DUPHALAC

Active substance: LACTULOSE

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base label
150 mm

MKP-02655-2013

P PL 00512/5001R

58 mm

®

trade mark

PIP 212-2620

Batch number:

Glue Area

The Marketing Authorisation Holder is
Abbott Healthcare Products Limited,
Southampton, SO18 3JD.

Expiry date:

DUMMY CODE

P. 294 - CYAN - MAGENTA - YELLOW - BLACK - CUTTING DIE - BRAILLE

PAGE 1

MKP-02655-2013_d5

Duphalac

®

58 mm

3.35g/5ml
lactulose solution

Relieves
Constipation
200ml
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87 mm

P. 294 - CYAN - MAGENTA - YELLOW - BLACK - CUTTING DIE - BRAILLE

PACKAGE LEAFLET: INFORMATION FOR THE USER

Duphalac

3.35g/5ml, Lactulose solution
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist have told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
• You must talk to your doctor if you do not feel better or if you feel worse after
several days.
What is in this leaflet:
1. What Duphalac is and what it is used for
2. What you need to know before you take Duphalac
3. How to take Duphalac
4. Possible side effects
5. How to store Duphalac
6. Contents of the pack and other information
1. What Duphalac is and what it is used for
What Duphalac is
• Duphalac contains a laxative called lactulose. It makes the stool softer and easier
to pass, by drawing water into the bowel. It is not absorbed into your body.
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What Duphalac is used for
• Duphalac is used to treat constipation (infrequent bowel movements, hard and dry
stools).
• Duphalac is used to treat hepatic encephalopathy (a liver disease causing confusion,
tremor, decreased level of consciousness including coma). This is also known as a
'hepatic coma'.
2. What you need to know 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).
• You have a rare problem called 'galactosaemia'.
• You have a blockage caused by anything else but normal constipation, digestive
perforation or risk of digestive perforation.
Do not take Duphalac if any of the above apply to you. If you are not sure, talk to your
doctor or pharmacist before taking Duphalac.
Warnings and precautions:
Talk to your doctor or pharmacist before taking Duphalac if you suffer from any medical
conditions or illnesses, in particular:
• if you suffer from unexplained tummy ache
• if you are unable to digest milk sugar (lactose)
• if you have diabetes
You should not take Duphalac if you suffer from:
• galactose or fructose intolerance
• Lapp lactase deficiency

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• glucose-galactose malabsorption
If you have diabetes and are treated for hepatic encephalopathy, your dose of
Duphalac will be higher. This high dose contains a large amount of sugar. Therefore,
you may need to adjust the dose of your anti-diabetic medicine.
Chronic use of unadjusted dosages (exceeding 2-3 soft stools per day) or misuse can
lead to diarrhoea and disturbance of the electrolytes balance.
During the treatment with laxatives you should drink sufficient amounts of fluids
(approx. 2 litres/day, equal to 6-8 glasses).
If you take Duphalac for several days and there is no improvement in your condition
or if your symptoms worsen, please contact your doctor.
Children
In special circumstances your doctor may prescribe Duphalac for a child, infant or
baby. In these cases your doctor will supervise the treatment carefully. Duphalac
should only be given to infants and smaller children if indicated as it can influence the
normal reflexes for passing stools.
Other medicines and Duphalac
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Taking Duphalac with food and drink
Duphalac can be taken with or without food. There are no restrictions on what you
can eat or drink.
Pregnancy, breast-feeding and fertility
Talk to your doctor or pharmacist before taking this medicine if you are pregnant,
might become pregnant or are breast-feeding. Duphalac can be used during
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pregnancy and when breast-feeding if necessary.
No effects on fertility are to be expected.
Driving and using machines
Duphalac has no or negligible influence on your ability to drive safely or use machines.
Important Information about some of the Ingredients of Duphalac
Duphalac may contain small amounts of milk sugar (lactose), galactose, epilactose or
fructose. If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicine.
3. How to take Duphalac
Always take Duphalac exactly as described in this leaflet or as your doctor or pharmacist
have told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
• Take Duphalac from a spoon or measuring cup.
• You can mix it with fruit juice or water. It is recommended that you drink plenty of fluids
(approximately 6-8 glasses throughout the day)
• Swallow the dose immediately. Do not keep it in your mouth as the sugar content may
lead to tooth decay, particularly if Duphalac is taken for long periods.
• Duphalac takes 2 to 3 days to start working.
• After this time you may be able to reduce the dose you take according to your needs.
Constipation
Adults and adolescents: The starting dose is 15-45ml or 1-3 sachets per day. After this
the dose can be adjusted to 15-30ml or 1-2 sachets daily.
Children 7 to 14 years: The starting dose is 15ml or 1 sachet daily. After this the dose
can be adjusted to 10-15ml or 1 sachet daily.
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MKP-02655-2013_d5

