Special precautions for use in animals: No studies have been performed with severely debilitated cats or individuals with seriously compromised kidney or liver function. The veterinary medicinal product is not recommended for such animals or only according to a benefit/risk assessment by the responsible veterinarian. Ensure cats and kittens weighing between 0.5 kg and ≤2 kg receive the appropriate tablet strength (4 mg milbemycin oxime/10 mg praziquantel) and the appropriate dose (1/2 or 1 tablet) for the corresponding weight band (1/2 tablet for cats weighing 0.5 to 1 kg; 1 tablet for cats weighing >1 to 2 kg). As the tablets are flavoured, they should be stored in a safe place out of the reach of animals
User safety: People with known hypersensitivity to the active substances or the excipients should avoid contact with the veterinary medicinal product. Accidental ingestion of a tablet by a child may be harmful. In order to prevent children from accessing the product, tablets should be administered and stored out of sight and reach of children. Part tablets should be returned to the open blister pocket and inserted into the outer carton. In the event of accidental ingestion of one or more tablets, seek medical advice immediately and show the package leaflet or the label to the doctor. Wash hands after use. Echinococcosis represents a hazard for humans. As Echinococcosis is a notifiable disease to the World Organisation for Animal Health (OIE), specific guidelines on the treatment and follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority.
Adverse reactions: On very rare occasions especially in young cats, hypersensitivity reaction, systemic disorder (such as lethargy), neurological disorder (such as ataxia and muscle tremors) and/or digestive tract disorder (such as emesis and diarrhoea) have been observed after administration of the combination milbemycin/praziquantel.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Overdose: In case of overdose, in addition to signs observed at the recommended dose, drooling may be observed. This sign will usually disappear spontaneously within a day.
Interactions: No interactions were observed when the recommended dose of the macrocyclic lactone selamectin was administered during treatment with the combination of milbemycin oxime and praziquantel at the recommended dose. Although not recommended, the concomitant use of milbemycin oxime and praziquantel with a spot-on containing moxidectin and imidacloprid at recommended dose rates following a single application was well tolerated in one laboratory study in 10 kittens. The safety and efficacy of the concurrent use have not been investigated in field studies. In the absence of further studies, caution should be taken in the case of concurrent use of the product and other macrocyclic lactones. Also, no such studies have been performed with reproducing animals.
Environmental safety: Medicines should not be disposed of via wastewater or household waste. Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned. The veterinary medicinal product should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Pharmaceutical precautions: Store in the original package in order to protect from moisture. Halved tablets should be stored below 25°C in the original blister and be used for the next administration. Keep the blister in the outer carton.
Shelf life of unopened packaging: 3 years.
Shelf life of opened packaging: Halved tablets should be stored below 25°C in the original blister for 6 months. Keep the blister in the outer carton.