Movicol 13.8g sachet, powder for oral solution

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Sodium bicarbonate; Sodium chloride; Macrogol 3350; Potassium chloride

Disponible des:

IMED Healthcare Ltd.

Codi ATC:

A06AD; A06AD65

Designació comuna internacional (DCI):

Sodium bicarbonate; Sodium chloride; Macrogol 3350; Potassium chloride

Dosis:

13.8 gram(s)

formulario farmacéutico:

Powder for oral solution

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Osmotically acting laxatives; macrogol, combinations

Estat d'Autorització:

Authorised

Data d'autorització:

2010-04-16

Informació per a l'usuari

PATIENT INFORMATION LEAFLET
MOVICOL® _13.8G 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
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR
YOU.
Always take this medicine exactly as described in this leaflet or
as your doctor, pharmacist or nurse has told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or
advice.

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.

You must talk to your doctor if you do not feel better
or if you feel worse.
WHAT IS IN THIS LEAFLET:
1.
What is MOVICOL and what is it 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 IS MOVICOL AND WHAT IS IT 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

Fitxa tècnica

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 the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution
_Product imported from_ United Kingdom_ and_ France
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 contains the following constituents: acacia
solids, maltodextrin, lime oil, lemon oil, citral,
citric acid and water).
6.2 INCOMPATIBILITIES
None are known.
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.
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Reconstituted solution: 6 hours
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Sachet: Do not store above 2