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DUPHALAC

Active substance(s): LACTULOSE

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ABT Olst Biologicals
Duphalac 3.335g/5ml Oral Solution, 200 mL
UK
LCR-M-05813-2018-DEV
1113741

Label/Leaflet

48601 1-0-5 NSD
112 ( X X I I I X )
Black/Cyan/Magenta/Yellow - Keyline - Braille - ----Varnish Free Area
Helvetica Neue / 7 pt
Equivalent Pantone+Color Bridge Coated colours: P. Process Black CP - P. 306 CP - P. 342 CP - P. 368 CP

19/01/2018
M. Pedacchia

base label
150 mm

P

PL 46302/0032

58 mm

®

Glue Area

Mylan Products Ltd., 20 Station Close,
Potters Bar, Herts, EN6 1TL, UK.

trade mark

Batch number:

1113741

Expiry date:

Pharma code
Reading direction

Black/Cyan/Magenta/Yellow - Keyline - Braille - ----Varnish Free Area

PAGE 1

1113741_d1

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

58 mm

Lactulose
3.335 g/5 ml oral 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.

87 mm

Black/Cyan/Magenta/Yellow - Keyline - Braille - ----Varnish Free Area

2

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.
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). Hepatic encephalopathy can lead to a
hepatic coma.
3

77 mm

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 intolerant)
• if you have diabetes
You should not take Duphalac if you suffer from:
• galactose or fructose intolerance
• Lapp lactase deficiency
• glucose-galactose malabsorption
4

76,5 mm

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, your doctor
may recommend that you 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.
5

76,5 mm

PAGE 2

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 pregnancy and when breastfeeding 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 sugars, such as milk sugar (lactose),
galactose and fructose. If you have been told by your doctor
6

77 mm

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 pharmacists 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.
7

77 mm

1113741_d1

(front of folded leaflet)

58 mm

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.
Children 1-6 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.
8

77 mm

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. The following side effects have been
reported with Duphalac:
Very common (may affect more than 1 in 10 people)
• diarrhoea

77 mm

9

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 your 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. You can also
report side effects directly via the MHRA Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard
10

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.
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 3.335g of lactulose.
• Duphalac does not contain any other ingredients. However
it may contain sugars from the manufacture process such
as lactose, galactose and fructose.
11

76,5 mm

76,5 mm

What Duphalac looks like and contents of the pack
• Duphalac is a clear, viscous liquid, colourless to
brownish- yellow liquid.
• Duphalac is available in 15 ml sachets and in plastic
bottles containing 200ml, 300ml, 500ml and 1000ml.
Not all pack sizes may be marketed.

200 ml
CONSTIPATION RELIEF

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan Products Ltd., 20 Station Close, Potters Bar, Herts,
EN6 1TL, UK.
Manufacturer
Abbott Biologicals B.V., 8121 AA, Olst, The Netherlands.
This leaflet was last updated in January 2018.

Lactulose
3.335 g/5 ml
oral solution

Duphalac is used to treat
constipation. It is also
sometimes used to treat a
liver problem called 'hepatic
encephalopathy'.
For more information see
leaflet.
Do not store above 25°C.
Do not refrigerate or freeze.
Read the leaflet before using
this medicine.
Keep out of the sight and
reach of children.
This medicine may contain
lactose, galactose and small
amounts of fructose.
Peel here but
do not remove
1113741

12

77 mm

87 mm

Pharma code
Reading direction

text in braille:
Black/Cyan/Magenta/Yellow - Keyline - Braille - ----Varnish Free Area

PAGE 3

duphalac

1113741_d1

ABT Olst Biologicals
Lactulose 3.335g/5mL_300mL
UK
LCR-M-04895-2017-DEV
1111869

Label/Leaflet

48601 1-0-5 NSD
26 ( X I X X )
Black/Cyan/Magenta/Yellow - Keyline - Braille - ----Varnish Free Area
Helvetica Neue / 7 pt
Equivalent Pantone+Color Bridge Coated colours: P. Process Black CP - P. 306 CP - P. 342 CP - P. 368 CP

14/07/2017
M. Pedacchia

14/07/2017
M. Pedacchia

20/07/2017
M. Pedacchia

18/01/2018
M. Pedacchia

19/01/2018
M. Pedacchia

19/01/2018
M. Pedacchia

20/07/2017
M. Pedacchia

24/07/2017
M. Blaz

base label
150 mm

P

PL 46302/0032

58 mm

®

Glue Area

Mylan Products Ltd., 20 Station Close,
Potters Bar, Herts, EN6 1TL, UK.

trade mark

Batch number:

1111869

Expiry date:

Pharma code
Reading direction

Black/Cyan/Magenta/Yellow - Keyline - Braille - ----Varnish Free Area

PAGE 1

1111869_d8

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

58 mm

Lactulose
3.335 g/5 ml oral 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.

87 mm

Black/Cyan/Magenta/Yellow - Keyline - Braille - ----Varnish Free Area

2

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.
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). Hepatic encephalopathy can lead to a
hepatic coma.
3

77 mm

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 intolerant)
• if you have diabetes
You should not take Duphalac if you suffer from:
• galactose or fructose intolerance
• Lapp lactase deficiency
• glucose-galactose malabsorption
4

76,5 mm

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, your
doctor may recommend that you 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.
5

76,5 mm

PAGE 2

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 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 sugars, such as milk sugar (lactose),
galactose and fructose. If you have been told by your doctor
6

77 mm

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 pharmacists 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.
7

77 mm

1111869_d8

(front of folded leaflet)

58 mm

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.
Children 1-6 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.
8

77 mm

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. The following side effects have been
reported with Duphalac:
Very common (may affect more than 1 in 10 people)
• diarrhoea
9

77 mm

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 your 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. You can also
report side effects directly via the MHRA Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard
10

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.
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 3.335g of lactulose.
• Duphalac does not contain any other ingredients. However
it may contain sugars from the manufacture process such
as lactose, galactose and fructose.
11

76,5 mm

76,5 mm

What Duphalac looks like and contents of the pack
• Duphalac is a clear, viscous liquid, colourless to
brownish- yellow liquid.
• Duphalac is available in 15 ml sachets and in plastic
bottles containing 200ml, 300ml, 500ml and 1000ml.
Not all pack sizes may be marketed.

