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PACKAGE LEAFLET: INFORMATION FOR THE USER
DUPHALAC
3.335 g / 5 ml Oral Solution lactulose
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
MEDICINES.
This medicine is available without prescription. However, you
still need to take Duphalac
carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• If you have any further questions
ask your doctor or pharmacist. This
medicine has been prescribed for you. Do not pass it on to
others. It
may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you
notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Duphalac is and what it is used for
2. Before you take Duphalac
3. How to take Duphalac
4. Possible side effects
5. How to store Duphalac
6. Further information
1. WHAT DUPHALAC IS,
Duphalac contains a laxative called lactulose. It makes the
stool softener and easier to
pass, by drawing water into the bowel. It is not absorbed
into your body.
WHAT DUPHALAC IS USED FOR
Duphalac is used to treat constipation (infrequent bowel movement, hard
and dry stools)
to produce a soft stool.
Duphalac is used to treat hepatic encephalopathy, also
called portal systemic
encephalopathy (a liver disease causing difficulty thinking, tremor,
decreased level of
consciousness including coma).
2. BEFORE YOU TAKE DUPHALAC
DO NOT TAKE DUPHALAC :
if you are allergic (hypersensitive) to lactulose or any of
the other ingredients of
Duphalac (listed in Section 6).
If you suffer from
– galactosaemia (a severe genetic disorder where you cannot
digest galactose)
– blockage in your bowel (apart from normal constipation) .
If you a
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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Duphalac 3.335 g / 5 ml Oral Solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Lactulose solution containing 3.335 g of lactulose per 5 ml.
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Oral solution.
Clear, colourless to pale brownish – yellow viscous liquid.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
(1) In the treatment of constipation.
(2) In the treatment of hepatic encephalopathy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The lactulose solution may be administered diluted or undiluted.
A single 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 a 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(1.5-2litres 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 Duphalac in bottles the measuring cup
should be used.
Several days (2-3days) of treatment may be needed
before treatment effect occurs.
Adults:
15 ml twice daily
Children 5-10 years:
10 ml twice daily
Children 2-5 years:
5 ml twice daily
Infants 1-2 years:
2.5 ml -5 ml twice daily
Infants 1 month-1 year:
2.5 ml twice daily
DOSING IN HEPATIC ENCEPHALOPATHY
Initially 30 to 50 ml three times daily; dosage should be
subsequently adjusted to produce 2 to 3
soft stools daily.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or
to any of the ingredients.
Use in patients who require a
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