Dulcosoft Powder for Oral Solution 10g

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MACROGOL

Available from:

Sanofi Malta Limited Level2, Fort Business Centre, Mriehel Bypass, Birkirkara, Malta

ATC code:

A06AD15

INN (International Name):

MACROGOL 10 g

Pharmaceutical form:

POWDER FOR ORAL SOLUTION

Composition:

MACROGOL 10 g

Prescription type:

OTC

Therapeutic area:

DRUGS FOR CONSTIPATION

Authorization status:

Withdrawn

Authorization date:

2016-08-29

Patient Information leaflet

D1/MT/PIL/2 DATED 31 MAY 2017
PACKAGE LEAFLET: INFORMATION FOR THE USER
DULCOSOFT 10 G POWDER FOR ORAL SOLUTION 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

Summary of Product characteristics

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dulcosoft 10 g powder for oral solution 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.
Page 2 of 7
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, treatment should not
exceed 3
month