NAME PRALEN 120 MG/G + 10 MG/G ORAL DROPS, SUSPENSION FOR CATS, PUPPIES AND SMALL DOGS ACTIVE INGREDIENTS Each g contains the following active substances: micronized mebendazole 120 mg; praziquantel (microencapsulated) 10 mg. EXCIPIENTS Malt extract, solid paraffin (white petrolatum), potassium dihydrogen phosphate, cellulose acetophthalate, sodium saccharin, light liquid paraffin (petroleum jelly). THERAPEUTIC INDICATIONS Treatment of parasitic infestations in dogs and cats caused by nematodes (roundworms) and cestodes (flatworms). Cat: Toxocara cati, Toxascaris leonina, Ancylostoma tubaeformae, Ancylostoma braziliense, Strongyloides spp., Taenia spp., Dipylidium caninum, Mesocestoides spp., Echinococcus spp.. Dog: Toxocara canis, Toxascenum stecinatoon, Unknown Strongyloides stercoralis, Trichuris vulpis, Taenia ovis, Taenia pisiformis, Taenia hydatigena, Taenia multiceps, Dipylidium caninum, Mesocestoides spp., Echinococcus spp.. By administering the veterinary medicinal product according to the indicated methods, the complete disappearance of the adult parasite is obtained; To eliminate the larval forms of Ascaris and Ancylostoma, the complete treatment must be repeated 60 days after the end of the first treatment for Ascaris and 18 days after the end of the first treatment for Ancylostoma. The elimination of parasites begins with the first administration; Complete disappearance of eggs usually occurs within 10-15 days of the last administration. Therefore, a stool test should be performed for control after the aforementioned period of time has elapsed. CONTRAINDICATIONS / ADVERSE EFFECTS Do not use in cases of hypersensitivity to the active substances or to any of the excipients. SAFETY IN TARGET SPECIES Administration of excessive doses may cause vomiting, which occurs for Mebendazole above 500 mg/kg in dogs and 300 mg/kg in cats and for Praziquantel at 200 mg/kg in dogs. DOSAGE Oral administration. One drop of suspension contains 3.75 mg mebendazole and 0.312 mg praziquantel. Administer 8 drops per kg body weight per day for two consecutive days, equivalent to 30 mg/kg body weight/day of mebendazole and 2.5 mg/kg body weight/day of praziquantel. To ensure the correct dose is administered, body weight should be determined as accurately as possible. Always round the animals weight to the next whole number. Underdosing may result in ineffective use and may promote the development of resistance. The veterinary medicinal product can be administered to puppies even in the first weeks of life. The drops are palatable to the animal; they can be administered directly into the mouth or incorporated into palatable food. During treatment, the animal does not lose activity or appetite. Shake vigorously before use, until the sediment is completely dispersed. STORAGE: Do not store above 25 degrees C. Keep the bottle tightly closed. Shelf life of the veterinary medicinal product as packaged for sale: 5 years. WARNINGS: In order to achieve effective parasite control, treatment should be based on the results of a faecal parasitological examination. The decision to use the veterinary medicinal product should be based on confirmation of the species and parasite load or the risk of infestation based on its epidemiological characteristics, for each individual animal. Parasite resistance to a particular class of anthelmintics may develop following frequent and repeated use of an anthelmintic of the same class. Unnecessary use of antiparasitics or use deviating from the indications given in the Summary of Product Characteristics may increase the selection pressure for resistance and may lead to reduced efficacy. In the case of a single confirmed infestation with cestodes or nematodes, a monovalent product containing a single cestocide or nematocide should be preferred. The possibility that other animals in the same environment may be a source of reinfestation with nematodes and cestodes should be considered and they should be treated, as necessary, with an appropriate veterinary medicinal product. In the case of infestations with Dipylidium caninum, appropriate control measures for fleas acting as vectors should be implemented to prevent reinfestation. Special precautions for safe use in the target species: It is not necessary to administer laxatives or to fast the animal during treatment; it is good practice to feed animals with lighter meals than usual during deworming. It is preferable to administer the veterinary medicinal product on an empty stomach and with a small amount of palatable food. During and after treatment, appropriate disinfection operations should be carried out in the premises, especially in kennels or breeding areas, to prevent reinfestation. In addition, it is recommended to chemically denature the faeces expelled by treated animals to interrupt the continuation of the parasitic cycle. Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental contact, wash hands thoroughly. People with known hypersensitivity to mebendazole and praziquantel should administer the veterinary medicinal product with caution. Special precautions for the protection of the environment: Not applicable. Administration of excessive doses may cause vomiting, which occurs for mebendazole above 500 mg/kg in dogs and 300 mg/kg in cats and for praziquantel at 200 mg/kg in dogs. Incompatibilities: In the absence of compatibility studies, do not mix with other medicinal products. TARGET SPECIES: Dogs and cats. INTERACTIONS: None known. DIAGNOSIS AND PRESCRIBING: Veterinary medicinal product not subject to medical prescription. ADVERSE REACTIONS: Dogs and cats. Very rare (< 1 animal/10,000 animals treated, including isolated reports): vomiting and diarrhoea*, liver disorders. * mild and transient gastrointestinal disorders. 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 the leaflet for contact details. PREGNANCY AND BREAST-FEEDING: Pregnancy and breast-feeding: Although mebendazole has not shown teratogenic or embryotoxic effects typical of other benzimidazoles, as a precautionary measure, its use is not recommended during the first fifteen days of pregnancy. It can be used during breast-feeding