Buscapina is a regionally concentrated brand of hyoscine butylbromide, registered in 13 countries with a clear footprint across Latin America and a smaller presence in southern and central Europe. The active ingredient is a quaternary ammonium antispasmodic compound used internationally for the relief of smooth-muscle spasm in the gastrointestinal and genitourinary tracts.
Hyoscine butylbromide is prescribed for a range of spasmodic and colicky conditions, including peptic ulcer-related discomfort, intestinal and biliary colic, cholecystitis, irritable bowel syndrome, renal colic, and in the context of biliary bypass procedures. The structured indication list below this introduction details each registered use as recognised by the national regulators in the markets where Buscapina is sold.
Markets where Buscapina is registered include Mexico, Argentina, Spain, Peru, Chile, and Austria, among others — a footprint that places the brand in front of travellers and expatriates moving across the Spanish-speaking world in particular. Outside this cluster, the same active ingredient is widely available under different brand names; in many countries hyoscine butylbromide is a familiar pharmacy-shelf antispasmodic, sometimes labelled as scopolamine butylbromide or butylscopolamine depending on local naming conventions.
Other antispasmodic medications used for similar indications circulate globally under different molecules and brand names, and the regulatory status of hyoscine butylbromide itself varies — prescription-only in some markets, available over the counter in others. A local pharmacist can confirm what is stocked in a given country and under which name. Anyone using Buscapina regularly, or looking to identify an equivalent abroad, should treat the question as a clinical one and discuss it with a healthcare provider familiar with their history.
Symptoms:
Serious signs of poisoning following acute overdosage have not been observed in man. In the case of overdosage, anticholinergic effects such as urinary retention, dry mouth, reddening of the skin, tachycardia, inhibition of gastrointestinal motility and transient visual disturbances may occur, and Cheynes-Stokes respiration has been reported.
Therapy:
In the case of oral poisoning, gastric lavage with medicinal charcoal should be followed by magnesium sulfate (15%). Symptoms of Buscopan overdosage respond to parasympathomimetics. For patients with glaucoma, pilocarpine should be given locally. Cardiovascular complications should be treated according to usual therapeutic principles. In case of respiratory paralysis, intubation and artificial respiration should be considered. Catheterisation may be required for urinary retention.
In addition, appropriate supportive measures should be administered as required.
None stated.
Many of the listed undesirable effects can be assigned to the anticholinergic properties of BUSCOPAN.
Adverse events have been ranked under headings of frequency using the following convention:
Very common (> 1/10); common (> 1/100, < 1/10); uncommon (> 1/1000, <1/100); rare (> 1/10000, <1/1000); very rare (<1/10000); not known - cannot be estimated from the available data.
Immune system disorders
Uncommon: skin reactions (e.g. urticaria, pruritus)
Not known*: anaphylactic shock , anaphylactic reactions, dyspnoea, rash, erythema, other hypersensitivity
Cardiac disorders
Uncommon: tachycardia
Gastrointestinal disorders:
Uncommon: dry mouth
Skin and subcutaneous tissue disorders
Uncommon: dyshidrosis
Renal and urinary disorders
Rare: urinary retention
* This adverse reaction has been observed in post-marketing experience. With 95% certainty, the frequency category is not greater than uncommon (3/1,368), 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 1,368 patients.
Reporting of suspected adverse reactions
Reporting suspected adverse reaction after authorisation of the medicinal product is important. It allows continued monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
In limited reproductive toxicity studies hyoscine butylbromide showed no evidence of teratogenicity in rats at 200 mg/kg in the diet or in rabbits at 200 mg/kg by oral gavage or 50 mg/kg by subcutaneous injection. Fertility in the rat was not impaired at doses of up to 200 mg/kg in the diet.
ATC code: A03BB01
Buscopan exerts a spasmolytic action on the smooth muscle of the gastrointestinal, biliary and genito-urinary tracts. As a quaternary ammonium derivative, hyoscine butylbromide does not enter the central nervous system. Therefore, anticholinergic side effects at the central nervous system do not occur. Peripheral anticholinergic action results from a ganglion-blocking action within the visceral wall as well as from an anti-muscarinic activity.
