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 900 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 side effects. Reporting allows continued monitoring of a medicine’s safety. If you experience any side effects, even those not listed in this leaflet, or if you think the medicine has not been effective, please contact your veterinarian first. You can also report any side effects to the Marketing Authorisation Holder using the contact details at the end of this leaflet, or via your national reporting system: {details of national system}. Target species: Cats. Very rare (<1 animal/10,000 animals treated, including isolated cases): Hyperactivity 1,2 Vomiting 2 Ataxia (lack of coordination), Muscle tremors Tachypnea (rapid and shallow breathing) Pruritus (itching) 1,2 Anorexia (loss of appetite), Lethargy 1 mild and transient 2 usually resolve without treatment. It is important to report side effects. Reporting allows continued monitoring of a medicine’s safety. If you experience any side effects, even those not listed in this leaflet, or if you think the medicine has not been effective, please contact your veterinarian first. You can also report any side effects to the Marketing Authorisation Holder using the contact details at the end of this leaflet, or via your national reporting system: {details of national system}.

Pregnancy and Lactation
3.7 Use during pregnancy, lactation, or egg-laying: The safety of this 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 in breeding dogs.

3.7 Use during pregnancy or lactation: The safety of this veterinary medicinal product has not been established during pregnancy or lactation. 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 treating breeding cats.

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 my