Movicol 13.8 g sachet, powder for oral solution

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Macrogol 3350; Sodium bicarbonate; Sodium chloride; Potassium chloride

Հասանելի է:

PCO Manufacturing Ltd.

ATC կոդը:

A06AD; A06AD65

INN (Միջազգային անվանումը):

Macrogol 3350; Sodium bicarbonate; Sodium chloride; Potassium chloride

Դոզան:

13.8 gram(s)

Դեղագործական ձեւ:

Powder for oral solution

Ռեկվիզորի տեսակը:

Product subject to prescription which may be renewed (B)

Թերապեւտիկ տարածք:

Osmotically acting laxatives; macrogol, combinations

Լիազորման կարգավիճակը:

Authorised

Հաստատման ամսաթիվը:

2005-12-22

Տեղեկատվական թերթիկ

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MOVICOL
® 13.8 G 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 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
Follow the special instructions in section 3 if you are taking
Movicol for faecal impaction.
OTHER MEDICINES AND

Ապրանքի հատկությունները

Health Products Regulatory Authority
05 February 2020
CRN009K2P
Page 1 of 2
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 ingredients:
Macrogol 3350
13.125
g
Sodium chloride
350.70
mg
Sodium bicarbonate
178.50
mg
Potassium chloride
46.60
mg
The content of electrolyte ions per sachet when made up to 125ml of
solution is as follows:
Sodium
65.00
mmol/l
Chloride
53.00
mmol/l
Potassium
5.40
mmol/l
Bicarbonate
17.00
mmol/l
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution.
_Product imported from France and United Kingdom:_
Free flowing, white powder.
4 CLINICAL PARTICULARS
As per PA1336/006/005
5 PHARMACOLOGICAL PROPERTIES
As per PA1336/006/005
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Product imported from France_
Lemon flavour
Acesulfame potassium (E950)
_Product imported form the UK:_
Lemon and lime flavour (containing acacia solids, maltodextrin, lime
oil, lemon oil, citral, citric acid and water).
Acesulfame potassium (E950)
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
05 February 2020
CRN009K2P
Page 2 of 2
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.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Sachet: Do not store above 25°C.
Store in the original package in order to protect from moisture.
Reconstituted solution: Store at 2ºC – 8ºC (in a refrigerator and
covered).
6.5 NATURE AND CONTENTS OF CONTAINER
20 or 30 overlabelled sachets contained in an outer cardboard carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Any unused solution should be discarded within 6 hours.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISAT