10g powder for oral solution in sachet
macrogol 4000
Package Leaflet: Information for the user
Read all of this leaflet carefully before you start taking this
medicine.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your pharmacist or
doctor
• Talk to your pharmacist or doctor if your symptoms worsen or do not improve
• If a side effect occurs and gets troublesome, or seems serious to you, or if you experience a side effect not listed in this leaflet, please tell your pharmacist or doctor.
In this leaflet:
1.What Dulcobalance® is and what it is used for
2.Before you take Dulcobalance®
3.How to take Dulcobalance®
4.Possible side effects
5.How to store Dulcobalance®
6.Further information
1. WHAT DULCOBALANCE® IS AND WHAT IT IS USED FOR
Dulcobalance® belongs to a group of medicines called osmotic
laxatives.
Dulcobalance® carries water to your stool, which loosens and
increases stool volume, helping to overcome sluggish bowels.
Dulcobalance® is not absorbed into the bloodstream or broken
down in the body.
Dulcobalance® is used for the treatment of constipation in
adults and children aged 8 years and over.
Dulcobalance® is a powder that you dissolve in a glass of water
(at least 50 ml) and then drink.
Dulcobalance® works gradually within 24 to 48 hours.
The treatment of constipation with any medicine should only be
in addition to a healthy lifestyle and diet.
2. BEFORE YOU TAKE DULCOBALANCE®
Do not take DULCOBALANCE® if:
• you are allergic (hypersensitive) to macrogol (polyethylene glycol) or any of the other ingredients of this medicine which are listed in section 6 “Further information”
• you have an existing severe intestinal disease such as:
-inflammatory bowel disease (such as ulcerative colitis,
Crohn’s disease)
-digestive perforation or risk of digestive perforation
-ileus or suspicion of intestinal obstruction
-painful abdominal conditions of unknown cause
Do not take this medicine if any of the above applies to you. If
you are not sure, talk to your pharmacist or doctor before taking
the medicine.
Take special care with DULCOBALANCE®
Very rare cases of allergic reactions involving rash and swelling of
the face (oedema) have been reported in adults after taking
products containing macrogol (polyethylene glycol). Isolated
allergic reactions have been reported causing faintness or collapse
and feeling generally unwell. If you experience any of these
symptoms you should stop taking Dulcobalance® 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
Taking other medicines
Please tell your pharmacist or doctor if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Pregnancy and breast feeding
Dulcobalance® can be taken during pregnancy and whilst breast
feeding. If you are pregnant, trying to become pregnant or breast
feeding, ask your pharmacist or doctor for advice before taking
Dulcobalance®.
Important information about some of the ingredients of
DULCOBALANCE®
If you have been told by your doctor that you have an intolerance
to some sugars (sorbitol), contact your doctor before taking this
medicine. This medicine contains a small amount of a sugar called
sorbitol, which is converted to fructose. Dulcobalance® can,
however, be used if you are diabetic, or if you are on a galactosefree diet. Due to the presence of sulphur dioxide, Dulcobalance®
may rarely cause severe hypersensitivity reactions and
bronchospasm.
abcd
Mandatory in
File information
TD
Printfile
Issue date of TD:
18. FEB 2011
Yes
Yes
PPM SKU:
P016687
No
Yes
PPM SKU version: 004
No
Yes
Issue date of artwork:
08. SEP 2011
No
Yes
Print colors:
PAN 357
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Yes
Mat. No. Pack. Site:
1025151
No
Yes
Legend case version:
V3.0 01/JUN/2010 (please do not change or remove it)
Technical information
a = Batch No.
b = Expiry date
c = Manufacturing date
d = Price/Sample/Clinic
Technical colors
BI-Diecut-Legendcase
Free area
Additional information
Dimension
150 x 210 mm
Gluepoints
3. HOW TO TAKE DULCOBALANCE®
Always take Dulcobalance® exactly as your pharmacist or doctor
has told you or as indicated in this leaflet. You should check with
your doctor or pharmacist if you are not sure.
