Movicol Pulver till oral lösning i dospåse

Χώρα: Σουηδία

Γλώσσα: Σουηδικά

Πηγή: Läkemedelsverket (Medical Products Agency)

Δραστική ουσία:

kaliumklorid; makrogol; natriumklorid; natriumvätekarbonat

Διαθέσιμο από:

Orifarm AB

Φαρμακολογική κατηγορία (ATC):

A06AD65

INN (Διεθνής Όνομα):

potassium chloride (potash); macrogol; sodium chloride; sodium bicarbonate

Φαρμακοτεχνική μορφή:

Pulver till oral lösning i dospåse

Σύνθεση:

natriumvätekarbonat 178 mg Aktiv substans; kaliumklorid 47 mg Aktiv substans; natriumklorid 351 mg Aktiv substans; makrogol 13,125 g Aktiv substans

Τρόπος διάθεσης:

Vissa förpackningar receptbelagda

Θεραπευτική περιοχή:

kombinationer

Καθεστώς αδειοδότησης:

Avregistrerad

Ημερομηνία της άδειας:

2006-06-27

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MOVICOL
®
13.8G SACHET, POWDER FOR ORAL SOLUTION
Macrogol 3350, Sodium Chloride, Sodium Bicarbonate , Potassium
Chloride
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 a doctor if you do not feel better or if you feel
worse.
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 MOVIC

Αρχείο Π.Χ.Π.

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 substances:
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. Free flowing white powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of chronic constipation. MOVICOL is also effective
in resolving
faecal impaction, defined as refractory constipation with faecal
loading of the rectum
and/or colon.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
CHRONIC CONSTIPATION
A course of treatment for constipation with MOVICOL does not normally
exceed 2
weeks, although this can be repeated if required.
As for all laxatives, prolonged use is not usually recommended.
Extended use may be
necessary in the care of patients with severe chronic or resistant
constipation, secondary
to multiple sclerosis or Parkinson’s Disease, or induced by regular
constipating
medication in particular opioids and antimuscarinics.
ADULTS, ADOLESCENTS AND OLDER PEOPLE:
1 –3 sachets daily in divided doses, according
to individual response.
For extended use, the dose can be adjusted down to 1 or 2 sachets
daily.
CHILDREN (BELOW 12 YEARS OLD):
Not recommended. Alternative products are available
for children.
FAECAL IMPACTION
A course of treatment for faecal impaction with MOVICOL does not
normally exceed
3 days.
ADULTS, ADOLESCENTS AND THE OLDER PEOPLE:
8 sachets daily, all of which should be
consumed within a 6 hour period.
CHILDREN (BELOW 12 YEARS OLD):
Not recommended. Alternative MOVICOL products
are available for children.
PATIENTS
WITH
IMPAIRED
CARDIOVASCULAR
FUNCTION:
For
the
treatment
of
fa