CosmoCol Paediatric 6.9g powder for oral solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

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

Available from:

Stirling Anglian Pharmaceuticals Ireland Limited 3 Burlington Road, Dublin 4, D04RD68, , Ireland

ATC code:

A06AD65

INN (International Name):

MACROGOL 3350 6.563 g SODIUM CHLORIDE 0.1754 g SODIUM HYDROGEN CARBONATE 0.0893 g POTASSIUM CHLORIDE 0.0233 g

Pharmaceutical form:

POWDER FOR ORAL SOLUTION

Composition:

MACROGOL 3350 6.563 g SODIUM CHLORIDE 0.1754 g SODIUM HYDROGEN CARBONATE 0.0893 g POTASSIUM CHLORIDE 0.0233 g

Prescription type:

POM

Therapeutic area:

DRUGS FOR CONSTIPATION

Authorization status:

Authorised

Authorization date:

2015-06-02

Patient Information leaflet

Stirling Anglian Pharmaceuticals CosmoCol Paediatric
Module 1.3.1
V019
PACKAGE LEAFLET: INFORMATION FOR THE USER
COSMOCOL 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 CosmoCol Paediatric is and what it is used for
2.
What you need to know before you give CosmoCol Paediatric
3.
How to use CosmoCol Paediatric
4.
Possible side effects
5.
How to store CosmoCol Paediatric
6.
Contents of the pack and other information
1.
WHAT COSMOCOL PAEDIATRIC IS AND WHAT IT IS USED FOR
CosmoCol 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 COSMOCOL PAEDIATRIC
_ _
DO NOT GIVE COSMOCOL 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 pharmac

Summary of Product characteristics

V019
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
CosmoCol Paediatric 6.9 g, powder for oral solution.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One sachet of CosmoCol 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 (0.31 mmol) 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.
V019
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.
Treatment of children with chronic constipation needs to be for a
prolonged period (at least 6 - 12
months). However, safety and efficacy of CosmoCol Paediatric has only
been proved for a period of
up to 3 months. Treatment should be stopped gradually andresume if
constipation recurs.
FAECAL IMPACTION
A course of treatment with CosmoCol Paediatric takes up to 7 days, as
follows:
DAILY DOSE REGIMEN
Number of CosmoCol Paediatric sachets
Age
Day 1
Day 2
Day 3
Day 4
Day 5
Day 6
Day 7
5 – 11 years
4
6
8
10
12
12
12
Take the daily number of sachets as divided doses