MOVICOL Paediatric Plain 6.9 g sachet, powder for oral solution

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

MACROGOL, SODIUM CHLORIDE, SODIUM HYDROGEN, CARBONATE, POTASSIUM CHLORIDE

Dostupné z:

Norgine BV Antonio Vivaldistraat 150, 1083 HP Amsterdam, Netherlands

ATC kód:

A06AD65

INN (Medzinárodný Name):

MACROGOL, SODIUM CHLORIDE, SODIUM HYDROGEN, CARBONATE, POTASSIUM CHLORIDE

Forma lieku:

POWDER FOR ORAL SOLUTION

Zloženie:

MACROGOL 3350 6.563 gram(s) ; SODIUM CHLORIDE 0.1754 gram(s) ; SODIUM HYDROGEN CARBONATE 0.0893 gram(s) ; POTASSIUM CHLORIDE 0.0251 gram(s)

Typ predpisu:

POM

Terapeutické oblasti:

DRUGS FOR CONSTIPATION

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2015-11-20

Príbalový leták

1
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 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, an impaired gag reflex or
reflux oesophagitis
(heart-burn caused by back-flow of

Súhrn charakteristických

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
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 sachet