BUSCOPAN 10 MG ( HYOSCIN - N - BUTYLBROMID ) 20 SUGAR-COATED TABLETS

PATIENT INFORMATION LEAFLET

BUSCOPAN® 10 mg TABLETS / HYOSCINE-N-BUTYLBROMIDE 10 mg TABLETS
(Hyoscine-N-butylbromide)

This medicine is available under either of the above names but will be referred to as Buscopan Tablets throughout this leaflet.

Please 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 become 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)

They 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 a condition called myasthenia gravis (a very rare muscle weakness problem).
• You are pregnant, likely to become 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 this 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.
• You have difficulty or pain passing urine (for example, men with prostate problems).
• You have constipation.
• You have a fever.

If you are not sure whether 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, worsens, or occurs with:

• Fever
• Feeling sick
• Being sick (vomiting)
• Changes in your bowel movements
• Abdominal tenderness
• Low blood pressure
• Feeling faint
• 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 heartbeat, 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 other atropine-like medicines.
• Amantadine – for Parkinson’s disease and flu.
• Metoclopramide – for feeling sick (nausea).

If you are not sure whether 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 become pregnant, or are breastfeeding.

Driving and using machines

Some people may experience 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 you have been told that you cannot tolerate or digest certain sugars.

3. HOW TO TAKE BUSCOPAN TABLETS

Always take this medicine exactly as your doctor or pharmacist has told you. 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 (IBS), 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 straight away. Take the medicine pack with you, even if there are no 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 almost time for your 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 occur 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, rash, redness of the skin) – affects fewer than 1 in 100 people.
• Severe allergic reactions (anaphylactic shock), such as difficulty breathing, feeling faint, or dizziness – affects fewer than 1 in 1,000 people.
• 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 urine – affects fewer than 1 in 1,000 people.

If any of the side effects become troublesome or serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

5. HOW TO STORE BUSCOPAN TABLETS

• Store below 25℃ in a dry place, protected from light.
• 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.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help to protect the environment.
• If the tablets become discoloured or show signs of deterioration, seek the advice of your pharmacist.

6. FURTHER INFORMATION

What Buscopan Tablets contain

• Each white, round, sugar-coated tablet contains 10 mg of hyoscine-N-butylbromide as the active ingredient.
• The tablets also contain the following inactive ingredients: calcium hydrogen phosphate, dried maize starch, soluble maize starch, colloidal silica, tartaric acid, stearic/palmitic acid, sucrose, talc, acacia, titanium dioxide (E171), macrogol, carnauba wax, beeswax, and povidone.

What Buscopan Tablets look like and contents of the pack

• Buscopan Tablets are white, round, sugar-coated tablets.
• They are available in packs of 20 tablets.

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