NAME: ADTAB CHEWABLE TABLETS FOR DOGS. ACTIVE INGREDIENTS: Lotilaner: 900 mg. EXCIPIENTS: Cellulose powder, lactose monohydrate, silicified microcrystalline cellulose, dried meat flavour, crospovidone, povidone K30, sodium lauryl sulphate, colloidal anhydrous silica, magnesium stearate. THERAPEUTIC INDICATIONS: For the treatment of flea and tick infestations in dogs. This veterinary medicinal product provides immediate and persistent elimination of fleas (Ctenocephalides felis and C. canis) and ticks (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus and Dermacentor reticulatus) for 1 month. Fleas and ticks must attach to the host and start feeding to be exposed to the active substance. CONTRAINDICATIONS / ADVERSE EFFECTS 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 puppies aged 8 to 9 weeks, 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 body weight) on eight occasions at monthly intervals. DOSAGE 45 kg. Dosage and number of tablets to be administered: appropriate combination of tablets. For dogs weighing more than 45 kg, use an appropriate combination of the available strengths to achieve the recommended dose of 20-43 mg/kg. Underdosing may cause ineffectiveness and promote the development of resistance. To ensure correct dosing, determine body weight as accurately as possible. AdTab is a chewable, flavored tablet. Administer the chewable tablet with food or after meals. For optimal control of flea and tick infestations, the product should be administered at monthly intervals during the flea and/or tick season, depending on the local epidemiological situation. 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, if necessary, they should be treated with an appropriate product. Fleas, at any stage of their development, can infest dog bedding and normal resting areas such as carpets and upholstered furniture. In case of severe flea infestation and at the beginning of control measures, these areas should be treated with a suitable environmental product and then cleaned regularly. Special precautions for safe use in the target species: All efficacy and safety data have been obtained from dogs and puppies 8 weeks of age or older and weighing 1.3 kg or more. In the absence of available data, a veterinarian should be consulted before treatment of puppies less than 8 weeks of age or weighing less than 1.3 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 label. Special precautions for the environment: Not applicable. No adverse reactions were observed after oral administration to puppies aged 8 to 9 weeks, 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 body weight) eight times at monthly intervals. Incompatibilities: Not applicable. TARGET SPECIES: Dogs. INTERACTIONS: None known. During clinical field studies, no interactions were observed between lotilaner and commonly used veterinary medicinal products. DIAGNOSIS AND PRESCRIBING: Veterinary medicinal product not subject to prescription. ADVERSE REACTIONS: Target species: Dogs. Very rare (<1 animal/10,000 animals treated, including isolated reports): , anorexia ^1,2, lethargy ^2, ataxia ^3, convulsions ^3, tremor ^3. ^1 Mild and transient. ^2 Usually resolve without treatment. ^3 In most cases, they are transient. Reporting of adverse events is important as it allows for the continued 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, lactation or in breeding dogs. Pregnancy and lactation: Laboratory studies in rats did not indicate teratogenic effects or adverse effects on the reproductive capacity of males and females. Consult a veterinarian before use during pregnancy and lactation. Fertility: Consult a veterinarian before treatment in breeding dogs