Trocoxil - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Trocoxil 6 mg chewable tablets for dogs

Trocoxil 20 mg chewable tablets for dogs

Trocoxil 30 mg chewable tablets for dogs

Trocoxil 75 mg chewable tablets for dogs

Trocoxil 95 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 :

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

Manufacturer responsible for batch release :

Pfizer Italia s.r.l.

Località Marino del Tronto

63100 Ascoli Piceno (AP)

ITALY

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Trocoxil 6 mg chewable tablets for dogs

Trocoxil 20 mg chewable tablets for dogs

Trocoxil 30 mg chewable tablets for dogs

Trocoxil 75 mg chewable tablets for dogs

Trocoxil 95 mg chewable tablets for dogs

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

Active substance:

Mavacoxib	6 mg
Mavacoxib	20 mg
Mavacoxib	30 mg
Mavacoxib	75 mg
Mavacoxib	95 mg

Tablets also contain the following ingredients:

Sucrose

Silicified microcrystalline cellulose

Artificial powdered beef flavour

Croscarmellose sodium

Sodium laurylsulfate

Magnesium stearate

Triangular tablet with mottled brown appearance embossed with the tablet strength on one side, the reverse side is blank.

• 4. INDICATION(S)

Trocoxil chewable tablets are indicated for the treatment of pain and inflammation associated with degenerative joint disease in dogs where treatment for more than one month is needed.

Trocoxil belongs to a group of medicines called Non-steroidal Anti-inflammatory drugs (NSAIDs) which are used to treat pain and inflammation.

• 5. CONTRAINDI­CATIONS

Do not use in dogs less than 12 months of age and/or less than 5 kg body weight.

Do not use in dogs suffering from gastro-intestinal disorders including ulceration and bleeding.

Do not use where there is evidence of a haemorrhagic disorder.

Do not use in cases of impaired kidney or liver function.

Do not use in cases of heart insufficiency.

Do not use in pregnant, breeding or lactating animals.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in case of known hypersensitivity to sulphonamides.

Do not use concomitantly with glucocorticoids or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.

• 6. ADVERSE REACTIONS

Adverse reactions of the digestive tract such as vomiting and diarrhoea were commonly reported, loss of appetite, haemorrhagic diarrhoea and melaena have been reported in uncommon cases.

Gastrointestinal ulceration was reported in rare cases. Apathy, degradation of renal biochemistry parameters and impaired renal function have been reported in uncommon cases. In rare cases these adverse reactions may be fatal.

If an adverse reaction following the administration of Trocoxil occurs, no further tablets should be administered and general supportive therapy, as applied to clinical overdose with NSAIDs, should be applied. Particular attention should be paid to maintaining haemodynamic status.

Gastrointestinal protectants and parenteral fluids, as appropriate, may be required for animals that experienced gastrointestinal or renal adverse reactions. Note that Trocoxil has an extended effect of duration (up to 2 months after administration of the second dose and following doses). Adverse reactions could occur at any time point during this period.

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 aged 12 months or more.

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

Oral use.

Use the dose prescribed by the veterinarian. The dose of Trocoxil chewable tablets is 2 mg/kg of body weight (see table below).

THIS IS NOT A DAILY TREATMENT.

The initial treatment should be repeated 14 days later, thereafter the dosing interval is one month. A treatment cycle with Trocoxil should not exceed 7 consecutive doses (6.5 months).

Bodyweight (kg)	Number and Strength of Tablets to be Administered
	6 mg	20 mg	30 mg	75 mg	95 mg
5–6	2
7–10		1
11–15			1
16–20		2
21–23		1	1
24–30			2
31–37				1
38–47					1
48–52			1	1
53–62			1		1
63–75				2

ADVICE ON CORRECT ADMINISTRATION

Trocoxil should be given immediately before or during the animal’s main meal. Care should be taken to ensure that the tablet is ingested.

• 10. WITHDRAWAL PERIOD(S)

Not applicable

• 11. SPECIAL STORAGE PRECAUTIONS

The veterinary medicinal product does not require any special storage conditions.

Keep out of the sight and reach of children.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and blister after Exp.

• 12. SPECIAL WARNING(S)

Advice for dog owner

Before prescribing Trocoxil and during treatment with Trocoxil, your veterinarian will check your dog for kidney and liver problems as well as for diseases of the intestines.

Trocoxil should not be used in dehydrated dogs.

If your dog needs surgery, inform the surgeon that the dog is using Trocoxil.

Do not administer other NSAIDs or glucocorticoids concurrently or within at least 1 month of the last administration of Trocoxil.

Trocoxil has an extended effect duration (up to 2 months after administration of the second dose and following doses). Adverse reactions could occur at any timepoint during this period.

If an adverse reaction to the administration of Trocoxil occurs, stop using the product, and seek medical advice from your veterinarian immediately.

Trocoxil must not be used in pregnant, breeding or lactating animals.

Tell your veterinarian if your dog is using a blood-thinning agent.

Do not exceed the stated dose prescribed by your veterinarian.

In case of accidental self-administration, seek medical advice immediately and show the package leaflet or the label to the physician.

If you have a known hypersensitivity to NSAIDs you should avoid contact with the veterinary medicinal product.

Ingestion of Trocoxil may be harmful for children, and prolonged pharmacological effects leading to e.g. gastrointestinal disorders may be observed. To avoid accidental ingestion, administer the tablet to the dog immediately after removal from the blister packaging.

Do not eat, drink, or smoke when handling the product. Wash hands after handling the product

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE

MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste.

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

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

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

• 15. OTHER INFORMATION