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DUPHALAC

Active substance(s): LACTULOSE

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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 10-15ml, corresponding to
sachet
1 sachet*

Children (1-6 years)

5-10ml

5-10ml

Infants under 1 year
up to 5ml
up to 5ml
* 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




4.4

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.

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

Gastrointestinal
disorders

Investigations

Frequency category
Common Uncommon

Very
common
Diarrhoea Flatulence,
abdominal
pain,
nausea,
vomiting

Rare

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

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 25-50g 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 25ºC. 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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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