Frontline Spot on Dog 10% w/v Spot on Solution

Composition

Each pipette contains:

Active substance:

Excipients:

Qualitative composition of excipients and other constituents

Quantitative composition if that information is essential for proper administration of the veterinary medicinal product

Butylhydroxyanisole (E320) 0.02% w/v

Butylhydroxytoluene (E321) 0.01% w/v

Ethanol

Polysorbate 80 (E433)

Polyvidone K17

Diethylene glycol monoethyl ether

Clear amber spot-on solution.

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Pharmacological properties

4.1 ATCvet code: QP53AX15

The veterinary medicinal product is an insecticidal and acaricidal solution for topical use, containing an adulticidal active ingredient, fipronil.

4.2 Pharmacodynamics

Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family. It acts by interacting with ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA), 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 and acarids.

Fipronil exhibits an insecticidal and acaricidal activity against fleas (Ctenocephalides spp), the veterinary medicinal product is effective against fleas for up to 2 months, depending on the level of environmental challenge. Newly arriving fleas are killed within 24 hours of landing on the animal. Ticks (Dermacentor spp., Rhipicephalus spp. and Ixodes spp. including Ixodes ricinus, important as the vector of Lyme disease) and lice (Trichodectes canis) within 48 hours post-exposure.

4.3 Pharmacokinetics

Absorption

After topical application of the veterinary medicinal product on the dog, absorption of fipronil through the skin is slight (approximately 15%). Low levels of fipronil may be detected in the plasma, with a very high variability between dogs.

Distribution

After topical application, the veterinary medicinal product will spread from the site of treatment to cover the entire surface of the animal within 24 hours. A concentration gradient of fipronil is set up on the fur of the animal extending from the point of application to the peripheral areas (lumbar zones, flanks).

Biotransformation

In ‘in vitro’ studies with subcellular liver fractions, the principal metabolite is the sulfone derivative of fipronil (RM1602), which also kills fleas and ticks.

Elimination

The concentrations of fipronil on the hair decrease with time to attain a level of approximately 3 to 4 µg.g –1 56 days after treatment.

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Target species

Dogs

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Indications

The treatment and prevention of flea and tick infestations and/or biting lice.

- Treatment of flea infestations (Ctenocephalides spp.). Insecticidal efficacy against new infestations with adult fleas persists for 4 weeks.

- Treatment of tick infestations (Ixodes ricinus, Dermacentor variabilis, Rhipicephalus sanguineus). The veterinary medicinal product has a persistent acaricidal efficacy for up to 2 weeks against ticks (based on experimental data).

- Treatment of infestations with biting lice (Trichodectes canis).

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Dosage

Spot-on.

Dogs should be weighed accurately prior to treatment.

By topical application to the skin according to bodyweight, corresponding to a minimum recommended dose of 6.7 mg/kg of fipronil, as follows:

For dogs > 60kg use two pipettes of 2.68ml

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

For infestations with fleas and/or ticks, the need for and frequency of re-treatment(s) should be based on professional advice and should take into account the local epidemiological situation and the animal’s lifestyle.

Method of Administration:

Hold upright. Tap the narrow part of the pipette to ensure the contents are within the main body of the pipette. Break back the snap-off top from the spot-on pipette along the scored line. Part the coat between the shoulder blades until the skin is visible. Place the tip of the pipette against the skin and squeeze gently at one or two spots to empty its contents directly onto the skin, preferably at two spots, one at the base of the skull and a second 2-3cms further back.

Care should be taken to avoid excessive wetting of the hair with the 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.

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Contraindications

In the absence of available data, the veterinary medicinal product should not be used on puppies less than 8 weeks old and /or weighing less than 2 kg.

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

Do not use on rabbits, as adverse events and even death could occur. This veterinary medicinal product is specifically developed for dogs. Do not use in non-target species.

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

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Adverse reactions

Dogs:

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

Application site reactions (skin discoloration1, localised hair loss1, itching1, reddening1).

Generalised itching or hair loss.

Hypersalivation2, vomiting.

Hyperaesthesia3,4.

Excitation3, unusual behaviour3.

Depression.

1 Transient

2 If licking occurs, a brief period of hypersalivation may be observed due mainly to the nature of the solvents in the veterinary medicinal product.

3 Reversible

4 Increased sensitivity to light and sound

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:

For external use only.

Avoid contact with the animal’s eyes.

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 groom each other following treatment until the application site is dry.

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

Keep pipettes in original packaging until ready to use. In order to prevent children from getting access to used pipettes, dispose of used pipettes immediately.

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

In the event of accidental exposure to the eye, it should be rinsed carefully with water.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

People with a known hypersensitivity (allergy) to insecticides, such as fipronil, or to alcohol should avoid contact with the veterinary medicinal product. Avoid contents coming into contact with the fingers. If this occurs, wash hands with soap and water.

Wash hands after use.

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.

Special precautions for the protection of the environment:

Dogs should not be allowed to swim in watercourses for 2 days after application. See section 5.5.

