DULCOLAX 5 MG SUPPOSITORIES FOR CHILDREN

Active substance: BISACODYL

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437462/GB/9



10 mg SUPPOSITORIES
and
5 mg SUPPOSITORIES
FOR CHILDREN
bisacodyl

Patient Information Leaflet:
Information for the user
Read all of this leaflet carefully because it contains
important information for you.
This medicine is available without prescription. You need to
use DULCOLAX Suppositories as instructed in this leaflet to
get the best results from it.
• Keep this leaflet. You may need to read it again
• Ask your pharmacist if you need more information or
advice
• You must contact your pharmacist or doctor if your
symptoms worsen or do not improve after 5 days of
treatment
• If a side effect occurs and gets troublesome, or seems
serious to you, or if you experience any side effect not
listed in this leaflet, please tell your pharmacist or doctor
In this leaflet:
1. What DULCOLAX Suppositories are and what they are
used for
2. Before you use DULCOLAX Suppositories
3. How to use DULCOLAX Suppositories
4. Possible side effects
5. How to store DULCOLAX Suppositories
6. Further information
1. WHAT DULCOLAX SUPPOSITORIES ARE AND WHAT
THEY ARE USED FOR
DULCOLAX Suppositories contain a medicine called
bisacodyl. This belongs to a group of medicines called
laxatives.
• DULCOLAX Suppositories are used for relief of
constipation
• DULCOLAX Suppositories are also used in hospitals to
clear the bowel before surgery, X-rays or other tests
• DULCOLAX Suppositories stimulate the muscles of the
bowel (large intestine), helping to return the body to its
natural rhythm. They have a laxative effect usually within
10 to 30 minutes
What is constipation?
Normal and regular bowel movement is important for most
people. However, what is “normal and regular” varies from
person to person. Some may have a bowel movement every
day, others less often. Whatever it is like for you, it is best
that your bowel movement has a regular pattern.
• Constipation is an occasional problem for some people;
for others, it may happen more often
• It happens when the normal muscle actions in the bowel
(large intestine) slow down. This can mean that the
material is not easily eliminated from the body
The cause of constipation is often not known. It can be
associated with:
• Sudden change of diet
• A diet with not enough fibre
• Loss of ‘tone’ of the bowel muscles in older people
• Pregnancy
• Medicines such as morphine or codeine
• Having to stay in bed for a long time
• Lack of exercise

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Whatever the cause, constipation is uncomfortable. It may
make you feel bloated and heavy, or generally “off colour”.
Sometimes it causes headaches.
These healthy tips are recommended to try and prevent
constipation happening:
• Eat a balanced diet including fresh fruit and vegetables
• Drink enough water so that you do not become
dehydrated
• Keep up your exercise and stay fit
• Make time to empty your bowels when your body tells
you
2. BEFORE YOU USE DULCOLAX SUPPOSITORIES
Do not use DULCOLAX Suppositories if:
• You are allergic (hypersensitive) to bisacodyl or hard fat
• You have severe dehydration
• You have a bowel condition called “ileus” (blockage in the
intestine)
• You have a serious abdominal condition such as
appendicitis
• You have severe abdominal pain with nausea and
vomiting
• You have a blocked bowel (intestinal obstruction)
• You have inflammation of the bowel (small or large
intestine)
• You have cracking of the skin around your back passage
(anal fissures)
• You have inflammation or ulcers around your back
passage (ulcerative proctitis)
Do not use DULCOLAX Suppositories if any of the above
applies to you. If you are not sure, talk to your pharmacist
or doctor before using this medicine.
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. This includes
herbal medicines. This is because DULCOLAX Suppositories
can affect the way some other medicines work. Also, some
other medicines can affect the way DULCOLAX
Suppositories work.
In particular, tell your pharmacist or doctor if you are taking
any of the following medicines:
• Water tablets (diuretics) such as bendrofluazide or
furosemide (frusemide)
• Steroid medicines such as prednisolone
Before using DULCOLAX Suppositories, tell your pharmacist
or doctor if you are not sure if any of the above applies to
you.
Pregnancy and breast-feeding
Talk to you pharmacist or doctor before using DULCOLAX
Suppositories if you are pregnant, planning to become
pregnant or are breast-feeding.
Driving and using machines
Some people may feel dizzy or faint while taking this
medicine. If this happens to you, wait until these feelings
go away before driving or using machines.

3. HOW TO USE DULCOLAX SUPPOSITORIES

4. POSSIBLE SIDE EFFECTS

If this medicine is from your doctor or pharmacist, do
exactly as they have told you. Otherwise, follow the
instructions below. If you do not understand the
instructions, or if you are not sure, ask your pharmacist or
doctor.

