What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.


Buscopan Ampoules

Package Leaflet: Information for the user

Buscopan® Ampoules 20 mg/ml Solution for Injection

(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 Ampoules are and what they are used for
2. Before you receive BUSCOPAN Ampoules
3. How BUSCOPAN Ampoules will be given
4. Possible side effects
5. How to store BUSCOPAN Ampoules
6. Further information

1. WHAT BUSCOPAN AMPOULES ARE AND WHAT THEY ARE USED FOR

The name of your medicine is BUSCOPAN Ampoules 20 mg/ml Solution for injection (called BUSCOPAN Ampoules in this leaflet).

BUSCOPAN Ampoules contain a medicine called ‘hyoscine butylbromide’. This belongs to a group of medicines called ‘antispasmodics’.

BUSCOPAN Ampoules are used to relieve cramps in the muscles of your:

  • Stomach
  • Gut (intestine)
  • Bladder and the tubes leading to the outside of your body (urinary system)

BUSCOPAN Ampoules can also be used in some diagnostic and therapeutic medical procedures where spasm may be a problem for example barium enema.

2. BEFORE YOU RECEIVE BUSCOPAN AMPOULES

You should not be given BUSCOPAN Ampoules 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 have a very fast heart rate
  • You have difficulty or pain passing water (urine) such as men with prostate problems
  • You have gut blockage problems or a totally inactive gut
  • You are pregnant, likely to get pregnant or are breast-feeding

You should not receive 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 Ampoules

Check with your doctor or pharmacist before having this medicine if:

  • You have any heart problems
  • You have a fever
  • You have problems with your thyroid gland such as an overactive thyroid gland

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before receiving BUSCOPAN Ampoules.

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 Ampoules can affect the way some other medicines work. Also some other medicines can affect the way BUSCOPAN Ampoules 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 such as haloperidol or fluphenazine
  • Medicines usually used for breathing problems such as salbutamol, ipratropium, tiotropium 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 receiving BUSCOPAN Ampoules.

Pregnancy and breast-feeding

You should not be given BUSCOPAN Ampoules if you are pregnant, likely to get pregnant or are breast-feeding.

Driving and using machines

Some people may have sight problems or feel dizzy while taking this medicine. If this happens to you, wait until your sight returns to normal or you stop feeling dizzy before driving or using any tools or machines.

Important information about some of the ingredients of BUSCOPAN Ampoules

BUSCOPAN Ampoules contain sodium chloride. The amount of sodium in a 1 ml ampoule is less than 1 mmol (23 mg), the total amount of sodium if you are given five ampoules in 24 hours is less than 1 mmol (23 mg) this means that your medicine is essentially sodium free.

3. HOW BUSCOPAN AMPOULES WILL BE GIVEN

BUSCOPAN Ampoules are usually given by a doctor or nurse. BUSCOPAN Ampoules should not be given every day for long periods of time.

Receiving the injection

BUSCOPAN Ampoules may be given in two ways:

  • By being slowly injected into a vein
  • By an injection into a muscle
  • BUSCOPAN Ampoules may be diluted with other solutions if needed

How much will you be given

  • You will usually be given one ampoule, but you may be given a further ampoule after half an hour if required
  • If you are being given BUSCOPAN Ampoules as part of an endoscopy your dose may need to be given more often
  • You should not be given more than 5 ampoules in any 24-hour period

BUSCOPAN Ampoules are not recommended for children.

If you have more BUSCOPAN Ampoules than you should

It is unlikely that you will be given too much of this medicine. However, tell the doctor or nurse if you think that you have been given too much.

4. POSSIBLE SIDE EFFECTS

Like all medicines, BUSCOPAN Ampoules 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 rash, nettle rash, redness of the skin and itching
  • Severe allergic reactions (anaphylaxis) 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 10 people)
  • Dizziness (affects fewer than 1 in 10 people)
  • Blurred vision (affects fewer than 1 in 10 people)
  • Increased heart rate (affects fewer than 1 in 10 people)
  • Constipation
  • Small blisters on hands and feet
  • Being unable to pass water (urine)
  • Low blood pressure, for example feeling faint
  • Flushing
  • Dilated pupils
  • Increased fluid pressure inside the eye

Pain at the place you had the injection may occur if you have been given BUSCOPAN Ampoules into a muscle.

Although unlikely, in certain circumstances it may be possible that BUSCOPAN may pass into the brain and cause side effects, for example confusion.

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance
Earlsfort Terrace
IRL – Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie

5. HOW TO STORE BUSCOPAN AMPOULES

  • Keep out of the reach and sight of children
  • Store below 30°C, keep the ampoules in the outer carton in order to protect from light
  • BUSCOPAN Ampoules should not be used after the expiry date which is printed on the carton and ampoules. The expiry date refers to the last day of that month

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 BUSCOPAN Ampoules contain

Each ampoule contains 20 mg of the active ingredient hyoscine butylbromide. The other ingredients are sodium chloride and water for injections.

What BUSCOPAN Ampoules looks like and contents of the pack

BUSCOPAN Ampoules are clear glass ampoules containing a colourless or almost colourless, clear solution.

BUSCOPAN Ampoules are supplied in cartons containing 10 x 1 ml ampoules.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisations are held by:

United Kingdom

Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
United Kingdom
Tel: 0845 372 7101

Ireland

sanofi-aventis Ltd. T/A SANOFI
Citywest Business Campus
Dublin 24
Ireland
Tel: +353 1 4035600
Fax: +353 1 4035687

and the ampoules are manufactured at:

Boehringer Ingelheim España, S.A.
Prat de la Riba, 50
08174 Sant Cugat del Vallès
Barcelona
Spain

This leaflet was revised in July 2017.

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