Contraindications
Do not use in case of paralytic ileus, mechanical obstruction, or cardiac disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in horses with glaucoma.
Do not use in horses less than 6 weeks of age.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
Horses should be monitored carefully following treatment.
The treatment is essentially symptomatic and an appropriate handling of the underlying disorder is necessary.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to hyoscine butylbromide or benzyl alcohol should avoid contact with the veterinary medicinal product.
Accidental self-injection may result in cardiac and circulatory effects. Avoid accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
The product can cause skin and eye irritation. Avoid contact with skin and eyes. In the case of contact with skin, wash with soap and water. If irritation persists, seek medical advice. Wash hands after use.
If the product comes into contact with the eyes, rinse the eyes immediately with plenty of water and seek medical attention if irritation persists.
Adverse reactions (frequency and seriousness)
On very rare occasions, tachycardia may occur.
In horses, the veterinary medicinal product may cause colic due to inhibition of motility.
The frequency of adverse reactions is defined using the following convention:
- Very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
- Common (more than 1 but less than 10 animals in 100 animals treated)
- Uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- Rare (more than 1 but less than 10 animals in 10,000 animals treated)
- Very rare (less than 1 animal in 10,000 animals treated, including isolated
reports
Use during pregnancy and lactation
Laboratory studies in mice have not produced any evidence of a teratogenic effect. No information on use during pregnancy in the target species is available. An effect upon the smooth muscles of the birth canal can occur.
Hyoscine butylbromide, like all other anticholinergic agents, can inhibit the production of milk. Due to its low solubility in fat, excretion of hyoscine butylbromide in milk is very low.
Use only according to the benefit-risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
This medicinal product may enhance the tachycardic effects of beta-adrenergic drugs and may alter the effect of other drugs, such as digoxin.
The effects of hyoscine butylbromide may be potentiated by the concomitant use of other anticholinergic drugs. Co-administration with other anticholinergic or parasympatholytic drugs should be avoided.
Withdrawal period(s)
Meat and offal:
Horse 3 days
Cattle 2 days
Sheep 18 days
Pig 9 day
Milk:
Horse, Cattle and Sheep 12 hours