Lotimil 12 mg Chewable Tablets for Cats (0.5–2.0 kg)

Composition

Active substance:

Each chewable tablet contains:

Excipients:

For the full list of excipients, see section 6.1.

6.1 List of excipients

Yeast powder (flavour)

Silicified microcrystalline cellulose

Cellulose, powdered

Lactose monohydrate

Povidone K30

Crospovidone

Sodium laurilsulfate

Vanillin (flavour)

Silica, colloidal anhydrous

Magnesium stearate

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Pharmaceutical form

Chewable tablet.

White to brownish round chewable tablets with brownish spots.

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Pharmacological properties

Pharmacotherapeutic group: parasiticides for systemic use

ATC Vet Code: QP53BE04

5.1 Pharmacodynamic properties

Lotilaner, a pure enantiomer from the isoxazoline class, is active against fleas (Ctenocephalides felis and Ctenocephalides canis) and ticks (Ixodes ricinus).

Lotilaner is a potent inhibitor of gamma–aminobutyric acid (GABA)-gated chloride channels, resulting in rapid death of ticks and fleas. In in vitro studies, the activity of lotilaner against some arthropod species 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 12 hours of attachment for one month after product administration. Fleas on the animal prior to administration are killed within 8 hours.

For ticks, the onset of efficacy is within 24 hours of attachment for one month after product administration. Existing ticks on the animal prior to administration are killed within 18 hours.

The veterinary medicinal product kills existing and newly emerged fleas on cats before they can lay eggs. Therefore, the product breaks the flea life cycle and prevents environmental flea contamination in areas to which the cat has access.

5.2 Pharmacokinetic particulars

Following oral administration, lotilaner is readily absorbed and peak blood concentration is reached at 4 hours. Lotilaner is approximately 10 times more bioavailable when administered with food. The terminal half-life is approximately 4 weeks (harmonic mean). This terminal half-life provides effective blood concentrations for the entire duration of the inter-dosing interval. The major route of elimination is biliary excretion, and renal excretion is the minor route of elimination (less than 10 % of the dose). Lotilaner is metabolized to a small extent into more hydrophilic compounds, which are observed in faeces and urine.

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Target species

Cats

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Indications

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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Dosage

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.

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.

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Contraindications

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

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Adverse reactions

Target species: Cats

Very rare (<1 animal / 10,000 animals treated, including isolated reports):

Hyperactivity 1,2

Vomiting2

Ataxia, Muscle tremor

Tachypnoea

Pruritus 1,2

Anorexia, Lethargy

1 Mild and transient

2 Typically resolves without treatment

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product.

Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also the last section of the package leaflet for respective contact details.

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Warnings

i). Special precautions for use in animals

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.

ii). 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 the label to the physician.

iii). Other precautions

Not applicable

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Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy or lactation.

Pregnancy and lactation:

Use only according to the benefit/risk assessment by the responsible veterinarian.

Laboratory studies in rats have not produced any evidence of teratogenic effects, or any adverse effect on the reproductive capacity of males and females.

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Interactions

None known.

During clinical testing, no interactions between Lotimil chewable tablets and routinely used veterinary medicinal products were observed.

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Overdose

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.

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Special warnings

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.

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Withdrawal period

Not applicable

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Incompatibilities

Not applicable.

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Immediate packaging

The tablets are packaged in aluminium/ aluminium blisters packaged into an outer cardboard box. Each tablet strength is available in pack sizes of 1, 3 or 6 tablets.

Not all pack sizes may be marketed.

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Storage

This veterinary medicinal product does not require any special storage conditions.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

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Disposal of unused product

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

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Additional information

Vm 00879/5048

9 DATE OF FIRST AUTHORISATION

29 November 2024

10 DATE OF REVISION OF THE TEXT

January 2026

11 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

Approved 03 February 2026

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Registration holder

Elanco Europe Ltd

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