SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Rilexine 600 mg Tablets for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Active substance:

Cefalexin………………………………………………….600 mg

(as Cefalexin Monohydrate) Excipients:

Qualitative composition of excipients and other constituents

Crospovidone

Mannitol

Starch pregelantinised

Croscarmellose sodium

Collodial anhydrous silica

Collodial hydrated silica

Povidone K30

Microcrystalline cellulose (type A)

Poultry liver powder

Magnesium stearate

Microcrystalline cellulose (type B)

Creamy oblong tablet with small brown spots marked with a score line. The tablets can be divided into halves.

3. CLINICAL INFORMATION

3.1 Target species

Dogs.

3.2 Indications for use for each target species

For the treatment of bacterial skin infections in dogs (including deep and superficial pyodermas) caused by organisms susceptible to cefalexin.

For the treatment of urinary-tract infections in dogs (including nephritis and cystitis) caused by organisms susceptible to cefalexin.

3.3 Contraindications

Do not use in cases of hypersensitivity to penicillins and cephalosporins.

Do not use in rabbits, guinea pigs, hamsters and gerbils.

3.4 Special warnings

None.

3.5 Special precautions for use

Special precautions for safe use in the target species:

As with other antibiotics which are excreted mainly by the kidneys, unnecessary accumulation may occur in the body when renal function is impaired. In case of known renal insufficiency, the dose should be reduced and antimicrobials known to be nephrotoxic should not be administered concurrently.

This product should not be used to treat puppies of less than 1 kg of bodyweight.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the cefalexin and may decrease the effectiveness of treatment with other cephalosporins and penicillins, due to the potential for crossresistance.

Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local epidemiological information.

Official, national and regional antimicrobial policies should be taken into account when the product is used.

As the tablets are palatable for animals there is a danger of excessive ingestion. The tablets must therefore be stored out of the reach of animals.

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 sensitivity to cephalosporin and vice versa. Allergic reactions to these substances may occasionally be serious.

1- Do not handle this product if you know you are sensitised or if you have been advised not to work with such preparations.

2- Handle this product with great care to avoid exposure, taking all recommended precautions. Wash hands after use.

3- If you develop symptoms following exposure such as skin rash, seek medical advice and show the package leaflet or the label to the physician. Swelling of the face, lips or eyes or difficulty with breathing are more-serious symptoms and require urgent medical attention.

Special precautions for the protection of the environment:

Not applicable.

3.6 Adverse events Dogs:

Uncommon (1 to 10 animals / 1,000 animals treated):	Lethargy
Rare (1 to 10 animals / 10,000 animals treated):	Hypersensitivity reaction1 (e.g Allergic skin reaction, Hives, Allergic oedema, Abnormal breathing, Circulatory disorder,)
Very rare (<1 animal / 10,000 animals treated, including isolated reports):	Vomiting2, Diarrhoea2

¹ In animals sensitive to penicillins/cephalosporins. Allergic cross-reactivity with other βlactam may occur.

² If vomiting and/or diarrhea occurs repeatedly, treatment should be discontinued and the advice of the treating veterinarian 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 also the package leaflet for respective contact details.

3.7 Use during pregnancy, lactation or lay Pregnancy and lactation:

Can be used during pregnancy and lactation.

3.8 Interaction with other medicinal products and other forms of interaction

The association of first-generation cephalosporins with aminoglycoside antibiotics and some diuretics such as furosemide can enhance nephrotoxicity risks.

The bactericidal activity of cephalosporins is reduced by concomitant administration of bacteriostatic acting compounds (tetracyclines, chloramphenicol, macrolides and rifampicin).

3.9 Administration routes and dosage

15 mg of cephalexin per kg of bodyweight twice daily (equivalent to 30 mg per kg of bodyweight per day) for a duration of:

- 14 days in case of urinary-tract infection in dogs;

- at least 15 days in case of superficial infectious dermatitis in dogs;

- at least 28 days in case of deep infectious dermatitis in dogs.

To achieve this dosage, administer:

• Twice daily, one tablet per 40 kg of bodyweight or ½ tablet per 20 kg of bodyweight.

To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.

Due to its palatable formulation, the product is well accepted by dogs but may be crushed or added to food if necessary.

In severe or acute conditions, the dose may be safely doubled.

3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)

Trials performed on animals with up to 5 times the recommended dosage demonstrated that the product is well tolerated.

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.

3.12 Withdrawal periods Not applicable.

4. PHARMACOLOGICAL INFORMATION

4.1 ATCvet code: QJ01DB01.

4.2 Pharmacodynamics

Cefalexin acts by inhibiting the nucleopeptide synthesis of the bacterial wall.

Cephalosporins interfere with the enzymes of transpepditation making it unable to crosslink the peptidoglycans of the bacterial cell wall. The glycan cross-linking is essential for the cell to build its cell wall. Inhibition of the biosynthesis results to a weakened cell wall, which eventually ruptures to osmotic pressure. The combined action results in cell lysis and filament formation.

Cefalexin is active against a wide range of gram-positive and gram-negative bacteria: Staphylococcus spp. (including penicillin-resistant strains), Streptococcus spp., Escherichia coli, Klebsiella spp. and Salmonella spp.. Cefalexin is not inactivated by βlactamases produced by gram-positive bacteria and which usually affect penicillins

4.3 Pharmacokinetics

After single oral administration of the recommended dosage of 15 mg of cefalexin per kg of bodyweight to Beagle dogs, plasma concentrations were observed within 30 minutes. The plasma peak was observed at 1.3 hour with a plasma concentration of 18.2 µg/ml. The bioavailability of the active was over 90 %. Cefalexin was detected until 24 hours after the administration. The first urine specimen was collected within 2 to 12 hours with peak concentrations of cefalexin measured at 430 to 2758 µg/ml within 12 hours.

After repeated oral administration of the same dosage, twice a day for 7 days, plasma peaks occurred 2 hours later with a concentration of 20 µg/ml. Over the treatment period, concentrations were maintained above 1 µg/ml. The mean elimination half-life is 2 hours. Skin levels were around 5.8 to 6.6 µg/g, 2 hours after treatment.

5. PHARMACEUTICAL PARTICULARS

5.1 Major incompatibilities

Not applicable.

5.2 Shelf life

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

5.3 Special precautions for storage

Keep the blisters in the outer carton in order to protect from light. Divided tablets should be stored in blister packs.

5.4 Nature and composition of immediate packaging

Blister packs consisting of blister aluminium – PVC/aluminium/OPA. Aluminium foil lid coated with lacquer.

Cardboard Box with 30 blisters of 7 tablets.

Not all pack sizes may be marketed.

5.5 Special precautions for the disposal of unused veterinary medicinal 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.

6. NAME OF THE MARKETING AUTHORISATION HOLDER

VIRBAC

7. MARKETING AUTHORISATION NUMBER

Vm 05653/4132

8. DATE OF FIRST AUTHORISATION

24 October 2005

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

March 2024

10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

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

Gavin Hall Approved: 25 July 2025