Movicol Paediatric Plain Powder for Oral Solution 6.9g

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MACROGOL 3350; SODIUM CHLORIDE; SODIUM HYDROGEN CARBONATE; POTASSIUM CHLORIDE

Available from:

Norgine Limited

ATC code:

A06AD65

INN (International Name):

MACROGOL 3350; SODIUM CHLORIDE; SODIUM HYDROGEN CARBONATE; POTASSIUM CHLORIDE

Pharmaceutical form:

POWDER FOR ORAL SOLUTION

Composition:

MACROGOL 3350 6.563 g; SODIUM CHLORIDE 175.4 mg; SODIUM HYDROGEN CARBONATE 89.3 mg; POTASSIUM CHLORIDE 25.1 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR CONSTIPATION

Authorization status:

Authorised

Patient Information leaflet

Norgine
Confidential
Page 1 of 5
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 act

Summary of Product characteristics

Page 1 of 7
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:
Macrogol 3350
6.563 g
Sodium Chloride
0.1754 g
Sodium Hydrogen
Carbonate
0.0893 g
Potassium Chloride
0.0251 g
The content of electrolyte ions per sachet when made up to 62.5 ml of
solution is as
follows:
Sodium
65
mmol/l
Chloride
53
mmol/l
Potassium
5.4
mmol/l
Bicarbonate
17
mmol/l
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.
Page 2 of 7
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:
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
consumed within a
12 hour period. The above dosage regimen should be stopped