Buscopan 20 mg/ml Solution for Injection for Horses and Calves

pregnancy.
Do not use in case of hypersensitivity to the active substance or to any of the
excipients.
4.4 Special warnings for each target species
In case of no clinical response the necessity for surgical intervention should be
taken into consideration. See also section 4.11 Withdrawal periods.
4.5 Special precautions for use
Special precautions for use in animals
Horses should be monitored carefully following treatment. If the response to
treatment with [the product] is poor, careful re-evaluation of the diagnosis should
be made and the possibility of surgical intervention should be considered, as [the
product] does not mask symptoms of surgical cases.
In cases of mechanical obstruction of the gut, concomitant therapy with polyionic
fluids, laxatives and analgetics should be considered.
In animals with cardiac dysfunction the product should be administered after
making a risk/benefit assessment.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals
People with known hypersensitivity to hyoscine butylbromide or methyl-, or propyl
parahydroxybenzoate should avoid contact with the product. Wear impermeable
gloves. In the case of accidental spillage onto the skin or eyes, wash off splashes
from skin and eyes with clean running water.
4.6 Adverse reactions (frequency and seriousness)
A slight transient increase in heart rate may be observed due to the
parasympatholytic activity of hyoscine butylbromide.
4.7 Use during pregnancy, lactation or lay
The use is not recommended during pregnancy.

Revised: November 2024
MA split from NI MA following AN: 02177/2024
4.8 Interaction with other medicinal products and other forms of
interaction
The effects of hyoscine butylbromide may be potentiated by the concomitant use
of other anticholinergic drugs. Do not use in combination with other drugs that act
on the (para) sympathic system. Concomitant therapy should take in
consideration the pharmacokinetic properties of hyoscine butylbromide.
Concurrent use of Non-Steroidal-Anti-Inflammatory Drugs (NSAIDS), or other
products with analgesic properties may mask signs of clinical conditions requiring
further diagnosis and treatment.
4.9 Amounts to be administered and administration route
Horse:
butylbromide per kg body weight, by a single intravenous injection.
This corresponds to 1.5 ml of [the product]/100 kg body weight i.v.
Calf:
butylbromide per kg body weight, by a single intramuscular injection.
This corresponds to 2 ml of [the product]/100 kg body weight i.m.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In a tolerance study in horses, using up to 5 –fold the recommended dosage of
0.3 mg/kg, the product caused no severe adverse reactions.
A five-fold overdose occasionally produced signs of a transient, slight decrease
in defecation frequency. A ten-fold over dosage in horses produced a transitory
absence of pupillary light reflex, a transitory increase of heart rate and lower
intestinal motility. Signs of colic due to enteroparalysis appear 6 - 8 hours after
administration. Adverse reactions after over dosage should disappear without
any further treatment within 6 hours.
Intramuscular injection of the product in calves at up to 3-fold of the
recommended dose of 0.4 mg/kg caused no systemic nor local adverse
reactions.
In case of overdose parasympatholytic symptomatology may be present.
4.11 Withdrawal period(s)
Horse:
Calf:
Not permitted for use in lactating animals producing milk for human consumption.
5.