300 ml
CONSTIPATION RELIEF

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan Products Ltd., 20 Station Close, Potters Bar, Herts,
EN6 1TL, UK.
Manufacturer
Abbott Biologicals B.V., 8121 AA, Olst, The Netherlands.
This leaflet was last updated in January 2018.

Lactulose
3.335 g/5 ml
oral solution

Duphalac is used to treat
constipation. It is also
sometimes used to treat a
liver problem called 'hepatic
encephalopathy'.
For more information see
leaflet.
Do not store above 25°C.
Do not refrigerate or freeze.
Read the leaflet before using
this medicine.
Keep out of the sight and
reach of children.
This medicine may contain
lactose, galactose and small
amounts of fructose.
Peel here but
do not remove
1111869

12

77 mm

87 mm

Pharma code
Reading direction

text in braille:
Black/Cyan/Magenta/Yellow - Keyline - Braille - ----Varnish Free Area

PAGE 3

duphalac

1111869_d8

ABT Olst Biologicals
Duphalac 667
Lactulose
3.335g/5mL_500mL
bottle 1l NO
Norway
UK
LCR-M-04392-2017-DEV
LCR-M-04896-2017-DEV
1110695
1111870

Label
Label/Leaflet

48602 1-0-5 NSD
256( (I IXI III II I) I I X )
39
P. Process Black C - P. 347 C (30%
& 100%)
- P. 306
C - Braille
- Varnish
Black/Cyan/Magenta/Yellow
- Keyline
- Braille
- Varnish
Free
Area Free Area - Cutting Die
Base label &
Helevetica
Nue
front:
/ 7 Helvetica
pt
8 pt; Leaflet: Helvetica Neue 8.5 pt
N/A
Equivalent
Pantone+Color Bridge Coated colours: P. Process Black CP - P. 306 CP - P. 342 CP - P. 368 CP

14/07/2017
30/03/2017
Prem
M.
Pedacchia
Prakash
22/01/2018
M. Pedacchia

19/07/2017
12/05/2017
M.
Yusuf
Pedacchia

20/07/2017
M. Pedacchia

24/07/2017
M. Blaz

19/01/2018
M. Pedacchia

base label
195 mm

P

PL 46302/0032

80 mm
®

trade mark

Glue Area

Mylan Products Ltd., 20 Station Close,
Potters Bar, Herts, EN6 1TL, UK.

1111870

Batch number:
Expiry date:

Black/Cyan/Magenta/Yellow - Keyline - Braille - Varnish Free Area

PAGE 1

1111870_d6

1. What Duphalac is and what it is used for

Lactulose
3.335 g/5 ml oral solution

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.
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). Hepatic encephalopathy can lead to a
hepatic coma.

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

132 mm
Black/Cyan/Magenta/Yellow - Keyline - Braille - Varnish Free Area

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.

2

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 intolerant)
• if you have diabetes
You should not take Duphalac if you suffer from:
• galactose or fructose intolerance
• Lapp lactase deficiency
• 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,
your doctor may recommend that you 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.

3

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.

122 mm

121,5 mm

Driving and using machines
Duphalac has no or negligible influence on your ability to drive safely or use
machines.

PAGE 2

5

121,5 mm

3. How to take Duphalac
Always take Duphalac exactly as described in this leaflet or as your doctor or
pharmacists 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.

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
pregnancy and when breast-feeding if necessary.
No effects on fertility are to be expected.

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Important Information about some of the Ingredients of Duphalac
Duphalac may contain sugars, such as milk sugar (lactose), galactose and fructose.
If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicine.

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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PACKAGE LEAFLET: INFORMATION FOR THE USER

Children 1-6 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.

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

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.
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Like all medicines, Duphalac can cause side effects, although not everybody gets
them. 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.
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Reporting of side effects
If you get any side effects, talk to your 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. You can also report side
effects directly via the MHRA Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard

What Duphalac looks like and contents of the pack
• Duphalac is a clear, viscous liquid, colourless to brownish- yellow liquid.
• Duphalac is available in 15 ml sachets and in plastic bottles containing 200ml,
300ml, 500ml and 1000ml.

5. How to store Duphalac

Marketing Authorisation Holder
Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, UK.

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.
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.

500 ml
CONSTIPATION RELIEF

Marketing Authorisation Holder and Manufacturer

Manufacturer
Abbott Biologicals B.V., 8121 AA, Olst, The Netherlands.
This leaflet was last updated in January 2018.

Lactulose
3.335 g/5 ml
oral solution

6. Contents of the pack and other information
What Duphalac contains
• The active substance in Duphalac is lactulose. Each 5ml of Duphalac contains
3.335g of lactulose.
• Duphalac does not contain any other ingredients. However it may contain sugars
from the manufacture process such as lactose, galactose and fructose.
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duphalac

Duphalac is used to treat
constipation. It is also sometimes
used to treat a liver problem
called 'hepatic encephalopathy'.
For more information see leaflet.
Do not store above 25°C.
Do not refrigerate or freeze.
Read the leaflet before using this
medicine.
Keep out of the sight and reach
of children.
This medicine may contain lactose,
galactose and small amounts of
fructose.

Peel here but
do not remove
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Text in braille:

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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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