Movicol Oral lösning i dospåse

देश: स्वीडन

भाषा: स्वीडिश

स्रोत: Läkemedelsverket (Medical Products Agency)

सक्रिय संघटक:

kaliumklorid; makrogol; natriumklorid; natriumvätekarbonat

थमां उपलब्ध:

Norgine Healthcare B.V.

ए.टी.सी कोड:

A06AD65

INN (इंटरनेशनल नाम):

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

फार्मास्यूटिकल फॉर्म:

Oral lösning i dospåse

रचना:

makrogol 13,125 g Aktiv substans; kaliumklorid 0,05 g Aktiv substans; natriumklorid 0,351 g Aktiv substans; natriumvätekarbonat 0,179 g Aktiv substans

प्रिस्क्रिप्शन प्रकार:

Receptfritt

उत्पाद समीक्षा:

Förpacknings: Dospåse, 10 st; Dospåse, 20 st; Dospåse, 30 st; Dospåse, 50 st

प्राधिकरण का दर्जा:

Godkänd

प्राधिकरण की तारीख:

2016-06-02

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MOVICOL ORAL SOLUTION IN SACHET
Macrogol 3350, Sodium Chloride, Sodium Hydrogen Carbonate, Potassium
Chloride
[For medicines available on prescription]
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.
[For medicines available without a prescription]
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 have 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 within 2 weeks 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 oral solution in sachet. It is a
laxative for the
treatment of constipation in adolescents, adults and older people. 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

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Movicol oral solution in sachet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 25 mL sachet of Movicol contains the following active substances:
Macrogol 3350
13.125 g
Sodium chloride
0.3508 g
Sodium hydrogen carbonate
0.1786 g
Potassium chloride
0.0502 g
The concentration of electrolyte ions present in each 25 mL sachet is
as follows:
Sodium
325 mmol/L
Chloride
267 mmol/L
Potassium
27 mmol/L
Hydrogen carbonate
85 mmol/L
This corresponds to the following amount of each electrolyte in each
25 mL dose:
Sodium
8.125 mmol
Chloride
6.675 mmol
Potassium
0.675 mmol
Hydrogen carbonate
2.125 mmol
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral solution in sachet
Clear, colourless to light yellow, free flowing liquid
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of constipation in adults and adolescents (12 years
and above).
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
Movicol should be used directly from the sachet. This product does not
need to be
diluted with water.
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 Movicol products
are available for children.
PATIENTS WITH RENAL INSUFFICIENCY:
No dosage change is necessary for