Lactulose 3.3g /5ml Oral Solution
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lactulose 3.3g/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lactulose Solution Ph. Eur 100%, containing 66% w/v lactulose
3 PHARMACEUTICAL FORM
Solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For treatment of constipation and hepatic encephalopathy (hepatic coma).
4.2 Posology and method of administration
Route of administration: Oral
Initial dosage for constipation: Adults - 15ml twice daily
Children 5 to 10 years - l0ml twice daily Children under 5 years - 5ml twice daily Babies under 1 year - 2.5ml twice daily
Lactulose may be taken with water or fruit juice.
Initial dosage for hepatic
encephalopathy: Adults (including the elderly) - 30 to
50ml three times daily
Children - no dosage recommendations
for this indication.
A doctor may wish to change these initial doses as ideally two or three soft stools should be produced daily.
4.3 Contraindications
Lactulose Solution should not be given to patients with gastro-intestinal obstruction or galactosaemia.
4.4 Special warnings and precautions for use
Lactulose Solution should be used with caution in patients with lactose intolerance. Because of the physiological mode of action of Lactulose Solution
Ph. Eur it may take up to 48 hours before effects are obtained. In addition there is a carry-over' effect which may enable the patient to reduce the effective dose gradually over a period of time.
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Fertility, pregnancy and lactation
Reports on the clinical experience of lactulose and data from animal reproduction studies has not revealed any increase in embryotoxic hazard to the foetus if used in the recommended dose during pregnancy. If drug therapy is needed in pregnancy the use of this drug is acceptable.
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
Side effects occur rarely. Cases of mild abdominal distension, cramps or flatulence have been reported following use of Lactulose Solution Ph. Eur, but these effects generally subside after the initial stage of treatment.
High doses may provoke nausea, vomiting, flatulence, or abdominal pain.
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
No cases of intoxication due to deliberate or accidental overdose with Lactulose Solution have been reported to the Company.
No specific antidote. Symptomatic treatment should be given.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Lactulose is a synthetic disaccharide which is used in the treatment of constipation and in hepatic encephalopathy. Lactulose is broken down by colonic bacteria mainly into acetic and lactic acids which exert a local osmotic effect in the colon resulting in increased faecal bulk and stimulation of peristalsis. It may take up to 48 hours before an effect is obtained. When larger
doses are given for hepatic encephalopathy the pH in the colon is reduced significantly by this acid production and the absorption of ammonium ions and other toxic nitrogenous compounds is decreased leading to a fall in blood-ammonia concentration.
5.2 Pharmacokinetic properties
Following oral administration, a negligible amount of Lactulose is absorbed in the gastro-intestinal tract. It passes essentially unchanged into the large intestine where it is metabolized by saccharolytic bacteria, forming simple organic acids such as lactic and acetic acid. Urinary excretion has been reported to be 3% or less.
5.3 Preclinical safety data
None stated
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
None
6.2 Incompatibilities
None known
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25°C. Do not freeze or refrigerate.
6.5 Nature and contents of container
HDPE bottle with white HDPE screw cap, containing 150, 200, 300, 500, 1000 or 5000ml of Lactulose Solution.
6.6 Special precautions for disposal
None
MARKETING AUTHORISATION HOLDER
Resolution Chemicals Ltd
Wedgwood Way Stevenage Herts SG1 4QT
8 MARKETING AUTHORISATION NUMBER(S)
PL 10321/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
12/07/1995
10 DATE OF REVISION OF THE TEXT
26/09/2014