Indications
Target species: Dog

For the treatment of flea and tick infestations in dogs.
This veterinary medicinal product has an immediate and persistent killing effect for 1 month against 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 begin feeding to be exposed to the active ingredient.

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

Administration
For oral use.

The veterinary medicinal product should be administered in such a way as to ensure a dose of 20 to 43 mg of lotilaner/kg of body weight.
This veterinary medicinal product is presented as flavored and palatable chewable tablets. Administer the chewable tablet(s) once a month with or after a meal.

For optimal control of tick and flea infestations, the veterinary medicinal product should be administered monthly during flea and/or tick season, depending on local epidemiological conditions.

Composition
Active ingredient:

Per chewable tablet:

Lotilaner 450 mg

Excipients:

Cellulose, as powder

Lactose monohydrate

Gelded microcrystalline cellulose

Dried meat flavor

Crospovidone

Povidone K30

Sodium lauryl sulfate

Anhydrous colloidal silica

Magnesium stearate

Side effects
Target species: dogs Very rare (<1 animal / 10,000 animals treated, including isolated cases): Diarrhea1,2, Bloody diarrhea1, Vomiting1,2; Anorexia1,2, Lethargy2, Polydipsia1,2; Ataxia3, Convulsions3, Tremors3; Pruritus1,2; Inappropriate urination1, Polyuria1,2, Urinary incontinence1,2 1 mild and transient 2 usually resolve without treatment 3 transient in most cases. It is important to report adverse reactions. Reporting allows continued monitoring of the safety of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, either to the Marketing Authorisation Holder or to the competent national authority via the national reporting system. See the “Contact details” section of the package leaflet. Target species: cats. Very rare (<1 animal / 10,000 animals treated, including isolated cases): Hyperactivity1,2 Vomiting2 Ataxia, Muscle tremors Tachypnea Pruritus1,2 Anorexia, Lethargy1 mild and transient 2 usually resolve without treatment. It is important to report adverse reactions. Reporting allows continued monitoring of the safety of a veterinary medicinal product. Notifications should be sent, preferably via a veterinarian, either to the marketing authorization holder or to the competent national authority via the national notification system. See the “Contact details” section of the package leaflet.

Pregnancy and lactation
The safety of the veterinary medicinal product has not been established during pregnancy, lactation, or in breeding dogs. Pregnancy and lactation: Laboratory studies in rats have not shown any teratogenic effects or adverse effects on the reproductive performance of males and females. Consult a veterinarian before treatment during pregnancy and lactation. Fertility: Consult a veterinarian before treatment of breeding dogs.

Interactions
3.8 Drug interactions and other forms of interaction: None known. In clinical trials, no interactions were observed between lotilaner and commonly used veterinary medicinal products.

Warnings
Special warnings: Parasites must have begun feeding on the host to be exposed to lotilaner; therefore, the risk of transmission of infectious diseases of parasitic origin cannot be excluded. The possibility that other animals in the same household may be a source of flea re-infestation should be considered, and these animals should be treated with an appropriate product if necessary. Fleas have the ability to infest dog bedding and regular resting areas such as carpets and upholstery during all stages of their development. In the event of a heavy flea infestation, these areas should be treated with a suitable environmental product and then vacuumed regularly, starting from the beginning of the infestation control process. Special precautions for safe use in target species: The safety and efficacy of this product have not been evaluated in puppies under 8 weeks of age or in dogs weighing less than 1.3 kg. In the absence of available data, a veterinarian should be consulted for advice before administering this veterinary medicinal product to puppies.