Document: leaflet MAH BRAND_PLPI 18067-0444 change

• leaflet MAH BRAND_PL 00015-0347
• leaflet MAH BRAND_PLPI 18067-0444

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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.

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

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 vou, 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 vou, 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® TABLETSl

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.

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)

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    _p0M

PL No: 18067/0444    -

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

This leaflet was last revised on 8^th June 2014.

To request a copy of this leaflet in Braille, large print or audio please call 01622 690172.

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.

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

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|

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

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.

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

This leaflet was revised on 8^th June 2014.

To request a copy of this leaflet in Braille, large print or audio please call 01622 690172.

5. HOW TO STORE HYOSCINE BUTYLBROMIDE|

•    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.