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BISACODYL 5MG TABLETS

Active substance(s): BISACODYL

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GBR 724-7729-APIL
Package leaflet: Information for the user

BISACODYL 5 mg TABLETS
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
This medicine is available without prescription. You need to take
Bisacodyl 5 mg 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 you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1. What Bisacodyl 5 mg Tablets are and what they are used for
2. What you need to know before you take Bisacodyl 5 mg
Tablets
3. How to take Bisacodyl 5 mg Tablets
4. Possible side effects
5. How to store Bisacodyl 5 mg Tablets
6. Contents of the pack and other information

1. What Bisacodyl 5 mg Tablets are and what
they are used for
• Bisacodyl 5 mg Tablets contain a medicine called bisacodyl.
This belongs to a group of medicines called laxatives
• Bisacodyl 5 mg Tablets are used for the short term relief of
constipation
• Bisacodyl 5 mg Tablets can also be used in a hospital to
empty a person’s bowel before child birth, surgery or
radiological investigations
• Bisacodyl 5 mg Tablets stimulate the muscles of the bowel
(large intestine). This brings about overnight relief from
constipation, helping to return the body to its natural rhythm
Bisacodyl 5 mg Tablets do not help with weight loss.

• 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. What you need to know before you take
Bisacodyl 5 mg Tablets
Do not take this medicine and tell your doctor:
• if you are allergic to bisacodyl or any of the other ingredients
in the medicine (listed in Section 6).
• if you are intolerant to or cannot digest some sugars (as the
tablet contains a small amount of lactose)
• if you have severe dehydration
• if you have a bowel condition called “ileus” (blockage in the
intestine)
• if you have a serious abdominal condition such as
appendicitis
• if you have severe abdominal pain with nausea and vomiting
• if you have a blocked bowel (intestinal obstruction)
• if you have inflammation of the bowel (small or large
intestine)
Do not take this medicine if any of the above applies to you. If you
are not sure, talk to your doctor or pharmacist before taking
Bisacodyl 5 mg Tablets.
Warnings and precautions
As with all laxatives, Bisacodyl 5 mg 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.
Other medicines and Bisacodyl 5 mg Tablets
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 Bisacodyl 5 mg Tablets can affect the way some other
medicines work. Also, some other medicines can affect the way
Bisacodyl 5 mg Tablets work.

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.

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 Bisacodyl 5 mg Tablets.

• 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

Pregnancy and 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.

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
Whatever the cause, constipation can be uncomfortable. It may
make you feel bloated and heavy or generally “off colour”.
Sometimes it causes headaches.
These healthy tips are recommended to try to prevent
constipation happening:
• Eat a balanced diet including fresh fruit and vegetables

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.
Bisacodyl 5 mg Tablets contains lactose and tartrazine
(E102)
If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicine.
Bisacodyl 5 mg Tablets also contain tartrazine (E102), which may
cause allergic reactions.

3. How to take Bisacodyl 5 mg Tablets
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

Taking this medicine
• Swallow the tablets whole with water. Do not crush or chew
the tablets.
• Milk, antacids or proton pump inhibitors (medicines which
reduce stomach acid) should not be taken within one hour
beforeReceived
or after taking
5 mg Tablets. This is because
Date: Bisacodyl
13/01/2016
they will
Bisacodyl
557253
mg Tablets from working
CDLstop
JOBthe
No.
:
properly
15/01/2016
Required By :
The recommended dose is:
Adults and children over 10 years
• Take one or two tablets (5 or 10 mg) daily before bedtime
• If you have not taken Bisacodyl 5 mg 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
Use in children
PRODUCT NAME: Bisacodyl 5 mg Tablets
Children aged
between 4 and 10GBR
years
PIP CODE:
724-7729-APIL
Bisacodyl COMPONENT: Leaflet
5 mg Tablets should only be given to children between
the ages of 4 and 10 if recommended by a doctor. The usual dose
SIZE:
mmbedtime
for children
is: One tablet (5 mg)150x220
daily before
MARKET:
Great Britain
Children under
4 years
TBC
PRODUCT
SITE:
Bisacodyl 5 mg Tablets are not recommended for children under
SCALE: 100%
4 years.
COLOURS: Black
If you take
more Bisacodyl 5 mg Tablets than you should
DATE: 15/01/2016
If you takeFONT
moreSIZE:
of this medicine8 than
pt you should, talk to a doctor
or go to a hospital straight away. Take your medicine and this
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leaflet withVERSION
you. ThisNO:
is so the doctor
knows what you have taken.
It may be AMENDED
harmful to: BY:

