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BUSCOPAN CRAMPS RELIEF 10 MG TABLETS

Active substance: HYOSCINE BUTYLBROMIDE

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Package leaflet: Information for the user

ABCD
PI000348v4-GB-1

10 mg tablets
hyoscine butylbromide
Read all of this leaflet carefully before you
start taking BUSCOPAN CRAMPS RELIEF,
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 RELIEF is and what it
is used for
2. Before you take BUSCOPAN CRAMPS RELIEF
3. How to take BUSCOPAN CRAMPS RELIEF
4. Possible side effects
5. How to store BUSCOPAN CRAMPS RELIEF
6. Further information
1. WHAT BUSCOPAN CRAMPS RELIEF IS AND
WHAT IT IS USED FOR
• BUSCOPAN CRAMPS RELIEF 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.
• It works by relaxing the cramping muscles of
your stomach and bowel.
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
RELIEF
Do not take BUSCOPAN CRAMPS RELIEF if:
• You are allergic to hyoscine butylbromide or
any of the other ingredients of BUSCOPAN
CRAMPS RELIEF (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
RELIEF
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
RELIEF can affect the way some other medicines
work. Also some other medicines can affect the
way BUSCOPAN CRAMPS RELIEF 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.

CONTROL CODE

Mandatory in

File information
Issue date of TD:

TD
Yes

PPM SKU:
PPM SKU version: 

Yes

No

05.03.2012

PITCH CODE

Printfile
Yes

No
27.01.2014

No

Yes

Print colors:

Black

No

2 mm

Yes

Issue date of artwork:

= 0,35 mm

Yes

= 1 mm

= 10 mm

Mat. No. Pack. Site:

PI000348v4-GB-1

Legend case version:

V3.0 01/JUN/2010 (please do not change or remove it)

No

5 mm

1 mm

Yes
= 0,65 mm

Technical information

= 9 mm

= 35 mm

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 mm 160 x 26

Gluepoints

= 2 mm

Pregnancy and breast-feeding
Do not take BUSCOPAN CRAMPS RELIEF if you are
pregnant, likely to get pregnant or are breastfeeding.
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 RELIEF
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 RELIEF 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
How much to take








For relief of painful spasm of the stomach, or
bowel
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

If you take more BUSCOPAN CRAMPS RELIEF
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 RELIEF 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.

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.
5. HOW TO STORE BUSCOPAN CRAMPS RELIEF
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 RELIEF after the
expiry date which you will find printed on the
packaging.
6. FURTHER INFORMATION
What BUSCOPAN CRAMPS RELIEF 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 RELIEF looks like
and contents of the pack
The tablets are white. BUSCOPAN CRAMPS RELIEF
is available in blister packs of 10 and 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 January 2014.
© Boehringer Ingelheim Limited 2014

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:
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
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

PI000348v4-GB-1

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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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