BENLAXID 13,7 g poeder voor drank

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

KALIUMCHLORIDE (E 508) 0,0466 g/stuk ; MACROGOL 3350 13,125 g/stuk ; NATRIUMCHLORIDE 0,3507 g/stuk ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) 0,1785 g/stuk

INN (Algemene Internationale Benaming):

KALIUMCHLORIDE (E 508) 0,0466 g/stuk ; MACROGOL 3350 13,125 g/stuk ; NATRIUMCHLORIDE 0,3507 g/stuk ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) 0,1785 g/stuk

farmaceutische vorm:

Poeder voor drank

Samenstelling:

ARABISCHE GOM (E 414) ; ASPARTAAM (E 951) ; BUTYLHYDROXYANISOL (E 320) ; CITROENSMAAKSTOF ; CITROENZUUR 0-WATER (E 330) ; MALTODEXTRINE ; SINAASAPPELSMAAKSTOF ; SUCRALOSE (E 955) ; TOCOFEROL, ALFA (OPTISCHE ROTATIE ONBEKEND), ARABISCHE GOM (E 414) ; ASPARTAAM (E 951) ; BUTYLHYDROXYANISOL (E 320) ; CITROENSMAAKSTOF ; CITROENZUUR 0-WATER (E 330) ; MALTODEXTRINE ; SINAASAPPELSMAAKSTOF ; SUCRALOSE (E 955) ; TOCOPHEROL, ALPHA (OPTICAL ROTATION UNKNOWN)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BENLAXID 13,7 g poeder voor drank
macrogol 3350,sodium chloride, sodium hydrogen carbonate, 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.
WHAT IS IN THIS LEAFLET
1.
What Benlaxid is and what it is used for
2.
What you need to know before you take Benlaxid
3.
How to take Benlaxid
4.
Possible side effects
5.
How to store Benlaxid
6.
Contents of the pack and other information
1.
WHAT BENLAXID IS AND WHAT IT IS USED FOR
The name of this medicine is Benlaxid 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.
Benlaxid helps you to have a comfortable bowel movement even if you
have been constipated for a
long time. Benlaxid also works in very bad constipation called faecal
impaction
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BENLAXID
DO NOT TAKE BENLAXID IF YOUR DOCTOR HAS TOLD YOU THAT YOU HAVE:
•
an allergy to the active substances or any of the other ingredients of
this medicine (listed in
section 6).
•
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,
WARNINGS AND PRECAUTIONS
When taking Benlaxid you should continue to take plenty of fluids. The
fluid content of
Benlaxid should not replace your regular liquid intake.
HEART CONDITIONS
Follow the special instructions in section 3 if you are taking
Benlax

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
BENLAXID 13,7 g poeder voor drank
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of
_ _
contains the following active ingredients:
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 5.0 mmol/l
Bicarbonate 17 mmol/l
Excipients with known effect:
Each sachet contains 25 mg Aspartame (E951)
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. Benlaxid
_ _
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 Benlaxid
_ _
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 THE ELDERLY:
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 Benlaxid
_ _
products are
available for children.
FAECAL IMPACTION
A course of treatment for faecal impaction with Benlaxid
_ _
does not normally exceed 3
days.
ADULTS, ADOLESCENTS AND THE ELDERLY:
8 sachets daily, all of which should be consumed
within a 6 hour period.
CHILDREN (BELOW 12 YEARS OLD):
Not recommended. Alternative Benlaxid
_ _
produc