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DUPHALAC

Active substance: LACTULOSE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Duphalac

®

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Lactulose 3.35 g/5 ml.
For excipients see 6.1

3.

PHARMACEUTICAL FORM
A colourless to brownish yellow, clear or not more than slightly opalescent
liquid.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the treatment of constipation.
For the treatment of hepatic encephalopathy (portal systemic encephalopathy);
hepatic coma.

4.2

Posology and method of administration
Constipation:
Adults (including the elderly)
and adolescents:
Children 5 to 10 years:
Children under 5 years:
Infants under 1 year:

initially 15 ml twice daily
10 ml twice daily
5 ml twice daily
2.5 ml – 5 ml daily

All dosages should subsequently be adjusted to the needs of the individual.
The starting dose can be adjusted to the individual after reaching adequate
treatment effect (maintenance dose). Several days (2-3 days) of treatment may
be needed in some patients before treatment effect occurs.

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.
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.
Hepatic encephalopathy:
Adults (including the elderly): Initially 30 - 50 ml (6-10 x 5 ml spoonfuls) three
times a day. Subsequently adjust the dose to produce two or three soft stools
each day.
Children: no dosage recommendations for this indication.

4.3.

Contraindications
Contraindicated in:
• galactosaemia
• gastro-intestinal obstruction
• hypersensitivity to the active substance or any of the ingredients.

4.4.

Special warnings and precautions for use
Lactulose should be administered with care to patients who are intolerant to lactose
(see 6.1).
The dose normally used in constipation should not pose a problem for diabetics. The
dose used in the treatment of (pre)coma hepaticum is usually much higher and may
need to be taken into consideration for diabetics.
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.
It should be taken into account that the defaecation reflex could be disturbed during
the treatment.
In case of insufficient therapeutic effect after several days, consultation of a physician
is advised.

4.5

Interactions with other medicinal products and other forms of interaction
None known.

4.6

Pregnancy and lactation
Pregnancy:
No effects during pregnancy are anticipated, since systemic exposure to lactulose is
negligible.
A large amount of data on pregnant women (more than 1000 exposed outcomes)
indicate no malformative nor foeto/neonatal toxicity of lactulose.
Duphalac 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.
Duphalac can be used during breast-feeding.

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 portosystemic encephalopathy, PSE) 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.
Because the following reactions were reported spontaneously from a population of
uncertain size it is not possible to reliably estimate their frequency.
Gastrointestinal disorders
Flatulence, abdominal pain, nausea and vomiting. If dosed too high, diarrhoea.
Investigations
Electrolyte imbalance due to diarrhoea.

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 25-50 g or 40-75 ml; 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
None.

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 1000 ml;
polyethylene bottles containing 5 litres; 15 ml foil sachets.

6.6

Instructions for use/handling
None.

7

MARKETING AUTHORISATION HOLDER

Abbott Healthcare Products Ltd.
Mansbridge Road
West End
Southampton
SO18 3JD
8.

MARKETING AUTHORISATION NUMBER(S)
PL 00512/5001R

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
14.03.88 / 23.07.99

10

DATE OF REVISION OF THE TEXT
30/10/2013

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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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