DULCOLAX 5 MG GASTRO-RESISTANT TABLETS

Active substance: BISACODYL

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5 mg Gastro-resistant Tablets
bisacodyl

Package 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 take DULCOLAX Tablets 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 five days
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

Whatever the cause, constipation can be uncomfortable. It
may make you feel bloated and heavy or generally “off
colour”. Sometimes it causes headaches.

In this leaflet:
1. What DULCOLAX Tablets are and what they are used for
2. Before you take DULCOLAX Tablets
3. How to take DULCOLAX Tablets
4. Possible side effects
5. How to store DULCOLAX Tablets
6. Further information

Do not take DULCOLAX Tablets if:
• You are allergic (hypersensitive) to bisacodyl or any of
the other ingredients in the product (listed in Section 6:
Further information)
• You are intolerant to or cannot digest some sugars (as
the tablet contains a small amount of lactose and
sucrose)
• 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)

1. WHAT DULCOLAX TABLETS ARE AND WHAT THEY
ARE USED FOR
• DULCOLAX Tablets contain a medicine called bisacodyl.
This belongs to a group of medicines called laxatives
• DULCOLAX Tablets are used for relief of constipation
• DULCOLAX Tablets can also be used in a hospital to
empty a person’s bowel before child birth, surgery or
radiological investigations
• DULCOLAX Tablets gently stimulate the muscles of the
bowel (large intestine). This brings predictable, overnight
relief from constipation, helping to return the body to its
natural rhythm
• DULCOLAX Tablets are gastro-resistant tablets which
have a special coating that helps to ensure the medicine
works only where it is needed
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 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

These healthy tips are recommended to try to 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 TAKE DULCOLAX TABLETS

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 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 Tablets can
affect the way some other medicines work. Also, some
other medicines can affect the way DULCOLAX Tablets
works.
In particular, tell your doctor or pharmacist if you are
taking:
• Water tablets (diuretics) such as bendrofluazide or
furosemide (frusemide)
• Steroid medicines such as prednisolone
If you are not sure if any of the above applies to you, talk
to your pharmacist or doctor before taking DULCOLAX
Tablets
Pregnancy and breast feeding
Talk to your pharmacist or doctor before taking
DULCOLAX Tablets 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.

abcd
315593-011

04/12/2013
P002856
011
11/07/2014
PAN 357
PPM SKU Description : PI DULCOLAX 5MG TABS ALL SIZES GB/IE/MT
Dimension : 160 x 290 mm

315593-011

No. of code : 295

Min. font size :

8 pt
V4.0 01/OCT/2012 (please do not change or remove it)

Ref. drawing : PR32
F

6

3. HOW TO TAKE DULCOLAX TABLETS
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 you are not sure, ask your pharmacist or
doctor.

As with all laxatives, DULCOLAX Tablets should not be
taken every day for more than five days. If you need
laxatives every day, or if you have abdominal pain which
does not go away, you should see your doctor.
Taking this medicine
• Swallow the tablets whole with water
• Milk, antacids or proton pump inhibitors (medicines
which reduce stomach acid) should not be taken within
one hour before or after taking DULCOLAX Tablets. This
is because they will stop the DULCOLAX Tablets from
working properly
How much to take
Adults and children over 10 years
• Take one or two tablets (5 or 10 mg) daily before bedtime
• If you have not taken DULCOLAX Tablets before, start
with one tablet and increase to two if necessary
• When your bowel regularity has returned to normal, the
dose can usually be stopped
Children aged between 4 and 10 years
DULCOLAX Tablets should only be given to children
between the ages of 4 and 10 if recommended by a
doctor. The usual dose for children is:
• One tablet (5 mg) daily before bedtime
Children under 4 years
DULCOLAX Tablets are not recommended for children
under 4 years.
If you take more DULCOLAX Tablets than you should
If you take 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
taken.
If you have any questions on the use of this product, ask
your pharmacist or doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, DULCOLAX Tablets can cause side
effects, although not everybody gets them. The following
side effects may happen with this medicine:
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

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly (see
details below). By reporting side effects you can help
provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL – Dublin 2.
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
5. HOW TO STORE DULCOLAX TABLETS
• Keep this medicine out of the sight and reach of children
• Do not take DULCOLAX Tablets 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
• Keep the blister strip within 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
to protect the environment
6. FURTHER INFORMATION
What DULCOLAX Tablets contain
• Each tablet contains 5 mg of bisacodyl as the active
ingredient
• The other ingredients are: lactose monohydrate, maize
starch, sucrose (approximately 21 mg per tablet),
glycerol, magnesium stearate, talc (E553b), acacia
(powdered), white beeswax (E901), shellac (E904),
carnauba wax (E903), titanium dioxide (E171), yellow
iron oxide (E172), methacrylic acid-methyl methacrylate
copolymer, castor oil and macrogol 6000
What DULCOLAX Tablets looks like and contents of
the pack
DULCOLAX Tablets are yellow. They are available in packs
of 10, 20, 30, 40, 50, 60, 80 and 100. Not all pack sizes
may be marketed.
The Marketing Authorisation is held by:
Boehringer Ingelheim Limited,
Consumer Healthcare, Ellesfield Avenue,
Bracknell, Berkshire, RG12 8YS, United Kingdom.
DULCOLAX Tablets are manufactured at:
Delpharm Reims S.A.S.
10 Rue Colonel Charbonneaux
51100 Reims, France.
This leaflet was revised in July 2014.
® Registered trade mark
© Copyright Boehringer Ingelheim Limited 2014

Common side effects (affect less than 1 in 10 people)
• Abdominal cramps or pain
• Diarrhoea
• Nausea

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315593-011

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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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