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BUSCOPAN® 10 mg tablets
Hyoscine butylbromide
BUSCOPAN® 10 mg tablets contain the active ingredient hyoscine butylbromide. Each sugar-coated tablet contains 10 mg hyoscine butylbromide and also contains sugar, specifically 41,2 mg sucrose per tablet.
BUSCOPAN 10 mg tablets are available without a doctor’s prescription for the treatment of a mild illness. Even though the medicine can be obtained without a prescription, it should still be used carefully and according to the instructions in the approved leaflet. Users should keep the leaflet for future reference and ask a healthcare provider or pharmacist for advice where needed. A doctor should be consulted if symptoms become worse or do not improve after 3 days.
1. What BUSCOPAN 10 mg tablets is and what it is used for
Hyoscine butylbromide belongs to a group of medicines known as antispasmodics. These medicines help relax cramping muscles in the stomach and bowel. BUSCOPAN 10 mg tablets are used for conditions linked to gastrointestinal spasm, meaning they help relieve cramps in the muscles of the stomach and gut.
2. What you need to know before you take BUSCOPAN 10 mg tablets
Before taking BUSCOPAN 10 mg tablets, patients should carefully consider the warnings, restrictions, and medical conditions listed in the official leaflet.
Do not take BUSCOPAN 10 mg tablets
BUSCOPAN 10 mg tablets should not be taken by people who are allergic to hyoscine butylbromide or to any of the other ingredients in the medicine.
It should also not be used by people with certain medical conditions, including:
| Do not take BUSCOPAN 10 mg tablets if you have |
|---|
| Myasthenia gravis |
| Suspected or confirmed bowel blockage |
| Paralytic or obstructive ileus |
| Megacolon |
| Glaucoma |
| Porphyria |
| Enlarged prostate |
| Fever |
| Tachycardia |
| Rare hereditary conditions that may be incompatible with the sugar content of the tablets |
Warnings and precautions
Medical advice should be obtained straight away if a person has severe or unexplained abdominal pain that persists, becomes worse, or occurs together with symptoms such as fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, low blood pressure, fainting, or blood in the bowel movements.
A doctor, pharmacist, or other healthcare provider should also be consulted before using BUSCOPAN 10 mg tablets if the patient has a tendency to a very fast heart rate or other heart problems, blockage problems of the gut or urinary tract, difficulty or pain when passing urine, a tendency to glaucoma, previous treatment for severe sweating problems, fever, or abnormal liver or kidney function.
Other medicines and BUSCOPAN 10 mg tablets
Patients should tell their healthcare provider about all medicines they are taking, including complementary and traditional medicines.
BUSCOPAN 10 mg tablets may interfere with medicines such as:
| Medicine type | Examples |
|---|---|
| Antihistamines | Allergy medicines |
| Antidepressants | Tricyclic or tetracyclic antidepressants |
| Heart rhythm medicines | Quinidine, disopyramide |
| Antiviral or Parkinson’s-related medicines | Amantadine |
| Antipsychotic medicines | Medicines used for certain mental health conditions |
| Inhaled anticholinergic medicines | Tiotropium, ipratropium |
| Atropine-like medicines | Medicines with similar anticholinergic effects |
| Dopamine antagonists | Metoclopramide |
| Beta-adrenergic medicines | Salbutamol |
Pregnancy and breastfeeding
Patients who are pregnant, breastfeeding, think they may be pregnant, or are planning to have a baby should consult a doctor, pharmacist, or healthcare provider before taking this medicine.
The approved leaflet states that BUSCOPAN 10 mg tablets should not be used during pregnancy or breastfeeding.
Driving and using machines
Some people may experience temporary blurred vision while taking BUSCOPAN 10 mg tablets. If this happens, the person should wait until their vision returns to normal before driving, using tools, or operating machines.
BUSCOPAN 10 mg tablets contain sugar
Each sugar-coated tablet contains 41,2 mg sugar. The maximum recommended daily dose of 10 tablets equals 411,8 mg sugar.
Patients with the rare hereditary condition of fructose intolerance should not take BUSCOPAN 10 mg tablets.
3. How to take BUSCOPAN 10 mg tablets
BUSCOPAN 10 mg tablets should always be taken exactly as described in the leaflet or as advised by a doctor or pharmacist. Patients who are unsure should check with a healthcare professional.
| Patient group | Usual dose |
|---|---|
| Adults and adolescents over 12 years of age | 1–2 tablets, 3 to 4 times daily |
| Children aged 6–12 years | 1 tablet, 3 times daily |
The tablets should be swallowed whole with enough liquid, such as water, and should not be crushed or chewed.
