Movicol Paediatric Chocolate Flavour 6.9 g sachet powder for oral solution

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Macrogol 3350; Sodium bicarbonate; Sodium chloride; Potassium chloride

Διαθέσιμο από:

Norgine Healthcare B.V.

Φαρμακολογική κατηγορία (ATC):

A06AD; A06AD65

INN (Διεθνής Όνομα):

Macrogol 3350; Sodium bicarbonate; Sodium chloride; Potassium chloride

Φαρμακοτεχνική μορφή:

Powder for oral solution

Θεραπευτική περιοχή:

Osmotically acting laxatives; macrogol, combinations

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

2004-11-05

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MOVICOL
® PAEDIATRIC CHOCOLATE FLAVOUR
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 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 CHOCOLATE
FLAVOUR
DO NOT GIVE MOVICOL PAEDIATRIC CHOCOLATE FLAVOUR 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
-

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
27 April 2023
CRN00DFS6
Page 1 of 6
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:
Macrogol 3350
6.563 g
Sodium Chloride
0.1754 g
Sodium Hydrogen Carbonate
0.0893 g
Potassium Chloride
0.0159 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
51 mmol/l
Potassium
5.4 mmol/l
Bicarbonate
17 mmol/l
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:
DAILY DOSAGE REGIMEN:
NUMBER OF MOVICOL PAEDIATRIC CHOCOLATE FLAVOUR SACHETS
AGE (YEARS)
DAY 1
DAY 2
DAY 3
DAY 4
DAY 5
DAY 6
D