Patient leaflet - Credelio
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
Credelio 56 mg chewable tablets for dogs (1.3–2.5 kg)
Credelio 112 mg chewable tablets for dogs (>2.5–5.5 kg)
Credelio 225 mg chewable tablets for dogs (>5.5–11 kg)
Credelio 450 mg chewable tablets for dogs (>11–22 kg)
Credelio 900 mg chewable tablets for dogs (>22–45 kg)
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder :
Elanco GmbH, Heinz-Lohmann-Str. 4, 27472 Cuxhaven, Germany
Manufacturer responsible for batch release :
Elanco France S.A.S., 26 rue de la Chapelle, 68330 Huningue, France
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Credelio 56 mg chewable tablets for dogs (1.3–2.5 kg)
Credelio 112 mg chewable tablets for dogs (>2.5–5.5 kg)
Credelio 225 mg chewable tablets for dogs (>5.5–11 kg)
Credelio 450 mg chewable tablets for dogs (>11–22 kg)
Credelio 900 mg chewable tablets for dogs (>22–45 kg)
lotilaner
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each chewable tablet contains:
| Credelio chewable tablets | lotilaner (mg) |
| for dogs (1.3–2.5 kg) | 56.25 |
| for dogs (>2.5–5.5 kg) | 112.5 |
| for dogs (>5.5–11 kg) | 225 |
| for dogs (>11–22 kg) | 450 |
| for dogs (>22–45 kg) | 900 |
White to beige round chewable tablets with brownish spots.
4. INDICATION(S)
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 product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
5.
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
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6. ADVERSE REACTIONS
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:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
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7. TARGET SPECIES
Dogs.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
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.
| Body weight of dog(kg) | Strength and number of tablets to be administered | ||||
| Credelio 56 mg | Credelio 112 mg | Credelio 225 mg | Credelio 450 mg | Credelio 900 mg | |
| 1.3–2.5 | 1 | ||||
| >2.5–5.5 | 1 | 1 | 1 | ||
| >5.5–11 | |||||
| >11–22 | |||||
| >22–45 | 1 | ||||
| >45 | Appropriate combination of tablets | ||||
Use an appropriate combination of available strengths to achieve the recommended dose of 2043 mg/kg.
9.
ADVICE ON CORRECT ADMINISTRATION
Credelio is a palatable chewable flavoured tablet. Administer the chewable tablet(s) monthly with or after food.
10.
WITHDRAWAL PERIOD(S)
Not applicable.
11.
SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions.
Do not use this veterinary medicinal product after the expiry date which is stated on the cartonbox and blister after EXP. The expiry date refers to the last day of that month.
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12. SPECIAL WARNING(S)
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 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. The administration of this 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.
Pregnancy and lactation :
Laboratory studies in rats have not produced any evidence of teratogenic effects.
The safety of the veterinary medicinal product in pregnant and lactating dogs has not been established. Use only accordingly to the benefit/risk assessment of the responsible veterinarian.
Fertility :
Laboratory studies in rats have not produced any evidence of any adverse effect on the reproductive capacity of males and females.
The safety of the veterinary medicinal product in breeding dogs has not been established. Use only accordingly 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.
Overdose (symptoms, emergency procedures, antidotes) :
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.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency ( . europa.eu/).
15. OTHER INFORMATION
Lotilaner, a pure enantiomer from the isoxazoline class is active against fleas (Ctenocephalides felis and Ctenocephalides canis ) as well as the tick species Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus.
Lotilaner is a potent inhibitor of gamma-aminobutyric acid (GABA)-gated chloride channels, resulting in rapid death of ticks and fleas. The activity of lotilaner was not affected by resistance to organochlorines (cyclodienes, e.g. dieldrin), phenylpyrazoles (e.g. fipronil), neonicotinoids (e.g. imidacloprid), formamidines (e.g. amitraz) and pyrethroids (e.g. cypermethrin).
For fleas, the onset of efficacy is within 4 hours of attachment for one month after product administration. Fleas on the animal prior to administration are killed within 6 hours.
For ticks, the onset of efficacy is within 48 hours of attachment for one month after product administration. Existing I. ricinus ticks on the animal prior to administration are killed within 8 hours.
The veterinary medicinal product kills existing and newly emerged fleas on dogs before they can lay eggs. Therefore, the product breaks the flea life cycle and prevents environmental flea contamination in areas to which the dog has access.
Each strength of Credelio chewable tablets is available in pack sizes of 1, 3 or 6 tablets.
Not all pack sizes may be marketed.
PACKAGE LEAFLET:
Credelio 12 mg chewable tablets for cats (0.5–2.0 kg)
Credelio 48 mg chewable tablets for cats (>2.0–8.0 kg)
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder :
Elanco GmbH, Heinz-Lohmann-Str. 4, 27472 Cuxhaven, Germany
Manufacturer responsible for batch release :
Elanco France S.A.S., 26 rue de la Chapelle, 68330 Huningue, France
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Credelio 12 mg chewable tablets for cats (0.5–2.0 kg)
Credelio 48 mg chewable tablets for cats (>2.0–8.0 kg)
lotilaner
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each chewable tablet contains:
| Credelio chewable tablets | lotilaner (mg) |
| for cats (0.5–2.0 kg) | 12 |
| for cats (>2–8.0 kg) | 48 |
White to brownish round chewable tablets with brownish spots.
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4. INDICATION(S)
For the treatment of flea and tick infestations on cats.
This veterinary medicinal product provides immediate and persistent killing activity for 1 month against fleas (Ctenocephalides felis and C. canis ) and ticks (Ixodes ricinus ).
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).
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5. CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
6.
ADVERSE REACTIONS
Vomiting has been reported very rarely based on post marketing safety experience and typically resolves 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).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
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7. TARGET SPECIES
Cats
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
For oral use.
The flavoured veterinary medicinal product should be administered in accordance with the following table to ensure a single dose of 6 to 24 mg lotilaner/kg bodyweight.
| Body weight of cat (kg) | Strength and number of tablets to be administered | |
| Credelio 12 mg | Credelio 48 mg | |
| 0.5–2.0 | 1 | |
| >2.0–8.0 | 1 | |
| >8.0 | Appropriate combination of tablets | |
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.
9. ADVICE ON CORRECT ADMINISTRATION
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
WITHDRAWAL PERIOD(S)
Not applicable.
11.
SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton box and blister after EXP. The expiry date refers to the last day of that month.
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12. SPECIAL WARNING(S)
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 in animals :
All safety and efficacy data have been acquired from cats and kittens 8 weeks of age and older and 0.5 kg of body weight and greater. 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.
Pregnancy and lactation :
Laboratory studies in rats have not produced any evidence of teratogenic effects.
The safety of the veterinary medicinal product in cats has not been established during pregnancy and lactation. Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Fertility :
Laboratory studies in rats have not produced any evidence of any adverse effect on the reproductive capacity of males and females.
The safety of the veterinary medicinal product in breeding queens has not been established. Use only accordingly to the benefit-risk assessment by 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.
Overdose (symptoms, emergency procedures, antidotes) :
No adverse reactions were observed following oral administration to kittens aged 8 weeks and weighing 0.5 kg treated with overdoses of more than 5 times the maximum recommended dose rate (130 mg lotilaner/kg bodyweight) on eight occasions at monthly intervals.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY