Tramsan 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:
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 and vanillin may cause hypersensitivity (allergic) reactions. People with
known hypersensitivity to these substances should avoid contact with the veterinary
medicinal product. Wash hands after use. Seek medical advice in case of
hypersensitivity reactions.
This veterinary medicinal product may cause eye irritation, e.g., if dust is formed when
broken into smaller parts. Avoid contact with the eyes, including hand-to-eye contact. If
the veterinary medicinal product comes into contact with the eyes, rinse immediately
with plenty of water.
Tramadol may cause sedation, nausea, and dizziness after accidental ingestion. To
avoid accidental ingestion, particularly by a child, unused part tablets should be
returned to the open blister space, 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.
Special precautions for the protection of the environment:
Not applicable.