Tolfedine 60 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tolfenamic acid

Available from:

Vetoquinol Ireland Limited

ATC code:

QM01AG02

INN (International Name):

Tolfenamic acid

Dosage:

60 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Canine

Therapeutic area:

tolfenamic acid

Therapeutic indications:

N.S.A.I.D.

Authorization status:

Authorised

Authorization date:

1993-08-12

Summary of Product characteristics

Health Products Regulatory Authority
06 November 2018
CRN008PTT
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tolfedine 60 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE
Tolfenamic Acid 60mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of acute inflammation due to chronic locomotor disease.
4.3 CONTRAINDICATIONS
Concurrent administration with other steroidal or non-steroidal
anti-inflammatory
drugs.
Do not use in animals with suspected gastro-duodenal ulceration.
Do not use in animals with impaired renal or hepatic function.Do not
use in pregnant
animals.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Health Products Regulatory Authority
06 November 2018
CRN008PTT
Page 2 of 5
SPECIAL PRECAUTION(S) FOR USE IN ANIMALS
Do not exceed the stated dose or duration of treatment.
Use in any animal less than 6 weeks of age or in aged animals may
involve additional
risk. If such use cannot be avoided, careful clinical management is
essential. Reduced
metabolism and excretion in these animals should be considered.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal as
there is a
potential risk of increased renal toxicity.
It is preferable that TOLFEDINE is not administered to animals
undergoing general
anaesthesia until fully recovered.
Where there is appearance of bloody or black faeces, a veterinary
surgeon should be
contacted for advice and the possibility of stopping treatment should
be considered.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
None.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Diarrhoea and vomiting may occur during treatment. Where either
persists,
treatment should be discontinued.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
Do not treat pregnant animals.
4.8 INTERAC