Lactulose Solution
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lactulose Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lactulose 3.35 g/5 ml.
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Oral Solution.
A clear or not more than slightly opalescent, viscous liquid, colourless to brownish yellow
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of constipation
For the treatment of hepatic encephalopathy (HE); hepatic coma.
4.2 Posology and method of administration Posology.
The lactulose solution may be administered diluted or undiluted. Each dose may if necessary be taken with water or fruit juices, etc.
Each dose of lactulose should be swallowed in one and should not be kept in the mouth for an extended period of time.
The posology should be adjusted according to the individual needs of the patient.
In case of single daily dose, this should be taken at the same time, e.g. during breakfast.
During the therapy with laxatives it is recommended to drink sufficient amounts of fluids (1.5-2 litres, equal to 6-8 glasses) during the day.
Dosing in constipation:
Lactulose may be given as a single daily dose or in two divided doses, for lactulose in bottles the measuring cup may be used.
After a few days the starting dosage may be adjusted to the maintenance dose based upon treatment response. Several days (2-3 days) of treatment may be needed before treatment effect occurs.
|
Starting dose daily |
Maintenance dose daily | |
|
Adults and adolescents |
15-45 ml, |
15-30 ml |
|
Children |
15 ml, |
10-15 ml |
|
(7-14 years) | ||
|
Children |
5-10 ml |
5-10 ml |
|
(1-6 years) | ||
|
Infants under 1 year |
up to 5 ml |
up to 5 ml |
Dosing in HE (for adults only):
Starting dose: 3 to 4 times daily 30-45 ml (6-9 x 5 ml spoonfuls) or 2-3 sachets. This dose may be adjusted to the maintenance dose to achieve two or three soft stools each day.
Paediatric population
The safety and efficacy in children (newborn to 18 years of age) with HE have not been established. No data are available.
Elderly patients and patients with renal or hepatic insufficiency
No special dosage recommendations exist, since systemic exposure to lactulose is negligible.
4.3 Contraindications
• Hypersensitivity to the active substance or any of the ingredients.
• Galactosaemia.
Gastro-intestinal obstruction, digestive perforation or risk of digestive perforation
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.
The dose normally used in constipation should not pose a problem for diabetics.
The dose used in the treatment of HE 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 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, Pregnancy and lactation
Pregnancy
No effects during pregnancy are anticipated, since systemic exposure to lactulose is negligible.
This can be used during pregnancy.
Lactation
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to lactulose is negligible.
This can be used during breast-feeding.
Fertility
No effects are to be expected, since systemic exposure to lactulose is negligible.
4.7 Effects on ability to drive and use machines
Lactulose has no or negligible influence on the ability to drive and use machines
4.8 Undesirable effects
Flatulence may occur during the first few days of treatment. As a rule it disappears after a couple of days. When dosages higher than instructed are
used, abdominal pain and diarrhoea may occur. In such a case the dosage should be decreased. See also overdose section 4.9.
If high doses (normally only associated with hepatic encephalopathy, HE) are used for an extended period of time, the patient may experience an electrolyte imbalance due to diarrhoea. Dosage should then be adjusted to obtain two or three formed stools per day.
Tabulated list of adverse reactions
The following undesirable effects have been experienced with the below indicated frequencies in lactulose-treated patients in placebo-controlled clinical trials:
very common (>1/10);
common (>1/100 to <1/10);
uncommon (>1/1,000 to <1/100);
rare (>1/10,000 to <1/1,000);
very rare (<1/10,000)].
|
MedDRA SOC |
Frequency category | |||
|
Very common |
Common |
Uncommon |
Rare | |
|
Gastrointestinal disorders |
Diarrhoea |
Flatulence, abdominal pain, nausea, vomiting | ||
|
Investigations |
Electrolyte imbalance due to diarrhoea | |||
Paediatric population
The safety profile in children is expected to be similar as in adults. Reporting of suspected adverse reactions
Reporting of suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product.
Overdose
4.9
If the dose is too high, the following may occur:
Symptom: diarrhoea and abdominal pain.
Treatment: cessation of treatment or dose reduction. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.
No specific antidote. Symptomatic treatment should be given.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Osmotically acting laxatives, ATC code: A 06A D11
In the colon lactulose is broken down by colonic bacteria into low molecular organic acids. These acids lead to a lowering of pH in the colonic lumen and via an osmotic effect to an increase of the volume of colonic contents. These effects stimulate peristalsis of the colon and return the consistency of the stool. The constipation is cleared and the physiological rhythm of the colon is reinstated.
In hepatic encephalopathy (HE), the effect has been attributed to suppression of proteolytic bacteria by an increase of acidophilic bacteria (e.g. lactobacillus), trapping of ammonia in the ionic form by acidification of the colonic contents, catharsis due to the low pH in the colon as well as an osmotic effect, and alteration of the bacterial nitrogen metabolism by stimulating the bacteria to utilize ammonia for bacterial protein synthesis.
5.2 Pharmacokinetic properties
Lactulose is poorly absorbed after oral administration and it reaches the colon unchanged. There it is metabolised by the colonic bacterial flora. Metabolism
is complete at doses up to 25-50 g or 40-75 ml; at higher dosages, a proportion may be excreted unchanged.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
None stated
6.2 Incompatibilities
None.
6.3 Shelf life
2 years
6.4 Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze.
6.5 Nature and contents of container
White HDPE bottles containing 300ml, 500ml
Special precautions for disposal
6.6
None
7 MARKETING AUTHORISATION HOLDER
Crescent Pharma Limited
3&4 Quidhampton Business Units
Polhampton Lane
Overton
Hampshire
RG25 3ED
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 20416/0399
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06 April 2010
10 DATE OF REVISION OF THE TEXT
20/03/2015