Wecol 6.9 g powder for oral solution

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

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

Dostupno od:

Stirling Anglian Pharmaceuticals Ireland Limited

ATC koda:

A06AD; A06AD65

INN (International ime):

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

Doziranje:

6.9 gram(s)

Farmaceutski oblik:

Powder for oral solution

Područje terapije:

Osmotically acting laxatives; macrogol, combinations

Status autorizacije:

Not marketed

Datum autorizacije:

2015-03-13

Uputa o lijeku

Stirling Anglian Pharmaceuticals
Wecol 6.9 g
Module 1.3.1
V019
PACKAGE LEAFLET: INFORMATION FOR THE USER
WECOL 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 Wecol is and what it is used for
2.
What you need to know before you use Wecol
3.
How to take Wecol
4.
Possible side effects
5.
How to store Wecol
6.
Contents of the pack and other information
1.
WHAT WECOL IS AND WHAT IT IS USED FOR
Wecol is a laxative.
This medicine is used in adults, adolescents and elderly to treat:
-
chronic constipation.
-
impaction. Impaction is persistent constipation, where a large volume
of stools cause a
blockage of the rectum and / or colon.
It is not recommended for children below 12 years of age.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE WECOL
_ _
DO NOT TAKE WECOL 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).
-
have a blockage in your intestine.
-
have a perforated gut wall.
-
have a severe inflammatory bowel disease like ulcerative colitis,
Crohn's disease or toxic
megacolon.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Wecol if you have
heart or kidney problems, an
impaired gag reflex, difficulty swallowing or suffer from heartburn.
When taking Wecol you should continue to take plenty of fluids. The
fluid content of Wecol should
not replace your regular liquid in

Svojstava lijeka

Health Products Regulatory Authority
10 May 2023
CRN00DFWK
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Wecol 6.9 g 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
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 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
Posology
CHRONIC CONSTIPATION
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.
Health Products Regulatory Authority
10 May 2023
CRN00DFWK
Page 2 of 6
_Children (below 12 years old)_
Not recommended. Alternative products are available for children.
FAE