General Description
Target Species: Cat

For the treatment of flea and tick infestations in cats.
This veterinary medicinal product has an immediate and persistent killing effect for 1 month against fleas (Ctenocephalides felis and C. canis) and ticks (Ixodes ricinus).
Fleas and ticks must attach to the host and begin feeding to be exposed to the active ingredient.

Indications
Treatment of flea and tick infestations in dogs. This veterinary medicinal product provides immediate and persistent insecticidal activity against fleas (Ctenocephalides felis and C. canis) and acaricidal activity against ticks (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus, and Dermacentor reticulatus) for 1 month. Fleas and ticks must have attached to the host and begun feeding to be exposed to the active ingredient. Contraindications
Do not use in case of hypersensitivity to the active substance or to any of the excipients.

Use
For oral administration.

The flavored veterinary medicinal product should be administered according to the table below to ensure a single dose of 6 to 24 mg of lotilaner/kg body weight.

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

Composition
Active ingredient:

Per chewable tablet:

Lotilaner 48 mg

Excipients:

Powdered yeast (flavoring)

Gelted microcrystalline cellulose

Powdered cellulose

Lactose monohydrate

Povidone K30

Crospovidone

Sodium lauryl sulfate

Vanillin (flavoring)

Colloidal anhydrous 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, Polydipsia (increased thirst)1,2; Ataxia3, Convulsions3, Tremors3; Pruritus (itching)1,2; Inappropriate urination1, Polyuria (increased urination)1,2, 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: 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 cats.

Gestation and lactation: Laboratory studies in rats have not shown any teratogenic effects. The safety of the veterinary medicinal product has not been established during gestation.