MOVICOL CHOCOLATE 13.9 Grams Powder for Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MACROGOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE

Available from:

Norgine Limited

ATC code:

A06AD65

INN (International Name):

MACROGOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE

Dosage:

13.9 Grams

Pharmaceutical form:

Powder for Oral Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Osmotically acting laxatives

Authorization status:

Authorised

Authorization date:

2008-11-13

Patient Information leaflet

 
1 

PACKAGE  LEAFLET: INFORMATION FOR THE PATIENT 

MOVICOL
® 
CHOCOLATE 13.9G, SACHET POWDER FOR ORAL SOLUTION 

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 Chocolate is and what it is used for 
2.  What you need to know before you take Movicol Chocolate 
3.  How to take Movicol Chocolate 
4.  Possible side effects 
5.  How to store Movicol Chocolate 
6.  Contents of the pack and other information  

1.  WHAT MOVICOL CHOCOLATE IS AND WHAT IT IS USED FOR 

The name of this product is Movicol Chocolate 13.9 g 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 Chocolate helps you to have a comfortable bowel
movement even if you 
have been constipated for a long time. Movicol Chocolate also
works in very bad 
constipation known as faecal impaction. 

2.  WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOVICOL CHOCOLATE 

DO NOT TAKE MOVICOL CHOCOLATE 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 a

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
MOVICOL Chocolate 13.9g sachet, powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of MOVICOL Chocolate contains the following active
substances:
Macrogol 3350
13.1250g
Sodium Chloride
0.3507g
Sodium Hydrogen Carbonate
0.1785g
Potassium Chloride
0.0317g
The content of electrolyte ions per sachet when made up to 125 ml of
solution is as follows:
Sodium
65 mmol/l
Chloride
51 mmol/l
Potassium
5.4 mmol/l
Hydrogen Carbonate
17 mmol/l
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution. White to light brown free flowing powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of chronic constipation in adults and children above
the age of 12. MOVICOL Chocolate 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 Chocolate 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 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 UNDER 12 YEARS OF AGE: Not recommended. Alternative MOVICOL
products are available for children.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_