Simparica 20mg Chewable Tablets for Small Dogs 5 - 10kg (pack of 3)

Simparica Chewable Tablets are an antiparastic tablet designed for dogs. To be given for the treatment of flea or tick infestations in dogs. Suitable for small dogs (5-10kg).

For the treatment of flea infestations (Ctenocephalides felis and Ctenocephalides canis) in dogs. Simparica has immediate and persistent flea killing activity against new infestations for at least 5 weeks. Simparica can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).

For the treatment of tick infestations (Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus). Simparica has immediate and persistent tick killing activity for at least 5 weeks.

For the treatment of sarcoptic mange (Sarcoptes scabiei). Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.

Prescription only medicine.
Simparica Chewable Tablets are only available with a prescription from your veterinary surgeon.
To check the most up to date information about this product, please read its Summary of Product Characteristics (SPC) below:
http://www.vmd.defra.gov.uk/ProductInformationDatabase/Default.aspx

Active substance
Sarolaner 20 mg

Simparica is a prescription product and must be applied according to the instructions by your veterinary surgeon.

Please read the product leaflet thoroughly before applying to your pet.

Marketing Authorisation Holder
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM

Marketing Authorisation Number
EU/2/15/191/001-018

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.
• 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.