BUSCOPAN 10 mg tablets should not be taken continuously every day or for long periods without investigating the cause of the pain. A doctor should be consulted if symptoms worsen or do not improve after 3 days.
For infants and children under 6 years of age, BUSCOPAN 0,1 % syrup is available.
If you take more BUSCOPAN 10 mg tablets than you should
In the event of overdosage, the patient should consult a doctor or pharmacist. If neither is available, the nearest hospital or poison centre should be contacted.
If you forget to take BUSCOPAN 10 mg tablets
If a dose is missed, it should be taken as soon as remembered. However, if it is nearly time for the next dose, the missed dose should be skipped and the usual dosing schedule resumed.
A double dose should not be taken to make up for forgotten individual doses.
4. Possible side effects
BUSCOPAN 10 mg tablets may cause side effects, although not all reported side effects are included in the leaflet. Patients should consult a healthcare provider if their general health worsens or if they experience unwanted effects while taking the medicine.
Side effects table
| Side effect / symptom | What it may indicate | What to do |
|---|---|---|
| Itchy rash spreading over the body | Possible serious allergic reaction | Stop taking the medicine and seek urgent medical attention |
| Swelling | Possible serious allergic reaction | Stop taking the medicine and seek urgent medical attention |
| Difficulty breathing | Possible serious allergic reaction | Stop taking the medicine and seek urgent medical attention |
| Loss of consciousness | Possible anaphylactic reaction or shock | Seek emergency medical help immediately |
| Painful red eyes with loss of vision | Possible glaucoma | Seek urgent medical attention |
| Hives | Skin reaction | Speak to a doctor or pharmacist |
| Itching | Skin reaction | Speak to a doctor or pharmacist if troublesome or persistent |
| Rash | Skin reaction | Speak to a doctor or pharmacist |
| Patchy red skin | Skin reaction | Speak to a doctor or pharmacist |
| Changes in heart rate | Possible heart-related side effect | Speak to a doctor or pharmacist |
| Palpitations | Awareness of heartbeat or irregular heartbeat | Speak to a doctor or pharmacist |
| Problems emptying the bladder | Urinary difficulty | Speak to a doctor or pharmacist |
| Dry mouth | Usually less serious | May not require treatment, but speak to a healthcare provider if troublesome |
| Reduced sweating | Usually less serious | Monitor and speak to a healthcare provider if concerning |
| Dryness of the skin | Usually less serious | May not require treatment, but speak to a healthcare provider if troublesome |
Reporting of side effects
Patients who experience side effects should speak to a doctor or pharmacist. Side effects can also be reported to the Pharmacovigilance Unit at Sanofi or to SAHPRA using the adverse drug reaction reporting process described in the official leaflet.
Reporting side effects helps provide more information about the safety of BUSCOPAN 10 mg tablets.
5. How to store BUSCOPAN 10 mg tablets
BUSCOPAN 10 mg tablets should be stored out of reach of children and kept at or below 30 °C.
The medicine should not be used after the expiry date shown on the carton.
Unused medicine should be returned to a pharmacist and should not be disposed of in drains or sewerage systems, including toilets.
6. Contents of the pack and other information
What BUSCOPAN 10 mg tablets contain
The active substance in BUSCOPAN 10 mg tablets is hyoscine butylbromide.
Each tablet contains 10 mg of hyoscine butylbromide.
Other ingredients include:
| Ingredient |
|---|
| Dibasic calcium phosphate |
| Maize starch |
| Starch soluble |
| Colloidal silica |
| Tartaric acid |
| Stearic acid |
| Polyvidone |
| Sucrose |
| Talc |
| Acacia |
| Titanium dioxide |
| Polyethylene glycol 6000 |
| Carnauba wax |
| White beeswax |
What BUSCOPAN 10 mg tablets look like and contents of the pack
BUSCOPAN 10 mg tablets are white, curved, sugar-coated tablets.
They are supplied in cartons containing blister packs of:
| Pack size |
|---|
| 10 tablets |
| 20 tablets |
| 100 tablets |
Holder of certificate of registration
sanofi-aventis south africa (pty) ltd
2 Bond Street
1685 Midrand
South Africa
Tel: 011 256 3700
This leaflet was last revised in
19 April 2022
Registration number
E501 (Act 101/1965)
Important note
This article is a structured informational version based on the SAHPRA-approved leaflet. For packaging, regulatory submission, patient distribution, or official medical-product information use, the official approved leaflet wording should be used as the authoritative source.
