NAME DRONCIT 50 MG TABLETS FOR DOGS AND CATS ACTIVE INGREDIENTS One 660 mg tablet contains the active substance: praziquantel 50 mg. EXCIPIENTS Lactose, microcrystalline cellulose, polyvinylpyrrolidone, sodium lauryl sulfate, magnesium stearate, colloidal anhydrous silica, corn starch. THERAPEUTIC INDICATIONS Anthelmintic for dogs and cats, with specific effect against adult tapeworms and immature intestinal forms. It is effective against: Echinococcus granulosus*, Echinococcus multilocularis, Dipylidium caninum, Taenia ovis, Taenia pisiformis, Taenia hydatigena, Mesocestoides corti, Hydatigera (Taenia) taeniaeformis, Taenia multiceps, Diphyllobothrium (Spirometra) erinacei. * Echinococcus granulosus: Dogs, carriers of Echinococcus tapeworms, become infected via sheep, cattle or pigs and can also transmit echinococcosis (hydatidosis, cystic form) to humans, a serious social disease in sheep-rearing regions. Therapeutic and/or prophylactic intervention with the veterinary medicinal product (possibly planned on a large scale) interrupts the biological cycle of the parasite and prevents transmission to humans. Hydatid cycle. CONTRAINDICATIONS / ADVERSE EFFECTS: Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in dogs weighing less than 2.5 kg. SAFETY IN TARGET SPECIES: None known. DOSAGE: Oral administration. The basic dose for dogs and cats is 5 mg/kg body weight. Therefore: 1 tablet up to 10 kg body weight, 2 tablets from 11 to 20 kg and 3 tablets from 21 to 30 kg. Against Diphyllobothrium (Spirometra), a dose of one tablet per 2.5 kg body weight is required. Overdoses of up to twice the recommended dose are not harmful, especially in cases of treatment against massive tapeworm infestations. The veterinary medicinal product is very well tolerated. In adult animals, doses up to 10 times the recommended dose (5 mg/kg body weight) are generally well tolerated. Underdosing may lead to ineffective use and may promote the development of resistance. The accuracy of the dose should be carefully monitored. The treatment should be administered on an empty stomach and the animals should be monitored immediately after administration so that the treatment can be repeated in the event of any rejection of the tablets. The veterinary medicinal product can be administered directly, rolled into meat or crushed into food. STORAGE: This veterinary medicinal product does not require any special storage conditions. Shelf life of the veterinary medicinal product as packaged for sale: 5 years. WARNINGS: Fleas act as intermediate hosts and are therefore a source of infection with Dipylidium caninum. To avoid reinfection, fleas should be removed from the animal and from the housing. Faeces of dogs should be collected and destroyed within 24 hours of treatment. The possibility that other animals in the same environment could be a source of reinfection with Dipylidium caninum should be considered and these should be treated, as necessary, with an appropriate product. Unnecessary use of antiparasitic drugs or use deviating from the instructions provided in the SPC may increase the selective pressure of resistance and may lead to reduced efficacy. The decision to use the product should be based on confirmation of the species and the parasite load or the risk of infection based on its epidemiological characteristics, for each animal. Special precautions for safe use in the target species: None. Special precautions to be taken by the person administering the veterinary medicinal product to animals: In the interest of good hygiene, the person administering the veterinary medicinal product to animals should wash their hands after use. 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. None known. Incompatibilities: None known. TARGET SPECIES: Dogs and cats. INTERACTIONS: None known. DIAGNOSIS AND PRESCRIBING: Veterinary medicinal product not requiring a veterinary prescription. ADVERSE REACTIONS: Dogs and cats. Very rare (<1 animal/10,000 animals treated, including isolated reports): digestive tract disorders (e.g. vomiting or diarrhoea). 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, to the marketing authorisation holder or his local representative or to the national competent authority via the national reporting system https://www.salute.gov.it/portale/moduliServizi/dettaglioSchedaModuliServizi.jsp?lingua=italiano&label=servizionline&idMat=MDV&idAmb=FMV&idSrv=PSK&flag=P. See also section 16 of the package leaflet for contact details. PREGNANCY AND LACTATION: Pregnancy and lactation: The veterinary medicinal product can be used in dogs and cats during pregnancy. Praziquantel is considered safe for both the dam and the foetus. The safety of the veterinary medicinal product during lactation has not been established. Use only according to the benefit-risk assessment by the responsible veterinarian