CosmoCol Paediatric 6.9g powder for oral solution

국가: 몰타

언어: 영어

출처: Medicines Authority

유효 성분:

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

제공처:

Stirling Anglian Pharmaceuticals Ltd Hillington Park Innovation Centre, 1 Ainslie Road, Hillington Park, Glasgow G52 4RU, United

ATC 코드:

A06AD65

INN (International Name):

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

약제 형태:

POWDER FOR ORAL SOLUTION

구성:

MACROGOL 3350 6.563 gram(s) ; SODIUM CHLORIDE 0.1754 gram(s) ; SODIUM HYDROGEN CARBONATE 0.0893 gram(s) ; POTASSIUM CHLORIDE 0.0233 gram(s)

처방전 유형:

POM

치료 영역:

DRUGS FOR CONSTIPATION

승인 상태:

Authorised

승인 날짜:

2015-06-02

환자 정보 전단

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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 childs.
-
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.
-
treat 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).
-
your child has a blockage in their intestine.
-
your child has a perforated gut wall.
-
your child has a severe inflammatory bowel disease like ulcerative
colitis, Crohn's disease or
toxic megacolon.
WARNINGS AND PRECAUTIONS
If your child has heart or kidney problems, an impair

제품 특성 요약

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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
This medicinal product contains sodium, equivalent to 93.87 mg per
sachet. Contains sorbitol. 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
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.
Treatment is required over a prolonged period (at least 6 to 12
months). However, safety and
efficacy data cover up to 3 months. Stop treatment gradually. Resume
if constipation recurs.
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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 over a 12 hour
period. Stop treatment once
disimpaction has occurred. Passage of a large volume of stools
indicates disimpaction. Afte