MOVICOL

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MACROGOL 3350 ; SODIUM BICARBONATE ; SODIUM CHLORIDE ; POTASSIUM CHLORIDE

Available from:

Primecrown 2010 Ltd

ATC code:

A06AD65

INN (International Name):

MACROGOL 3350 ; SODIUM BICARBONATE ; SODIUM CHLORIDE ; POTASSIUM CHLORIDE

Dosage:

13.8 Grams

Pharmaceutical form:

Powder for Oral Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

macrogol, combinations

Authorization status:

Authorised

Authorization date:

2010-07-16

Patient Information leaflet

MOVICOL
®
13.8G SACHET, POWDER FOR ORAL SOLUTION
PATIENT INFORMATION 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).
HEART CONDITIONS
Follow the special instructions in section 3 if you are taking Movicol
for faecal
impaction
OTHER MEDICINES AND MOVICOL
Tell your doctor or pharmacist if you are taking, have recently taken
or might
take any other medicines.
Some medicines, e.g. anti-epileptics, may not work as effectively
during use
with
Mov

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:
Macrogol 3350
13.125 g
Sodium chloride
350.7 mg
Sodium bicarbonate
178.5 mg
Potassium chloride
46.6 mg
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 a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution
_Product imported from_ United Kingdom
Free flowing white powder.
4 CLINICAL PARTICULARS
As per PA0102/023/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0102/023/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Acesulfame potassium (E950)
Lime and lemon flavour
(Lime and lemon flavour consisting of: acacia solids, maltodextrin,
lime oil, lemon oil, citral, citric acid and water).
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the
market in the country of origin.
Reconstituted solution: 6 hours
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Sachet: Do not store above 25°C.
Reconstituted solution: Store at