Elaxigol 13.7g sachet powder for oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

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

Available from:

Chanelle Medical

ATC code:

A06AD; A06AD65

INN (International Name):

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

Dosage:

13.7 gram(s)

Pharmaceutical form:

Powder for oral solution in sachet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Osmotically acting laxatives; macrogol, combinations

Authorization status:

Not marketed

Authorization date:

2013-02-01

Patient Information leaflet

ID: PL 165 M
VERSION: 05
EFFECTIVE DATE: 11/11/2019
Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
ELAXIGOL
_13.7g sachet, powder for oral solution _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor, pharmacist or
nurse has told you.
•
_Keep this leaflet. You may need to read it again. _
_• _
_If you have further questions, ask your doctor, pharmacist or nurse.
_
_• _
_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 get any of the side effects talk to your doctor, pharmacist or
nurse. This includes _
_any possible side effects not listed in this leaflet. See section 4._
WHAT IS IN THIS LEAFLET:
1. What Elaxigol is and what it is used for
2.
What you need to know
before you take Elaxigol
3. How to take Elaxigol
4. Possible side effects
5. How to store Elaxigol
6.
Contents of the pack and other information
The name of this medicine is Elaxigol 13.7g sachet, powder for oral
solution. It is a laxative for
the treatment of constipation in adults, adolescents and the elderly.
This product is not
recommended for children below 12 years of age.
It helps you to have a comfortable bowel movement even if you have
been constipated for a
long time. Elaxigol 13.7g sachet also works in very bad constipation
called faecal impaction.
DO NOT TAKE ELAXIGOL IF YOUR DOCTOR HAS TOLD YOU THAT YOU HAVE:

a blockage in your intestine (gut obstruction, ileus)

a perforated gut wall.

severe inflammatory bowel disease like ulcerative colitis, Crohn’s
disease or toxic
megacolon

an allergy to the active substances or any of the other ingredients of
Elaxigol (listed in
section 6).

.
WARNINGS AND PRECAUTIONS
When
TAKING
Elaxigol 13.7g sachet,
you should continue to take plenty of fluids. The fluid content
of
Elaxigol 13.7g sachet
should not replace your

Summary of Product characteristics

Health Products Regulatory Authority
19 December 2019
CRN009HHK
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Elaxigol 13.7g sachet powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains the following active
ingredients:
Macrogol 3350
13.125 g
Sodium chloride
0.3507 g
Sodium hydrogen carbonate
0.1785g
Potassium chloride
0.0466g
The content of electrolyte ions per sachet
when made up to 125 ml of solution is as
follows:
Sodium
65 mmol/l
Chloride
53 mmol/l
Hydrogen carbonate
17 mmol/l
Potassium
5.4 mmol/l
For a 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. It is also effective in
resolving faecal impaction, defined as refractory constipation
with faecal loading of the rectum and/or colon.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
CHRONIC CONSTIPATION
A course of treatment for constipation does not normally exceed 2
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 older people_
1 –3 sachets daily in divided doses, according to individual
response.
For extended use, the dose can be adjusted down to 1 or 2 sachets
daily.
_Paediatric population_
Children (below 12 years old)_:_ Not recommended. Alternative products
are available for children.
Health Products Regulatory Authority
19 December 2019
CRN009HHK
Page 2 of 5
FAECAL IMPACTION
A course of treatment for faecal impaction does not normally exceed 3
days.
_Adults, adolescents and older people_
_ _
8 sachets daily, all of which should be consumed within a 6 hour
period.
_Paediatric population_
(Childr