Tolfedine Tablets 6 mg

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Tolfenamic Acid

Available from:

Vetoquinol UK Ltd

INN (International Name):

Tolfenamic Acid

Pharmaceutical form:

Tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Dogs

Therapeutic area:

Anti Inflammatory NSAID

Authorization status:

Authorized

Authorization date:

1993-10-15

Summary of Product characteristics

Revised: October 2023
AN: 01786/2023
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tolfedine Tablets 6mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Tolfenamic acid 6mg
FOR A FULL LIST OF EXCIPIENTS, SEE SECTION 6.1
3.
PHARMACEUTICAL FORM
Tablet
White convex tablets
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
IN SMALL DOGS : Treatment for alleviation of acute episodes of
inflammation and pain
in chronic locomotor disease.
IN CATS : in febrile syndrome (abscess, fever of unknown origin).
4.3
CONTRA-INDICATIONS
Do not administer to animals suffering from cardiac, hepatic or renal
disease, where
there is a possibility of gastro-intestinal ulceration or bleeding,
where there is
evidence of a blood dyscrasia or hypersensitivity to the product.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
NSAIDS
can
cause
inhibition
of
phagocytosis
and
hence
in
the
treatment
of
inflammatory conditions associated with bacterial infections
appropriate concurrent
antimicrobial therapy should be instigated.
In dogs, long term treatment of over 3 months duration should be under
regular
veterinary supervision. In particular, dogs with hepatic insufficiency
should be
closely monitored.
Revised: October 2023
AN: 01786/2023
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
(I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use in animals less than 6 weeks of age, or in aged animals, may
involve additional
risk. If such a use cannot be avoided, animals may require a reduced
dosage and
careful clinical management.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as
there is a
potential risk of increased renal toxicity.
Concurrent administration of potential nephrotoxic drugs should be
avoided.
It is preferable that the product is not administered to animals
undergoing general
anaesthesia until fully recovered.
Do not exceed the prescribed dosage or duration of treatment.
Animals
suffering
from
a
chronic
renal
i