Credelio Tablets are indicated to provide treatment for flea and tick infestations in dogs. They will provide immediate and persistent killing activity for 1 month and can be used safely as part of a treatment strategy for the control of flea allergy dermatitis.
Credelio Tablets are round chewable tablets that are white to beige in colour, with brownish spots.
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.
Acceptable levels of efficacy may not be achieved if the veterinary medicinal product is not administered with food or within 30 minutes after feeding.
Due to insufficient data to support efficacy against ticks in young cats, this product is not recommended for the treatment of ticks in kittens 5 months of age or younger.
Special precautions for use
Special precautions for use in Dogs
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 for use in Cats
Safety and efficacy data has been studied in cats aged 8 weeks and older with a body weight of 0.5 kg or more. Therefore, use of this veterinary medicinal product in kittens younger than 8 weeks of age or less than 0.5 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 effects such as vomiting, and diarrhoea have been reported to occur very rarely based on post-marketing safety experience. These signs typically resolve without treatment.
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
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 to ensure a dose of 20 to 43 mg lotilaner/kg bodyweight.
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.
The flavoured veterinary medicinal product should be administered to ensure a single dose of 6 to 24 mg lotilaner/kg bodyweight.
For cats of more than 8 kg body weight, use an appropriate combination of available strengths to achieve the recommended dose of 6–24 mg/kg.
Administer the veterinary medicinal product with food or within 30 minutes after feeding.
For optimal control of tick and flea infestations, the veterinary medicinal product should be administered at monthly intervals and continued throughout the flea and/or tick season based on local epidemiological situations.
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.
No adverse reactions were observed following oral administration to kittens aged 8 weeks, weighing 0.5 kg, which were treated with more than 5 times the maximum recommended dose (130 mg lotilaner/kg bodyweight) on eight occasions at monthly intervals.