Absorption
As a quaternary ammonium compound, hyoscine butylbromide is highly polar and hence only partially absorbed following oral (8%) or rectal (3%) administration. After oral administration of single doses of hyoscine butylbromide in the range of 20 to 400 mg, mean peak plasma concentrations between 0.11 ng/mL and 2.04 ng/mL were found at approximately 2 hours. In the same dose range, the observed mean AUC0-tz-values varied from 0.37 to 10.7 ng h/mL. The median absolute bioavailabilities of different dosage forms, i.e. coated tablets, suppositories and oral solution, containing 100 mg of hyoscine butylbromide each were found to be less than 1%.
Distribution
Because of its high affinity for muscarinic receptors and nicotinic receptors, hyoscine butylbromide is mainly distributed on muscle cells of the abdominal and pelvic area as well as in the intramural ganglia of the abdominal organs. Plasma protein binding (albumin) of hyoscine butylbromide is approximately 4.4%. Animal studies demonstrate that hyoscine butylbromide does not pass the blood-brain barrier, but no clinical data to this effect is available. Hyoscine butylbromide (1 mM) has been observed to interact with the choline transport (1.4 nM) in epithelial cells of human placenta in vitro.
Metabolism and elimination
Following oral administration of single doses in the range of 100 to 400 mg, the terminal elimination half-lives ranged from 6.2 to 10.6 hours. The main metabolic pathway is the hydrolytic cleavage of the ester bond. Orally administered hyoscine butylbromide is excreted in the faeces and in the urine. Studies in man show that 2 to 5% of radioactive doses is eliminated renally after oral, and 0.7 to 1.6% after rectal administration. Approximately 90% of recovered radioactivity can be found in the faeces after oral administration. The urinary excretion of hyoscine butylbromide is less than 0.1% of the dose. The mean apparent oral clearances after oral doses of 100 to 400 mg range from 881 to 1420 L/min, whereas the corresponding volumes of distribution for the same range vary from 6.13 to 11.3 x 105 L, probably due to very low systemic availability. The metabolites excreted via the renal route bind poorly to the muscarinic receptors and are therefore not considered to contribute to the effect of the hyoscine butylbromide.
No studies on the effects on the ability to drive and use machines have been performed. Because of possible visual accommodation disturbances patients should not drive or operate machinery if affected.
None stated.
Buscapina is prescribed for the management of cramping and spasmodic pain associated with the gastrointestinal and urinary tracts, including peptic ulcer-related discomfort, intestinal colic, biliary colic, cholecystitis, irritable bowel syndrome, renal colic, and in the setting of biliary bypass. The structured indication block further down this page lists each registered use as recognised by the national regulators in the markets where Buscapina is sold.
Buscapina contains hyoscine butylbromide, a quaternary ammonium antispasmodic agent used internationally for smooth-muscle spasm in the gastrointestinal and genitourinary tracts. The same molecule is sometimes labelled scopolamine butylbromide or butylscopolamine on packaging in other markets, and circulates worldwide under several brand names depending on the manufacturer and the local regulatory tradition.
Buscapina is registered in 13 countries, with a clear regional concentration in Latin America alongside two European markets. Examples include Mexico, Argentina, Spain, Peru, Chile, Austria, Venezuela, and Panama. If your country is not on the list, a local pharmacist can usually confirm whether hyoscine butylbromide is available under a different brand or as a generic in that market.
Hyoscine butylbromide is sold under several brand names worldwide, particularly in markets where multiple manufacturers produce the same molecule. Other antispasmodic agents used for similar indications also exist, although they are not freely interchangeable — molecules differ in their profile and clinical positioning. To identify a local product, search the active ingredient on Pill2Trip or ask a pharmacist in your country about available antispasmodic options.
Yes. Although hyoscine butylbromide is available without prescription in some countries and only by prescription in others, the underlying conditions Buscapina is used for — biliary, renal, or intestinal colic, persistent abdominal pain, suspected ulcer disease — generally warrant medical evaluation rather than self-treatment. Travellers and expatriates should also be aware that regulatory status varies between countries, and a healthcare provider should lead any decision to start or continue therapy.
