Tramcoat 20 mg Film-coated 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:
The tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of
reach of animals. 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:
Tramadol may cause sedation, nausea and dizziness after accidental ingestion. To
avoid accidental ingestion, particularly by children, blisters should be inserted back into
the carton and kept in a safe place out of the sight and reach of children. 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.