Effipro 50 mg Spot-on Solution for Cats

Composition

One 0.5 ml pipette contains:

Active substance:

Fipronil 50 mg

Excipients:

Clear, colourless to yellow spot-on solution.

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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 h. Ticks will usually be killed within 48 h after contact with Fipronil, however if ticks of some species (Rhipicephalus sanguineus and Ixodes ricinus) are present when the product is applied, all the ticks may not be killed within the first 48 hours.

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 of flea (Ctenocephalides spp.) and tick (Dermacentor reticulatus) infestations.

The veterinary medicinal product has a persistent insecticidal efficacy for up to 5 weeks against fleas (Ctenocephalides felis).

The veterinary medicinal product has a persistent acaricidal efficacy for up to 2 weeks against ticks (Rhipicephalus sanguineus, Ixodes ricinus, Dermacentor reticulatus). If ticks of some species (Rhipicephalus sanguineus and Ixodes ricinus) are present when the product is applied, all the ticks may not be killed within the first 48 hours but they may be killed within a week.

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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.

Method of administration:

Thermoformed pipettes:

Hold the pipette upright. Tap the narrow part of the pipette to ensure that the contents are within the main body of the pipette. Break the snap-off top of the spot-on pipette along the scored line.

Part the pet’s coat until its skin is visible. Place the tip of the pipette directly against the bared skin and squeeze gently several times to empty its contents Repeat this procedure at one or two different points along the cat’s back, preferably at the base of the head and between the shoulders.

(Note: the shape of the marketed pipettes can be different as well as the pictures on the marketed boxes/package leaflets.)

(Note : The pipettes can be marketed in a blister. In this case, the above images will appear on the box and leaflet)

Polypropylene pipettes:

Remove the pipette from the blister packaging. Hold the pipette in an upright position, twist and pull the cap off. Turn the cap around and place the other end of the cap back on the pipette. Twist the cap to break the seal, then remove the cap from the pipette.

Part the pet’s coat until its skin is visible. Place the tip of the pipette directly against the bared skin and squeeze gently several times to empty its contents. Repeat this procedure at one or two points along the cat’s back, preferably at the base of the head and between the shoulders.

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.

Care should be taken to avoid excessive wetting of the hair with the veterinary medicinal product since this will cause a sticky appearance of hairs at the treatment spot. However, should this occur, it will disappear within 24 hours post application.

White deposits may also be seen at the site for up to 48 hours after application.

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

In the absence of available data, the veterinary medicinal product should not be used on kittens less than 2 months old and/or weighing less than 1 kg.

Do not use on sick (systemic diseases, fever…) or convalescent animals.

Do not use in rabbits, due to a risk of adverse drug reactions or even death.

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

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Adverse reactions

Cats:

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

Application site reaction1 (skin squamosis, alopecia, pruritus, erythema)

Generalised itching, Alopecia general

Hypersalivation2

Neurological disorders3 (e.g. Hyperaesthesia, central nervous system depression and neurological symptoms)

Vomiting

1Transient cutaneous reactions at the application site.

2 If licking occurs, a brief period of hypersalivation may be observed due mainly to the nature of the carrier.

3Reversible symptoms.

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 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 rinse the eyes with clean water.

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

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

Keep pipettes in original packaging until ready to use.

People with a known hypersensitivity to fipronil or excipients (see section 2.) should avoid contact with the veterinary medicinal product.

This veterinary medicinal product can cause mucous membrane and eye irritation. Therefore, contact between the product and the mouth or eyes should be avoided. In the case of accidental eye contact, immediately rinse the eyes with clean water. If eye irritation persists seek medical advice and show the package leaflet or the label to the physician.

Avoid contents coming into contact with the skin. If this occurs, wash hands with soap and water.

Ingestion of the product is harmful. Prevent children getting access to the pipettes and discard the used pipettes immediately after applying the product.

In case of accidental ingestion of product seek medical advice immediately.

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.

Do not smoke, drink or eat during application. Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

Other precautions:

The alcohol carrier may have adverse effects on painted, varnished or other household surfaces or furnishings.

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

Pregnancy and lactation:

Laboratory studies in cats have not produced any evidence of teratogenic or embryotoxic effects.

Studies have not been carried out with this product in pregnant and lactating queens. 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 at five times the recommended dose (daily therapeutic dose applied on five consecutive days) for three consecutive months except for itching and vomiting that occurred once. The risk of adverse effects may increase in cases of over-dose.

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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 ticks 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, shampooing an hour prior to treatment does not affect the efficacy of the veterinary medicinal product against fleas.

For optimum control of flea problems in a multi-pet household, all 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

Thermoformed pipettes: White or transparent multi-layer plastic single-dose pipette containing an extractible volume of 0.5 ml.

The internal layers in contact with the product are made of polyacrylonitrile-methacrylate or polyethylene-ethylene vinyl alcohol-polyethylene. The white or transparent external complex is composed of polypropylene/ cyclic olefine copolymer/ polypropylene.

Boxes of 1, 2, 3, 4 or 6 pipettes.

Polypropylene pipettes: White polypropylene single-dose pipette with an integral polyacetal cap for piercing the pipette, containing an extractible volume of 0.5 ml packaged in uncoloured plastic blister composed of polypropylene/cyclic olefine copolymer / polypropylene closed by heat sealing with a thermosealable lacquered aluminium foil and placed in a carton box or blister card.

Blister cards or boxes of 1, 2, 3, 4 or 6 pipettes.

Not all pack sizes may be marketed.

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Storage

Store below 30°C.

Store in a dry place.

Store in the original package.

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Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale:

Thermoformed pipette only: 2 years

Thermoformed pipette with overblister: 3 years

Polypropylene pipette: 2 years

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Disposal of unused product

Medicines should not be disposed of via wastewater.

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.

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.

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Additional information

Vm 05653/5088 (GB) Vm 05653/3056 (NI)

8 DATE OF FIRST AUTHORISATION

10 June 2013

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

August 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

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: 01 August 2025

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Registration holder

VIRBAC

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