Buscopan ® 10 mg Tablets

Hyoscine butylbromide belongs to a group of medicines called antispasmodics (medicines that relax the cramping muscles of your stomach and bowel). BUSCOPAN 10 mg tablets are used in the treatment of conditions associated with gastrointestinal spasm, that is, to relieve cramps in the muscles of the stomach and gut.

Do not take BUSCOPAN 10 mg tablets:

• if you are hypersensitive (allergic) to hyoscine butylbromide or any of the other ingredients (listed in section 6)
• if you have myasthenia gravis (a very rare muscle weakness problem)
• if you have suspected or confirmed blockage of the bowel
• if you have a condition where the bowel is blocked and does not work properly (paralytic or obstructive ileus)
• if you have a very enlarged bowel (megacolon)
• If you have glaucoma (an eye problem with increased pressure in the eye)
• if you have porphyria (disturbances of metabolism that can be seen as disorders of the skin or other organs)
• if you have an enlarged prostate
• if you have a fever
• if you have tachycardia (fast heartbeat)
• if you have rare hereditary (inherited) conditions that may be incompatible with an ingredient in BUSCOPAN 10 mg tablets, namely sugar. Please refer to “BUSCOPAN 10 mg tablets contain sugar”.

Warnings and precautions

Take special care with BUSCOPAN 10 mg tablets: Consult your doctor, pharmacist or other health care provider straight away:

• If you have severe, unexplained abdominal (belly) pain that persists or worsens or occurs together with fever, nausea (feeling sick), vomiting, changes in your bowel movements, abdominal (belly) tenderness, low blood pressure, fainting or blood in your bowel movements.

Consult your doctor, pharmacist or other health care provider before taking BUSCOPAN 10 mg tablets:

• if you tend to have a very fast heart rate or other heart problems
• if you have a tendency to blockage problems of the gut or urinary tract or if you have difficulty or pain passing water (urine) such as men with prostate problems
• if you are prone to glaucoma (increased pressure in the eye)
• if you have been treated by a doctor for a severe sweating problem
• if you have a fever
• if you have abnormal liver or kidney function.

Always take BUSCOPAN 10 mg tablets exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is:

• Adults and adolescents over 12 years of age: 1 – 2 tablets 3 to 4 times daily.
• Children 6 – 12 years of age: 1 tablet 3 times daily.

Swallow the tablets whole with enough liquid like water. Do not crush or chew the tablets. BUSCOPAN 10 mg tablets should not be taken on a continuous daily basis or for long periods without investigating the cause of the pain. You must see a doctor if your symptoms worsen or do not improve after 3 days.

For infants and children under 6 years, BUSCOPAN 0,1 % syrup (containing 5 mg hyoscine butylbromide per 5 ml) is available.

If you take more BUSCOPAN 10 mg tablets than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take BUSCOPAN 10 mg tablets

If you miss a dose, take it as soon as you remember. If it is nearly time for your next dose, skip the missed dose and go back to your usual dosing schedule. Do not take a double dose to make up for forgotten individual doses.

BUSCOPAN 10 mg tablets may have side effects. Not all side effects reported for BUSCOPAN 10 mg tablets are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking BUSCOPAN 10 mg tablets, please consult your health care provider for advice.

If any of the following happens, stop taking BUSCOPAN 10 mg tablets and tell your doctor immediately or go to the casualty department at your nearest hospital. You may need urgent medical attention:

• Anaphylactic reaction and shock – this is a severe type of allergic reaction. The itchy rash may spread all over the body, as well as swelling. You may have difficulty in breathing and may lose consciousness.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to BUSCOPAN 10 mg tablets. You should seek urgent medical attention that may require hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• If you experience painful red eyes with loss of vision after taking BUSCOPAN 10 mg tablets, stop taking it and tell your doctor immediately. You may have an eye problem called glaucoma and should seek urgent medical attention.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Less frequent side effects:

• Skin reactions such as hives, itching, rash or patchy red skin.
• Increased heart rate, slowing of the heart rate followed by increased heart rate with faster or irregular heartbeats, also called palpitations, and changes in the way the heart beats.
• Problems emptying the bladder.

Other side effects that do not normally need medical treatment:

• Dry mouth.
• Making less sweat than usual.
• Dryness of the skin.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to:

• The Pharmacovigilance Unit at Sanofi: [email protected] (email) or 011 256 3700 (tel), or
• SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8.

By reporting side effects, you can help provide more information on the safety of BUSCOPAN 10 mg tablets.

Store all medicines out of reach of children. Store at or below 30 °C. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).