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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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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.

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.
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.
Warnings and precautions
When taking Movicol Paediatric Plain 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
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.
Duration of treatment
Chronic Constipation:
Treatment needs to be for a prolonged period
of time, at least 6 to 12 months.

If you forget to give Movicol Paediatric Plain
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 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
UK: 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.
IE: 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 viaHPRA Pharmacovigilance, Earlsfort
Terrace, IRL - Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517. Website: www.hpra.ie;
E-mail: medsafety@hpra.ie. 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 10/2015
MOVICOL, NORGINE and the sail logo are
registered trademarks of the Norgine group of
companies.

22601504

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.

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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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