BUSCOPAN TABLETS

Active substance: HYOSCINE BUTYLBROMIDE

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Package Leaflet: Information for the User

Buscopan® Tablets

abcd

(hyoscine butylbromide)
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 gets 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

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.

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”.

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

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).

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.

2. BEFORE YOU TAKE BUSCOPAN TABLETS

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.

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
breast-feeding
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.

437211/GB/2

Technical Information
for pitch code

TD

Printfile

02.08.2013

Yes

Yes

PPM SKU:

P019632

No

Yes

PPM SKU version: 

002

No

Yes

Issue date of artwork:

21.01.2014

No

Yes

Print colors:

PAN Black

No

Yes

No

Yes

Mat. No. Pack. Site:

437211/GB/2

Min. font size:

7.6pt

Legend case version:

V4.0 01/OCT/2012 (please do not change or remove it)

Technical information
a = Batch No.

b = Expiry date

c = Manufacturing date

d = Price/Sample/Clinic

Technical colors
BI-Diecut-Legendcase

Free area

Additional Requirements of Packaging Site
Dimensions: mm 160 x 215,9 folded at 26 mm

Gluepoints

G

Issue date of TD:

F

F

D = 2 mm
D

E

Technical Information
for control code

E = 5 mm
F = 1 mm
G = 80 mm

H

Mandatory in

File information

D = 1 mm
E = 0,65 mm
F = 0,35 mm

I

E
G

D

F

G = 10 mm
H = 35 mm
I = 2 mm

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
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
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
5. HOW TO STORE BUSCOPAN TABLETS
• Do not take this medicine after the expiry date which
is printed on the packaging
• BUSCOPAN Tablets should be protected from light
and stored in a dry place below 25°C
• Keep this medicine out of the sight and reach of children
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,
maize starch, soluble starch, colloidal silica, tartaric
acid, stearic acid, sucrose, talc, acacia, titanium
dioxide, 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.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation is held by:
Boehringer Ingelheim Limited, Ellesfield Avenue,
Bracknell, Berkshire, RG12 8YS, United Kingdom.
and the tablets are manufactured by:
Istituto De Angeli S.r.l.
Loc. Prulli, 103/C, 50066 Reggello (FI), Italy.
This leaflet was revised in January 2014.
© Boehringer Ingelheim Limited 2014

437211/GB/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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