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BISACODYL 5MG TABLETS

Active substance(s): BISACODYL / BISACODYL / BISACODYL

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3. How to take Bisacodyl 5 mg Tablets

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.
Bisacodyl 5 mg Tablets do not help with weight loss.
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
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

Size 150 x 220 mm

• 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.
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.
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.
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.

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.
Received Date:
04/08/2016
Taking this medicine
CDLthe
JOB
No. :whole with
57253
• Swallow
tablets
water. Do not crush or chew
Required By :
05/08/2016
the tablets.
• Milk-containing products or antacids 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 PRODUCT
have not taken
Bisacodyl
5 mg Tablets
before, start with
NAME:
Bisacodyl
5 mg Tablets
one tablet
and increase to two
if necessary
PIP CODE:
GBR
724-7729-APIL
• When your bowel regularity has returned to normal, the dose
COMPONENT:
Leaflet
can usually
be stopped
SIZE:
150x220 mm
Use in children
MARKET:
Great Britain
Children aged
between
4 and 10TBC
years
PRODUCT
SITE:
Bisacodyl 5 mg Tablets should only be given to children between
SCALE:
100%
the ages of 4 and 10 if recommended by a doctor. The usual dose
COLOURS:
for children
is: One tablet (5 mg)Black
daily before bedtime
Cutterguide
Children under
4
years
DATE:
05/08/2016
Bisacodyl 5 mg Tablets are not recommended for children under 4
8 pt
years. FONT SIZE:
VERSION NO:
9
If you take
more Bisacodyl
5 mg
AMENDED
BY:
CH Tablets than you should
If you take more of this medicine than you should, talk to a doctor
PROJECT:
or go to a hospital straight away.Sovereign
Take yourMedical
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 forAUTHORITY
too long.
REGULATORY
This is because taking too much for too long may lead to:
APPROVAL
CONFIRMATION
• a ‘lazy bowel’, where the muscle in the bowel becomes too
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• imbalance of fluid and salts in the body. This license
can affect the
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tightness
of muscles such as those in the bowel. It can also
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affect the salts in the blood;
• low levels of potassium in the blood (called ‘hypo-kalaemia’).
.................................................................
Accept
Artwork
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
Reject Artwork
headaches. It can also mean you cannot pass enough urine.
Signature
..........................................................................
If you forget
to take
your medicine
If you forget to take your tablets, just take the next dose at the
usual time,Name
DO NOT
take a double dose to make up for the
.................................................................................
forgotten dose.

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

4. Possible side effects

PAGE 1 OF 2

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

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-containing products or antacids 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
Children under 4 years
Bisacodyl 5 mg Tablets are not recommended for children under 4
years.
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.
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.
If you have any further questions on the use of this product, ask
your pharmacist or doctor.

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
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

Received Date:
CDL JOB No. :
Required By :

04/08/2016
57253
05/08/2016

PRODUCT NAME:
PIP CODE:
COMPONENT:
SIZE:
MARKET:
PRODUCT SITE:
SCALE:
COLOURS:

Bisacodyl 5 mg Tablets
GBR 724-7729-APIL
Leaflet
150x220 mm
Great Britain
TBC
100%
Black
Cutterguide
05/08/2016
8 pt
9
CH
Sovereign Medical

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.
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.
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® (contains hypromellose, titanium dioxide, polyethylene
glycol and tartrazine (E102)) and Carnauba Wax.
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.
Not all pack sizes may be marketed.
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: August 2016

DATE:
FONT SIZE:
VERSION NO:
AMENDED BY:
PROJECT:

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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