BENLAXID 6,9 g poeder voor drank

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

KALIUMCHLORIDE (E 508) 0,0233 g/stuk ; MACROGOL 3350 6,563 g/stuk ; NATRIUMCHLORIDE 0,1754 g/stuk ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) 0,0893 g/stuk

INN (Algemene Internationale Benaming):

KALIUMCHLORIDE (E 508) 0,0233 g/stuk ; MACROGOL 3350 6,563 g/stuk ; NATRIUMCHLORIDE 0,1754 g/stuk ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) 0,0893 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

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BENLAXID 6,9 g poeder voor drank
macrogol 3350,sodium chloride,sodium hydrogen carbonate,potassium
chloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU GIVE THIS MEDICINE TO
YOUR CHILD 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 your child only. Do not pass it
on to others. It
may harm them, even if their signs of illness are the same as your
child’s.
If your child gets 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 give Benlaxid
3.
How to give 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 chronic constipation in children
aged 1 to 11 years and for
the treatment of very bad constipation (called faecal impaction) in
children aged 5 to 11 years.
Benlaxid helps your child to have a comfortable bowel movement even if
they have been
constipated for a long time.
2.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE BENLAXID
DO NOT GIVE BENLAXID IF YOUR DOCTOR HAS TOLD YOU THAT YOUR CHILD HAS:
-
an allergy to the active substances of Benlaxid or any of the other
ingredients of this
medicine (listed in section 6).”
-
a blockage in their intestine (gut obstruction, ileus)
-
a perforated gut wall
-
severe inflammatory bowel disease like ulcerative colitis, Crohn’s
disease or toxic
megacolon.
If your child has a heart or kidney problem, an impaired gag reflex or
reflux oesophagitis
(heart-burn caused by back-flow of stomach contents into the
oesophagus), you should talk to
your doctor before giving Benlaxid
.
WARNINGS

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
BENLAXID 6,9 g poeder voor drank
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of Benlaxid contains the following active substances:
Macrogol 3350
6.563 g
Sodium Chloride
0.1754 g
Sodium Hydrogen
Carbonate
0.0893 g
Potassium Chloride
0.0233 g
The content of electrolyte ions per sachet when made up to 62.5 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 12.5 mg of 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 in children 1 to 11 years of
age.
For the treatment of faecal impaction in children from the age of 5
years, defined as
refractory constipation with faecal loading of the rectum and/or
colon.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
CHRONIC CONSTIPATION
The usual starting dose is 1 sachet daily for children aged 1 to 6
years, and 2 sachets
daily for children aged 7 – 11 years. The dose should be adjusted up
or down as required
to produce regular soft stools. If the dose needs increasing this is
best done every second
day.
For children below 2 years of age, the maximum recommended dose should
not
exceed 2 sachets a day. For children aged 2 to 11 years, the maximum
recommended
dose needed does not normally exceed 4 sachets a day
Treatment of children with chronic constipation needs to be for a
prolonged period (at
least 6 – 12 months). Treatment should be stopped gradually and
resumed if constipation
recurs.
FAECAL IMPACTION
A course of treatment for faecal impaction with Benlaxid is for up to
7 days as follows:
DAILY DOSAGE REGIMEN:
NUMBER OF BENLAXID SACHETS
Age (years)
Day 1
Day 2
Day 3
Day 4
Day 5
Day 6
Day 7
5 - 11
4
6
8
10
12
12
12
The daily number of sachets should be taken in divided doses, all
consumed within a 12
hour