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BISACODYL 5 MG TABLETS

Active substance(s): BISACODYL

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Product:

Biolax (Bisacodyl)
5 mg Tablets (P)

Printing Colours:

Non-Printing Colours:

Black

MA Holder:

Chelonia

PL No.:

33414/0138

Pack Size:

All Packs

Dimensions:

148 x 297 mm

Livery:

Chelonia

Created By:

DTawde

Manufacturer:

-

Artwork Code:

CL0138/P/PIL-Br/CL2

Bar Code:

-

Font Type:
Font Size:

Arial Narrow
9.5 pt

Market:

UK

Component:

Leaflet

Chelonia

HEALTHCARE

Final Preparation Date For Submission: 09/01/2015

Packing Site Technical Approval:

00/00/0000
Authority Approval Date:
Latest Implementation Deadline:
Print Proof Approval:

00/00/0000
00/00/0000
00/00/0000

PACKAGE LEAFLET: INFORMATION FOR THE USER

BIOLAX
5 mg TABLETS
BISACODYL

Read all of this leaflet carefully before you
start taking this medicine because it
contains important information for you.
- Keep this leaflet. You may need to read it
again.
- If you have any further questions, ask your
doctor or pharmacist if you need more
information or advice.
- This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the
same as yours.
- 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.

THIS LEAFLET CONTAINS
1. What Biolax is for
2. Before you take Biolax
3. How to take Biolax
4. Possible side effects
5. How to store Biolax
6. Further information

1. WHAT BIOLAX IS FOR
Biolax tablets contain a medicine called bisacodyl.
This belongs to a group of medicines known as
stimulant laxativeBiolax tablets belong to a group of
medicines known as stimulant laxatives. Stimulant
laxatives increase bowel movements.
Biolax tablets are used for recent or long term
constipation. They can also be used in a hospital to
clear your bowels before surgery, labour or
radiological investigation.
Biolax tablets do not help with weight loss.

2. BEFORE YOU TAKE BIOLAX
Do not take Biolax and tell your pharmacist or
doctor if you:
 are allergic to bisacodyl or any of the other
ingredients in the tablets (see section 6 of this
leaflet)
 have in the past been told not to use laxatives
 are severely dehydrated
 have a bowel condition called ileus or intestinal
obstruction (blockage of the small or large
intestine)
 have inflammation of the bowel (swelling of the
small or large intestine)
 have a serious abdominal condition such as
appendicitis (swelling of the appendix)
 have severe abdominal pain (aches and pains in
the stomach area) with nausea and vomiting
Do not take this medicine if any of the above apply
to you. If you are not sure, check with your
pharmacist or doctor before taking Biolax.

have recently taken any other medicines, including
medicines bought without a prescription.
This is because Biolax can affect the way some
medicines work. Also some medicines can affect the
way Biolax works.
In particular, tell your pharmacist or doctor if you are
taking any of the following:
 antacids (used to treat indigestion). Antacids
should not be taken one hour before or after
taking Biolax, as they can make the medicine
less effective
 diuretics (water tablets) such as
bendroflumethiazide or furosemide (used to treat
high blood pressure or a build-up of excess fluid
in the body)
 steroids such as prednisolone (used to treat
inflammatory conditions and allergies)
 cardiac glycosides such as digoxin (medicines
used to treat heart failure or irregular
heartbeats).
If you are not sure if any of the above apply to you,
talk to your pharmacist or doctor before taking
Biolax.
Taking Biolax with food and drink
Milk or milk products should not be taken one hour
before or after taking Biolax, as they can make the
medicine less effective.
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or
are breast-feeding, talk to your pharmacist or doctor
before taking Biolax.
Driving and using machines
Some people may feel dizzy or faint whilst taking
this medicine. If this happens to you, wait until these
feelings go away before driving or using machines.
Important information about some of the
ingredients of Biolax tablets
This medicine contains lactose and sucrose (types
of sugars). If you know you have an intolerance to
some sugars contact your pharmacist or doctor
before taking Biolax.

