Tralieve 80 mg Chewable Tablets for Dogs

The analgesic effects of tramadol hydrochloride may be variable. This is thought to
be due to individual differences in the metabolism of the drug to the primary active
metabolite O-desmethyltramadol. In some dogs (non-responders) this may result in
the veterinary medicinal product failing to provide analgesia. For chronic pain,
multimodal analgesia should be considered. Dogs should be monitored regularly by a
veterinarian to ensure adequate pain relief. In case of recurrence of pain or
insufficient analgesia the analgesic protocol may need to be reconsidered.

Special precautions for safe use in the target species:
Use with caution in dogs with renal or hepatic impairment. In dogs with hepatic
impairment the metabolism of tramadol to the active metabolites may be decreased
which may reduce the efficacy of the veterinary medicinal product. One of the active
metabolites of tramadol is renally excreted and therefore in dogs with renal
impairment the dosing regimen used may need to be adjusted. Renal and hepatic
function should be monitored when using this veterinary medicinal product.
Cessation of long-term analgesic therapy should be done gradually whenever
possible.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
People with known hypersensitivity to tramadol or any of the excipients should avoid
contact with the veterinary medicinal product.
Tramadol may cause sedation, nausea and dizziness after accidental ingestion,
especially by children. To avoid accidental ingestion, particularly by a child, unused
tablet parts should be returned to the open blister space and inserted back into the
carton and kept in a safe place out of the sight and reach of children as they pose a
health risk to small children due to accidental ingestion. In case of accidental
ingestion, particularly by children, seek medical advice and show the package leaflet
or the label to the physician. In case of accidental ingestion by adults: DO NOT
DRIVE as sedation may occur.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.