Very rare (affects less than 1 user in 10,000) but potentially
serious side effects
Symptoms of an allergic reaction such as rash, urticaria, oedema,
facial swelling (in the form of Quincke’s oedema) with swelling of
the upper and/or lower lip and/or cheeks.
Adults and children over 8 years
• The usual dose is one to two sachets per day, preferably taken as a single dose in the morning
• Start by taking 1 sachet each day and if needed increase to
2 sachets each day
• The daily dose can be adjusted according to the effect obtained and may range from one sachet every other day (especially in children) up to a maximum of two sachets per day.
• Dissolve the contents of the sachets in a glass of water (at least 50 ml) immediately before use and drink the liquid.
Unknown frequency (post marketing data)
• Hyponatraemia (low blood levels of sodium)
• Hypokalaemia (low blood levels of potassium)
• Possible dehydration caused by severe diarrhoea especially in the elderly
Please note:
• Dulcobalance® usually takes 24 to 48 hours to work
• In the management of children with constipation, the duration of treatment with Dulcobalance® should not exceed 3 months
• Improvement in the frequency of your bowel movements after taking Dulcobalance® 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
5. HOW TO STORE DULCOBALANCE®
If you take more DULCOBALANCE® than you should
Taking too much Dulcobalance® may cause diarrhoea, which
usually disappears when treatment is stopped or the dose
reduced.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no
longer required. These measures will help protect the
environment.
If you suffer from severe diarrhoea or vomiting you should
contact a doctor as soon as possible as you may require
treatment to prevent loss of salts (electrolytes) due to fluid loss.
6. FURTHER INFORMATION
4. POSSIBLE SIDE EFFECTS
Like all medicines, Dulcobalance® can cause side effects, although
not everybody gets them. The side effects that are usually mild
and do not last long include:
In children:
Common (affects 1 to 10 users in 100)
• Abdominal pain
• Diarrhoea which may also cause soreness around the back passage (anus)
Uncommon (affects 1 to 10 users in 1,000)
• Nausea or vomiting
• Abdominal bloating
Unknown frequency
• Allergic (hypersensitivity) reactions
In adults:
Common (affects 1 to 10 users in 100)
• Abdominal pain and bloating
• Nausea
• Diarrhoea
Uncommon (affects 1 to 10 users in 1,000)
• Vomiting
• Urgent need to go to the toilet
• Faecal incontinence
abcd
Keep this medicine out of the sight and reach of children.
Do not take Dulcobalance® after the expiry date which is printed
on the base of the carton. The expiry date refers to the last day of
that month.
Dulcobalance® does not require any special storage conditions.
What DULCOBALANCE® contains:
The active substance in each sachet is 10 grams of macrogol
4000.
The other ingredients are:
Saccharin sodium (E954) and orange-grapefruit flavour which
contains orange and grapefruit oils, concentrated orange juice,
citral, acetaldehyde, linalol, ethyl butyrate, alpha terpineol,
octanal, beta and gamma hexenol, maltodextrin, gum arabic,
sorbitol (E420), BHA (E320) and sulphur dioxide (E220).
What DULCOBALANCE® looks like and contents of pack
Dulcobalance® is an almost white powder that smells and tastes
of orange-grapefruit, for making up into a drink.
Dulcobalance® is available in packs of 10, 20, 50 and 100 sachets.
Not all pack sizes may be marketed.
Marketing authorisation holder
Boehringer Ingelheim Limited, Consumer Healthcare,
Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS,
United Kingdom.
Manufacturer
Beaufour Ipsen Industrie,
Rue Ethe Virton, 28100 Dreux, France.
This leaflet was last revised in September 2011
® Registered trade mark
© Boehringer Ingelheim Limited 2011
1025151
If you forget to take DULCOBALANCE®
Take the next dose as soon as you remember but do not take a
double dose to make up for a forgotten dose.
If a side effect occurs and gets troublesome, or seems serious to
you, or if you experience a side effect not listed in this leaflet,
please tell your pharmacist or doctor.