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BUSCOPAN CRAMPS

Active substance(s): HYOSCINE BUTYLBROMIDE

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437209/GB/3

ABCD
hyoscine butylbromide
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Read all of this leaflet carefully before you
start taking BUSCOPAN CRAMPS, because it
contains important information for you to get
the best results.
• Keep this leaflet. You may need to use it again
• Ask your pharmacist if you need more
information or advice
• You must contact a doctor if your symptoms
worsen or do not improve after two weeks
• If a side effect occurs and gets troublesome,
or seems serious to you, or if you experience
a side effect not listed in this leaflet, please
tell your pharmacist or doctor
In this leaflet:
1. What BUSCOPAN CRAMPS is and what it is
used for
2. Before you take BUSCOPAN CRAMPS
3. How to take BUSCOPAN CRAMPS
4. Possible side effects
5. How to store BUSCOPAN CRAMPS
6. Further information
1. WHAT BUSCOPAN CRAMPS IS AND WHAT
IT IS USED FOR
• BUSCOPAN CRAMPS is a tablet containing
hyoscine butylbromide. It belongs to a
group of medicines called antispasmodics.
• It is used to relieve stomach and bowel
cramps which cause pain and discomfort
associated with your digestive tract, and in
Irritable Bowel Syndrome.
• It may also be recommended by your doctor
for spasm of the bladder and urinary tubes
(urinary tract).
• It works by relaxing the cramping muscles
of your stomach and bowel, or urinary tract.
What are abdominal cramps?
Abdominal cramps (or spasm) are due to the
sudden, irregular tightening up of muscles in
the wall of your stomach or bowel. While the
precise cause is unknown, the muscles of the
stomach and bowel appear to be very
sensitive to things like:
• Stress, eating and drinking habits
• Food allergies or intolerances
• Stimulants such as coffee
• Hormonal factors
Such things can trigger painful abdominal
cramps or spasms if you have a sensitive
digestive tract. You may also feel bloated,
with excess wind and abdominal discomfort.
2. BEFORE YOU TAKE BUSCOPAN CRAMPS
Do not take BUSCOPAN CRAMPS if:
• You are allergic to hyoscine butylbromide or
any of the other ingredients of BUSCOPAN
CRAMPS (listed in Section 6)
• You are intolerant to or cannot digest some
sugars (as the tablet coating contains a
small amount of sucrose)
• 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
applies to you. If you are not sure, talk to your
pharmacist or doctor before taking this
medicine.

Take special care with BUSCOPAN CRAMPS
Check with your pharmacist or doctor before
taking your medicine if any of the following
apply to you:
• You are 40 years or over
• You have recently passed blood from the
bowel
• You have severe constipation
• You are feeling sick or vomiting
• You have lost your appetite or lost weight
• You are looking pale and feeling tired
• You have difficulty or pain passing water
(urine)
• You have a fever
• You have abnormal vaginal bleeding or
discharge
• You have recently travelled abroad (in case
you have picked up a stomach bug)
• You have a very fast heart rate or other
heart problems
• You have been treated by a doctor for a
severe sweating problem
If you are not sure if any of the above applies
to you, talk to your pharmacist or doctor
before taking this medicine.
Check with your pharmacist or doctor 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 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 BUSCOPAN
CRAMPS can affect the way some other
medicines work. Also some other medicines
can affect the way BUSCOPAN CRAMPS
works.
In particular tell your pharmacist or doctor if
you are taking any of the following medicines:
• Antihistamines - used to treat hay fever and
other allergies
• Tetracyclic or tricyclic medicines - used to
treat depression and some types of pain
• Antipsychotic medicines such as
butyrophenones or phenothiazines - used to
treat severe mental illness such as
schizophrenia
• Dopamine antagonists such as
metoclopramide for feeling sick
• Beta 2 adrenergic medicines such as
salbutamol inhalers for asthma
• Quinidine or disopyramide - used to control
your heart beat
• Amantadine - used for Parkinson’s disease
and flu
• Anticholinergic medicines such as
tiotropium, ipratropium or atropine-like
medicines - usually inhaled to treat
breathing problems
If you are not sure if any of the above applies
to you, talk to your pharmacist or doctor
before taking this medicine.

