Ficoxil 227 mg chewable tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Firocoxib

Available from:

LIVISTO Int'l, S.L.

ATC code:

QM01AH90

INN (International Name):

Firocoxib

Dosage:

227 mg/tablet

Pharmaceutical form:

Chewable tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

firocoxib

Authorization status:

Authorised

Authorization date:

2021-06-18

Summary of Product characteristics

Health Products Regulatory Authority
18 June 2021
CRN009JDP
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ficoxil 227 mg chewable tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
​
ACTIVE SUBSTANCE:
​
​
​
Firocoxib
​227
mg​
​
​
​
​
EXCIPIENTS:
​
​
​
Red iron oxide (E172)
​0.525
​
mg
​
Yellow iron oxide(E172)
​0.225
​
mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablets.
Biconvex rosaceous round tablets with a double groove on one side
without inscriptions.
Tablets can be divided into 2 or 4 equal parts.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the relief of pain and inflammation associated with osteoarthritis
in dogs.
For the relief of post-operative pain and inflammation associated with
soft-tissue, orthopaedic and dental surgery in dogs.
4.3 CONTRAINDICATIONS
Do not use in pregnant or lactating bitches.
Do not use in animals less than 10 weeks of age or less than 3 kg body
weight.
Do not use in animals suffering from gastrointestinal bleeding, blood
dyscrasia or haemorrhagic disorders.
Do not use concomitantly with corticosteroids or other non-steroidal
anti-inflammatory drugs (NSAIDs).
Do not use in known cases of hypersensitivity to the active substance
or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
As the tablets are flavoured, they should be stored in a safe place
out of the reach of animals.
The recommended dose, as indicated in the dosing table, should not be
exceeded.
Use in very young animals, or animals with suspected or confirmed
impairment of renal, cardiac or hepatic function may
involve additional risk. If such use cannot be avoided, those dogs
require careful veterinary monitoring.
Health Products Regulatory Authority
18 June 2021
CRN009JDP
Page 2 of 5
Avoid use in any dehydrated,