MOVICOL PAEDIATRIC CHOCOLATE FLAVOUR SACHET 6.9 Grams Powder for Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MACROGOL 3350, SODIUM CHLORIDE, SODIUM HYDROGEN CARBONATE (E500), POTASSIUM CHLORIDE

Available from:

Norgine Limited

ATC code:

A06AD65

INN (International Name):

MACROGOL 3350, SODIUM CHLORIDE, SODIUM HYDROGEN CARBONATE (E500), POTASSIUM CHLORIDE

Dosage:

6.9 Grams

Pharmaceutical form:

Powder for Oral Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Osmotically acting laxatives

Authorization status:

Authorised

Authorization date:

2004-11-05

Patient Information leaflet

 
1 

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 CHO

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Movicol Paediatric Chocolate Flavour 6.9 g sachet, powder for oral
solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of MOVICOL Paediatric Chocolate flavour contains the
following active substances:
The content of electrolyte ions per sachet when made up to 62.5 ml of
solution is as follows:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution.
Free flowing white to light brown powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of chronic constipation in children 2 to 11 years of
age.
For the treatment
of faecal
impaction in children from the age of five years,
defined as refractory constipation with
faecal loading of the rectum and /or colon.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_CHRONIC CONSTIPATION_
The usual starting dose is 1 sachet daily for children aged 2 to 6
years, and 2 sachets daily for children aged 7 to 11
years. The dose should be adjusted up or down as required to produce
regular soft stools. If the dose needs increasing
this is best done every second day. The maximum dose needed does not
normally exceed 4 sachets a day.
Treatment of children with chronic constipation needs to be for a
prolonged period (at least 6-12 months). However
safety and efficacy of MOVICOL Paediatric Chocolate flavour has only
been proved for a period of up to three months.
Treatment should be stopped gradually and resumed if constipation
recurs.
_FAECAL IMPACTION_
A course of treatment for faecal impaction with MOVICOL Paediatric
Chocolate flavour is for up to 7 days as follows:
Macrogol 3350
6.563 g
Sodium Chloride
0.1754 g
Sodium Hydrogen Carbonate
0.0893 g
Potassium Chloride
0.0159 g
Sodium
65 mmol/l
Chloride
51 mmol/l
Potassium
5.4 mmol/l
Bicarbonate
17 mmol/l
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