Indications for use, specifying the target species
For the treatment of flea and tick infestations in dogs.
This veterinary medicinal product provides immediate and persistent killing activity for 1 month for fleas (Ctenocephalides felis and C. canis) and ticks (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus and Dermacentor reticulatus).
Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.
The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
Parasites need to start feeding on the host to become exposed to lotilaner; therefore the risk of the transmission of parasite borne diseases cannot be completely excluded.
Special precautions for use
Special precautions for use in animals
All safety and efficacy data have been acquired from dogs and puppies 8 weeks of age and older and 1.3 kg of body weight and greater. Use of this veterinary medicinal product in puppies younger than 8 weeks of age or less than 1.3 kg of body weight should be based on a benefit-risk assessment by the responsible veterinarian.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after handling the product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician.
Adverse reactions (frequency and seriousness)
Mild and transient gastrointestinal signs (vomiting; diarrhoea; anorexia) and lethargy have been reported very rarely based on post-marketing safety experience. These signs typically resolve without treatment.
Neurological disorders such as tremor, ataxia or convulsion may occur in very rare cases. In most cases these signs are transient.
The frequency of adverse reactions is defined using the following convention
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
Laboratory studies in rats have not produced any evidence of teratogenic effects, or any adverse effect on the reproductive capacity of males and females. The safety of the veterinary medicinal product in breeding, pregnant and lactating dogs has not been established. Use only according to the benefit-risk assessment of the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
None known. During clinical testing, no interactions between Credelio chewable tablets and routinely used veterinary medicinal products were observed.
Amounts to be administered and administration route
For oral use.
The veterinary medicinal product should be administered in accordance with the following table to ensure a dose of 20 to 43 mg lotilaner/kg bodyweight.
Strength and number of tablets to be administered
Bodyweight of dog (kg)
Credelio 56 mg
Credelio 112 mg
Credelio 225 mg
Credelio 450 mg
Credelio 900 mg
Appropriate combination of tablets
Use an appropriate combination of available strengths to achieve the recommended dose of 20-43 mg/kg.
Credelio is a palatable chewable flavoured tablet. Administer the chewable tablet(s) monthly with or after food.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions were observed following oral administration to puppies aged 8–9 weeks and weighing 1.3–3.6 kg treated with overdoses of up to 5 times the maximum recommended dose (43 mg, 129 mg and 215 mg lotilaner/kg bodyweight) on eight occasions at monthly intervals.