Movicol 13.8 g sachet powder for oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Macrogol 3350; Sodium bicarbonate; Sodium chloride; Potassium chloride

Available from:

Norgine Healthcare B.V.

ATC code:

A06AD; A06AD65

INN (International Name):

Macrogol 3350; Sodium bicarbonate; Sodium chloride; Potassium chloride

Pharmaceutical form:

Powder for oral solution

Therapeutic area:

Osmotically acting laxatives; macrogol, combinations

Authorization status:

Marketed

Authorization date:

1996-12-03

Patient Information leaflet

1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MOVICOL
®
13.8G SACHET, POWDER FOR ORAL SOLUTION
(Macrogol 3350, Sodium Chloride, Sodium Bicarbonate, 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 is and what it is used for
2.
What you need to know before you take Movicol
3.
How to take Movicol
4.
Possible side effects
5.
How to store Movicol
6.
Contents of the pack and other information
1. WHAT MOVICOL IS AND WHAT IT IS USED FOR
The name of this medicine is Movicol 13.8g sachet, powder for oral
solution. It is a
laxative for the treatment of constipation in adults, adolescents and
elderly. It is not
recommended for children below 12 years of age.
Movicol helps you to have a comfortable bowel movement even if you
have been
constipated for a long time. Movicol also works in very bad
constipation called faecal
impaction.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOVICOL
DO NOT TAKE MOVICOL 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
Movicol
(listed in section 6).
WARNINGS AND PRECAUTIONS
When taking Movicol you should continue to take plenty of fluids. The
fluid content
of Movicol should not replace your regular liquid intake.
HEART CONDITIONS
2
Follow the special instructions in section 3 if you are t

Summary of Product characteristics

Health Products Regulatory Authority
27 April 2023
CRN00DFS6
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Movicol 13.8 g sachet powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of Movicol contains the following active substance:
Macrogol 3350 13.125 g
Sodium chloride 0.3507 g
Sodium bicarbonate 0.1785 g
Potassium chloride 0.0466 g
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
Potassium 5.4 mmol/l
Bicarbonate 17 mmol/l
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. Movicol 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 with Movicol 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.
CHILDREN (BELOW 12 YEARS OLD): Not recommended. Alternative Movicol
products are available for children.
FAECAL IMPACTION
A course of treatment for faecal impaction with Movicol 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.
CHILDREN (BELOW 12 YEARS OLD): Not recommended. Alternative Movicol
products are available for child