NAME PRALEN MAXI 480 MG + 40 MG CHEWABLE TABLETS FOR MEDIUM AND LARGE DOGS ACTIVE INGREDIENTS Each tablet contains the active substances: micronized mebendazole 480 mg, praziquantel (microencapsulated) 40 mg. EXCIPIENTS Dye E 110 (sunset yellow) 0.86 mg, dye black PN (E 151) 0.48 mg, sucrose, corn starch, rice starch, fish meal, maltodextrin, lactose monohydrate, corn flour diastase, chicken meal, magnesium stearate, sodium chloride, potassium dihydrogen phosphate, cellulose acetophthalate, talc. THERAPEUTIC INDICATIONS Treatment of parasitic infestations in dogs caused by nematodes (roundworms) and tapeworms (flatworms): Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Uncinaria stenocephala, 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 instructions, complete elimination of adult parasites is achieved; for the elimination of larval forms of Ascaris and Ancylostoma, it is necessary to repeat the complete treatment 60 days after the end of the first treatment for Ascaris infestations and 18 days after the end of the first treatment for Ancylostoma infestations. Elimination of parasites begins with the first administration; complete elimination of eggs usually occurs within 10-15 days of the last administration. Therefore, the examination of the faeces for control should be carried out after the aforementioned period. 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 tablet for every 16 kg of body weight per day for two consecutive days, equivalent to 30 mg/kg of body weight/day of Mebendazole and 2.5 mg/kg of body weight/day of Praziquantel. To ensure the administration of a correct dose, body weight should be determined as accurately as possible. Always round the animals weight to the next whole number. Underdosing may lead to ineffective use and may promote the development of resistance. The tablet can be easily divided into four parts, each of which can be used to treat 4 kg of animal. Place the tablet on a flat surface with the lined side up. Press the center of the tablet with your thumb to divide it into 4 quarters. The chewable tablets are palatable to animals; with rare exceptions, they are consumed spontaneously; in these cases, they can be crushed and incorporated into a small amount of palatable food or mixed with kibble. During treatment, the animal does not lose activity or appetite. STORAGE: This veterinary medicinal product does not require any special storage conditions. Store in the original packaging. 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 carried out 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 anthelmintics 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 tapeworms or nematodes, a monovalent product containing a single tapeworm or nematode should be preferred. The possibility that other animals in the same environment may be a source of reinfestation with roundworms and tapeworms 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 procedures should be carried out to prevent reinfestation, especially in kennels or breeding units. 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 environmental protection: 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: Not applicable. TARGET SPECIES: Dog. INTERACTIONS: None known. DIAGNOSIS AND PRESCRIBING: Veterinary medicinal product not subject to medical prescription. ADVERSE EFFECTS: Dog. Very rare (< 1 animal/10,000 animals treated, including isolated reports): vomiting and diarrhoea*, liver disorders. * Mild and transient gastrointestinal disorders. The 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 package 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