Wecol 6.9 g powder for oral solution

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

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

Dostupné z:

Stirling Anglian Pharmaceuticals Ltd

ATC kód:

A06AD; A06AD65

INN (Medzinárodný Name):

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

Dávkovanie:

6.9 gram(s)

Forma lieku:

Powder for oral solution

Spôsob podávania:

Oral use

Počet v balení:

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

Typ predpisu:

Product subject to prescription which may be renewed (B)

Výrobca:

Klocke Pharma-Service GmbH

Terapeutické skupiny:

osmotically acting laxatives

Terapeutické oblasti:

Osmotically acting laxatives; macrogol, combinations

Terapeutické indikácie:

For the treatment of chronic constipation in adults, adolescents and the elderly. For resolving faecal impaction in adults, adolescents and the elderly. Faecal impaction is defined as refractory constipation with faecal loading in the rectum and/or colon confirmed by physical or radiological examination of the abdomen and rectum.

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

2015-03-13

Príbalový leták

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

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Wecol 6.9g powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One sachet of Wecol 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
Hydrogen carbonate 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 adults, adolescents and
the elderly.
For
resolving faecal
impaction in adults,
adolescents
and the elderly.
Faecal
impaction is
defined as
refractory
constipation with faecal loading in the rectum and/or colon confirmed
by physical or radiological examination of the
abdomen and rectum.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
A course of treatment for constipation does not normally exceed two
weeks, although this can be repeated if required.
As for all laxatives. Prolonged use is not usually recommended.
Extended use may be necessary in the care of patients
with severe chronic or resistant constipation, secondary to multiple
sclerosis or Parkinson’s disease, or induced by
regular constipating medication, in particular opioids and
antimuscarinics.
Adults, Adolescents and the Elderly
2-6 sachets daily in divided doses, accrding to individual response.
For extended use, dose can be adjusted down to 2-4 sachets daily.
FAECAL IMPACTION
Adults, Adolescents and the Elderly
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