Movicol Paediatric Plain 6.9g sachet, powder for oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Potassium chloride; Macrogol 3350; Sodium bicarbonate; Sodium chloride

Available from:

PCO Manufacturing Ltd.

ATC code:

A06AD; A06AD65

INN (International Name):

Potassium chloride; Macrogol 3350; Sodium bicarbonate; Sodium chloride

Dosage:

6.9 gram(s)

Pharmaceutical form:

Powder for oral solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Osmotically acting laxatives; macrogol, combinations

Authorization status:

Authorised

Authorization date:

2011-01-28

Patient Information leaflet

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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.
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-

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Movicol Paediatric Plain 6.9g sachet, powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of Movicol Paediatric Plain contains the following active
ingredients:
The content of electrolyte ions per sachet when made up to 62.5 ml of
solution is as follows:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution
_Product imported from the UK_
Free flowing white powder
4 CLINICAL PARTICULARS
As per PA0102/023/004
5 PHARMACOLOGICAL PROPERTIES
As per PA0102/023/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
None
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the
market in the country of origin.
Macrogol 3350
6.563 g
Sodium Chloride
0.1754 g
Sodium Bicarbonate
0.0893 g
Potassium Chloride
0.0251 g
Sodium
65 mmol/1
Chloride
53 mmol/l
Potassium
5.4 mmol/l
Bicarbonate
17 mmol/l
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Sachet: Do not store above 25ºC.
Reconstituted solution: Store in a refrigerator (2ºC - 8ºC) and
covered.
6.5 NATURE AND CONTENTS OF CONTAINER
Pack sizes: box of 30 sachets in an overlabelled outer carton.
6.6 SPECIAL PRECAUTIONS FOR DISPO