NAME PANACUR TABLETS FOR DOGS AND CATS ACTIVE INGREDIENTS Each 250 mg and 500 mg tablet contains the active substance: fenbendazole 250 mg; fenbendazole 500 mg. EXCIPIENTS Lactose monohydrate, maize starch, colloidal anhydrous silica, hydroxyethylcellulose, sodium starch glycolate (type A), magnesium stearate. THERAPEUTIC INDICATIONS Dogs. Treatment of the following gastrointestinal infections with nematodes and tapeworms: ascarids (Toxocara canis, Toxascaris leonina), mature stages; hookworms (Ancylostoma caninum, Uncinaria stenocephala), mature stages; whipworms (Trichuris vulpis), mature stages; tapeworms (Taenia pisiformis), mature stages. Prevention and control of Giardia infections. Cats. Treatment of gastrointestinal infections with nematodes and cestodes: ascarids (Toxocara cati), mature stages; hookworms (Ancylostoma tubaeforme), immature and mature stages; tapeworms (Taenia hydatigena), mature stages. It is recommended to repeat the treatment against ascarids and tapeworms, taking into account the development cycle of the parasite from larva to mature stage. CONTRAINDICATIONS / ADVERSE EFFECTS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. SAFETY IN TARGET SPECIES Data not available. DOSAGE Oral administration. The dose for dogs and cats is 50 mg fenbendazole/kg body weight/day. Panacur 250 mg tablets: 1/2 tablet (= 125 mg fenbendazole) per 2.5 kg body weight; 1 tablet (= 250 mg fenbendazole) per 5 kg body weight. Panacur forte 500 mg tablets: 1/2 tablet (= 250 mg fenbendazole) per 5 kg body weight; 1 tablet (= 500 mg fenbendazole) per 10 kg body weight. The treatment should be repeated for 3 consecutive days. Dogs: Crush the tablets and mix them with the food. It is also possible to dissolve the tablets in a little water and mix them with the food. Cats: Dissolve the tablets in a little water and mix them with the food. It is recommended to administer the tablets mixed with the first portion of the daily food ration to ensure complete absorption. It is not recommended to administer the tablets as such or dissolved in water to fasting animals to avoid a possible decrease in efficacy. Avoid concomitant administration of milk. Underdosing could lead to a lack of efficacy and could promote the development of resistance. To ensure correct dosage, determine the body weight as accurately as possible. STORAGE: Panacur 250 mg tablets: This veterinary medicinal product does not require any special storage conditions. Panacur forte 500 mg tablets: Do not store above 25 degrees C. Shelf life of the veterinary medicinal product as packaged for sale: 3 years. WARNINGS: The tablets have a neutral flavour. For both animal species, to achieve effective control of gastrointestinal nematodes, tapeworms and giardiasis in dogs, treatment should be based on the results of a faecal parasitological examination. Unnecessary use of anthelmintic products or use deviating from the instructions provided in this summary of product characteristics may increase the selection pressure for resistance and reduce their efficacy. The decision to use the veterinary medicinal product should be based on confirmation of the parasite species and the parasite load or the risk of infestation based on the epidemiological characteristics of each individual animal. Precautions should be taken to avoid the following practices, which may increase the risk of resistance development and ultimately lead to ineffective therapy: excessively frequent and repeated use of anthelmintics of the same class over an extended period of time; underdosing of the veterinary medicinal product, which may be due to underestimation of the animals body weight, incorrect administration of the veterinary medicinal product or loss of calibration of the dosing device. It is also advisable to verify the success of the treatment (e.g. by checking the clinical appearance and the number of eggs in the faeces). Clinical cases of suspected anthelmintic resistance should be further investigated using appropriate methods (e.g. faecal egg reduction test (FECRT). If the results of diagnostic methods clearly indicate resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mechanism of action should be used. Special precautions for safe use in the target species: The possibility that other animals living in the same household may be a source of reinfestation with gastrointestinal nematodes should be considered and these should be treated, as necessary, with an appropriate veterinary medicinal product. Special precautions to be taken by the person administering the veterinary medicinal product to animals: Wash hands after use. Do not eat, drink or smoke during administration. This veterinary medicinal product may be toxic if ingested by humans. This veterinary medicinal product may cause hypersensitivity reactions. Avoid contact with skin, eyes and mucous membranes. Always wear protective gloves when handling. administer the veterinary medicinal product. Handle the veterinary medicinal product. In case of contact with skin and/or eyes, rinse immediately with plenty of water. Remove any clothing contaminated by the product. Special environmental precautions: Not applicable. No data available. Incompatibilities: None known. TARGET SPECIES: Dogs, cats (adults and puppies). INTERACTIONS: None known. DIAGNOSIS AND PRESCRIBING: Veterinary medicinal product not subject to medical prescription. ADVERSE EFFECTS: Dogs. Rare (1 to 10 animals in 10,000 animals treated): gastrointestinal disorders (e.g. vomiting and diarrhoea ^1); very rare (< 1 animal in 10,000 animals treated, including isolated reports): allergic reaction. ^1 Diarrhoea is usually mild. Cats. Very rare (< 1 animal in 10,000 animals treated, including isolated reports): disorders gastrointestinal (e.g. vomiting and diarrhoea ^1). ^1 Diarrhoea is usually mild. Reporting of adverse events is important as it allows for 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. See also the package leaflet for contact details. PREGNANCY AND LACTATION: Do not use in pregnant animals. In the absence of studies in the target species, use during lactation only according to the benefit-risk assessment by the responsible veterinarian