Movicol 13.8g sachet, powder for oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

Macrogol 35000; Sodium bicarbonate; Sodium chloride; Potassium chloride

Available from:

Imbat Limited

ATC code:

A06AD; A06AD65

INN (International Name):

Macrogol 35000; Sodium bicarbonate; Sodium chloride; Potassium chloride

Dosage:

13.8 gram(s)

Pharmaceutical form:

Powder for oral solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Osmotically acting laxatives; macrogol, combinations

Authorization status:

Authorised

Authorization date:

2009-05-08

Patient Information leaflet

                                Page 1 of 2
PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
MOVICOL
® 13.8G SACHET, POWDER FOR ORAL
SOLUTION
Your medicine is available using the above name, but will be
referred to as ‘Movicol’ throughout this leaflet.
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
F
                                
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Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Movicol 13.8g sachet, powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of Movicol contains the following active ingredients:
The content of electrolyte ions per sachet when made up to 125 ml of
solution is as follows:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
_UK:_ Free flowing white powder for oral solution.
_France:_ Powder for oral solution
_Product imported from France and the UK_
4 CLINICAL PARTICULARS
As per PA0102/023/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0102/023/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_UK:_ Acesulfame potassium (E950) as a sweetener
Lime and lemon flavour*
* (Lime and lemon flavour contains the following constituents: acacia
solids, maltodextrin, lime oil, lemon oil, citral,
citric acid and water).
_France:_ Acesulfame potassium (E950) and lemon flavour
6.2 INCOMPATIBILITIES
Not applicable.
Macrogol 3350
13.125 g
Sodium Chloride
350.7 mg
Sodium Bicarbonate
178.5 mg
Potassium Chloride
46.6 mg
Sodium
65 mmol/l
Chloride
53 mmol/l
Potassium
5.4 mmol/l
Bicarbonate
17 mmol/l
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6.3 SHELF LIFE
The shelf-life expiry date of the product shall be the date shown on
the container and outer package of the product on
the market in the country of
                                
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