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MOVICOL PAEDIATRIC CHOCOLATE FLAVOUR 6.9G SACHET POWDER FOR ORAL SOLUTION

Active substance(s): MACROGOL 3350 / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM HYDROGEN CARBONATE

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Package leaflet: Information for the patient

MOVICOL Paediatric
Chocolate Flavour
®

6.9g sachet, powder for oral solution
Read all of this leaflet carefully before you
start to give this medicine to your child because
it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor, pharmacist or nurse.
• This medicine has been prescribed for your child.
Do not pass it on to others.
It may harm them, even if their signs of illness
are the same as your child's.
• If your child gets any side effects, talk to your
doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.

If you need the information on this leaflet
in an alternative format, such as large print,
please ring from the UK: 0800 198 5000.
From Ireland: 00 44 1895 826 606.
What is in this leaflet:
1. What Movicol Paediatric Chocolate flavour is and
what it is used for
2. What you need to know before you give Movicol
Paediatric Chocolate flavour
3. How to give Movicol Paediatric Chocolate flavour
4. Possible side effects
5. How to store Movicol Paediatric Chocolate flavour
6. Contents of the pack and other information
1. What Movicol Paediatric Chocolate
flavour is and what it is used for
The name of this medicine is Movicol Paediatric
Chocolate flavour 6.9g sachet, powder for oral
solution. It is a laxative for the treatment of chronic
constipation in children aged 2 to 11 years and for
the treatment of very bad constipation (called faecal
impaction) in children aged 5 to 11 years.
Movicol Paediatric Chocolate flavour helps your
child to have a comfortable bowel movement even
if they have been constipated for a long time.
2. What you need to know before you give
Movicol Paediatric Chocolate flavour
Do not give Movicol Paediatric Chocolate flavour if
your doctor has told you that your child has:
• a blockage in their intestine (gut obstruction, ileus)
• a perforated gut wall
• severe inflammatory bowel disease like ulcerative
colitis, Crohn’s disease or toxic megacolon
• an allergy to the active substances or any of the
other ingredients of Movicol Paediatric
Chocolate flavour (listed in section 6).
If your child has a heart or kidney problem, an
impaired gag reflex or reflux oesophagitis
(heart-burn caused by back-flow of stomach contents
into the oesophagus), you should talk to your doctor
before giving Movicol Paediatric Chocolate flavour.
Warnings and precautions
When taking Movicol Paediatric Chocolate you
should continue to take plenty of fluids. The fluid
content of Movicol should not replace your regular
liquid intake.
Other medicines and Movicol Paediatric Chocolate
flavour
Tell your doctor if your child is taking, or has
recently taken or might take any other medicines.
Some medicines e.g. anti-epileptics may not work as
effectively during use with Movicol Paediatric
Chocolate flavour. When taking large volumes of
Movicol Paediatric Chocolate flavour (e.g. for faecal
impaction), your child should not take other
medicines within one hour of taking Movicol
Paediatric Chocolate flavour.
Pregnancy and breast feeding
Movicol Paediatric Chocolate flavour can be given
during pregnancy and whilst breast feeding.

Ask your pharmacist or doctor for advice before
giving Movicol Paediatric Chocolate flavour.
3. How to give Movicol Paediatric
Chocolate flavour
This medicine can be given at any time with or
without food.
Dissolve the content of each sachet in 62.5 ml (1⁄4 of
a glass) of water and drink.
Chronic Constipation:
The dose of Movicol Paediatric
Chocolate flavour depends on
the age of the child and their
response to treatment.
• As a starting dose, children
aged 2 to 6 years should be given 1 sachet
(=1 dose) each day.
• Children aged 7 to 11 should be given 2 sachets
each day.
• Your doctor may tell you to increase the number
of sachets taken until your child has a soft bowel
movement. If the dose does need increasing, this
should be done every other day. Normally, no
more than 4 sachets are required to be taken in
one day.
It is not necessary to take all of the drink at one
time, if the child prefers it, half the drink can be
taken in the morning and half in the evening.
Faecal impaction:
Before your child takes Movicol Paediatric Chocolate
flavour for faecal impaction, it should be confirmed
medically that your child has this condition.
A course of treatment with Movicol Paediatric
Chocolate flavour is as follows:
Number of Movicol Paediatric Chocolate flavour Sachets
Age (years) Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7
5 – 11

