MOVICOL PAEDIATRIC PLAIN 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:

2006-01-27

Patient Information leaflet

22601504
1
CR/15/0257
MOVICOL Paediatric 
Plain
09/12/15
UK/Ireland
PIL
Hengoed
NOR-LFT4-V1
157 x 290mm
690
N/A
N/A
500871A02
Black
Page 1 of 2
FONTS USED:
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Frutiger LT Std-75 Black
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Helvetica-Regular
AVERAGE TEXT SIZE (BODY TEXT):
9.0 pt
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 ag

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Movicol Paediatric Plain 6.9 g sachet, powder for oral solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of MOVICOL Paediatric Plain contains the following active
substances:
The content of electrolyte ions per sachet when made up to 62.5 ml of
solution is as follows:
3 PHARMACEUTICAL FORM
Powder for oral solution.
Free flowing white 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 – 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 or a
prolonged period (at least 6 – 12 months).
However,
safety and efficacy of MOVICOL Paediatric Plain 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
Plain is for up to 7 days as follows:
DAILY DOSAGE REGIMEN:
Macrogol 3350
6.563 g
Sodium Chloride
0.1754 g
Sodium Hydrogen
Carbonate
0.0893 g
Potassium Chloride
0.0251 g
Sodium
65
mmol/l
Chloride
53
mmol/l
Potassium
5.4
mmol/l
Bicarbonate
17
mmol/l
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