Like all medicines, DULCOLAX Suppositories can cause side
effects, although not everybody gets them. The following
side effects may happen with this medicine:

As with all laxatives, DULCOLAX Suppositories should not
be used every day for more than 5 days. If you need
laxatives every day, or if you have abdominal pain which
does not go away, you should see your doctor.
How to use the suppositories
The suppositories should only be used in your back passage.
1. Take off the foil wrapping
2. Lie on one side and pull your knees up towards your
chest. Keep one leg drawn up more than the other
3. Use your first finger (index finger) or middle finger to
push in the suppository
4. Gently push the suppository as far as possible into your
back passage, pointed end first
5. Once it is as far as it will go, push it side-ways to make
sure it touches the wall of the bowel
6. Lower your legs to a comfortable position whilst the
suppository is retained in place
7. Keep the suppository inside you for at least 30 minutes

If you feel the suppository might come out straight away:
• You may not have put it in high enough. Push it in as far as
possible
• Try to keep it in for 30 minutes, even if you feel like you
urgently need to go to the toilet. This is how long it takes
to work
How much to use
For constipation
Adults and children over 10 years
• Put one 10 mg suppository into the back passage for
immediate effect. Only use one suppository per day






Children under 10 years
DULCOLAX 5 mg Suppositories for Children should only
be used if recommended by a doctor. The usual dose is:
• Put one 5 mg suppository into the back passage for
immediate effect. Only use one suppository per day

For bowel clearance before surgery, X-rays or other tests
In hospitals, when patients are being prepared for surgery,
X-rays or other tests, DULCOLAX Suppositories and
DULCOLAX Tablets are both used. This helps to get
complete bowel clearance.

Adults and children over 10 years
• Take two tablets in the morning and two tablets in the
evening and use one 10 mg suppository on the following
morning





Children 4 -10 years
• Give one tablet in the evening and one 5 mg suppository
(DULCOLAX 5 mg Suppositories for Children) on the
following morning

Rare side effects (affect less than 1 in 1000 people)
• Severe allergic reactions which may cause swelling of the
face or throat and difficulty in breathing or dizziness. If
you have a severe allergic reaction, stop taking this
medicine and see a doctor straight away.
• Colitis (inflammation of the large intestine which causes
abdominal pain and diarrhoea)
• Dehydration
• Allergic reactions which may cause a skin rash
• Fainting
Uncommon side effects (affect less than 1 in 100 people)
• Blood in the stools
• Vomiting
• Abdominal discomfort
• Discomfort inside and around the back passage
• Dizziness
Common side effects (affect less than 1 in 10 people)
• Abdominal cramps or pain
• Diarrhoea
• Nausea
If a side effect occurs and gets troublesome or seems
serious to you, or if you experience any side effect not listed
in this leaflet, please tell your pharmacist or doctor.
5. HOW TO STORE DULCOLAX SUPPOSITORIES
• Keep this medicine out of the sight and reach of children
• Do not use DULCOLAX Suppositories after the expiry date
which is stated on the carton and blister after EXP. The
expiry date refers to the last day of that month.
• Do not store above 25°C
• The suppositories should be protected from light. Keep
them in the outer carton
• 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
6. FURTHER INFORMATION
What DULCOLAX Suppositories contain
• DULCOLAX 10 mg Suppositories contain 10 mg of the
active ingredient bisacodyl
• DULCOLAX 5 mg Suppositories for Children contain 5 mg
of the active ingredient bisacodyl
• Both the suppositories are made from hard fat, which is
an ingredient needed to mould the suppository into the
correct shape
What DULCOLAX Suppositories look like and contents
of the pack
• The suppositories are white and torpedo shaped
• DULCOLAX 10 mg Suppositories are available in packs
of 10, 12 and 20. Not all pack sizes may be marketed
• DULCOLAX 5 mg Suppositories for Children are available
in packs of 5

If you use more DULCOLAX Suppositories than you
should
If you use more of this medicine than you should, talk to a
doctor or go to a hospital straight away. Take the medicine
pack with you. This is so the doctor knows what you have
used.

Marketing Authorisations are held by:
Boehringer Ingelheim Limited,
Consumer Healthcare,
Ellesfield Avenue,
Bracknell, Berkshire
RG12 8YS, United Kingdom.

If you have any questions on the use of this product, ask
your pharmacist or doctor.

DULCOLAX Suppositories are manufactured by:
Instituto De Angeli. S.r.I.
Localitá Prulli di Sotto n. 103/c
Regello (Fl), Italy.
This leaflet was revised in August 2011

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Material number

© Boehringer Ingelheim Limited 2011

20100819

® Registered trade mark

437462/GB/9

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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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