Do not use in cats.
Do not use in pregnant or lactating bitches.
Do not use in dogs less than 4 months of age.
Do not use in case of hypersensitivity to active substance or to any of the excipients.
Do not use in dogs suffering from cardiac, hepatic or renal disease, where there is a possibility of gastrointestinal ulceration or bleeding, or where there is evidence of a blood dyscrasia.
Special precautions for safe use in the target species:
Use in aged dogs may involve additional risk. If such a use cannot be avoided, dogs may require careful clinical management. Avoid use in any dehydrated, hypovolaemic or hypotensive dog, as there is a potential risk of increased renal toxicity. NSAIDs can cause inhibition of phagocytosis and hence in the treatment of inflammatory conditions associated with bacterial infection, appropriate concurrent antimicrobial therapy should be instigated. See section 3.8. The tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands after handling the product.
Adverse events
Dogs: Rare (1 to 10 animals / 10 000 animals treated): Renal disorder, Hepatic disorder1.
Undetermined frequency (cannot be estimated from the available data): Vomiting2, loose stool2, diarrhoea2, blood in faeces2, appetite loss2, lethargy2.
1 - Idiosyncratic reaction.
2 - Transient. Generally, occur within the first treatment week and in most cases disappear following termination of the treatment but in very rare cases may be serious or fatal.
If adverse reactions occur, use of the veterinary medicinal product should be stopped and the advice of a veterinarian should be sought.
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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Overdose
Although studies investigating the safety of carprofen at overdose have been performed, no signs of toxicity appeared when dogs were treated with carprofen at levels up to 6 mg/kg twice daily for 7 days (3 times the recommended dose rate of 4mg/kg) and 6mg/kg once daily for a further 7 days. (1.5 times the recommended dose rate of 4 mg/kg).
There is no specific antidote for carprofen overdosage but general supportive therapy, as applied to clinical Overdosage with NSAIDs should be applied.
Interactions with other medicinal products and other forms of interaction
Do not administer other NSAIDs and glucocorticoids concurrently or within 24 hours of administration of the product. Carprofen is highly bound to plasma proteins and may compete with other highly bound drugs, which can lead to toxic effects.
Concurrent administration of potential nephrotoxic drugs should be avoided.