Dulcosoft 10 g, poeder voor drank in sachet

Land: Nederländerna

Språk: nederländska

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

Aktiva substanser:

MACROGOL 4000

Tillgänglig från:

sanofi-aventis Netherlands B.V.

ATC-kod:

A06AD15

INN (International namn):

MACROGOL 4000

Läkemedelsform:

Poeder voor drank

Sammansättning:

ACESULFAAM KALIUM (E 950) ; CALCIUMCITRAAT 0-WATER ; CITROEN-GRAPEFRUIT FLAVOUR, Code 154 ; CITROENOLIE ; CITROENZUUR 0-WATER (E 330) ; FRAMBOZENSMAAKSTOF ; GLUCONOLACTON (E 575) ; GRAPEFRUITSMAAKSTOF ; KALIUMCHLORIDE ; MAGNESIUMCITRAAT 0-WATER ; MANNITOL (D-) (E 421) ; MARACUJA SMAAKSTOF ; SILICIUMDIOXIDE (E 551) ; SORBITOL (D-)(E 420),

Administreringssätt:

Oraal gebruik

Terapiområde:

Macrogol

Produktsammanfattning:

Hulpstoffen: ACESULFAAM KALIUM (E 950); CALCIUMCITRAAT 0-WATER; CITROEN-GRAPEFRUIT FLAVOUR, Code 154; CITROENOLIE; CITROENZUUR 0-WATER (E 330); FRAMBOZENSMAAKSTOF; GLUCONOLACTON (E 575); GRAPEFRUITSMAAKSTOF; KALIUMCHLORIDE; MAGNESIUMCITRAAT 0-WATER; MANNITOL (D-) (E 421); MARACUJA SMAAKSTOF; SILICIUMDIOXIDE (E 551); SORBITOL (D-)(E 420);

Tillstånd datum:

2016-12-16

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DULCOSOFT 10 G, POEDER VOOR DRANK IN SACHET
Macrogol 4000
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 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 after 14 days.
WHAT IS IN THIS LEAFLET
1.
What Dulcosoft is and what it is used for
2.
What you need to know before you take Dulcosoft
3.
How to take Dulcosoft
4.
Possible side effects
5.
How to store Dulcosoft
6.
Contents of the pack and other information
1.
WHAT DULCOSOFT IS AND WHAT IT IS USED FOR
Dulcosoft belongs to a group of medicines called osmotic laxatives. It
works by carrying water
to your stool, which loosens and increases stool volume, helping to
overcome sluggish bowels,
working gradually within 24 to 48 hours
Dulcosoft is not absorbed into the bloodstream or broken down in the
body. It is used for the
treatment of constipation in adults and children aged 8 years and
above.
The treatment of constipation with any medicine should only be in
addition to a healthy
lifestyle and diet.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DULCOSOFT
DO NOT TAKE DULCOSOFT:
- if you are allergic to macrogol (polyethylene glycol) or any of the
other ingredients of this
medicine (listed in section 6).
- if you have an existing severe intestinal disease such as:
-
inflammatory bowel disease (such as ulcerative colitis, Crohn’s
disease) or abnormal
dilation of the bowel
-
perforation of the bowel or risk of perforation of the bowel
-
intestinal obstruction or suspicion of intestinal obstruction or
symptomatic narrowing
of the bowel
-
painful

Produktens egenskaper

1
1.
NAME OF THE MEDICINAL PRODUCT
Dulcosoft 10 g, poeder voor drank in sachet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 10 g macrogol 4000.
Excipient with known effect:
Each sachet contains 0.2 mg sorbitol (contained in lemon-grapefruit
flavour).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral solution in sachet.
White powder, free of large agglomerates, with an odour and taste of
lemon, packed in a sachet
for the preparation of an oral solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of constipation in adults and children aged 8
years and above.
An organic disorder should have been ruled out before initiation of
treatment with Dulcosoft
should remain a temporary adjuvant treatment to appropriate lifestyle
and dietary management
of constipation, with a maximum 3-months treatment course in children.
If symptoms persist
despite associated dietary measures, an underlying cause should be
suspected and treated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
It is generally recommended to consider healthy lifestyle measures
such as adequate hydration,
physical activity, and increased natural fibre intake. In case the
symptoms persist or get worse,
a physician should be consulted.
_Adults _
1 to 2 sachets (10 to 20 g macrogol 4000) per day, preferably taken as
a single dose in the
morning.
_Paediatric population_
~ _CHILDREN ≥8 YEARS AND ADOLESCENTS: _1 to 2 sachets (10 to 20 g
macrogol 4000) per day,
preferably taken as a single dose in the morning.
~_ CHILDREN (<8 YEARS):_ Dulcosoft is not recommended for use in
children below the age of 8
years.
The daily dose should be adapted as required to produce regular soft
stools and may range
from one sachet every other day (especially in children) up to 2
sachets a day. If administered
regularly, the frequency of bowel movements tends to be one movement
per day. In children,
2
treatment should not exceed 3 months due to a lack of clinical data
for treatment lasting longe