Metacam 1 mg Chewable Tablets for Dogs

Composition

Each chewable tablet contains:

Active substance:

Meloxicam: 1 mg

Excipients:

Qualitative composition of excipients and other constituents

Sodium citrate dihydrate

Starch, pregelatinized

Iron oxide brown

Iron oxide yellow

Cellulose, microcrystalline

Meat Dry Flavour

Silica, colloidal anhydrous

Magnesium stearate

Round mottled beige biconvex tablet, scored on the upper side with embedded code

"M10" on one side.

The tablet can be divided into equal halves.

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Pharmacological properties

4.1 ATCvet code:

QM01AC06

4.2 Pharmacodynamics

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti- inflammatory, analgesic, anti-exudative and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

4.3 Pharmacokinetics

Absorption Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are obtained after approximately 4.5 hours. When the product is used according to the recommended dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.

Distribution There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins. The volume of distribution is 0.3 l/kg.

Metabolism Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. All major metabolites have been shown to be pharmacologically inactive.

Elimination Meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose is eliminated in faeces and the remainder in urine.

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Target species

Dogs

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Indications

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

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Dosage

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day, which can be given orally or alternatively using Metacam 5 mg/ml solution for injection for dogs and cats.

Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.

Each chewable tablet contains 1 mg meloxicam, which corresponds to the daily maintenance dose for a 10 kg body weight dog.

Each chewable tablet can be halved for accurate dosing according to the individual body weight of the dog. Particular care should be taken with regard to the accuracy of dosing. To ensure a correct dosage, body weight should be determined as accurately as possible. The use of suitably calibrated measuring equipment is recommended.

The veterinary medicinal product can be administered with or without food, are flavoured and are taken by most dogs voluntarily.

Dose scheme for the maintenance dose:

The use of Metacam oral suspension for dogs may be considered for an even more precise dosing. For dogs weighing less than 4 kg the use of Metacam oral suspension for dogs is recommended.

A clinical response is normally seen within 3 to 4 days. Treatment should be discontinued after 10 days if no clinical improvement is apparent.

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Contraindications

Do not use in dogs suffering from gastrointestinal disorders such as irritation or haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in dogs less than 6 weeks of age or less than 4 kg body weight. Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

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Adverse reactions

Dogs:

Very rare (<1 animal / 10,000 animals treated, including isolated reports): Appetite loss1, lethargy1

Vomiting1, diarrhoea1, blood in faeces1,2, haemorrhagic diarrhoea1, haematemesis1, gastric ulcer1, small intestine ulcer1

Elevated liver enzymes1

Renal failure1

1 These adverse events occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

2 Occult

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

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 its local representative 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:

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

This veterinary medicinal product for dogs should not be used in cats as it is not suitable for use in this species. In cats, Metacam 0.5 mg/ml oral suspension for cats should be used.

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

People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

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

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 and lactation The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Do not use in pregnant or lactating animals.

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Interactions

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. The veterinary medicinal product must not be administered in conjunction with other NSAIDs or glucocorticosteroids.

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

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Overdose

In case of overdose symptomatic treatment should be initiated.

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Special warnings

None.

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Withdrawal period

Not applicable.

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Incompatibilities

None known.

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Immediate packaging

Cardboard boxes containing 7, 84 or 252 tablets in Alu/Alu child-resistant blisters. Not all pack sizes may be marketed.

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Storage

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

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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

product or waste materials derived from the use of such products

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 61700/5038

8 DATE OF FIRST AUTHORISATION

23 March 2006

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

February 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.

Gavin Hall Approved: 16 April 2025

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Registration holder

Boehringer Ingelheim Vetmedica GmbH

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