Patient leaflet - Credelio Plus
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
Credelio Plus 56.25 mg/2.11 mg chewable tablets for dogs (1.4–2.8 kg)
Credelio Plus 112.5 mg/4.22 mg chewable tablets for dogs (> 2.8–5.5 kg)
Credelio Plus 225 mg/8.44 mg chewable tablets for dogs (> 5.5–11 kg)
Credelio Plus 450 mg/16.88 mg chewable tablets for dogs (> 11–22 kg)
Credelio Plus 900 mg/33.75 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 Plus 56.25 mg/2.11 mg chewable tablets for dogs (1.4–2.8 kg)
Credelio Plus 112.5 mg/4.22 mg chewable tablets for dogs (> 2.8–5.5 kg)
Credelio Plus 225 mg/8.44 mg chewable tablets for dogs (> 5.5–11 kg)
Credelio Plus 450 mg/16.88 mg chewable tablets for dogs (> 11–22 kg)
Credelio Plus 900 mg/33.75 mg chewable tablets for dogs (> 22–45 kg)
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
4.
INDICATION(S)
Each chewable tablet contains:
| Credelio Plus chewable tablets | lotilaner (mg) | milbemycin oxime (mg) |
| for dogs (1.4–2.8 kg) | 56.25 | 2.11 |
| for dogs (> 2.8–5.5 kg) | 112.5 | 4.22 |
| for dogs (> 5.5–11 kg) | 225 | 8.44 |
| for dogs (> 11–22 kg) | 450 | 16.88 |
| for dogs (> 22–45 kg) | 900 | 33.75 |
White to beige round biconvex chewable tablets with brownish spots.
For use in dogs with, or at risk from, mixed infestations/infections of ticks, fleas, gastrointestinal nematodes, heartworm and/or lungworm. This veterinary medicinal product is indicated for use when treatment against ticks/fleas and gastrointestinal nematodes or the treatment against ticks/fleas and prevention of heartworm disease/angiostrongylosis is required concurrently.
Ticks and Fleas
For the treatment of tick (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus and I. hexagonus ) and flea (Ctenocephalides felis and C. canis ) infestations in dogs.
This veterinary medicinal product provides immediate and persistent killing activity for 1 month for ticks and fleas.
The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Gastrointestinal Nematodes
Treatment of gastrointestinal nematodes: hookworm (L4, immature adult (L5) and adult Ancylostoma caninum ), roundworms (L4, immature adult (L5) and adult Toxocara canis and adult Toxascaris leonina ) and whipworm (adult Trichuris vulpis ).
Heartworm
Prevention of heartworm disease (Dirofilaria immitis ).
Lungworm
Prevention of angiostrongylosis by reduction of the level of infection with immature adult (L5) and adult stages of Angiostrongylus vasorum (lungworm) with monthly administration.
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5. CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substances, or to any of the excipients.
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6. ADVERSE REACTIONS
Gastrointestinal signs (diarrhoea and vomiting), anorexia, muscle tremors, lethargy, pruritus and changes in behaviour were uncommonly reported. These occurrences were generally self-limiting and of short duration.
Neurological signs (convulsion, muscle tremor, and ataxia) have been recorded rarely in postmarketing safety experience for the active substance lotilaner used as a mono-active (Credelio) at the same dose as in this product. These signs typically resolve without treatment.
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
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Oral use.
The veterinary medicinal product should be administered in accordance with the following table to ensure a dose of 20 to 41 mg lotilaner/kg bodyweight and 0.75 to 1.53 mg milbemycin oxime/kg bodyweight.
| Dog bodyweight | Strength and number of Credelio Plus tablets to be administered | ||||
| 56.25 mg/ 2.11 mg | 112.5 mg/ 4.22 mg | 225 mg/ 8.44 mg | 450 mg/ 16.88 mg | 900 mg/ 33.75 mg | |
| 1.4–2.8 kg | 1 | ||||
| > 2.8–5.5 kg | 1 | ||||
| > 5.5–11 kg | 1 | ||||
| > 11–22 kg | 1 | ||||
| > 22–45 kg | 1 | ||||
| > 45 kg | Appropriate combination of tablets | ||||
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9. ADVICE ON CORRECT ADMINISTRATION
Credelio Plus is a palatable chewable flavoured tablet. Administer the chewable tablet(s) with or after food.
Use an appropriate combination of available strengths to achieve the recommended dose of 20–41 mg lotilaner/kg and 0.75–1.53 mg milbemycin oxime/kg for animals > 45 kg bodyweight.
The treatment schedule should be based on the individual risk assessment of the dog, the local epidemiological situation and/or the epidemiological situation of other areas the dog has visited or is going to visit. If based on the veterinarian’s opinion the dog requires re-administration(s) of the product, any subsequent administration(s) must follow the 1 month interval schedule.
The product should be used in dogs with, or at risk from, mixed infestations of ectoparasites (ticks or fleas) and endoparasites (gastrointestinal nematodes and/or for prevention of heartworm/lungworm). Otherwise, a narrower spectrum parasiticide should be used.
Dogs living in non-heartworm endemic areas:
The veterinary medicinal product can be used as part of the seasonal treatment of ticks and/or fleas in dogs with diagnosed, or at risk from, concurrent gastrointestinal nematode infections or at risk of lungworm. A single treatment is effective for the treatment of gastrointestinal nematodes.
Dogs living in heartworm endemic areas:
Prior to treatment with the veterinary medicinal product the advice in special warnings should be considered.
For the prevention of heartworm disease and the concurrent treatment of tick and/or flea infestations, the veterinary medicinal product must be given at regular monthly intervals during the time of the year when mosquitoes, ticks and/or fleas are present. The first dose of the veterinary medicinal product may be given after first possible exposure to mosquitoes, but not more than one month after this exposure.
When the veterinary medicinal product is used to replace another heartworm preventive product, the first dose of the product must be given within a month of the last dose of the former medication. Dogs travelling to a heartworm region should start medication within a month after arrival there. Heartworm prevention treatment should be continued monthly, with the last administration being given 1 month after the dog has left the region.
Lungworm:
In endemic areas, monthly administration of the veterinary medicinal product will reduce the level of infection with immature adults (L5) and adults of Angiostrongylus vasorum in the heart and lungs. It is recommended that lungworm prevention should be continued until at least 1 month after the last exposure to slugs and snails.
Seek veterinary advice regarding information on the optimal time to start treatment with this veterinary medicinal product.
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10. WITHDRAWAL PERIOD(S)
Not applicable.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store in the original package
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 and blister after EXP.
The expiry date refers to the last day of that month.
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12. SPECIAL WARNING(S)