Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipient(s).
Special warnings for each target species
None
Special precautions for use
Special precautions for use in animals
Stress (including high performance training and competition), feeding, management and husbandry practices may be associated with the
development of gastric ulceration in horses. Individuals responsible for the well-being of horses should consider reducing the ulcerogenic challenge by modifying husbandry practices to achieve one or more of the following: reduced stress, reduced fasting, increased intake of roughage and access to grazing. The product should not be used in animals under 4 weeks of age or weighing less than 75 kg bodyweight.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
As this product may cause irritation and hypersensitivity reactions, avoid direct contact with skin and eyes.
People with known hypersensitivity to omeprazole and/or sesame should avoid contact with the veterinary medicinal product.
Personal protective equipment consisting of impervious gloves should be worn when handling the veterinary medicinal product.
Do not eat or drink when handling and administering the product.
Wash hands or any exposed skin after use.
The dosing syringe should be returned to the original packaging and suitably stored to prevent access by children.
In case of contact with eyes, wash immediately with clean running water and seek medical advice, and show the package leaflet or the label to the physician if symptoms persist.
Persons developing a reaction after contact with the product should avoid handling the product in future.
Special precautions for the protection of the environment
Not applicable
Other precautions
Not applicable
Adverse reactions (frequency and seriousness)
None known.
Do not use in cases of hypersensitivity to the active substance or to any of the excipient(s).
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for contact details.
Use during pregnancy, lactation or lay
Laboratory studies in rats and rabbits have not produced any evidence of a teratogenic effect.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation in the target species. The use is not recommended during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
Omeprazole may delay the elimination of warfarin. Omeprazole may potentially alter benzodiazepine metabolism and prolong CNS effects. Clarithromycin may increase levels of omeprazole. Omeprazole may reduce cyclosporine metabolism. Omeprazole may decrease absorption of drugs requiring decreased gastric pH for optimal absorption (ketoconazole, itraconazole, iron, ampicillin esters).
No other interaction with medicines routinely used in the treatment of horses is expected, although interaction with drugs metabolised by liver enzymes cannot be excluded.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No undesirable effects related to treatment were observed following daily use for 91 days at omeprazole dosages up to 20 mg/kg in adult horses and in foals older than 2 months.
No undesirable effects related to treatment (in particular no adverse effect on the semen quality or reproductive behaviour) were observed following daily use for 71 days at an omeprazole dosage of 12 mg/kg in breeding stallions.
No undesirable effects related to treatment were observed following daily use for 21 days at an omeprazole dosage of 40 mg/kg in adult horses.