BUSCOPAN 10MG TABLETS

Active substance: HYOSCINE N-BUTYLBROMIDE

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

This medicine is known by the above name but will usually be referred to as Buscopan throughout this
leaflet.

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BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

In this leaflet:
1. What Buscopan is and what it is used for
2. Before you take Buscopan
3. How to take Buscopan
4. Possible side effects
5. How to store Buscopan
6. Further information





PROOF HISTORY:
v.1 - waymade - 04/07/13

Leaflet Flat Size = 148 x 400

Read all of this leaflet carefully before you start taking Buscopan, 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

1. What Buscopan is and what it is used for
Buscopan is a tablet containing hyoscine–N-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

DATE:

UK PIL DATED JULY 2012

6464/1493A

04/07/13
CODE:

DT

DATE OF PROOF:

DATE:

Take special care with Buscopan
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 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
• You are feeling sick or vomiting
If you are not sure if any of the above applies to you, talk to your pharmacist or doctor before taking this
medicine.

Buscopan 10mg tabs

ARTWORKER:

WARNING!

2. Before you take Buscopan
Do not take Buscopan if:
• You are allergic to hyoscine-N-butylbromide or any of the other ingredients of Buscopan (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.

PRODUCT:

05-0269
CUSTOMER: Waymade

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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.

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 can
affect the way some other medicines work. Also some other medicines can affect the way Buscopan 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

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If you are not sure if any of the above applies to you, talk to your pharmacist or doctor before taking this
medicine.
Pregnancy and breast-feeding
Do not take Buscopan 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.

Black

WARNING!

27mm

BUSCOPAN® 10mg TABLETS
(hyoscine-N-butylbromide)
Patient Information Leaflet

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000D

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

3. How to take Buscopan
Always take this medicine exactly as your pharmacist or doctor has told you. You should check with them if
you are not sure. Buscopan 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, 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

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Not recommended for children under 12 years
If you take more Buscopan than you should
If you take more Buscopan 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 can cause side effects in some people. The following side effects may happen
with this medicine:

WARNING!

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.

DATE:

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

5. How to store Buscopan
Buscopan should be protected from light and stored in a dry place below 25°C.
Do not use after the expiry date printed on the carton label or blister strip.
Keep out of the sight and reach of children.
If you stop taking the tablets, please take them back to the pharmacist for safe disposal. If the
tablets become discoloured or show any other signs of deterioration, consult your pharmacist who
will advise you what to do.

04/07/13
DATE OF PROOF:






UK PIL DATED JULY 2012

6464/1493A

6. Further information
Your medicine is called Buscopan 10mg Tablets. Each tablet contains 10mg of the active ingredient,
hyoscine-N-butylbromide. The tablets are white, round, sugar-coated and unmarked.

CODE:

DT
ARTWORKER:
Buscopan 10mg tabs
PRODUCT:

CUSTOMER: Waymade

05-0269

DATE:

If you notice a side effect not listed in this leaflet, please tell your pharmacist or doctor.

Buscopan 10mg Tablets also contain the following ingredients:
Calcium phosphate dibasic, maize starch, soluble maize starch, tartaric acid, stearic/palmitic acid, sucrose,
talc, acacia, titanium dioxide (E171), macrogol 6000, colloidal silicon dioxide, povidone, carnauba wax and
beeswax.
Buscopan 10mg Tablets are available as blister packs of 20 tablets.
P

PL No: 6464/1493

This product is manufactured by Boehringer Ingelheim Hellas S.A., 5th km Paiania-Markopoulo Ave. Koropi,
GR-19400 Greece and is procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 04.07.2013
Buscopan is a registered trademark of Boehringer Ingelheim Ltd.

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WARNING!

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

PRE-PRESS NO.:

Q.A.
APPROVED:

CUSTOMER
APPROVED:

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:

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

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

PROOF HISTORY:
v.1 - waymade - 04/07/13

Leaflet Flat Size = 148 x 400

Not recommended for children under 6 years

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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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