(front of folded leaflet)

58 mm

Children 1 to 6 years: The usual dose is 5-10ml daily.
Infants under 1 year: The usual dose is up to 5ml daily.
Use in Children: Use of laxatives in children, infants, and babies should be exceptional and
under medical supervision because it can influence the normal reflexes for passing stools.
Please do not give Duphalac to children (under 14 years) before consulting your doctor for
prescription and careful supervision.
Hepatic encephalopathy (adults only)
Adults: The usual starting dose is 3 to 4 times a day of 30-45ml or 2-3 sachets.
Use in Children: No information is available for treatment of children (newborn to 18 years
of age) with hepatic encephalopathy.
Use in elderly patients and patients with renal or hepatic insufficiency: No special dosage
recommendations exist.
If you take more Duphalac: than you should
If you take more Duphalac than you should stop taking Duphalac and talk to a doctor or
pharmacist.
You may have diarrhoea and abdominal pain.
If you forget to take Duphalac
If you forget a dose of Duphalac, do not worry. Just take the next dose at the usual time. Do
not take a double dose to make up for a forgotten dose.
If you stop taking Duphalac
Do not stop or change the treatment before talking to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Duphalac can cause side effects, although not everybody gets them. 7

The following side effects have been reported with Duphalac:
Very common (may affect more than 1 in 10 people)
• diarrhoea
Common (may affect up to 1 in 10 people)
• flatulence (wind)
• nausea (feeling sick)
• vomiting
• abdominal pain
Uncommon (may affect up to 1 in 100 people)
• electrolyte imbalance due to diarrhoea
Flatulence may occur during the first few days of treatment. As a rule it disappears
after a few days. When dosages higher than instructed are used, abdominal pain and
diarrhoea may occur. In such a case the dosage should be decreased.
If you use high doses (normally only associated with hepatic encephalopathy, HE)
for an extended period of time, you may experience an electrolyte imbalance due to
diarrhoea.
Reporting of side effects
If you get any side effects, talk to you doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Duphalac
Keep this medicine out of the reach and sight of children.
Do not use Duphalac after the expiry date which is stated on the carton or bottle.
The expiry date refers to the last day of that month.
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Do not store above 25°C. Do not refrigerate or freeze.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
to protect the environment.
6. Contents of the pack and other information
What Duphalac contains
• The active substance in Duphalac is lactulose. Each 5ml of Duphalac contains 3.35g
of lactulose.
• Duphalac does not contain any other ingredients. However, it may contain small
amounts of other sugars, such as lactose, galactose, epilactose and fructose.
What Duphalac looks like and contents of the pack
• Duphalac is a clear, viscous liquid, colourless to brownish yellow liquid.
• Duphalac is available in plastic bottles containing 200ml, 300ml, 500ml and 1000ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is Abbott Healthcare Products Limited,
Southampton, S018 3JD.
The manufacturer is Abbott Biologicals B.V., 8121 AA, Olst, The Netherlands.
This leaflet was last updated in December 2013.

Duphalac®
Remember
This medicine is for you.
Please do not offer it to your family
and friends, even if they have the
same symptoms as you.

If you wish to receive this PIL in Braille, large font or audio format
please contact 023 8046 7000.

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Duphalac contains a laxative called lactulose.
Each 5ml of Duphalac contains 3.35g of lactulose.
Duphalac contains lactose, galactose and small amounts of
fructose (all are types of sugar).
3.35g/5ml
If you have been told by your doctor that you cannot tolerate
lactulose
solution
or digest some sugars (have an intolerance to some sugars),
talk to your doctor before taking this medicine.
Relieves
Duphalac is a colourless to brownish yellow liquid. Duphalac
is available in plastic bottles containing:
Constipation
200ml, 300ml, 500ml, 1000ml.
Not all pack sizes may be marketed.
Duphalac contains a Read the package leaflet before use.
Keep out of the reach and sight of children.
medicine called lactulose. Do not use Duphalac after the expiry date on the bottle.
Do not store above 25°C. Do not refrigerate or freeze.
Each 5ml of Duphalac
contains 3.35g of lactulose. This medicine is available without prescription. Duphalac is
used to treat constipation. It is also sometimes used to treat a
200ml
liver problem called ‘hepatic encephalopathy’.
This is also known as a ‘hepatic coma’.

MKP-02655-2013
DUMMY CODE

77 mm

87 mm
text in braille:

duphalac
P. 294 - CYAN - MAGENTA - YELLOW - BLACK - CUTTING DIE - BRAILLE

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MKP-02655-2013_d5

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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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