Amflee 50 mg Spot-on Solution for Cats

Composition

Each 0.5 ml pipette contains:

Active substances:

Fipronil 50 mg

Light yellow to yellow, clear liquid.

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Pharmacological properties

4.1 ATCvet code : QP53AX15

4.2 Pharmacodynamics

Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family. It acts by inhibiting the GABA complex, binding to the chloride channel and thereby blocking pre-and post-synaptic transfer of chloride ions across cell membranes. This results in uncontrolled activity of the central nervous system and death of insects or acarids. Fipronil exhibits an insecticidal and acaricidal activity against fleas (Ctenocephalides spp.) and ticks (Rhipicephalus spp., Dermacentor spp., Ixodes spp. including Ixodes ricinus) in the cat.

Fleas will be killed within 24 hours. Ticks will usually be killed within 48 h after contact with fipronil, however if Rhipicephalus sanguineus ticks are present when the veterinary medicinal product is applied, all of the ticks may not be killed within the first 48 hours, but may be killed within a week.

4.3 Pharmacokinetics

In vitro, fipronil is mainly metabolised with subcellular liver fractions to its sulfone derivative. However, this may be of limited relevance in vivo as fipronil is poorly absorbed in the cat. The concentrations of fipronil on the hair decrease with time.

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Target species

Cats

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Indications

Treatment and prevention of flea (Ctenocephalides spp.) and tick (Dermacentor reticulatus, Ixodes ricinus) infestations in cats.

The veterinary medicinal product has a persistent insecticidal efficacy for up to 4 weeks against fleas (Ctenocephalides spp.) and acaricidal efficacy for up to 4 weeks against Ixodes ricinus and for up to 1 week against Dermacentor reticulatus and Rhipicephalus sanguineus. If Rhipicephalus sanguineus ticks are present when the veterinary medicinal product is applied, all the ticks may not be killed within the first 48 hours but they may be killed within a week.

The veterinary medicinal product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD), where this has been previously diagnosed by a veterinary surgeon.

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Dosage

Route of administration and dosage:

External use only.

Administer by topical application to the skin 1 pipette of 0.5 ml per animal.

To ensure a correct dosage, body weight should be determined as accurately as possible.

Method of administration:

1. Remove the pipette from its packaging. Hold the pipette in an upright position, twist and pull the cap off.

2. Turn the cap around and place the other end of the cap back on the pipette. Push and twist the cap to break the seal, then remove the cap from the pipette.

3. Part the coat on the back of the animal at the base of the neck in front of the shoulder blades until the skin is visible. Place the tip of the pipette onto the skin and squeeze the pipette several times to empty its contents completely and directly onto the skin in one spot.

It is important to make sure that the veterinary medicinal product is applied to an area where the animal cannot lick it off, and to make sure that animals do not lick each other following treatment.

Temporary changes to the coat (clumped/greasy hair and/or deposits on the hair) may be noted at the application site which normally disappears within 24 hours.

Treatment schedule:

For optimal control of flea and/or tick infestation the treatment schedule can be based on the local epidemiological situation.

In the absence of safety studies, the minimum treatment interval is 4 weeks.

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Contraindications

Do not use on kittens less than 2 months old and/or weighing less than 1 kg in the absence of available data.

Do not use in sick (e.g. systemic diseases, fever…) or convalescent animals. Do not use in rabbits, as adverse reactions and even death could occur.

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

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Adverse reactions

Cats:

1Transient.

2May be observed for a brief period in the case of licking the administration site.

3Reversible.

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 its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Avoid contact with the animal's eyes. In the case of accidental eye contact, immediately and thoroughly flush the eyes with water.

Do not apply the veterinary medicinal product on wounds or damaged skin.

It is important to make sure that the veterinary medicinal product is applied to an area where the animal cannot lick it off and to make sure that animals do not lick each other following treatment.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

This veterinary medicinal product can cause mucous membrane and eye irritation. Therefore, contact between the veterinary medicinal product and the mouth or eyes should be avoided.

In the case of accidental eye contact, immediately and thoroughly flush the eyes with water. If eye irritation persists seek medical advice immediately and show the package leaflet or the label to the physician.

Avoid contents coming into contact with the fingers. If this occurs, wash off immediately with soap and water.

Wash hands after use.

Do not smoke, drink or eat during application.

People with known hypersensitivity to fipronil or dimethyl sulfoxide or other excipients should avoid contact with the veterinary medicinal product.

Treated animals should not be handled until the application site is dry, and children should not be allowed to play with treated animals until the application site is dry. It is therefore recommended that animals are not treated during the day, but should be treated during the early evening, and that recently treated animals should not be allowed to sleep with owners, especially children.

Keep pipettes in original packaging and dispose of used pipettes immediately.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

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 and lactation.

Pregnancy and lactation:

Laboratory studies have not produced any evidence of teratogenic or embryotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.

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Interactions

None known.

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Overdose

No adverse effects were observed in target animal safety studies in cats and kittens aged 2 months and older and weighing about 1 kg treated once a month at five times the recommended dose for three consecutive months. The risk of experiencing adverse effects may however increase with overdosing (see section 3.6).

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Special warnings

Fleas from pets often infest the animal's basket, bedding and regular resting areas such as carpets and soft furnishings which should be treated, in case of massive infestation and at the beginning of the control measures, with a suitable insecticide and vacuumed regularly.

The veterinary medicinal product does not prevent ticks from attaching to the animals. If the animal has been treated prior to exposure to the ticks, the tick will be killed in the first 24-48 hours after attachment. This will usually be prior to engorgement, minimising but not excluding the risk of transmission of diseases. Once dead, ticks will often drop off the animal, but any remaining ticks may be removed with a gentle pull.

No data on the effect of bathing/shampooing on the efficacy of the veterinary medicinal product in cats are available. However, based on information available for dogs, weekly immersion in water for one minute reduces the period of persistent insecticidal efficacy against fleas by one week.

For optimal control of flea infestation in a multi-pet household, all animals in the household (e. g. dogs, cats, ferrets, rabbits) should be treated with a suitable insecticide.

When used as part of a strategy for the treatment of Flea Allergy Dermatitis, monthly applications to the allergic patient is recommended and other dogs and cats in the household should be treated with a suitable insecticide.

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Withdrawal period

Not applicable.

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Incompatibilities

None known.

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Immediate packaging

White polypropylene pipette closed with either a polyethylene or polyoxymethylene cap. Each 0.5 ml pipette is packed in a polyethylene terephthalate/aluminium/low density polyethylene triplex bag.

Pack sizes:

Box containing 1, 3, 6, 10, 20 or 30 pipettes.

Not all pack sizes may be marketed.

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Storage

Store in the original container in order to protect from light and moisture. Do not remove from bag until required for use.

The product should be maintained at room temperature (above 14° C) for approximately one hour prior to administration.

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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

Medicines should not be disposed of via wastewater.

The veterinary medicinal product should not enter water courses as Fipronil may be dangerous for fish and other aquatic organisms.

Do not contaminate ponds, waterways or ditches with the product or empty container. Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 01656/4086

8 DATE OF FIRST AUTHORISATION

27 May 2015

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

December 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product not subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Gavin Hall Approved: 19 February 2026

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Registration holder

KRKA, d.d., Novo mesto

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