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Buscopan Tablets 10mg

Document: leaflet MAH BRAND_PLPI 20774-1261 change

Buscopan® Tablets 10mg

(hyoscine butylbromide)

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.    Howto take Buscopan Tablets

4.    Possible side effects

5.    Howto 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.

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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 breastfeeding.

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. Howto 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.

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 straightaway. 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.    Howto store Buscopan Tablets

Do not take this medicine after the expiry date which is printed on the packaging. Keep this medicine out of the sight and reach of children. Store below 30°C. Store in the original package.

6.    Further information

What Buscopan Tablets contain

Each tablet contains hyoscine butylbromide 10 mg as the active ingredient

The other ingredients are: calcium hydrogen phosphate anhydrous, tartaric acid, colloidal anhydrous silica, stearic-palmitic acid mixture, sucrose, talc, acacia, titanium dioxide E171, macrogol 6,000, carnauba wax, povidone, soluble starch, white beeswax and dried maize starch.

What Buscopan Tablets look 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

PL 20774/1261 Buscopan Tablets

Manufactured by Delpharm Reims , 10 Rue Du Colonel Charbonneaux Reims 51100, France or Istituto De Angeli S.r.l., Loc. Prulli, 103/C, 50066 Reggello (FI), Italy. Procured from within the EU. Product Licence Holder: Quadrant Pharmaceuticals Ltd, Bolton,

BL6 4SA. Repackaged by Maxearn Ltd,

Bolton, BL6 4SA.

Leaflet revision date 4th June 2014

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

KG.

PP3/1261/V1

POM