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

The veterinary medicinal product can be used during pregnancy and lactation. Laboratory studies using fipronil have not shown any evidence of toxicity to the embryo or developmental abnormalities in the young.

The safety of the veterinary medicinal product was demonstrated in breeding, pregnant and lactating female dogs treated with multiple consecutive doses with up to 3 times the maximum recommended dose.

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Interactions

Do not use simultaneously with other flea products which are applied directly onto the animal.

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Overdose

Do not overdose.

The risk of experiencing adverse effects may however increase with overdosing (see section 3.6.), so dogs should always be treated with the correct pipette size according to bodyweight.

No adverse effects were observed in target animal safety studies in 8-week-old puppies, growing dogs and dogs weighing about 2 kg treated once at 5 times the recommended dose.

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Special warnings

Bathing/immersion in water within 2 days after application of the veterinary medicinal product and more frequent bathing than once a week should be avoided, as no study has been performed to investigate how this affects the efficacy of the veterinary medicinal product. Emollient shampoos can be used prior to treatment but reduce the duration of protection against fleas to approximately 5 weeks when used weekly after application of the veterinary medicinal product. Weekly bathing with a 2% chlorhexidine medicated shampoo did not affect efficacy against fleas during a 6 week-long study.

There may be an attachment of single ticks. For this reason, transmission of infectious diseases cannot be completely excluded if conditions are unfavourable.

FRONTLINE SPOT ON DOG does not prevent ticks from attaching to the animals, but ticks will be killed in the first 24-48 hours after attachment, before they are fully fed and therefore minimising the risk of transmission of diseases. Once dead, ticks will often drop off the animal, but any remaining ticks may easily be removed using a suitable tick remover.

In case of infestation, carpets and non-washable furnishings should be treated with an appropriate insecticide household spray to kill eggs and larvae already in the home. Wash all pet bedding at 60°C as fleas often infest the animal's regular resting areas. Vacuum the whole house, including under furniture.

Other pets living in the same household should also be treated with a suitable veterinary medicinal product.

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Withdrawal period

Not applicable.

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Incompatibilities

None known.

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Immediate packaging

A blue pipette composed of a heat-formed shell (polyacrylonitrile-methyl acrylate copolymer in contact with the solution / polypropylene) and a film (polyacrylonitrile-methyl acrylate copolymer in contact with the solution / aluminium / polyethylene terephthalate).

Or

A blue pipette composed of a heat-formed shell (polyethylene in contact with the solution / ethylene vinyl alcohol / polyethylene / polypropylene / cyclic-olefin-copolymer / polypropylene) and a film (polyethylene in contact with the solution / ethylene vinyl alcohol / polyethylene / aluminium / polyethylene terephthalate).

Package sizes:

0.67 ml

Blister card of 1 x 0.67 ml pipette with a scored tip

Box of 1 foil blister strip of 1 x 0.67 ml pipette with a scored tip

Box of 1 foil blister strip of 1 x 0.67 ml pipette with a scored tip and two empty blister spaces

Box of 1 foil blister strip of 3 x 0.67 ml pipettes with a scored tip

Box of 2 foil blister strips of 3 x 0.67 ml pipettes with a scored tip

1.34 ml

Blister card of 1 x 1.34 ml pipette with a scored tip

Box of 1 foil blister strip of 1 x 1.34 ml pipette with a scored tip

Box of 1 foil blister strip of 1 x 1.34 ml pipette with a scored tip and two empty blister spaces

Box of 1 foil blister strip of 3 x 1.34 ml pipettes with a scored tip

Box of 2 foil blister strips of 3 x 1.34 ml pipettes with a scored tip

2.68 ml

Blister card of 1 x 2.68 ml pipette with a scored tip

Box of 1 foil blister strip of 1 x 2.68 ml pipette with a scored tip

Box of 1 foil blister strip of 1 x 2.68 ml pipette with a scored tip and two empty blister spaces

Box of 1 foil blister strip of 3 x 2.68 ml pipettes with a scored tip

Box of 2 foil blister strips of 3 x 2.68 ml pipettes with a scored tip

4.02 ml

Blister card of 1 x 4.02 ml pipette with a scored tip

Box of 1 foil blister strip of 1 x 4.02 ml pipette with a scored tip

Box of 1 foil blister strip of 1 x 4.02 ml pipette with a scored tip and two empty blister spaces

Box of 1 foil blister strip of 3 x 4.02 ml pipettes with a scored tip

Box of 2 foil blister strips of 3 x 4.02 ml pipettes with a scored tip

Not all pack sizes may be marketed.

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Storage

Do not store above 25°C.

Store in the original package.

Store in a dry place.

Flammable.

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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 veterinary medicinal product or empty containers.

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 08327/5078

8 DATE OF FIRST AUTHORISATION

27 November 1996

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

July 2026

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.

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Registration holder

Boehringer Ingelheim Animal Health UK Limited

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