Each chewable tablet contains:

Chewable tablet.

White to beige round chewable tablets with brownish spots.

Dogs.

For the treatment of flea and tick infestations in dogs.

This veterinary medicinal product provides immediate and persistent killing activity for 1 month for fleas (Ctenocephalides felis and C. canis) and ticks (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus and Dermacentor reticulatus).

Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.

The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).

For the treatment of demodicosis (caused by Demodex canis)

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

Parasites need to start feeding on the host to become exposed to lotilaner; therefore the risk of the transmission of parasite borne diseases cannot be completely excluded.aused by Demodex canis)

All safety and efficacy data have been acquired from dogs and puppies 8 weeks of age and older and 1.3 kg of body weight and greater. Use of this veterinary medicinal product in puppies younger than 8 weeks of age or less than 1.3 kg of body weight should be based on a benefit-risk assessment by the responsible veterinarian.

Wash hands after handling the product.

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

iii) Other precautions

Not applicable

Target species: Dogs

1 Mild and transient

2 Typically resolve without treatment

3 Transient in most cases

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 also the last section of the package leaflet for the respective contact details.

Laboratory studies in rats have not produced any evidence of teratogenic effects, or any adverse effect on the reproductive capacity of males and females. The safety of the veterinary medicinal product in breeding, pregnant and lactating dogs has not been established. Use only according to the benefit-risk assessment of the responsible veterinarian.

None known. During clinical testing, no interactions between Credelio chewable tablets and routinely used veterinary medicinal products were observed.

For oral use.

The veterinary medicinal product should be administered in accordance with the following table to ensure a dose of 20 to 43 mg lotilaner/kg bodyweight.

Use an appropriate combination of available strengths to achieve the recommended dose of 20-43 mg/kg.

Credelio is a palatable chewable flavoured tablet. Administer the chewable tablet(s) monthly with or after food.

For the treatment of demodicosis (caused by Demodex canis)

Monthly administration of the product for two consecutive months is efficacious and leads to a marked improvement of clinical signs. Treatment should be continued until two negative skin scrapings are obtained one month apart. Severe cases may require prolonged monthly treatments. As demodicosis is a multi factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.

No adverse reactions were observed following oral administration to puppies aged 8–9 weeks and weighing 1.3–3.6 kg treated with overdoses of up to 5 times the maximum recommended dose (43 mg, 129 mg and 215 mg lotilaner/kg bodyweight) on eight occasions at monthly intervals.

Not applicable.

Pharmacotherapeutic group: ectoparasiticides for systemic use, isoxazolines.

ATCvet code: QP53BE04

Lotilaner, a pure enantiomer from the isoxazoline class is active against fleas (Ctenocephalides felis and Ctenocephalides canis) the tick species Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus as well as Demodex canis mites.

Lotilaner is a potent inhibitor of gamma–aminobutyric acid (GABA)-gated chloride channels, resulting in rapid death of ticks and fleas. The activity of lotilaner was not affected by resistance to organochlorines (cyclodienes, e.g. dieldrin), phenylpyrazoles (e.g. fipronil), neonicotinoids (e.g. imidacloprid), formamidines (e.g. amitraz) and pyrethroids (e.g. cypermethrin).

For fleas, the onset of efficacy is within 4 hours of attachment for one month after product administration. Fleas on the animal prior to administration are killed within 6 hours.

For ticks, the onset of efficacy is within 48 hours of attachment for one month after product administration. Existing I. ricinus ticks on the animal prior to administration are killed within 8 hours.

The veterinary medicinal product kills existing and newly emerged fleas on dogs before they can lay eggs. Therefore, the product breaks the flea life cycle and prevents environmental flea contamination in areas to which the dog has access.

Following oral administration, lotilaner is readily absorbed and peak blood concentration is reached within 2 hours. Food enhances absorption. The terminal half-life is approximately 4 weeks. This long terminal half-life provides effective blood concentrations for the entire duration of the inter-dosing interval.

The major route of elimination is biliary excretion and renal excretion is the minor route of elimination (less than 10% of the dose). Lotilaner is metabolized to a small extent into more hydrophilic compounds which are observed in faeces and urine.

Cellulose, powdered

Lactose monohydrate

Silicified microcrystalline cellulose

Meat dry flavour

Crospovidone

Povidone K30

Sodium laurilsulfate

Silica, colloidal anhydrous

Magnesium stearate

Incompatibilities

Not applicable.

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

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

The tablets are packaged in aluminium/aluminium blisters packaged into an outer cardboard box. Each tablet strength is available in pack sizes of 1, 3, 6 or 18 tablets.

Not all pack sizes may be marketed.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Elanco GmbH

Heinz-Lohmann-Str. 4

Groden

27472 Cuxhaven

Germany

Date of first authorisation: 25/04/2017

November 2023

Veterinary medicinal product subject to prescription