BUSCOPAN 10 MG TABLETS

Active substance: HYOSCINE BUTYLBROMIDE

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504203/PL1b

®

Buscopan 10 mg Tablets
(hyoscine butylbromide)
Package Leaflet: Information for the User
This medicine is available using 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 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
®

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
®
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.
Continued overleaf

®

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.

Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd, repackager Ginova UK Ltd, both of St James' House, 8
Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Istituto De Angeli S.r.l., Localita Prulli di Sotto No. 103/C,
Reggello, FIorence, I-50066, Italy
®

Buscopan 10 mg Tablets
PL No: 18067/0444

POM

®

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

Buscopan is a registered trademark of Boehringer Ingelheim
Pharma GmbH & Co. KG.
th

This leaflet was last revised on 8 June 2014.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

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 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 TABLETS
• Keep out of the sight and reach of children.
• Do not take this medicine after the expiry date which is
printed on the packaging
• Do not store above 25°C.
• Protect from light.
• Store in a dry place.
• Store in the original package.
• If the tablets show any signs of discolouration or
deterioration, please tell your pharmacist immediately.
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, maize starch dried, soluble starch, colloidal
anhydrous silica, 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 round, white, biconvex, sugar-coated
tablets.
®

Buscopan Tablets are available in blister packs of 56 tablets.

504203/PL1b

504205/PL1b

Hyoscine Butylbromide 10 mg Tablets
Package Leaflet: Information for the User
This medicine is available using the above name but will be
referred to as Hyoscine Butylbromide 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 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 Hyoscine Butylbromide Tablets are and what
they are used for
2. Before you take Hyoscine Butylbromide Tablets
3. How to take Hyoscine Butylbromide Tablets
4. Possible side effects
5. How to store Hyoscine Butylbromide Tablets
6. Further information
1. WHAT HYOSCINE BUTYLBROMIDE TABLETS ARE
AND WHAT THEY ARE USED FOR
Hyoscine Butylbromide Tablets contain a medicine called
“hyoscine butylbromide”. This belongs to a group of medicines
called “antispasmodics”.
Hyoscine Butylbromide 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 HYOSCINE BUTYLBROMIDE
TABLETS
Do not take Hyoscine Butylbromide 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 Hyoscine Butylbromide 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 Hyoscine
Butylbromide 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 Hyoscine Butylbromide Tablets can affect the way
some other medicines work. Also some other medicines can
affect the way Hyoscine Butylbromide 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 Hyoscine
Butylbromide Tablets.
Pregnancy and breast-feeding
Do not take Hyoscine Butylbromide 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
Hyoscine Butylbromide Tablets
Hyoscine Butylbromide 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 HYOSCINE BUTYLBROMIDE 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. Hyoscine Butylbromide 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
Hyoscine Butylbromide Tablets are not recommended for
children under 6 years.
Continued overleaf

If you take more Hyoscine Butylbromide Tablets than you
should
If you take more Hyoscine Butylbromide 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 Hyoscine
Butylbromide Tablets left.
If you forget to take Hyoscine Butylbromide 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, Hyoscine Butylbromide Tablets can cause
side effects, although not everybody gets them. The following
side effects may happen with this medicine.

Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd, repackager Ginova UK Ltd, both of St James' House, 8
Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Istituto De Angeli S.r.l., Localita Prulli di Sotto No. 103/C,
Reggello, FIorence, I-50066, Italy
Hyoscine Butylbromide 10 mg Tablets
PL No: 18067/0444

POM

th

This leaflet was revised on 8 June 2014.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

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 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 HYOSCINE BUTYLBROMIDE
TABLETS
• Keep out of the sight and reach of children.
• Do not take this medicine after the expiry date which is
printed on the packaging
• Do not store above 25°C.
• Protect from light.
• Store in a dry place.
• Store in the original package.
• If the tablets show any signs of discolouration or
deterioration, please tell your pharmacist immediately.
6. FURTHER INFORMATION
What Hyoscine Butylbromide Tablets contain
Each tablet contains 10 mg of the active ingredient hyoscine
butylbromide.
The other ingredients are: calcium hydrogen phosphate
anhydrous, maize starch dried, soluble starch, colloidal
anhydrous silica, tartaric acid, stearic/palmitic acid, sucrose,
talc, acacia, titanium dioxide (E171), macrogol 6000,
carnauba wax, white beeswax and povidone.
What Hyoscine Butylbromide Tablets look like and
contents of the pack
Hyoscine Butylbromide Tablets are round, white, biconvex,
sugar-coated tablets.
Hyoscine Butylbromide Tablets are available in blister packs
of 56 tablets.

504205/PL1b

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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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