, and is broken down to lactic acid. The pH of the intestinal contents is lowered, the growth of acidophilic flora is promoted and the putrefactive micro-organisms are suppressed. This reduces the formation of ammonia and amines and their absorption from the gut, thus leading to a fall in blood ammonia levels (responsible for hepatic encephalopathy). By normalising the intestinal flora Lactulose solution ensures the passage of normal stools, without excessive peristalsis.
5.2 Pharmacokinetic properties
Not appropriate
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to those already included in other sections of the Summary of Product Characteristics.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Other sugars (lactose, galactose, tagatose and other ketoses)
Purified water
6.2 Incompatibilities
Not applicable
6.3 Shelf life
36 months
6.4 Special precautions for storage
Do not store above 25°C
6.5 Nature and contents of container
Amber glass bottles, plastic bottles (HDPE), PET bottles with polyethylene closure (polyethylene wad faced with PP. PVDC or PET lining), containing 200ml, 300ml, 500ml or 1 litre of Lactulose solution.
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
Novartis Consumer Health UK Limited Trading as Novartis Consumer Health Wimblehurst Road
Horsham West Sussex RH12 5AB UK
8 MARKETING AUTHORISATION NUMBER
PL 00030/0175
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10/04/2000 / 02/05/2002
10 DATE OF REVISION OF THE TEXT
04/01/2006