Cephacare flavour 50 mg tablets for cats and dogs

Composition

Each tablet contains:

Active substance:

Cefalexin (as cefalexin monohydrate) 50 mg

Excipients:

Beige speckled, round biconvex tablets.

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Pharmacological properties

ATCvet code: QJ01DB01.

Pharmacodynamics

Cefalexin is a semi-synthetic bactericidal antibiotic belonging to the cephalosporin group which acts by interference with bacterial cell wall formation.

Cefalexin is active against a wide range of Gram-positive and Gram-negative bacteria. The following micro-organisms have been shown to be sensitive to cefalexin in vitro: Staphylococcus spp (including penicillin-resistant strains), Streptococcus spp, Corynebacterium spp, Pasteurella multocida, Escherichia coli, Micrococcus spp, Moraxella spp.

Cefalexin is resistant to the action of staphylococcal penicillinase and is therefore active against the strains of Staphylococcus aureus that are insensitive to penicillin (or related antibiotics such as ampicillin or amoxycillin) because of production of penicillinase.

Cefalexin is also active against the majority of ampicillin-resistant E.coli.

Pharmacokinetics

Following oral administration, cefalexin is rapidly and almost completely absorbed. Peak plasma concentrations (Cmax= 14.38 μg/ml) are achieved within approximately 2 hours (Tmax= 2.1 hours) in the cat. Peak plasma concentrations in the dog (Cmax= 17.49 μg/ml) are achieved within approximately 1.5 hours (Tmax= 1.55). In both species, cefalexin is excreted in the urine in high concentrations and has an elimination half life (T1/2) of approximately 2.5–3 hours.

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Target species

Cats and dogs.

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Indications

In dogs:

Treatment of infections of the respiratory tract, gastrointestinal tract, urogenital tract, the skin and localised infections in soft tissue caused by bacteria sensitive to cefalexin.

In cats:

Treatment of infections of the respiratory tract, urogenital tract, the skin and localised infections in soft tissue caused by bacteria sensitive to cefalexin.

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Dosage

Oral use.

Dogs:

A dose of 15 mg/kg twice daily is recommended, to be doubled where appropriate.

Treatment for five days is recommended. Any increase in dose or duration of use should be according to the benefit-risk assessment by the responsible veterinarian (e.g. in cases of chronic pyoderma).

Cats:

A dose of 15 mg/kg twice daily for 5 days is recommended.

Tablets may be added to food if necessary.

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

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Contraindications

Do not use in cases of hypersensitivity to the active substance, to other cephalosporins, to other substances of the β-lactam group or to any of the excipients. Do not use in rabbits, gerbils, guinea pigs and hamsters.

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Adverse reactions

Cats:

Undetermined frequency (cannot be estimated from the available data): Diarrhoea*, vomiting*

* Transient. When observed, treatment should be stopped.

Dogs:

Rare (1 to 10 animals / 10,000 animals treated): Hypersensitivity*

Undetermined frequency (cannot be estimated from the available data): Diarrhoea**, vomiting**

*When observed, the treatment should be discontinued and occurring symptoms should be treated symptomatically.

**When observed, treatment should be stopped and the advice of the attending 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 target species:

Use of the veterinary medicinal product should be based on susceptibility testing and take into account official and local antimicrobial policies.

Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to cefalexin and may decrease the effectiveness of treatment with penicillins, due to the potential for cross-resistance.

In the case of an allergic reaction, treatment should be withdrawn.

As with other antibiotics which are excreted mainly by the kidneys, unnecessary accumulation may occur in the body when renal function is impaired. In cases of known renal insufficiency the dose should be reduced, antimicrobials known to be nephrotoxic should not be administered concurrently and the veterinary medicinal product should be used only according to the benefit-risk assessment by the responsible veterinarian.

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

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin may lead to cross-reactions to cephalosporin and vice versa. Allergic reactions to these substances may occasionally be serious. People with known hypersensitivity to cefalexin should avoid contact with the veterinary medicinal product.

Handle this veterinary medicinal product with great care to avoid exposure, taking all recommended precautions. If you develop symptoms following exposure such as skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty breathing are more serious symptoms and require urgent medical attention.

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

Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

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

To be completed in accordance with national requirements.

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Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy or lactation. Use only according to the benefit-risk assessment by the responsible veterinarian.

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Interactions

The bactericidal activity of cephalosporins is reduced by concomitant administration of bacteriostatic acting compounds (macrolides, sulphonamides and tetracyclines). Nephrotoxicity can be increased when 1st generation cephalosporins are combined with polypeptide antibiotics, aminoglycosides and some diuretics (furosemide). Concomitant use with such active substances should be avoided.

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Overdose

The administration of cefalexin has been shown to produce no serious side effects at many times the recommended dose rate.

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Special warnings

None.

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Withdrawal period

Not applicable.

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Incompatibilities

Not applicable.

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Immediate packaging

The veterinary medicinal product is supplied in PVC/aluminium foil blister packs, each containing 10 tablets, in cardboard boxes containing 20, 100 or 250 tablets.

Not all pack sizes may be marketed.

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Storage

Do not store above 25 °C.

Store in a dry place.

Keep the blister in the outer carton.

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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 32742/4029

DATE OF FIRST AUTHORISATION

19 December 2008

DATE OF THE LAST REVISION OF THE SUMARY OF THE PRODUCT CHARACTERISTICS

March 2025

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

Ecuphar NV

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