Buscopan Side Effects

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Answer the side-effect intent for buscopan without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Buscopan?

Buscopan contains the active ingredient Hyoscine butylbromide.

• Active ingredient — Hyoscine butylbromide
• Registration number — Z/11.2/93
• Registration holder — Sanofi-aventis south africa (pty) ltd

It is approved for:

• The active substance is hyoscine butylbromide
• Each 5 mL of syrup contains 5 mg of the active ingredient hyoscine butylbromide
• The solution is preserved with 0,08 % sorbic acid
• The other ingredients are: saccharin sodium, hydroxyethylcellulose, banana flavour and water purified

Common side effects of Buscopan

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Reported side effects

• 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 0,1 % syrup. You may need urgent medical attention or 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 0,1 % syrup, stop taking it and tell your doctor immediately. You may have an eye problem called glaucoma and need 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

Serious side effects and warning signs

The leaflet lists these as serious side effects needing immediate attention.

Less frequent

• 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

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• 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)

Use with care, and tell your doctor, if

• 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

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine
• Do not use BUSCOPAN if you are pregnant or breastfeeding your baby

Interactions and medicines to check

The approved leaflet names these interactions.

• Antihistamines – used to treat hayfever and other allergies
• Tricyclic or tetracyclic antidepressant medicines – used to treat depression
• Quinidine or disopyramide – used to control your heartbeat
• Amantadine – used for Parkinson’s disease and flu
• Antipsychotic medicines such as butyrophenones or phenothiazines – used to treat severe mental illness such as schizophrenia
• Tiotropium, ipratropium or atropine-like medicines – medicines inhaled to treat breathing problems
• Dopamine antagonists such as metoclopramide for feeling nauseous
• Beta-adrenergic medicines such as salbutamol for asthma

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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