Wecol Paediatric 6.9 g powder for oral solution

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Macrogol 3350; Sodium chloride; Potassium chloride; Sodium hydrogen carbonate

Tilgængelig fra:

Stirling Anglian Pharmaceuticals Ireland Limited

ATC-kode:

A06AD; A06AD65

INN (International Name):

Macrogol 3350; Sodium chloride; Potassium chloride; Sodium hydrogen carbonate

Dosering:

6.9 gram(s)

Lægemiddelform:

Powder for oral solution

Terapeutisk område:

Osmotically acting laxatives; macrogol, combinations

Autorisation status:

Not marketed

Autorisation dato:

2015-03-13

Indlægsseddel

Stirling Anglian Pharmaceuticals
Wecol Paediatric
Module 1.3.1
V019
PACKAGE LEAFLET: INFORMATION FOR THE USER
WECOL PAEDIATRIC 6.9 G, POWDER FOR ORAL SOLUTION
Macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium
chloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 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 or pharmacist.
-
This medicine has been prescribed for your child. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as your child‘s.
-
If you or your child notice any side effects, talk to your doctor or
pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Wecol Paediatric is and what it is used for
2.
What you need to know before you give Wecol Paediatric
3.
How to use Wecol Paediatric
4.
Possible side effects
5.
How to store Wecol Paediatric
6.
Contents of the pack and other information
1.
WHAT WECOL PAEDIATRIC IS AND WHAT IT IS USED FOR
Wecol Paediatric is a laxative.
This medicine is used to treat:
-
chronic constipation in children aged 2-11 years.
-
impaction in children from 5 years. Impaction is persistent
constipation, where a large volume
of stools cause a blockage of the rectum and / or colon.
A medicine with a higher dose is recommended for children over the age
of 12.
2.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE WECOL PAEDIATRIC
_ _
DO NOT GIVE WECOL PAEDIATRIC TO YOUR CHILD IF YOUR DOCTOR HAS TOLD YOU
THAT YOUR CHILD:
-
is allergic to Macrogol 3350, sodium chloride, sodium hydrogen
carbonate, potassium
chloride, or any of the other ingredients in this medicine (listed in
section 6).
-
has a blockage in their intestine.
-
has a perforated gut wall.
-
has a severe inflammatory bowel disease like ulcerative colitis,
Crohn's disease or toxic
megacolon.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before giving Wecol Paedia

Produktets egenskaber

Health Products Regulatory Authority
17 May 2023
CRN00DFX1
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Wecol Paediatric 6.9 g powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One sachet of Wecol Paediatric contains the following active
ingredients:
Macrogol 3350, 6.563 g
Sodium chloride, 0.1754 g
Sodium hydrogen carbonate, 0.0893 g
Potassium chloride, 0.0233 g
Content of electrolyte ions when one sachet is dissolved in 62.5 mL
water:
Sodium 65 mmol/l
Chloride 53 mmol/l
Bicarbonate 17 mmol/l
Potassium 5.0 mmol/l
Excipients with known effect
Each sachet contains:

12.22 mg potassium

93.86 mg sodium

0.38 mg sorbitol (E420)
For the full list of excipients, see section 6.1.
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 aged 2 to 11
years.
For the treatment of faecal impaction in children aged 5 years or
above. Faecal impaction is defined as refractory constipation
with faecal loading in the rectum and/or colon.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
CHRONIC CONSTIPATION
Children aged 2 to 6 years: starting dose of 1 sachet daily.
Children aged 7 to 11 years: starting dose of 2 sachets daily.
Adjust dose as required to produce regular, soft stools. Introduce
dose increases every other day. Normal maximum dose is 4
sachets daily.
Doses may be reduced or temporarily omitted in cases of loose stools.
Health Products Regulatory Authority
17 May 2023
CRN00DFX1
Page 2 of 6
Treatment of children with chronic constipation needs to be for a
prolonged period (at least 6 - 12 months). However, safety
and efficacy of Wecol Paediatric has only been proved for a period of
up to 3 months. Treatment should be stopped gradually
and resume if constipation recurs.
FAECAL IMPACTION
A course of treatment with Wecol Paediatric takes up to 7 days, as
follows:
DAILY DOSE REGIMEN
Number of Wecol Paediatric sachets
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