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DULCOSOFT 10 G POWDER FOR ORAL SOLUTION IN SACHET

Active substance(s): MACROGOL 4000 / MACROGOL 4000

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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 narrowing
of the bowel
- painful belly of unknown cause
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Dulcosoft

D1/UK/MAT/PIL

Without investigating the cause of constipation, Dulcosoft should not be taken on a continuous
daily basis for an extended period of time. Medical advice should be sought in case the
symptoms persist for more than 2 weeks or in case of persistent abdominal pain.
Cases of allergic reactions involving rash, hives and swelling of the face or throat have been
reported in adults after taking products containing macrogol (polyethylene glycol). Isolated
severe allergic reactions have been reported causing faintness, collapse or breathing difficulties
and feeling generally unwell. If you experience any of these symptoms you should stop taking
Dulcosoft and seek medical help immediately.
If you experience any of these symptoms you should stop taking Dulcosoft and seek medical
help immediately.
As this medicine can sometimes cause diarrhoea, check with a doctor or pharmacist before
taking this medicine if you:
• have impaired liver or kidney function
• are taking diuretics (water tablets) or are elderly as you may be at risk of low sodium
(salt) or potassium levels in the blood
Children
Dulcosoft is not recommended for use in children below the age of 8 years.
Other medicines and Dulcosoft
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, since the way this medicine works may influence the intertinal absorption of other
medicines.
Pregnancy and breast-feeding
Dulcosoft can be taken during pregnancy and whilst breast feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
Dulcosoft contains sorbitol
If you have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicinal product.
3.

How to take Dulcosoft

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or
nurse have told you. Check with your your doctor, pharmacist or nurse if you are not sure.
The recommended dose is 1 to 2 sachets daily, preferably taken as a single dose in the
morning. Dulcosoft is a powder that you dissolve in a glass of water (125 ml) and drink
immediately.
In case the symptoms persist or get worst, a physician should be consulted.
Use in children and adolescents
In children 8 years and above, the recommended dose is 1 to 2 sachets daily, preferably taken
as a single dose in the morning.
D1/UK/MAT/PIL

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.
Also please note:
• Dulcosoft usually takes 24 to 48 hours to work
• Improvement in the frequency of your bowel movements after taking Dulcosoft can be
maintained by keeping to a healthy lifestyle and diet.
• Talk to your pharmacist or doctor if the symptoms worsen or do not improve
If you take more Dulcosoft than you should
Taking too much Dulcosoft may cause diarrhoea, which usually disappears when treatment is
stopped or the dose reduced. If you have lost a large amount of fluids by diarrhoea or vomiting,
contact your doctor as you may require treatment to prevent loss of salts (electrolytes) due to
fluid loss.
If you forget to take Dulcosoft
Take the next dose as soon as you remember.
Do not take a double dose to make up for a forgotten dose.
If you do not feel better or if you feel worse after 14 days you must contact a doctor.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Whilst taking Dulcosoft, if you develop any of the following symptoms you should contact
your doctor immediately:
• Allergic reactions (rash, hives, swelling of the face or throat, breathing difficulties,
faintness or collapse) (frequency not known, frequency cannot be estimated from the
available data)
Other side effects
The side effects that are usually mild and do not last long include:
However if any of the following side effects gets serious, contact your doctor as soon as
possible.
In adults:
Common (may affect up to 1 in 10 people):
• Abdominal pain
• Bloating
• Nausea
• Diarrhoea
Uncommon (may affect up to 1 in 100 people):
• Vomiting
• Urgent need to go to the toilet
D1/UK/MAT/PIL

Not known (frequency cannot be estimated from the available data):
• Passing gas
In children:
Common (may affect up to 1 in 10 people):
• Abdominal pain
• Diarrhoea
Uncommon (may affect up to 1 in 100 people):
• Vomiting
• Bloating
• Nausea
Not known (frequency cannot be estimated from the available data):
• Passing gas
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the national
reporting system; please see www.yellowcard.mhra.gov.uk. By reporting side effects you can
help provide more information on the safety of this medicine.
5.

How to store Dulcosoft

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and sachet after
EXP. The expiry date refers to the last day of that month.
Do not store above 30°C. Store in its original container to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.

D1/UK/MAT/PIL

6.

Contents of the pack and other information

What Dulcosoft contains
The active substance is macrogol 4000 (polyethylene glycol). Each sachet contains 10 g.
The other ingredient(s) are magnesium citrate (anhydrous), citric acid (anhydrous),
calcium citrate, acesulfame K, potassium chloride (with 0.9% silicia colloidal,
anhydrous), lemon-grapefruit flavour (contains natural lemon oil, liquid flavour
grapefruit, powder flavour maracuja, powder flavour grenadine/raspberry, mannitol
(E421), gluconolactone (E575), sorbitol (E420), anhydrous silica colloidal (E551)). See
section 2 “Dulcosoft contains sorbitol (E420)”.
What Dulcosoft looks like and contents of the pack
Dulcosoft is a white powder, free of large agglomerates, with an odour and taste of lemon,
packed in an Aluminium / Paper sachet. The reconstituted solution is colourless & clear.
Pack sizes of 10 or 20 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
United Kingdom
Tel: 0845 372 7101
Email: uk-medicalinformation@sanofi.com
Manufacturer
Hermes Pharma Ges.m.b.H.
Allgäu 36, A-9400 Wolfsberg,
Austria
This medicinal product is authorised in the Member States of the EEA under the
following names:
Austria:
Belgium

Bulgaria:
Czech Republic:
Cyprus:
Denmark:
Greece:
Finland:
France:
Ireland:
Italy:
Luxemburg:
D1/UK/MAT/PIL

Dulcosoft 10 g Pulver zur Herstellung einer Lösung zum Einnehmen
in Beutel
Dulcosoft 10 g, Poudre pour solution buvable en sachet
Dulcosoft 10g Poeder voor drank in zakje
Dulcosoft 10g Pulver zur Herstellung einer Lösung zum Einnehmen
in Beutel
Dulcosoft 10 g Прах за перорален разтвор в саше
Macrolax 10 g
Dulcosoft 10 g Κόνις για πόσιμο διάλυμα σε φακελίσκο
Dulcosoft
Dulcosoft 10 g Κόνις για πόσιμο διάλυμα σε φακελίσκο
Dulcosoft 10 g Jauhe oraaliliuosta varten, annospussi
Laxosoft 10 g, Poudre pour solution buvable en sachet
Dulcosoft 10 g Powder for Ooral Ssolution in Ssachet
Dulcosoft
Dulcosoft 10 g Poudre pour solution buvable en sachet

Malta:
Netherlands:
Portugal:
Romania:
Sweden:
Spain:
United Kingdom:

Dulcosoft 10 g Powder for oral solution in sachet
Dulcosoft, 10 g Poeder voor drank in zakje
Dulcosoft
Macrogol PharOS 10 g Pulbere pentru soluţie orală în plic
Dulcosoft, 10 g Ppulver till oral lösning i dospåse
Macrolaxo Laxomacro 10 g Polvo para solución oral en sobre EFG
Dulcosoft 10 g powder for oral solution in sachet

This leaflet was last revised in August 2017

D1/UK/MAT/PIL

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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