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BUSCOPAN TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

BUSCOPAN® TABLETS 10 MG
(hyoscine butylbromide)
Your medicine is known by the above name, but will be
referred to as Buscopan Tablets throughout this leaflet.
Read all of this leaflet carefully before you start
taking this medicine.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or
pharmacist.
 This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if their
symptoms are the same as yours.
 If any of the side effects get troublesome or serious, or
if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Buscopan Tablets are and what they are used
for
2. Before you take Buscopan Tablets
3. How to take Buscopan Tablets
4. Possible side effects
5. How to store Buscopan Tablets
6. Further information
1. WHAT BUSCOPAN TABLETS ARE AND WHAT
THEY ARE USED FOR
Buscopan Tablets contain a medicine called “hyoscine
butylbromide”. This belongs to a group of medicines
called “antispasmodics”.
Buscopan Tablets are used to relieve cramps in the
muscles of your:
 Stomach
 Gut (intestine)
 Bladder and the tubes that lead to the outside of your
body (urinary system)
It can also be used to relieve the symptoms of Irritable
Bowel Syndrome (IBS).
2. BEFORE YOU TAKE BUSCOPAN TABLETS

CNM/PIL/04/15/0004

Do not take Buscopan Tablets if:
 You are allergic (hypersensitive) to hyoscine
butylbromide or any of the other ingredients (listed in
section 6)
 You have glaucoma (an eye problem)
 You have megacolon (a very enlarged bowel)
 You have something called “myasthenia gravis” (a very
rare muscle weakness problem)
 You are pregnant, likely to get pregnant, or are breastfeeding
Do not take this medicine if any of the above apply to
you. If you are not sure, talk to your doctor or
pharmacist before taking this medicine.

Take special care with Buscopan Tablets
Check with your doctor or pharmacist before taking your
medicine if:
 You have a very fast heart rate or other heart problems
 You have a problem with your thyroid gland such as an
overactive thyroid gland
 You have difficulty or pain passing water (urine) such as
men with prostate problems
 You have constipation
 You have a fever
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Buscopan
Tablets.
Check with your doctor or pharmacist straight away if you
have unexplained abdominal pain which persists or
worsens or occurs with:
 fever
 feeling sick
 being sick
 changes in your bowel movements
 abdominal tenderness
 low blood pressure
 feeling faint or,
 blood in your bowel movements
Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines. This includes
medicines obtained without a prescription and herbal
medicines. This is because Buscopan Tablets can affect
the way some other medicines work. Also some other
medicines can affect the way Buscopan Tablets work.
In particular, tell your doctor or pharmacist if you are
taking any of the following:
 Medicines for depression called “tetracyclic
antidepressants” or “tricyclic antidepressants” such as
doxepin
 Medicines for allergies and travel sickness called
“antihistamines”
 Medicines to control your heart beat such as quinidine
or disopyramide
 Medicines for severe mental illness called
“antipsychotics” such as haloperidol or fluphenazine
 Medicines usually used for breathing problems such
as tiotropium, ipratropium or atropine-like medicines
 Amantadine - for Parkinson’s disease and flu
 Metoclopramide - for feeling sick (nausea)
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Buscopan
Tablets.
Pregnancy and breast-feeding
Do not take Buscopan Tablets if you are pregnant, likely
to get pregnant or are breast-feeding.
Driving and using machines
Some people may have sight problems while taking this
medicine. If this happens to you, wait until your sight
returns to normal before driving or using any tools or
machines.

Important information about some of the ingredients
of Buscopan Tablets
Buscopan Tablets contain sucrose. Talk to your doctor
before taking this medicine if they have told you that you
cannot tolerate or digest some sugars.
3. HOW TO TAKE BUSCOPAN TABLETS
Always take your medicine exactly as your doctor or
pharmacist has told you. You should check with your
doctor or pharmacist if you are not sure. Buscopan
Tablets should not be taken continuously for long periods
of time.
Taking this medicine
 Take your tablets with water
 Do not break, crush or chew the tablets
How much to take
Adults and children over 12 years
 The usual dose is two tablets 4 times a day
 For Irritable Bowel Syndrome, your doctor may give
you a lower starting dose of one tablet 3 times a day.
This dose may be increased, if further relief is
necessary
Children 6 - 12 years:
 The usual dose is one tablet 3 times a day
Buscopan Tablets are not recommended for children
under 6 years.
If you take more Buscopan Tablets than you should
If you take more Buscopan Tablets than you should,
talk to a doctor or go to a hospital straight away. Take the
medicine pack with you even if there are no Buscopan
Tablets left.
If you forget to take Buscopan Tablets
 If you forget a dose, take it as soon as you remember.
However, if it is time for the next dose, skip the
missed dose.
 Do not take a double dose to make up for a forgotten
dose.
4. POSSIBLE SIDE EFFECTS

CNM/PIL/04/15/0004

Like all medicines, Buscopan Tablets can cause side
effects, although not everybody gets them. The following
side effects may happen with this medicine.
Stop taking your medicine and see a doctor straight
away if you notice any of the following serious side
effects - you may need urgent medical treatment:
 Allergic reactions such as skin reactions e.g. nettle
rash, itching (affects fewer than 1 in 100 people),
rash, redness of the skin
 Severe allergic reactions (anaphylactic shock) such as
difficulty breathing, feeling faint or dizzy (shock)
 Painful red eye with loss of vision
Other side effects
 Dry mouth (affects fewer than 1 in 100 people)
 Small blisters on hands and feet (affects fewer than 1
in 100 people)

 Increased heart rate (affects fewer than 1 in 100
people)
 Being unable to pass water (urine) (affects fewer than
1 in 1,000 people)
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
5. HOW TO STORE BUSCOPAN TABLETS
 Keep out of the sight and reach of children
 Do not store above 25°C.
 Store in the original package in order to protect from
light and moisture.
 Do not use after the last day of the month shown in
the expiry date on the carton and blister
 If your tablets show signs of deterioration or
discolouration, you should seek the advice of your
pharmacist who will tell you what to do.
Medicines should not be disposed of via waste water or
household waste. Ask your pharmacist how to dispose of
medicines you no longer require or medicines that have
expired. These measures will help to protect the
environment.
6. FURTHER INFORMATION
What Buscopan Tablets contain
Each tablet contains 10 mg of the active ingredient
hyoscine butylbromide.
The other ingredients are: calcium hydrogen phosphate
anhydrous, dried maize starch, soluble starch, colloidal
silica anhydrous, tartaric acid, stearic/palmitic acid,
sucrose, talc, acacia, titanium dioxide (E171), macrogol
6000, carnauba wax, white beeswax and povidone.
What Buscopan Tablets look like and contents of the
pack
Buscopan Tablets are sugar-coated, round and white in
colour.
Buscopan Tablets are available in blister packs of 56
tablets.
Who manufactured your medicine
Manufactured by Delpharm Reims S.A.S.,10 Rue Colonel
Charbonneaux, 51100 Reims, France.
Product Licence Holder: C&N Medical Ltd, Unit G2, RD
Park, Stephenson Close, Hoddesdon, EN11 0BW, UK.
Procured from within the EU.
Repackaged by:
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Buscopan Tablets 10 mg PL 40775/0004
th
Leaflet date: 8 April 2015

POM

Buscopan® is a registered trademark of Boehringer Ingelheim Limited.

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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