Mandatory in

File information

TD

Printfile

Yes

Yes

P019596

No

Yes

PPM SKU version: 

003

No

Yes

Issue date of artwork:

20.08.2015

No

Yes

Print colors:

PAN Black

No

Yes

Example
Technical information
control code

F

F

D = 2 mm
D

E

E = 5 mm
F = 1 mm
G = 9 mm

H

01.08.2013

PPM SKU:

G

Issue date of TD:

Example
Technical information
pitch code

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

Mat. No. Pack. Site:

437209/GB/3

Min. font size:

8pt

Legend case version:

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

No

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 305 folded at 26 mm

Gluepoints

Yes

Pregnancy and breast-feeding
Do not take BUSCOPAN CRAMPS if you are
pregnant, likely to get pregnant or are
breast-feeding.
Driving and using machines
Some people may have temporary blurring of
vision while taking this medicine. If this
happens to you, wait until your vision returns
to normal before driving or using any tools or
machines.
3. HOW TO TAKE BUSCOPAN CRAMPS
Always take this medicine exactly as your
pharmacist or doctor has told you. You should
check with them if you are not sure.
BUSCOPAN CRAMPS should not be taken
continuously for more than two weeks. Talk to
your pharmacist or doctor if you develop new
symptoms or if your symptoms get worse or
have not improved over two weeks.
Taking this medicine
• Swallow the tablet whole with water
• Do not crush or chew the tablet

Isolated events - some side effects are so rare
that it is not known how many people may be
affected
• Anaphylactic reaction and shock - this is a
severe type of allergic reaction. An itchy
rash may spread all over the body, as well as
swelling. You may have difficulty in
breathing and may lose consciousness
• Dyspnoea (difficult or laboured breathing)
• Allergic reactions (hypersensitivity) such as
skin rash and erythema (patchy red skin)
• If you experience a painful red eye with loss
of vision after taking this medicine, stop
taking it and tell your doctor straight away.
You may have an eye problem called
glaucoma and need urgent medical attention
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.

How much to take









For relief of painful spasm of the stomach,
bowel or bladder and urinary tubes (urinary
tract).
Adults, and children 12 years or over:
• 2 tablets four times a day
Children 6 to 12 years:
• 1 tablet three times a day
Not recommended for children under 6 years









For the relief of abdominal pain in Irritable
Bowel Syndrome (IBS)
Adults, and children 12 years or over:
• Start by taking 1 tablet three times a day
• You can increase your dose to a maximum
of 2 tablets four times a day, if needed
Not recommended for children under 12 years

If you take more BUSCOPAN CRAMPS than
you should
If you take more than you should, talk to a
doctor or go to a hospital straight away. Take
the medicine pack with you.
If you have any further questions on the use of
this product, ask your pharmacist or doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, BUSCOPAN CRAMPS can
cause side effects in some people. The
following side effects may happen with this
medicine:
Mild side effects that do not normally require
medical treatment:
Uncommon - affects fewer than 1 in 100 people
• Dry mouth
• Dyshidrosis (outbreaks of sweat and
dryness of skin)
If any of these side effects get troublesome or
seem serious to you please tell your
pharmacist or doctor.

5. HOW TO STORE BUSCOPAN CRAMPS
Do not store above 25°C. Keep in the original
packaging.
Keep out of the sight and reach of children.
Do not take BUSCOPAN CRAMPS after the
expiry date which you will find printed on the
packaging.
6. FURTHER INFORMATION
What BUSCOPAN CRAMPS contains
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 CRAMPS looks like and
contents of the pack
The tablets are white. BUSCOPAN CRAMPS is
available in blister packs of 20 tablets.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation is held by:
Boehringer Ingelheim Limited,
Consumer Healthcare,
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 August 2015.

If you get any of the side effects described
below stop taking this medicine and tell your
doctor straight away. You may need urgent
medical treatment:

© Boehringer Ingelheim Limited 2015


Uncommon - affects fewer than 1 in 100 people
• Skin reactions such as urticaria and pruritus
(itching)
• Tachycardia (increased heart rate)
Rare - affects fewer than 1 in 1,000 people
• Problems emptying the bladder

437209/GB/3

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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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