NAME: ADTAB CHEWABLE TABLETS FOR CATS. ACTIVE INGREDIENTS: 2.0-8.0 kg). Lotilaner: 48 mg. EXCIPIENTS: Yeast powder (flavour), silicified microcrystalline cellulose, powdered cellulose, lactose monohydrate, povidone K30, crospovidone, sodium lauryl sulphate, vanillin (flavour), colloidal anhydrous silica, magnesium stearate. THERAPEUTIC INDICATIONS: For the treatment of flea and tick infestations in cats. This veterinary medicinal product provides immediate and persistent flea (Ctenocephalides felis and C. canis) and tick (Ixodes ricinus) killing activity for 1 month. Fleas and ticks must attach to the host and begin feeding to be exposed to the active substance. CONTRAINDICATIONS / ADVERSE REACTIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. SAFETY IN TARGET SPECIES No adverse reactions were observed after oral administration to 8-week-old kittens weighing 0.5 kg, which were treated with doses higher than 5 times the maximum recommended dose (130 mg lotilaner/kg body weight) on eight occasions at monthly intervals. DOSAGE 8.0 kg. Dosage and number of tablets to be administered: appropriate combination of tablets. In cats weighing more than 8 kg, use an appropriate combination of the available strengths to achieve the recommended dose of 6-24 mg/kg. Underdosing may result in ineffective use and may promote the development of resistance. To ensure correct dosing, determine body weight as accurately as possible. Administer the veterinary medicinal product with food or within 30 minutes of feeding. For optimal control of tick and flea infestations, the veterinary medicinal product should be administered at monthly intervals and continued throughout the flea and/or tick season, depending on local epidemiological situations. STORAGE: This veterinary medicinal product does not require any special storage conditions. Shelf life of the veterinary medicinal product as packaged for sale: 3 years. WARNINGS: Parasites must start feeding on the host to be exposed to lotilaner; therefore, the risk of transmission of diseases transmitted by parasites cannot be completely excluded. The possibility that other animals in the same household may be a source of flea reinfection should be considered and these should be treated, if necessary, with an appropriate product. Fleas, at any stage of their development, can infest the cats litter box and normal resting areas such as carpets and upholstered furniture. In cases of severe flea infestation and at the beginning of control measures, these areas should be treated with an appropriate environmental product and then cleaned regularly. Acceptable levels of efficacy may not be achieved if the veterinary medicinal product is not administered with food or within 30 minutes of feeding. Due to insufficient data to support efficacy against ticks in young cats, this product is not recommended for the treatment of ticks in kittens aged 5 months or less. Special precautions for safe use in the target species: Safety and efficacy data have been studied in cats aged 8 weeks or more, weighing 0.5 kg or more. In the absence of available data, a veterinarian should be consulted before treatment of kittens aged less than 8 weeks or weighing less than 0.5 kg. Special precautions to be taken by the person administering the veterinary medicinal product to animals: Wash hands after handling the product. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label. Special precautions for the protection of the environment: Not applicable. No adverse reactions were observed after oral administration to 8-week-old kittens weighing 0.5 kg, which were treated with doses higher than 5 times the maximum recommended dose (130 mg lotilaner/kg body weight) eight times at monthly intervals. Incompatibilities: Not applicable. TARGET SPECIES: Cat. INTERACTIONS: None known. During clinical field studies, no interactions between lotilaner and commonly used veterinary medicinal products were observed. DIAGNOSIS AND PRESCRIBING: Veterinary medicinal product not subject to medical prescription. ADVERSE REACTIONS: Target species: Cats. Very rare (<1 animal/10,000 animals treated, including isolated reports): vomiting ^1. ^1 Usually resolves without treatment. Reporting of adverse events is important as it allows the continuous monitoring of the safety of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, the marketing authorisation holder or the national competent authority via the national reporting system. See also the “Contact details” section of the package leaflet. PREGNANCY AND LACTATION: The safety of the veterinary medicinal product has not been established during pregnancy or lactation. Pregnancy and lactation: Laboratory studies in rats did not indicate teratogenic effects or adverse effects on male and female reproductive capacity. Consult a veterinarian before use during pregnancy and lactation. Fertility: Consult a veterinarian before use in breeding cats