Tolfedine Tablets 60 mg

Composition

Each tablet contains:

Active substance:

Tolfenamic acid 60 mg

Excipients:

Qualitative composition of excipients and other constituents

Calcium Hydrogen Phosphate Dihydrate

Wheat Starch

Docusate Sodium

Microcrystalline Cellulose

Magnesium Stearate

White convex tablets, divisible in two.

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Pharmacological properties

4.1 ATCvet code:

QM01AG02.

4.2 Pharmacodynamics

Tolfenamic acid (N-(2-methyl-3-chlorophenyl) anthranilic acid) is a non-steroidal anti-inflammatory drug belonging to the fenamate group. Tolfenamic acid possesses anti-inflammatory, analgesic and antipyretic properties.

The anti-inflammatory activity of tolfenamic acid is due to inhibition of cyclooxygenase leading to a reduction in prostaglandin and thromboxane synthesis, major inflammatory mediators.

4.3 Pharmacokinetics

Absorption:

Tolfenamic acid is rapidly absorbed. After a single oral administration of 4 mg/kg tolfenamic acid, the mean maximal plasma concentration (Cmax) of about 4µg/ml is reached in about 1 hour. When the same intake of tolfenamic acid is taken with food, Cmax is 1.9 ± 1.4 µg/ml. These variations are due to a strong enterohepatic recycling of the product.

Distribution, metabolism, excretion:

Tolfenamic acid is distributed in all organs with a strong concentration in plasma, digestive tract, liver, lungs and kidneys. The concentration in the brain however is low.

Tolfenamic acid and its metabolites do not cross the placenta barrier to any great extent.

Tolfenamic acid is excreted mainly unchanged.

In dogs with renal insufficiency, the elimination of tolfenamic acid is unchanged.

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Target species

Dogs.

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Indications

Treatment for alleviation of acute episodes of inflammation and pain in chronic locomotor disease.

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Dosage

Oral administration with food.

To ensure a correct dosage, body weight should be determined as accurately as possible.

4 mg tolfenamic acid/kg once daily, i.e. 1 tablet for 15 kg of bodyweight administered in feed for 3 days according to the following table:

Subject to clinical response, the administration may be repeated every 7 days, ie 3 days of medication followed by 4 days without medication.

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Contraindications

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.

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

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Adverse reactions

Dogs:

Rare (1 to 10 animals / 10,000 animals treated): Vomiting1, diarrhoea1, Polyuria1,2, Polydipsia1,2

1 In most of the cases, these signs cease spontaneously after the treatment

2 Temporary

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Not for use in dogs under 7 kg bodyweight.

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 tablets are 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 insufficiency and requiring an anti-inflammatory treatment may be treated with tolfenamic acid without requiring an adjustment of the dosage. However, the use of this product is contraindicated in acute cases of renal insufficiency.

In case of undesirable effects (anorexia, vomiting, diarrhoea, presence of blood in faeces) occurring during the treatment, your veterinarian should be contacted for advice.

Long term treatment of over 3 months duration should be under regular veterinary supervision. In particular, dogs with hepatic insufficiency should be closely monitored.

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

In case of accidental contact with eyes, wash with plenty of water.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy:

The use is not recommended during pregnancy.

Laboratory studies in animals have not produced any evidence of effects on reproduction.

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Interactions

Do not administer NSAIDs concurrently or within 24 hours of each other. Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs, which can lead to toxic effects.

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Overdose

In case of overdose, administer symptomatic treatment.

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Special warnings

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.

See also section 3.5

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Withdrawal period

Not applicable.

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Incompatibilities

None known.

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Immediate packaging

Box of 1 PVC-aluminium blister of 8 tablets.

Box of 2 PVC-aluminium blisters of 8 tablets.

Box of 12 PVC-aluminium blisters of 8 tablets.

Box of 24 PVC-aluminium blisters of 8 tablets.

Box of 48 PVC-aluminium blisters of 8 tablets.

Not all pack sizes may be marketed.

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Storage

Do not store above 25°C.

Store in a dry place.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale 3 years.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 08007/5065

8 DATE OF FIRST AUTHORISATION

15 October 1993

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

December 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk

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Registration holder

Vetoquinol UK Limited

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