Contra-indications, warnings, etc
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Parasites need to start feeding on the host to become exposed to sarolaner; therefore, the transmission of infectious parasite-borne diseases cannot be excluded.
In the absence of available data, treatment of puppies less than 8 weeks of age and/or dogs less than 1.3 kg bodyweight should be based on a benefit-risk assessment by the responsible veterinarian.
In very rare cases (less than 1 animal in 10,000 animals treated, including isolated reports) adverse reactions associated with mild and transient gastrointestinal effects such as vomiting and diarrhoea may occur. In very rare cases transient neurological disorders such as tremor, ataxia or convulsion may occur. These signs typically resolve without treatment.
The safety of Simparica has not been established during pregnancy and lactation or in animals intended for breeding. Laboratory studies in rats and rabbits have not produced any evidence of any teratogenic effects. Use only according to the benefit/risk assessment by the responsible veterinarian.
Simparica has been administered orally to 8 week old Beagle puppies at doses of 0, 1, 3, and 5 times the maximum dose of 4 mg/kg at 28 day intervals for 10 doses. No adverse effects were observed at the maximum dose of 4 mg/kg. In the overdose groups, transient and self-limiting neurological signs were observed in some animals: mild tremors at 3 times the maximum dose and convulsions at 5 times the maximum dose. All dogs recovered without treatment.
Sarolaner is well tolerated in Collies with a deficient multidrug-resistance-protein 1 (MDR1 -/-) following single oral administration at 5 times the recommended dose. No treatment-related clinical signs were observed.

User warnings
Wash hands after handling the product. The accidental ingestion of the product may potentially result in adverse effects, such as transient excitatory neurological signs. To prevent children from accessing the product, only one chewable tablet at a time should be removed from the blister pack and only when required. The blister pack should then be returned into the carton immediately after use and the carton should be stored out of the sight and reach of children. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician.

Pharmaceutical precautions
Simparica does not require any special storage conditions.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Keep out of the sight and reach of children.
For animal treatment only.

Further information
Sarolaner is an acaricide and insecticide belonging to the isoxazoline family. The primary target of action of sarolaner in insects and acarines is functional blockade of ligand-gated chloride channels (GABA-receptors and glutamate-receptors). Sarolaner blocks GABA- and glutamate-gated chloride channels in the central nervous system of insects and acarines.
For fleas, the onset of efficacy is within 8 hours of attachment during the 28 day period after product administration. For ticks (I. ricinus), the onset of efficacy is within 12 hours of attachment during the 28 day period after product administration. Ticks on the animal prior to administration are killed within 24 hours.
Simparica kills newly emerged fleas on the dog before they can lay eggs and therefore it prevents environmental flea contamination in areas to which the dog has access.
During clinical field trials, no interactions between Simparica chewable tablets for dogs and routinely used veterinary medicinal products were observed.
In laboratory safety studies, no interactions were observed when sarolaner was co-administered with milbemycin oxime, moxidectin and pyrantel pamoate. (In these studies efficacy was not investigated).
Sarolaner is highly bound to plasma proteins and might compete with other highly bound drugs such as non-steroidal anti-inflammatory drugs (NSAIDs) and the cumarin derivative warfarin.