Wecol Paediatric 6.9 g powder for oral solution

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

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

Disponible desde:

Stirling Anglian Pharmaceuticals Ltd

Código ATC:

A06AD; A06AD65

Designación común internacional (DCI):

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

Dosis:

6.9 gram(s)

formulario farmacéutico:

Powder for oral solution

Vía de administración:

Oral use

Unidades en paquete:

Packs of 6, 8, 10, 20, 30, 40, 50, 60 or 100 sachets

tipo de receta:

Product subject to prescription which may be renewed (B)

Fabricado por:

Klocke Pharma-Service GmbH

Grupo terapéutico:

Osmotically acting laxatives

Área terapéutica:

Osmotically acting laxatives; macrogol, combinations

indicaciones terapéuticas:

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.

Estado de Autorización:

Not marketed

Fecha de autorización:

2015-03-13

Información para el usuario

Stirling Anglian Pharmaceuticals
CosmoCol Half
Module 1.3.1
Sequence 0002
MAA
June 2014
C. PACKAGE LEAFLET
Stirling Anglian Pharmaceuticals
CosmoCol Half
Module 1.3.1
Sequence 0002
MAA
June 2014
PACKAGE LEAFLET: INFORMATION FOR THE USER
COSMOCOL HALF 6.9 G, POWDER FOR ORAL SOLUTION
Macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium
chloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU TAKE THIS MEDICINE
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 you. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
-
If you 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 Half is and what it is used for
2.
What you need to know before you use CosmoCol Half
3.
How to use CosmoCol Half
4.
Possible side effects
5.
How to store CosmoCol Half
6.
Contents of the pack and other information
1.
WHAT COSMOCOL HALF IS AND WHAT IT IS USED FOR
CosmoCol Half is a laxative.
This medicine is used to:
-
treat chronic constipation.
-
treat impaction. Impaction is persistent constipation, where a large
volume of stools
cause a blockage of the rectum and / or colon.
2.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE COSMOCOL HALF
_ _
DO NOT TAKE COSMOCOL HALF IF:
-
you are allergic to Macrogol 3350, sodium chloride, sodium hydrogen
carbonate,
potassium chloride or any of the other ingredients in this medicine
(listed in section
6).
-
you have a blockage in you intestine.
-
you have a perforated gut wall.
-
you have a severe inflammatory bowel disease like ulcerative colitis,
Crohn's disease
or toxic megacolon.
WARNINGS AND PRECAUTIONS
If you have heart or kidney problems, an impaired gag reflex or suffer
from heart-burn, talk to
your doctor before taking
CosmoCol Half.
OTHER MEDICINES AND COSMOCOL HA

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Wecol Paediatric 6.9g 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
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.
FAECAL IMPACTION
A course of treatment with Wecol Paediatric takes up to 7 days, as
follows:
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___