Movicol 13.8g sachet, powder for oral solution

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Sodium bicarbonate; Sodium chloride; Macrogol 3350; Potassium chloride

Предлага се от:

LTT Pharma Limited

АТС код:

A06AD; A06AD65

INN (Международно Name):

Sodium bicarbonate; Sodium chloride; Macrogol 3350; Potassium chloride

дозиране:

13.8 gram(s)

Лекарствена форма:

Powder for oral solution

Вид предписание :

Product subject to prescription which may be renewed (B)

Терапевтична област:

Osmotically acting laxatives; macrogol, combinations

Статус Оторизация:

Authorised

Дата Оторизация:

2009-05-28

Листовка

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:
What Movicol is and what it is used for
What you need to know before you take
Movicol
How to take Movicol
Possible side effects
How to store Movicol
Contents of the pack and other information
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.
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 MOVICOL
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Some medicines, e.g.

Данни за продукта

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 substance:
Macrogol 3350
13.125 g
Sodium chloride
0.3507 g
Sodium bicarbonate
0.1785 g
Potassium chloride
0.0466 g
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 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
gum (E414), maltodextrin, lime oil, lemon oil,
citral and citric acid).
6.2 INCOMPATIBILITIES
None are known.
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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.
Reconstituted solut