Target species
Horses
Indications for use, specifying the target species
For treatment of gastric ulcers in horses.
Contraindications
Do not use in known cases of hypersensitivity to the active substance or any of the excipients.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
As the safety of the product has not been assessed in foals under 8 months of age or weighing less than 125 kg bodyweight, the use of the product is not recommended in these 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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product may cause adverse gastrointestinal effects or hypersensitivity (allergic) reactions if accidentally ingested, particularly by children.
Do not eat or drink whilst handling or administering the product.
Wash hands or any exposed skin after use.
Any part-used sachets should be returned to the original carton and suitably stored to prevent access by children.
In case of accidental ingestion, especially by a child, seek medical advice if symptoms persist.
Adverse reactions (frequency and seriousness)
There are no known treatment-related clinical adverse effects.
Use during pregnancy, lactation or lay
Laboratory studies in rats and rabbits have not produced any evidence of a teratogenic effect with omeprazole. The safety of the veterinary medicinal product has not been established during pregnancy and lactation in the target species; use only according to the benefit-risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
Omeprazole may delay the elimination of warfarin. Interaction with drugs metabolised by liver enzymes cannot be excluded. 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 the drugs requiring decreased gastric pH for optimal absorption (ketoconazole, itraconazole, iron, ampicillin esters).
Amounts to be administered and administration route
For oral administration.
Each sachet contains sufficient omeprazole to treat 200 kg body weight. Sachets should not be subdivided. Therefore, calculate the dose required (2 mg/kg per day) and round up to the nearest 200 kg increment. Mix the appropriate number of whole sachets into a small amount of the horse’s feed. This product may only be added to dry feed and the feed should not be dampened.
Bodyweight range (kg) | 125-200 | 201-400 | 401-600 | 601-800 |
Number of sachets | 1 | 2 | 3 | 4 |
It is recommended to associate the treatment with changes of husbandry and training practices.
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.
Withdrawal period(s)
Meat and offal: 2 days. Not authorised for use in animals producing milk for human consumption.