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NAME DRONTAL MULTI FLAVOURED MEAT XL 525/504/175 MG TABLETS FOR DOGS ACTIVE INGREDIENTS Each tablet contains active ingredients: 525 mg febantel; 175 mg pyrantel equivalent to 504 mg pyrantel embonate; 175 mg praziquantel. Excipients: for a full list of excipients, see section 6.1. EXCIPIENTS Maize starch, lactose monohydrate, microcrystalline cellulose, povidone K25, magnesium stearate, sodium lauryl sulfate, colloidal anhydrous silica, croscarmellose sodium, meat flavour. THERAPEUTIC INDICATIONS Treatment of mixed infections by nematodes and cestodes of the following species. Nematodes: ascarids (adults and late immature forms): toxocara canis, toxascaris leonina; Hookworms (adults): Uncinaria stenocephala, Ancylostoma caninum; Whipworms (adults): Trichuris vulpis. Tapeworms (adults and immature forms): Echinococcus granulosus; Echinococcus multilocularis; Dipylidium caninum; Taenia spp. CONTRAINDICATIONS / SIDE EFFECTS Do not use in case of hypersensitivity to the active substances or to any of the excipients. Do not use during the first and second third of pregnancy (see section 4.7). SAFETY IN TARGET SPECIES Product doses 10 times those recommended have been tolerated by dogs and puppies without signs of adverse reactions. DOSAGE 35-52.5 kg; number of tablets: 1. Body weight: 52.5-70 kg; number of tablets: 2. For every additional 17.5 kg of body weight, administer an additional half tablet. Administration and duration of treatment: The tablets are flavored and studies have shown that they are palatable and are taken spontaneously by the majority (88%) of dogs tested. The tablets can be administered with or without food. It is not necessary to restrict access to a normal diet before or after treatment. The tablets should be administered as a single administration. After opening the blister, any remaining halved tablets should be discarded immediately or returned to the opened blister until use. A veterinarian should be consulted regarding the need and frequency of repeat treatment. Do not use in dogs weighing less than 7 kg. 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. Shelf life of halved tablets: 7 days. WARNINGS: Fleas act as intermediate hosts for a common type of tapeworm: Dipylidium caninum. Tapeworm infestation will recur if intermediate hosts, such as fleas, mice, etc., are not controlled. Special precautions for use in animals: Parasite resistance to a particular class of anthelmintics may develop following frequent, repeated use of an anthelmintic of that class. To minimize the risk of reinfestation or reinfestation, excreta should be collected and disposed of properly for 24 hours after treatment. Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician. In the interests of good hygiene, those administering the product directly to a dog or by adding it to the dogs food should wash their hands afterwards. Other precautions: Because it contains praziquantel, the product is effective against Echinococcus spp., which are not present in all EU member states but are becoming more common in some. Echinococcosis poses a risk to humans. Since echinococcosis is a notifiable disease to the World Organisation for Animal Health (OIE), specific guidelines on treatment, follow-up, and human safety must be obtained from the relevant competent authority. Ten times the recommended dose of the product have been tolerated by dogs and puppies without signs of adverse reactions. Main incompatibilities: Not applicable. TARGET SPECIES: Dogs. INTERACTIONS: The anthelmintic effects of this product and products containing piperazine may be antagonized when the two drugs are used together. DIAGNOSIS AND PRESCRIPTION: Veterinary medicinal product available without a prescription. SIDE EFFECTS: In very rare cases, mild and transient digestive tract disorders (e.g., vomiting) may occur. The frequency of adverse reactions is defined using the following conventions: very rare (less than 1 in 10,000 animals treated, including isolated reports). PREGNANCY AND LACTATION: Teratogenic effects attributed to high doses of febantel, administered during early pregnancy, have been reported in rats, sheep, and dogs. The safety of the product has not been studied during the first and second thirds of pregnancy. Do not use in pregnant bitches during the first and second thirds of pregnancy (see section 4.3). A single treatment during the last third of pregnancy or while breastfeeding has been shown to be safe
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