• take too many Bisacodyl
5 mg Tablets or
• take Bisacodyl 5 mg Tablets for too long.
This is because taking too much for too long may lead to:
• a ‘lazy bowel’, where the muscle in the bowel becomes too
relaxed. ThisREGULATORY
means that bowelAUTHORITY
emptying happens less often.
This can lead to long-term constipation;
APPROVAL
• imbalance of
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in the body. This can affect the
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MHRA, IMB, etc and that Waymade Plc have license
• low levels
of potassium in the blood (called ‘hypo-kalaemia’).
approval to distribute this component for sale in the
This can
make you tired, dizzy, make your muscles weak and
relevent market.
cause an uneven heart-beat;
• dehydration, making you thirsty, feel faint and giving you
Accept Artwork .................................................................
headaches.
It can also mean you cannot pass enough urine.
If you forget
to Artwork
take your
medicine
Reject
..................................................................
If you forget to take your tablets, just take the next dose at the
usual time, DO NOT take a double dose to make up for the
Signature ..........................................................................
forgotten dose.
If you have any further questions on the use of this product, ask
Name .................................................................................
your pharmacist
or doctor.

4. Possible
side effects
Date ...................................................................................
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
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

PAGE 1 OF 2

Taking this medicine
• Swallow the tablets whole with water. Do not crush or chew
the tablets.
• Milk, antacids or proton pump inhibitors (medicines which
reduce stomach acid) should not be taken within one hour
before or after taking Bisacodyl 5 mg Tablets. This is because
they will stop the Bisacodyl 5 mg Tablets from working
properly
The recommended dose is:
Adults and children over 10 years
• Take one or two tablets (5 or 10 mg) daily before bedtime
• If you have not taken Bisacodyl 5 mg 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
Use in children
Children aged between 4 and 10 years
Bisacodyl 5 mg 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

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
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 via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information
on the safety of this medicine.

5. How to store Bisacodyl 5 mg Tablets
Keep this medicine out of the sight and reach of children.

Children under 4 years
Bisacodyl 5 mg Tablets are not recommended for children under
4 years.

Do not use this medicine after the expiry date which is stated on
the blister or container and on the carton. The expiry date refers
to the last day of that month.

If you take more Bisacodyl 5 mg 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 your medicine and this
leaflet with you. This is so the doctor knows what you have taken.
It may be harmful to:
• take too many Bisacodyl 5 mg Tablets or
• take Bisacodyl 5 mg Tablets for too long.
This is because taking too much for too long may lead to:
• a ‘lazy bowel’, where the muscle in the bowel becomes too
relaxed. This means that bowel emptying happens less often.
This can lead to long-term constipation;
• imbalance of fluid and salts in the body. This can affect the
tightness of muscles such as those in the bowel. It can also
affect the salts in the blood;
• low levels of potassium in the blood (called ‘hypo-kalaemia’).
This can make you tired, dizzy, make your muscles weak and
cause an uneven heart-beat;
• dehydration, making you thirsty, feel faint and giving you
headaches. It can also mean you cannot pass enough urine.

Do not store above 25ºC.
Blister packs: Store in the original package in order to protect
from moisture.
Securitainers: Keep the container tightly closed. Store in the
original container in order to protect from moisture.
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.

6. Contents of the pack and other information
What Bisacodyl 5 mg Tablets contain
The active substance is bisacodyl.
Bisacodyl 5 mg gastro-resistant tablets contain 5 mg of bisacodyl.
The other ingredients are lactose, maize starch, liquid paraffin,
magnesium stearate, polyvinyl acetate phthalate, stearic acid,
Opadry® and Carnauba Wax.

If you forget to take your medicine
If you forget to take your tablets, just take the next dose at the
usual time, DO NOT take a double dose to make up for the
forgotten dose.

What Bisacodyl 5 mg Tablets look like and the contents of
the pack
Bisacodyl 5 mg Tablets are yellow, shiny, round tablets with no
markings.
They are available in foil blister packs of 60 tablets, 100 tablets
and in a securitainer pack of 1000 tablets.

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

Not all pack sizes may be marketed.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sovereign Medical,
Sovereign House,
Miles Gray Road,
Basildon, Essex,
SS14 3FR
UK.
Manufacturer
Waymade Plc
Sovereign House,
Miles Gray Road,
Basildon,
Essex SS14 3FR,
UK
This leaflet was last revised in: January 2016

Received Date:
CDL JOB No. :
Required By :

13/01/2016
57253
15/01/2016

PRODUCT NAME: Bisacodyl 5 mg Tablets
PIP CODE:
GBR 724-7729-APIL
COMPONENT: Leaflet
SIZE:
150x220 mm
MARKET:
Great Britain
PRODUCT SITE:
TBC
SCALE: 100%
COLOURS: Black
DATE: 15/01/2016
FONT SIZE:
8 pt
VERSION NO:
5
AMENDED BY:
VK
PROJECT:
Sovereign Medical

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, IMB, etc and that Waymade Plc have license
approval to distribute this component for sale in the
relevent market.
Accept Artwork .................................................................
Reject Artwork ..................................................................
Signature ..........................................................................
Name .................................................................................
Date ...................................................................................

PAGE 2 OF 2

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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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