HYOSCINE BUTYLBROMIDE 10MG TABLETS

Active substance: HYOSCINE BUTYLBROMIDE

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Ref: LTT0152/170714/1/F

®

Buscopan 10mg Tablets
(hyoscine butylbromide)
Patient Information 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.
Your medicine is called Buscopan 10mg Tablets and will be referred to as
Buscopan Tablets throughout this leaflet.
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 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.
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

Ref: LTT0152/170714/1/B

®

Buscopan 10mg Tablets
(hyoscine butylbromide)
Patient Information Leaflet (continued)
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 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 store above 30°C.
* Keep in the original package
* Do not take this medicine after the expiry date shown on the carton label.
If your doctor tells you to stop taking this medicine, take any remaining
medicine back to the pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
* If your medicine become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
* Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help protect the environment.

6

Further information

What this medicine contains:
Each tablet contains 10 mg of the active ingredient hyoscine butylbromide.
The other ingredients are: calcium hydrogen phosphate anhydrous, maize
starch, soluble starch, colloidal silica anhydrous, tartaric acid, stearic acid,
sucrose, talc, acacia, titanium dioxide (E171), macrogol 6000, carnauba wax,
white beeswax and povidone.
What this medicine looks 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.
Manufacturer and Licence Holder
This medicine is manufactured by Istituto De Angeli S.r.I, Loc. Prulli,
103/C 50066 Reggello (FI), Italy and procured from within the EU. Product
Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon (UK)
Limited, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 33723/0152

Buscopan 10mg Tablets

Buscopan is a registered Trade Mark of Boehringer Ingelheim Pharma
GmbH & Co. KG.
Revision date: 17/07/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: LTT0152/170714/2/F

Hyoscine Butylbromide 10mg Tablets
Patient Information 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.
Your medicine is called Hyoscine Butylbromide 10mg Tablets and will be
referred to as Hyoscine Butylbromide Tablets throughout this leaflet.
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 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.
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.
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

Ref: LTT0152/170714/2/B

Hyoscine Butylbromide 10mg Tablets
Patient Information Leaflet (continued)
Hyoscine Butylbromide Tablets are not recommended for children under 6
years.
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.
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 store above 30°C.
* Keep in the original package
* Do not take this medicine after the expiry date shown on the carton label.

*
*

If your doctor tells you to stop taking this medicine, take any remaining
medicine back to the pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
If your medicine become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help protect the environment.

6

Further information

What this medicine contains:
Each tablet contains 10 mg of the active ingredient hyoscine butylbromide.
The other ingredients are: calcium hydrogen phosphate anhydrous, maize
starch, soluble starch, colloidal silica anhydrous, tartaric acid, stearic acid,
sucrose, talc, acacia, titanium dioxide (E171), macrogol 6000, carnauba wax,
white beeswax and povidone.
What this medicine looks like and contents of the pack
Hyoscine Butylbromide Tablets are sugar-coated, round and white in colour.
Hyoscine Butylbromide Tablets are available in blister packs of 56 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Istituto De Angeli S.r.I, Loc. Prulli,
103/C 50066 Reggello (FI), Italy and procured from within the EU. Product
Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon (UK)
Limited, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 33723/0152

Hyoscine Butylbromide 10mg Tablets

Revision date: 17/07/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand view ⇕

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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