Movicol Ready to Take 13.9 g/25 ml oral solution in sachet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

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

Available from:

Norgine B.V.

ATC code:

A06AD; A06AD65

INN (International Name):

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

Dosage:

13.9 g/25 millilitre(s)

Pharmaceutical form:

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:

2016-09-02

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MOVICOL READY TO TAKE ORAL SOLUTION IN SACHET
Macrogol 3350, Sodium Chloride, Sodium Hydrogen Carbonate, Potassium
Chloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.

If you get any 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 Movicol Ready to Take is and what it is used for
2.
What you need to know before you take Movicol Ready to Take
3.
How to take Movicol Ready to Take
4.
Possible side effects
5.
How to store Movicol Ready to Take
6.
Contents of the pack and other information
1.
WHAT MOVICOL READY TO TAKE IS AND WHAT IT IS USED FOR
The name of this medicine is Movicol Ready to Take oral solution in
sachet. It is a
laxative for the treatment of constipation in adolescents, adults and
older people. It is
not recommended for children below 12 years of age.
Movicol Ready to Take helps you to have a comfortable bowel movement
even if you
have been constipated for a long time. Movicol Ready to Take also
works in very bad
constipation called faecal impaction.
You must talk to a doctor if you do not feel better within 2 weeks or
if you feel worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOVICOL READY TO TAKE
DO NOT TAKE MOVICOL READY TO TAKE IF YOUR DOCTOR HAS TOLD YOU THAT YOU
HAVE:
-
a blockage in your intestine (gut obstruction, ileus)
-
a perforated gut (a hole in the gut wall)
-
severe inflammatory bowel disease like ulcerative colitis, Crohn’s
disease or toxic
megacolon
2
-
an allergy to the active substances or any of the other ingredients of
Movicol Ready
to Take (listed in

Summary of Product characteristics

Health Products Regulatory Authority
05 July 2021
CRN009W3G
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Movicol Ready to Take 13.9 g/25 ml oral solution in sachet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 25 mL sachet of Movicol Ready to Take contains the following
active substances:
Macrogol 3350
13.125 g
Sodium chloride
0.3508 g
Sodium hydrogen carbonate
0.1786 g
Potassium chloride
0.0502 g
The concentration of electrolyte ions present in each 25 mL sachet is
as follows:
Sodium
325 mmol/L
Chloride
267 mmol/L
Potassium
27 mmol/L
Hydrogen carbonate
85 mmol/L
This corresponds to the following amount of each electrolyte in each
25 mL dose:
Sodium
8.125 mmol
Chloride
6.675 mmol
Potassium
0.675 mmol
Hydrogen carbonate
2.125 mmol
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution in sachet
Clear, colourless to light yellow, free flowing liquid
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of constipation in adults and adolescents (12 years
and above).
Movicol Ready to Take 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
Movicol Ready to Take should be used directly from the sachet. This
product does not need to be diluted with water.
CHRONIC CONSTIPATION
A course of treatment for constipation with Movicol Ready to Take 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.
Health Products Regulatory Authority
05 July 2021
CRN009W3G
Page 2 of 5
For extended use, th