4

6

8

10

12

12

12

The daily number of sachets should be taken in
divided doses, all taken within 12 hours (e.g. 8 am – 8pm).
Each sachet dissolved in 62.5 ml (1⁄4 of a glass) of water.
Treatment can be stopped when the medicine has
worked. This is shown by the child passing large
volumes of stool and/or watery diarrhoea.
How to mix:
• Open the sachet and pour the contents into
a glass. Add 1⁄4 glass (about 62.5ml) of water to the
glass. Stir well until all the powder has dissolved
and the Movicol Paediatric Chocolate flavour
solution is clear or slightly hazy, then give it to
your child to drink.
• If you like you can add a flavour such as orange
squash to the drink. If your child is taking Movicol
Paediatric Chocolate flavour for faecal impaction
it may be easier to dissolve 12 sachets in 750ml of
water.
Duration of treatment
Chronic Constipation:
Treatment needs to be for a prolonged period of
time, at least 6 to 12 months.
Faecal impaction:
Treatment with Movicol Paediatric Chocolate flavour
can be for up to 7 days.
If your child takes more Movicol Paediatric Chocolate
flavour than they should:
Your child may develop excessive diarrhoea, which can
lead to dehydration. If this occurs, stop taking Movicol
Paediatric Chocolate flavour and drink plenty of fluids.
If you are worried contact your doctor or pharmacist.
If you forget to give Movicol Paediatric
Chocolate flavour:
Give the dose as soon as you remember.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Tell your doctor immediately and stop giving Movicol
Paediatric Chocolate flavour if your child:
• gets a serious allergic reaction which causes
difficulty in breathing or swelling of the face,
lips, tongue or throat.

Very common side effects (more than 1 person
in 10)
• stomach pains
• stomach rumbles
Common side effects (more than 1 in 100 but less
than 1 in 10 people):
• diarrhoea
• vomiting (being sick)
• nausea (feeling sick)
• anal discomfort
(uncomfortable sensation
around the bottom).
If your child is being treated
for chronic constipation,
diarrhoea will usually improve
when the dose is reduced.
Uncommon side effects (more than 1 in 1000 but
less than 1 in 100 people):
• swollen stomach
• wind
Rare side effects (less than 1 person in 1000)
• allergic reactions, which may include,
breathlessness or difficulty in breathing.
Other side effects reported include:
Skin rash (hives), itching, reddening of the skin or a
nettle rash, swollen hands, feet or ankles,
headaches, indigestion, high or low levels of
potassium in the blood.
Reporting of side effects
If your child gets any side effects, talk to your
doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can
also report side effects directly via Yellow Card
Scheme Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Movicol Paediatric
Chocolate flavour
Keep this medicine out of the sight and reach
of children.
• Do not use Movicol Paediatric Chocolate flavour
after the expiry date which is stated on the sachet
and carton.
• The expiry date refers to the last day of that
month
• Do not store your Movicol Paediatric Chocolate
flavour above 25°C.
• Once you have made up Movicol Paediatric
Chocolate flavour in water, if your child cannot
drink it straight away keep it covered and in the
fridge (2°C - 8°C). Throw away any solution not
used within a 24 hour period.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

Not all pack sizes may be marketed.
UK Marketing authorisation holder:
Norgine Pharmaceuticals Ltd, Moorhall Rd,
Harefield, Middlesex UB9 6NS, U.K.
IE Marketing authorisation holder:
Norgine Ltd, Moorhall Rd, Harefield, Uxbridge,
Middlesex UB9 6NS, U.K.
Manufacturer:
Norgine Limited, New Road, Hengoed,
Mid Glamorgan, CF82 8SJ, U.K.
This medicinal product is authorised in the Member
States of the EEA under the following names
Austria
Belgium
Germany
Finland
Ireland
Italy
Luxembourg
Netherlands
Portugal
Spain
Sweden
United Kingdom

MOVICOL® Junior Schoko
MOVICOL® Junior Aroma /
MOVICOL® Junior Arôme
MOVICOL® Junior
Schokoladengeschmack
MOVICOL® Junior Chocolate
MOVICOL® Paediatric Chocolate
flavour
MOVICOL® Bambini 6,9 g polvere
per soluzione orale gusto Cioccolato
MOVICOL® Junior Arôme
MOVICOLON® Junior Chocolate
MOVICOL® Pediátrico Chocolate
MOVICOL® Pediátrico Sabor
Chocolate
MOVICOL® Junior Choklad
MOVICOL® Paediatric Chocolate
flavour

This leaflet was last revised in 10/2015

MOVICOL, NORGINE and the sail logo are registered
trademarks of the Norgine group of companies.

6. Contents of the pack and other information
What Movicol Paediatric Chocolate
flavour contains
Each 6.9g sachet of Movicol Paediatric Chocolate
flavour powder for oral solution contains the
following:
Macrogol 3350
6.563 g
Sodium Chloride
0.1754 g
Sodium Hydrogen Carbonate
0.0893 g
Potassium Chloride
0.0159 g
Movicol Paediatric Chocolate flavour contains
chocolate flavour and acesulfame potassium as
a sweetner.
When it is made into a drink with 1⁄4 glass (62.5ml) of
water each sachet gives the equivalent of:
Sodium
65 millimoles/litre
Chloride
51 millimoles/litre
Potassium
5.4 millimoles/litre
Bicarbonate
17 millimoles/litre
What Movicol Paediatric Chocolate flavour looks
like and contents of the pack
Movicol Paediatric Chocolate flavour is a white to
light brown powder.
Movicol Paediatric Chocolate flavour is available in
boxes of 6, 8, 10, 20, 30, 40, 50, 60 or 100 sachets.
10074005

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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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