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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 / MACROGOL 3350 / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM HYDROGEN CARBONATE / MACROGOL 3350 / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM HYDROGEN CARBONATE

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PACKAGE LEAFLET

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.

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 flavour 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
breastfeeding. Ask your pharmacist or doctor for advice before giving Movicol Paediatric
Chocolate flavour.
MOVICOL Paediatric Chocolate contains benzyl alcohol
MOVICOL Paediatric Chocolate contains 7.0 mg of benzyl alcohol per sachet. Benzyl
alcohol may cause allergic reactions.
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:

Age
(years)
5-11

Day 1

Number of Movicol Paediatric Chocolate flavour sachets
Day 2
Day 3
Day 4
Day 5
Day 6

4

6

8

10

12

12

Day 7
12

The daily number of sachets should be taken in divided doses, all taken within 12 hours (e.g.
8am – 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 ¼ 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 – 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 the
national reporting system listed in Appendix V*. 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 – 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 Chocolate flavour contains

Each 6.9g sachet of Movicol Paediatric Chocolate flavour powder for oral solution contains
the following:
Macrogol 3350
Sodium Chloride
Sodium Hydrogen
Carbonate
Potassium Chloride

6.563 g
0.1754 g
0.0893 g
0.0159 g

Movicol Paediatric Chocolate flavour contains chocolate flavour (which includes benzyl
alcohol E1519, see section 2 “MOVICOL Paediatric Chocolate contains benzyl alcohol”) and
acesulfame potassium E950 as a sweetener.
When it is made into a drink with ¼ glass (62.5ml) of water, each sachet gives the equivalent
of:
Sodium
Chloride
Potassium
Bicarbonate

65 millimoles/litre
51 millimoles/litre
5.4 millimoles/litre
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.
Not all pack sizes may be marketed.
Marketing authorisation holder:
[To be completed nationally]

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

Movicol Junior Schoko

Belgium

MOVICOL Junior Aroma /MOVICOL Junior Arôme

Germany

Macrogol Norgine Junior Schokoladengeschmack

Finland

Movicol Junior Chocolate

Ireland

Movicol Paediatric Chocolate flavour

Italy

MOVICOL Bambini 6,9 g polvere per soluzione orale gusto Cioccolato

Luxembourg

MOVICOL Junior Arôme

Netherlands

Movicolon Junior Chocolate

Portugal

Movicol Pediátrico Chocolate

Spain

MOVICOL Pediátrico Sabor Chocolate

Sweden

Movicol Junior Choklad

United Kingdom

Movicol Paediatric Chocolate flavour

This leaflet was last revised in [YY/MMMM]

Expand Transcript

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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