Sugar-coated tab: Like all medicines, BUSCOPAN Tablets can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.
Stop taking the medicine and see a doctor straight away for any of the following serious side effects ‐ the patient may need urgent medical treatment: Allergic reactions such as skin reactions e.g. nettle rash, itching (affects fewer than 1 in 100 people), rash, redness of the skin; Severe allergic reactions (anaphylactic shock) 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 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 water (urine) (affects fewer than 1 in 1,000 people).
Reporting of side effects: If the patient gets any of the side effects, talk to the doctor, pharmacist or nurse. This includes any possible side effects not previously listed. The patient can also report side effects directly. By reporting side effects, the patient can help provide more information on the safety of this medicine.
Inj: Many of the listed undesirable effects can be assigned to the anticholinergic properties of BUSCOPAN. Anticholinergic side effects of Buscopan are generally mild and self-limited.
Adverse events have been ranked under headings of frequency using the following convention: Very common ≥ 1/10; Common ≥ 1/100, < 1/10; Uncommon ≥ 1/1,000, <1/100; Rare ≥ 1/10,000, <1/1,000; Very rare <1/10,000; Not known cannot be estimated from the available data.
Immune system disorders: Not known*: anaphylactic shock including cases with fatal outcome, anaphylactic reactions, dyspnoea, skin reactions (e.g. urticaria, rash, erythema, pruritus) and other hypersensitivity.
Eye disorders: Common: accomodation disorders; Not known*: mydriasis, increased intraocular pressure.
Cardiac disorders: Common: tachycardia.
Vascular disorders: Common: dizziness; Not known*: blood pressure decreased, flushing.
Gatrointestinal disorders: Common: dry mouth, constipation.
Skin and subcutaneous tissue disorders: Not known*: dyshidrosis.
Renal and urinary disorders: Not known*: urinary retention; injection site pain, particularly after intramuscular use, occurs.
Hyoscine butylbromide, the active ingredient of Buscopan, due to its chemical structure as a quaternary ammonium derivate, is not expected to enter the central nervous system. Hyoscine butylbromide does not readily pass the blood-brain barrier. However, it cannot totally be ruled out that under certain circumstances psychiatric disorders (e.g. confusion) may also occur after administration of Buscopan.
*This adverse reaction has been observed in post-marketing experience. With 95% certainty, the frequency category is not greater than common, but might be lower. A precise frequency estimation is not possible as the adverse drug reaction did not occur in a clinical trial database of 185 patients.