Duphalac
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Duphalac®
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lactulose 3.335 g/5 ml
3. PHARMACEUTICAL FORM
Oral solution.
A clear, viscous liquid, colourless to brownish yellow.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
1. For the treatment of constipation.
2. For the treatment of hepatic encephalopathy (HE); hepatic coma.
4.2 Posology and method of administration
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.
For lactulose in bottles the measuring cup may be used.
For lactulose in 15ml single dose sachets the corner of the sachet should be torn off and contents taken immediately.
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.
Lactulose oral solution in bottles or 15ml single dose sachets:
|
Starting dose daily |
Maintenance dose daily | |
|
Adults and adolescents |
15-45ml, corresponding to 1-3 sachets |
15-30ml, corresponding to 1-2 sachets |
|
Children (7-14 years) |
15ml, corresponding to 1 sachet |
10-15ml, corresponding to 1 sachet* |
|
Children (1-6 years) |
5-10ml |
5-10ml |
|
Infants under 1 year |
up to 5 ml |
up to 5 ml |
* If the maintenance dose is below 15ml, lactulose in bottles should be used.
For a precise dosing for infants and children up to 7 years lactulose in bottles should be used.
Dosing in HE (for adults only):
Starting dose: 3 to 4 times daily 30-45ml (6-9 x 5ml 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 excipients listed in section 6.1.
• Galactosaemia.
• Gastro-intestinal obstruction, digestive perforation or risk of digestive perforation.
4.4 Special warnings and special 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 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 or fructose 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
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation Pregnancy
No effects during pregnancy are anticipated, since systemic exposure to lactulose is negligible.
Duphalac can be used during pregnancy.
Breast-feeding
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to lactulose is negligible.
Duphalac 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 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 MHRA Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard
4.9 Overdose
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.
5.1 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 25-50g or 40-75ml; at higher dosages, a proportion may be excreted unchanged.
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
Duphalac does not contain any excipients, but may contain small amounts of related sugars (e.g. lactose, galactose, epilactose, fructose) from the route of synthesis.
6.2 Incompatibilities
None known.
6.3 Shelf life
HDPE: 2 years.
Other containers: 3 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
Brown glass and white HDPE bottles containing 200, 300, 500 and 1000ml; polyethylene bottles containing 5 litres; 15ml foil sachets.
6.6 Instructions for use and handling
No special requirements.
7 MARKETING AUTHORISATION HOLDER
BGP Products Ltd.
Abbott House Vanwall Business Park Vanwall Road Maidenhead SL6 4XE UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 43900/0034
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
14/03/1988
10 DATE OF REVISION OF THE TEXT
22/04/2016