1. NAME OF THE VETERINARY MEDICINAL PRODUCT

AdTab 12 mg chewable tablets for cats (0.5–2.0 kg)
AdTab 48 mg chewable tablets for cats (>2.0–8.0 kg)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:

Each chewable tablet contains:
AdTab chewable tablets
lotilaner (lotilanerum) (mg)
for cats (0.5–2.0 kg)
12 mg
for cats (>2.0–8.0 kg)
48 mg

Excipients:

Qualitative composition of excipients and other constituents
Yeast powder (flavor)
Silicified microcrystalline cellulose
Powdered cellulose
Lactose monohydrate
Povidone K30
Crospovidone
Sodium lauryl sulfate
Vanillin (flavoring)
Colloidal anhydrous silicon dioxide
Magnesium stearate
Round, white-brown chewable tablets with brown dots.

3. CLINICAL INFORMATION
3.1 Target species

Cats.

3.2 Indications for use for each target species

For the treatment of flea and tick infestations in cats.
The veterinary medicinal product has immediate and persistent elimination activity for up to one month against fleas (Ctenocephalides felis and C. canis) and ticks (Ixodes ricinus).
Fleas and ticks must attach to the host and begin feeding to be exposed to the active substance.

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

3.4 Special warnings
Parasites must start feeding to be exposed to lotilaner; therefore, the risk of disease transmission via parasites cannot be completely excluded.

The possibility that other animals in the household may be a source of flea re-infestation should be considered and should be treated with an appropriate product. Fleas in all stages of development can infest the cat's litter box and usual resting areas such as carpets and soft furnishings. In the event of a heavy flea infestation and at the start of control measures, these areas should be treated with an environmentally appropriate product and then vacuumed regularly.

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 effectiveness against ticks in young cats, this product is not recommended for the treatment of ticks in kittens 5 months of age or younger.

3.5 Special precautions for use

Special precautions for safe use in target species:
Safety and efficacy data have been studied in cats 8 weeks of age and older, weighing 0.5 kg or more. In the absence of available data, a veterinarian should be consulted before treatment in kittens less than 8 weeks of age or weighing less than 0.5 kg.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Wash your 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.
Special precautions for environmental protection:

That's not the case.

3.6 Adverse events
Target species: Cats

Very rare

(<1 animal / 10,000 animals treated, including isolated reports):
Vomit1

1 Usually resolves without treatment
Reporting of adverse events is important. It allows for the continuous monitoring of the safety of the veterinary medicinal product. Reports should be sent, preferably by the veterinarian, either to the marketing authorisation holder or to the national competent authority via the national reporting system. See the “Contact details” section of the package leaflet.

3.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product during pregnancy or lactation has not been established.
Gestation and lactation:
Laboratory studies in rats have produced no evidence of teratogenic effects or any other adverse effects on male or female reproductive capacity. Consult a veterinarian before treatment, during pregnancy and lactation.
Fertility:
Consult a veterinarian before treatment in breeding cats.

3.8 Interaction with other medicinal products and other forms of interaction

They don't know each other.
During clinical trials, no interactions were observed between lotilanerum and common veterinary medicinal products.

3.9 Routes of administration and doses

For oral administration.
The flavoured veterinary medicinal product should be administered according to the following table, to provide a single dose of 6-24 mg lotilaner/kg body weight.
Body weight
of the cat (kg)
Strength and number of tablets to be administered
AdTab 12 mg
AdTab 48 mg
0.5–2.0
1
>2.0–8.0
1
>8.0

The right combination of tablets
For cats weighing over 8 kg, use an appropriate combination of available strengths to achieve the recommended dose of 6-24 mg/kg.

Underdosing may lead to ineffective use and may promote the emergence of resistance.
To ensure correct dosage, the body weight of the animals should be determined as accurately as possible.
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 administration should be continued throughout the flea and/or tick season, depending on local epidemiological situations.

3.10 Symptoms of overdose (and, where appropriate, emergency procedures and antidotes)

No adverse reactions were observed after oral administration to 8-week-old kittens weighing 0.5 kg treated with doses 5 times the maximum recommended dose (130 mg
lotilaner/kg body weight) eight times, at monthly intervals.

3.11 Special restrictions on use and special conditions of use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products, to limit the risk of development of resistance
That's not the case.

3.12 Waiting periods

That's not the case.

4. PHARMACOLOGICAL INFORMATION
4.1 ATCvet code: QP53BE04
4.2 Pharmacodynamics

Lotilaner, a pure enantiomer of the isoxazolines class, is active against fleas (Ctenocephalides felis and Ctenocephalides canis) as well as ticks (Ixodes ricinus).
Lotilaner is a potent inhibitor of gamma-aminobutyric acid (GABA)-gated chloride ion channels, causing rapid death of ticks and fleas. In in vitro studies, activity 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 occurs within 12 hours of attachment and lasts for one month after administration of the product. Fleas present on the animal before administration are eliminated within 8 hours.
For ticks, the onset of efficacy occurs within 24 hours of attachment and lasts for one month after administration of the product. Ticks present on the animal before administration are eliminated within 18 hours.
The veterinary medicinal product kills existing and newly hatched fleas on cats before they can lay eggs. The product therefore breaks the flea life cycle and prevents the environment from being contaminated with fleas in areas where cats have access.

4.3 Pharmacokinetics

After oral administration, lotilaner is absorbed immediately, with peak plasma concentrations occurring within 4 hours. Lotilaner is approximately 10-fold more bioavailable when administered with food. The elimination half-life is approximately 4 weeks (harmonic mean). This long elimination half-life ensures effective plasma concentrations throughout the dosing interval.
The main route of elimination is biliary excretion, with renal excretion being a minor route of elimination (less than 10% of the dose). Lotilaner is metabolized to a small extent to several hydrophilic compounds that can be detected in feces and urine.

5. PHARMACEUTICAL INFORMATION
5.1 Major incompatibilities

That's not the case.

5.2 Expiration date

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

5.3 Special precautions for storage

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

5.4 Nature and composition of primary packaging

The tablets are packed in aluminium/aluminium blisters packed in an outer cardboard box.
Each strength is available in packs of 1 or 3 tablets.
Not all pack sizes may be marketed.

5.5 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products

Medicines should not be disposed of via wastewater or household waste.
Use systems for the collection of unused veterinary medicinal products or waste materials derived from such products, in accordance with local requirements and national collection systems applicable to the veterinary medicinal product concerned.

6. NAME OF THE MARKETING AUTHORISATION HOLDER
Elanco GmbH

7. MARKETING AUTHORISATION NUMBER(S)
EU/2/22/288/011–014

8. DATE OF FIRST AUTHORISATION

Date of first authorisation: 13/09/2022

9. DATE ON WHICH THE SUMMARY OF PRODUCT CHARACTERISTICS WAS LAST REVISION
DD/MM/YYYY

10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS
Veterinary medicinal product not available on prescription.
Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary). Product compliance information Product compliance information Product safety Manufacturer information Personal information Product safety information

Currently, product safety information is not available.

Manufacturer information

Currently, manufacturer information is not available.

Responsible person information

Currently, information about the person responsible is not available.

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Presentation type: Tablets

Action: Ticks, Fleas

Pieces Set: 1 piece

Brand Name: Elanco

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Quantity: 1 Piece