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MOVICOL PAEDIATRIC PLAIN 6.9G SACHET POWDER FOR ORAL SOLUTION

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

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22601503
5
CR/14/0082
MOVICOL Paediatric
Plain
02/09/15
UK
PIL
Hengoed
NOR-LFT1-V1
157 x 230mm
616
N/A
N/A

Package leaflet: Information for
the patient

MOVICOL Paediatric Plain
®

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.

475335A06

Black

Digitally signed by Wendy Worthy
DN: cn=Wendy Worthy, o=Schawk,
ou=Newcastle,
email=wendy.worthy@schawk.com, c=GB
Date: 2015.09.02 16:20:18 +01'00'

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 Plain is and what it is
used for
2. What you need to know before you give Movicol
Paediatric Plain
3. How to give Movicol Paediatric Plain
4. Possible side effects
5. How to store Movicol Paediatric Plain
6. Contents of the pack and other information
1. What Movicol Paediatric Plain is and what it
is used for
The name of this medicine is Movicol Paediatric
Plain 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 Plain helps your child to have a
comfortable bowel movement even if they have
been constipated for a long time.

Fonts used:
Frutiger LT Std-55 Roman
Frutiger LT Std-56 Italic
Frutiger LT Std-57 Condensed
Frutiger LT Std-65 Bold
Frutiger LT Std-66 Bold Italic
Frutiger LT Std-67 Bold Condensed
Frutiger LT Std-75 Black
Frutiger LT Std-76 Black Italic
Helvetica-Regular
Average Text Size (Body Text):
8.0 pt

Page 1 of 2

2. What you need to know before you give
Movicol Paediatric Plain
Do not give Movicol Paediatric Plain 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 of Movicol
Paediatric Plain (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 Plain.

Other medicines and Movicol Paediatric Plain
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 Plain.
When taking large volumes of Movicol Paediatric
Plain (e.g. for faecal impaction), your child should
not take other medicines within one hour of taking
Movicol Paediatric Plain.
Pregnancy and breast feeding
Movicol Paediatric Plain can
be given during pregnancy
and whilst breast feeding. Ask
your pharmacist or doctor for
advice before giving Movicol
Paediatric Plain.
3. How to give Movicol Paediatric Plain
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 Plain depends on the age of the child and
their response to treatment.
• As a starting dose, children aged 2 to 6 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 Plain for
faecal impaction, it should be confirmed medically
that your child has this condition.
A course of treatment with Movicol Paediatric Plain
is as follows:
Number of Movicol Paediatric Plain 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 your child passing
large volumes of stool and/or watery diarrhoea.
How to mix
• Open the sachet and pour the contents into a
glass. Add about 62.5ml or 1/4 glass of water
to the glass. Stir well until all the powder has
dissolved and the Movicol Paediatric Plain
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 Plain for faecal impaction it may be
easier to dissolve 12 sachets in 750ml of water.

22601503
5
CR/14/0082
MOVICOL Paediatric
Plain

475335A06

Black

Fonts used:
Frutiger LT Std-55 Roman
Frutiger LT Std-56 Italic
Frutiger LT Std-57 Condensed
Frutiger LT Std-65 Bold
Frutiger LT Std-66 Bold Italic
Frutiger LT Std-67 Bold Condensed
Frutiger LT Std-75 Black
Frutiger LT Std-76 Black Italic
Helvetica-Regular
Average Text Size (Body Text):
8.0 pt

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 Plain can be for
up to 7 days.
If your child takes more Movicol Paediatric Plain
than they should:
Your child may develop excessive diarrhoea. If this
occurs, stop taking Movicol Paediatric Plain and drink
plenty of fluids. If you are worried contact your doctor
or pharmacist.
If you forget to give Movicol
Paediatric Plain
Give the dose as soon as you
remember.

Page 2 of 2

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 Plain 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 Plain
Keep this medicine out of the sight and reach of
children.
• Do not use Movicol Paediatric Plain 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 Plain above 25°C.
• Once you have made up Movicol Paediatric Plain
in water, if your child cannot drink it straight
away keep it covered and in the fridge (2–8°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.
6. Contents of the pack and other information
What Movicol Paediatric Plain contains
Each 6.9g sachet of Movicol Paediatric Plain contains
the following:
Macrogol 3350
6.563 g
Sodium chloride
0.1754 g
Sodium hydrogen carbonate 0.0893 g
Potassium chloride
0.0251 g
Movicol Paediatric Plain contains no colours, flavours
or sweeteners.
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
53 millimoles/litre
Potassium
5.4 millimoles/litre
Bicarbonate
17 millimoles/litre
What Movicol Paediatric Plain looks like and
contents of the pack
Movicol Paediatric Plain is a white powder.
Movicol Paediatric Plain is available in boxes of 6, 8,
10, 20, 30, 40, 50, 60 or 100 sachets. Not all pack
sizes may be marketed.
UK Marketing authorisation holder:
Norgine Pharmaceuticals Limited,
Moorhall Rd, Harefield, Middx UB9
6NS, U.K.
IE Marketing authorisation holder:
Norgine Ltd, Moorhall Rd, Harefield,
Uxbridge, Middx 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
Austria
MOVICOL® Junior aromafrei
Germany
MOVICOL® Junior aromafrei
Belgium
MOVICOL® Junior Neutral
Sweden
MOVICOL® Junior Neutral
Finland
MOVICOL® Junior Plain
UK
MOVICOL® Paediatric Plain
Ireland
MOVICOL® Paediatric Plain
Italy
MOVICOL® Bambini 6,9 g polvere per
soluzione orale Senza Aroma
Spain
MOVICOL® Pediátrico Sabor Neutro
Netherlands MOVICOLON® Junior Naturel
Luxembourg MOVICOL® Junior Neutral
Denmark
MOVICOL® Junior Neutral
Norway
MOVICOL® Junior
Switzerland
MOVICOL® Paediatric Plain
The leaflet was last revised in 03/2015

22601503

02/09/15
UK
PIL
Hengoed
NOR-LFT1-V1
157 x 230mm
616
N/A
N/A

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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