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BISACODYL 5MG GASTRO-RESISTANT TABLETS

Active substance(s): BISACODYL / BISACODYL / BISACODYL

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PACKAGE LEAFLET: INFORMATION LEAFLET FOR THE USER

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 Bisacodyl. This is because they will stop Bisacodyl from working
properly.

Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you. Always use this medicine exactly as described in this leaflet or as your doctor
or pharmacist told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

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.

You must talk to a doctor if you do not feel better or if you feel worse after 5 days of treatment.

How much to take
Adults and children over 10 years old
• Take one or two tablets (5 to 10 mg) daily before bedtime.
• If you have not taken Bisacodyl 5mg Gastro-resistant 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.

Bisacodyl
5mg Gastro-resistant Tablets
(Bisacodyl)

What is in this leaflet:
1. What Bisacodyl is and what it is used for
2. What you need to know before you take Bisacodyl
3. How to take Bisacodyl
4. Possible side effects
5. How to store Bisacodyl
6. Contents of the pack and other information

1. WHAT BISACODYL IS AND WHAT IT IS USED FOR


Bisacodyl 5mg Gastro-resistant tablets contain a medicine called bisacodyl. This belongs to a group
of medicines called laxatives.
Bisacodyl is used for relief of constipation.
Bisacodyl can also be used in a hospital to empty a person’s bowel before child birth,
surgery or radiological investigations.
Bisacodyl 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.
Bisacodyl 5mg Gastro-resistant Tablets have a special coating that helps to ensure the
medicine works only where it is needed.






Bisacodyl 5mg Gastro-resistant 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’ in 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.
• Drink enough water so that you do not become dehydrated.
• Keep up your exercise and stay fit.
• Make time to empty your bowel when your body tells you.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISACODYL
Do not take Bisacodyl if:
• You are allergic to bisacodyl or any of the other ingredients in this medicine (listed in Section 6.).
• 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).

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 this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bisacodyl
Other medicines and Bisacodyl
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including
medicines obtained without a prescription. This includes herbal medicines. This is because Bisacodyl can affect
the way some other medicines work. Also, some other medicines can affect the way Bisacodyl 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
• indigestion remedies
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Bisacodyl
5mg Gastro-resistant Tablets.
Pregnancy and breast feeding
Talk to your doctor or pharmacist before taking Bisacodyl 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.
Bisacodyl contains Lactose, Sucrose and Tartrazine
This medicine contains lactose (a milk sugar) and sucrose. If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor before taking this medicine. The tablets also contain
Tartrazine (E102) which may cause allergic reactions.

3. HOW TO TAKE BISACODYL

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
Check with your doctor or pharmacist if you are not sure.
As with all laxatives, Bisacodyl 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.

Client

Chanelle

Colours used:

Date

15.1.17

Black

Product

BISACODYL 5mg PIL

Pack Code
Scale / Size

1:1 / 156 x 348mm

Software

Illustrator CS5

Proof No

2
Minimum Text 8pt

Children aged between 4 and 10 years
Bisacodyl 5mg Gastro-resistant 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 5mg Gastro-resistant Tablets are not recommended for children under 4 years.
Elderly patients:
If you are elderly, you may be prescribed a lower dose.
If you take more Bisacodyl than you should
It may be harmful to:
• take too much bisacodyl
• take bisacodyl 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 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 forget to take Bisacodyl
If you have forgotten to take your tablet at night, wait for the next dose and continue as before. Do not take
any more tablets in one day than your doctor has prescribed. Do not take a double dose to make up for a
missed dose.
If you feel that the effect of your medicine is too strong or too weak, talk to your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Bisacodyl 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 diarrhea)
• 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
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via Yellow Card Scheme Website:
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

Keep this medicine out of the sight and reach of children.
Do not use Bisacodyl after the expiry date which is stated on the label after EXP. The expiry date refers to the
last day of that month.
Do not store above 25°C. Store in the original container. Keep the container tightly closed (for polypropylene
containers only).
Do not use Bisacodyl if you notice any deterioration or damage to the outer packaging
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Bisacodyl contains
•The active substance is Bisacodyl. Each tablet contains 5 mg of bisacodyl.
The other ingredients are: Core Tablet: Lactose monohydrate, Liquid paraffin, Maize starch and Magnesium
stearate. Enteric Coating: Methacrylic acid Co-Polymer Ethyl Acrylate Co Polymer (1:1) dispersion 30%
material, Macrogol 3350, Talc and Simethicone PD30. Sugar Coat; Povidone K30, Talc, Kaolin light and
Sucrose. Colour Coat; Titanium dioxide (E171) and Tartrazine lake (E102). Polishing; Carnauba wax.
What Bisacodyl looks like and contents of the pack
Bisacodyl are yellow shiny biconvex sugar coated gastro resistant tablets.
Bisacodyl 5mg, gastro-resistant tablets are available in blister packs (cartons) of 20, 60 and 100 tablets and in
polypropylene containers of 500 and 1000 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder Chanelle Medical, Loughrea, Co. Galway, Ireland.
Manufacturer Chanelle Medical, Loughrea, Co. Galway, Ireland.
This leaflet was last revised in: November 2016.

LE7762

Expand Transcript

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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