3. HOW TO TAKE BIOLAX
If this medicine is from your pharmacist or doctor, do
exactly as they have told you to. Otherwise, follow
the instructions provided in this leaflet. If you are not
sure how much you need to take talk to your
pharmacist or doctor.
Taking this medicine
 Swallow the tablets whole with water
 The tablets should not be chewed or crushed
 Antacids, milk, milk products or
proton-pump inhibitors, (medicines which
reduce stomach acid, e.g. omeprazole), should
not be taken one hour before or after taking
Biolax, as they can make the medicine less
effective.
Length of treatment
Biolax should not be used every day for more than
5 days, unless your pharmacist or doctor tells you
to.
Dosage

Warnings and precautions
Biolax should not be used every day for more than 5
days, unless your pharmacist or doctor tells you to.
If you need laxatives every day, then you should see
your doctor to find the cause of your constipation.

For constipation:

Other medicines and Biolax
Tell your pharmacist or doctor if you are taking or

When your bowel movements have returned to
normal, the dose can usually be stopped.

Adults (including the elderly) and children over
10 years: 1 to 2 tablets (5 to 10 mg) daily before
bedtime.

Children 4-10 years: Please consult your
pharmacist or doctor before giving this medicine to
children 4 to 10 years old. The usual dose is 1 tablet
(5 mg) daily before bedtime.
In preparation for radiological investigation or
surgical procedure:
Adults (including the elderly) and children over
10 years: 2 tablets (10 mg) in the morning, and 2
tablets (10 mg) in the evening on the day before the
investigation or operation. The following morning
the doctor may give you a bisacodyl suppository via
the back passage.
Children 4-10 years: 1 tablet (5 mg) in the evening
on the day before the investigation or operation. The
following morning the doctor may give the child a
bisacodyl suppository via the back passage.
Children under 4 years: Biolax tablets should not
be given to children under 4 years old.
If you take more Biolax than you should
If you or your child accidentally takes too many
tablets, tell a doctor or go to a hospital casualty
department immediately. Take this leaflet and the
medicine pack with you so that the doctor knows
what has been taken.
It may be harmful to
 Take too much of Biolax or
 Take Biolax 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 Biolax
If you forget to take Biolax, skip the missed dose
then go on as before. Do not take a double dose
(two doses at the same time) to make up for the
forgotten dose.
If you have any further questions on the use of this
medicine, ask your pharmacist or doctor.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Biolax can cause side effects,
although not everybody gets them.
STOP TAKING this medicine and see a doctor
or go to a hospital straight away if you notice
any of the following side effects:
 an allergic reaction. The signs may include a
rash, swelling of the face, lips, tongue or throat,
difficulty in breathing or swallowing, sudden
wheezing or collapse.
Tell your pharmacist or doctor if any of the
following side effects last longer than a few
days:
Common (affects less than 1 in 10 people)
 pains or cramps in the stomach area
 feeling sick (nausea)
 diarrhoea

Uncommon (affects less than 1 in 100 people)
 dizziness
 being sick (vomiting)
 blood in the stools
 discomfort in the stomach area
 discomfort inside and around the back passage
Rare (affects less than 1 in 1000 people)
 dehydration
 fainting
 inflammation of the large intestine (colitis), which
may cause aches and pain in the stomach area,
diarrhoea, tiredness, fever, joint pain or weight
loss
Reporting of side effects
If you get any side effects talk to your pharmacist or
doctor.
This includes any possible side effects not listed in
this leaflet. You can also report side effects directly
via the 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 BIOLAX
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original
package or container and keep the container tightly
closed.
Do not use the tablets after the expiry date, which is
stated on the package or container. The expiry date
refers to the last day of that month.
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 Biolax tablets contain
The active ingredient (the ingredient which makes
this medicine work) is bisacodyl. Each tablet
contains 5 mg of bisacodyl.
The tablets also contain lactose, maize starch,
magnesium stearate, pregelatinised maize starch,
cellulose acetate phthalate, diethyl phthalate,
sucrose, talc, povidone, titanium dioxide (E171) and
quinoline yellow (E104).
What Biolax tablets look like and contents of
the pack
Biolax tablets are round, yellow, sugar-coated
gastro-resistant tablets which come in blister packs
and containers of 8, 10, 28, 30, 50, 56, 60, 84, 100,
250, 500 and 1000 tablets. Not all pack sizes may
be marketed.
Marketing Authorisation Holder
Chelonia Healthcare Limited,
11 Boumpoulinas,
Nicosia, P.C. 1060, Cyprus
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road,
London SW5 9JQ
For more information about this product, please
contact the Marketing Authorisation Holder.
This leaflet was last revised in 01/2015.

CL0138/P/PIL-Br/CL2

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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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