Movicol Paediatric Plain 6.9 g sachet powder for oral solution

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Macrogol 3350; Sodium bicarbonate; Sodium chloride; Potassium chloride

Dostopno od:

Norgine Healthcare B.V.

Koda artikla:

A06AD; A06AD65

INN (mednarodno ime):

Macrogol 3350; Sodium bicarbonate; Sodium chloride; Potassium chloride

Farmacevtska oblika:

Powder for oral solution

Terapevtsko območje:

Osmotically acting laxatives; macrogol, combinations

Status dovoljenje:

Marketed

Datum dovoljenje:

2006-01-27

Navodilo za uporabo

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MOVICOL
® PAEDIATRIC PLAIN 6.9G SACHET, POWDER FOR ORAL SOLUTION
(Macrogol 3350, Sodium Chloride, Sodium Hydrogen Carbonate, Potassium
Chloride)
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 1 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,

Lastnosti izdelka

Health Products Regulatory Authority
27 April 2023
CRN00DFS6
Page 1 of 6
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 1 to 11 years of
age.
For the treatment of faecal impaction in children from the age of 5
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 1 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. For children below 2 years of age, the maximum
recommended dose should not exceed 2 sachets a day. For
children aged 2 to 11 years, the maximum recommended 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 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
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AGE (Y