Previcox - Patient leaflet, side effects, dosage

3B

PACKAGE LEAFLET

Previcox 57 mg chewable tablets for dogs

Previcox 227 mg chewable tablets for dogs

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder :

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelhe­im/Rhein

GERMANY

Manufacturer responsible for batch release :

Boehringer Ingelheim Animal Health France SCS,

4 Chemin du Calquet, 31000 Toulouse, France

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Previcox 57 mg chewable tablets for dogs

Previcox 227 mg chewable tablets for dogs

firocoxib

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each chewable tablet contains:

Active substance:

firocoxib 57 mg

or

firocoxib 227 mg

Excipients:

Iron oxides (E172)

Caramel (E150d)

Tan-brown, round, convex, tablets with a cross-shaped break line on one side. The tablets can be divided into 2 or 4 equal parts.

• 4. INDICATION(S)

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.

• 5. 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 bodyweight.

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).

• 6. ADVERSE REACTIONS

Emesis and diarrhoea have occasionally been reported. These reactions are generally of a transitory nature and are reversible when the treatment is stopped. Renal and/or hepatic disorders have been reported in very rare cases in dogs administered the recommended treatment dose. Rarely, nervous system disorders have been reported in treated dogs.

If adverse reactions like vomiting, repeated diarrhoea, faecal occult blood, sudden weight loss, anorexia, lethargy, degradation of renal or hepatic biochemistry parameters occur, use of the product should be stopped and the advice of a veterinarian should be sought. As with other NSAIDs, serious adverse effects can occur and, in very rare cases, may be fatal.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Dogs.

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

5 mg/kg once daily.

For the reduction of post-operative pain and inflammation, the animals can be dosed starting approximately 2 hours before surgery for up to 3 consecutive days as needed. Following orthopaedic surgery and depending on the response observed, treatment using the same daily dosing schedule may be continued after the first 3 days, upon judgement of the attending veterinarian.

For oral use as per table below.

Body weight (kg)	Number of chewable tablets by size		mg/kg range
	57 mg	227 mg
3.0 – 5.5	0.5		5.2 – 9.5
5.6 – 7.5	0.75		5.7 – 7.6
7.6 – 10	1	0.25	5.7 – 7.5
10.1 – 13	1.25		5.5 – 7.1
13.1 – 16	1.5		5.3 – 6.5
16.1 – 18.5	1.75		5.4 – 6.2
18.6 – 22.5		0.5	5.0 – 6.1
22.6 – 34		0.75	5.0 – 7.5
34.1 – 45		1	5.0 – 6.7
45.1 – 56		1.25	5.1 – 6.3
56.1 – 68		1.5	5.0 – 6.1
68.1 – 79		1.75	5.0 – 5.8
79.1 – 90		2	5.0 – 5.7

Tablets can be divided into 2 or 4 equal parts to enable accurate dosing.

ADVICE ON CORRECT ADMINISTRATION

Tablets can be administered with or without food. Do not exceed the recommended dose.

Duration of treatment will be dependent on the response observed. As field studies were limited to 90 days, longer-term treatment should be considered carefully and regular monitoring undertaken by the veterinarian.

• 10. WITHDRAWAL PERIOD

Not applicable.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Do not store above 30 °C.

Store in the original package.

Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.

Divided tablets may be stored for up to 1 month in the original package.

Special precautions for use in animals :

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. Appropriate laboratory testing is recommended prior to treatment in order to detect subclinical (asymptomatic) renal or hepatic disorders that may predispose to adverse effects. Avoid use in dehydrated, hypovolaemic or hypotensive animals, as there is a risk of increased renal toxicity. Concurrent administration of potentially nephrotoxic drugs should be avoided.

Use this product under strict veterinary monitoring where there is a risk of gastro-intestinal bleeding, or if the animal previously displayed intolerance to NSAIDs. The treatment should be discontinued if any of these signs are observed: repeated diarrhoea, vomiting, faecal occult blood, sudden weight loss, anorexia, lethargy, degradation of renal or hepatic biochemistry parameters.

Special precautions to be taken by the person administering the veterinary medicinal product to animals :

Wash hands after use of the product.

In case of accidental ingestion, seek medical advice immediately and show the package insert or the label to the physician.

Divided tablets should be returned to the original package.

Pregnancy and lactation :

Do not use in pregnant or lactating bitches.

Laboratory studies in rabbits have shown evidence of maternotoxic and foetotoxic effects at dose rates approximating the recommended treatment dose for the dog.

Interaction with other medicinal products and other forms of interaction :

Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before the commencement of treatment with Previcox. The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.

Previcox must not be administered in conjunction with other NSAIDs or glucocorticos­teroids. Gastrointestinal tract ulceration may be exacerbated by corticosteroids in animals given non-steroidal anti-inflammatory drugs.

Concomitant treatment with molecules displaying action on renal flow, e.g. diuretics or Angiotensin Converting Enzyme (ACE) inhibitors, should be subject to clinical monitoring. Concurrent administration of potentially nephrotoxic drugs should be avoided as there might be an increased risk for renal toxicity. As anaesthetic drugs may affect renal perfusion, the use of parenteral fluid therapy during surgery should be considered to decrease potential renal complications when using NSAIDs peri-operatively.

Concurrent use of other active substances that have a high degree of protein binding may compete with firocoxib for binding and thus lead to toxic effects.

Overdose (symptoms, emergency procedures, antidotes):

In dogs ten weeks of age at the start of treatment at dose rates equal or greater to 25 mg/kg/day (5 times the recommended dose) for three months, the following signs of toxicity were observed: bodyweight loss, poor appetite, changes in the liver (accumulation of lipid), brain (vacuolisation), duodenum (ulcers) and death. At dose rates equal or greater to 15 mg/kg/day (3 times the recommended dose) for six months, similar clinical signs were observed, albeit that the severity and frequency were less and duodenal ulcers were absent.

In those target animal safety studies, clinical signs of toxicity were reversible in some dogs following cessation of therapy.

In dogs seven months of age at the start of treatment at dose rates greater than or equal to

25 mg/kg/day (5 times the recommended dose) for six months, gastrointestinal adverse effects, i.e. vomiting were observed.

Overdose studies were not conducted in animals over 14 months of age.

If clinical signs of overdosing are observed, discontinue treatment.

Incompatibilities :

Not applicable.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this product is available on the website of the European Medicines Agency

• 15. OTHER INFORMATION

Mode of action:

Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) that acts by selective inhibition of cyclooxygenase-2 (COX-2) – mediated prostaglandin synthesis. COX-2 is the isoform of the enzyme that has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. In in-vitro canine whole blood assays, firocoxib exhibited approximately 380-fold selectivity for COX-2 over COX-1.

Previcox chewable tablets are scored to facilitate accurate dosing and contain caramel and smoke flavours to facilitate administration to dogs.

The chewable tablets (57 mg or 227 mg) are available in the following pack sizes:

• – 1 cardboard box containing 1 blister of 10 tablets (10 tablets).

• – 1 cardboard box containing 3 blisters of 10 tablets (30 tablets).

• – 1 cardboard box containing 18 blisters of 10 tablets (180 tablets).

• – 1 cardboard box containing 1 bottle of 60 tablets.