Frontline Plus Dog Spot-On (20-40kg) - Flea, Tick & Lice Treatment

What does this product do?
Kills fleas on your dog for 8 weeks.
Prevents development of flea eggs, larvae and pupae for 8 weeks.
Kills ticks on your dog for up to 4 weeks.
Kills biting lice.

Statement of Active and Other Substances
Clear amber solution containing:
Fipronil - 268.00 mg
(S)-methoprene - 241.20 mg
Butylhydroxyanisole (E320) - 0.54 mg
Butylhydroxytoluene (E321) - 0.27 mg
Excipient(s): q.s - 2.68 ml

Pharmaceutical Form
Spot-on solution.

Blister card of 1 x 2.68 ml pipette; Box of 1 blister card of 1 x 2.68 ml pipette; Box of 1 blister card of 3 x 2.68 ml pipettes; Box of 1 blister card of 4 x 2.68 ml pipettes; Box of 2 blister cards of 3 x 2.68 ml pipettes.
Not all pack sizes may be marketed.

Marketing authorisation holder:
Boehringer Ingelheim Animal Health UK Ltd,
Bracknell,
RG12 8YS,
UK.

Boehringer Ingelheim Animal Health France SCS,
4 Chemin du Calquet,
31000 Toulouse,
France.

For protection against fleas and ticks, and to prevent flea eggs from hatching, apply every 4 weeks.*
*Before every use, read the information on the inside of the box for full instructions and all warnings.

How to treat a home infestation:
In addition to treating your pet follow the 2 steps below:
1) Use a household flea treatment to kill eggs and larvae already in the home.
2) Regularly vacuum your carpets and furnishings.
For dogs 8 weeks or older. Can be used in pregnancy and lactation.

Indication(s)
For the treatment of dogs weighing 20 to 40 kg bodyweight
- To be used against infestations with fleas, alone or in association with ticks and/or biting lice.
- Treatment of flea infestations (ctenocephalides spp.). Insecticidal efficacy against new infestations with adult fleas persists for 8 weeks. Prevention of the multiplication of fleas by inhibiting the development of eggs (ovicidal activity), larvae and pupae (larvicidal activity) originating from eggs laid by adult fleas for eight weeks after application.
- Treatment of tick infestations (ixodes ricinus, dermacentor variabilis, dermacentor reticulatus, rhipicephalus sanguineus). The product has a persistent acaricidal efficacy for up to 4 weeks against ticks (based on experimental data).
- Treatment of infestations with biting lice (trichodectes canis). fipronil kills fleas within 24 hours and ticks and lice within 48 hours post-exposure.

Method and Route(s) of Administration
Spot-on

Method of Administration
1. Take the pipette out of its packaging. Hold the pipette upright. Tap the narrow part of the pipette to ensure the contents remain within the main body of the pipette. Snap back the tip.
2. 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.
3. Place the tip of the pipette on the skin and squeeze the pipette several times to empty its contents completely and directly onto the skin in one spot.

Dosage: One pipette of 2.68 ml (L) per dog weighing over 20 and up to 40 kg, corresponding to a minimum recommended dose of 6.7 mg/kg for fipronil and 6 mg/kg for (S)-methoprene, by topical application to the skin. Temporary changes to the coat (clumped/greasy hair) may be noted at the application site.

For animal treatment only.
Keep out of the sight and reach of children.
Fipronil and (S)-methoprene may adversely affect aquatic organisms.
Dogs should not be allowed to swim in watercourses for 2 days after application.

Contraindications: In the absence of available data, the product should not be used on puppies less than 8 weeks old. Do not use on sick (e.g. systemic diseases, fever) or convalescent animals.
Do not use in rabbits, as adverse drug reactions and even mortality could occur. In absence of studies, the use of the product is not recommended in non-target species.
This product is specifically developed for dogs. Do not use in cats and ferrets, as this could lead to overdosing.
In the absence of safety studies, the minimum treatment interval is 4 weeks. Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

Undesirable Effects: Among the very rare suspected adverse reactions, transient skin reactions at the application site (skin discoloration, local hair loss, itching, redness) and general itching or hair loss have been reported after use. Excessive salivation, reversible nervous signs (increased sensitivity to stimulation, depression, other nervous signs), vomiting or respiratory symptoms have also been observed after use.
If licking occurs, a brief period of excessive salivation may be observed due mainly to the nature of the carrier.
Do not overdose.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any serious effects or other effects not mentioned here, please inform your veterinary surgeon.

Overdose: 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 five times the recommended dose. The risk of experiencing adverse effects may however increase with overdosing (see Undesirable Effects) so animals should always be treated with the correct pipette size according to bodyweight.

User warnings: This product can cause mucous membrane, skin and eye irritation. Therefore, contact of the product with mouth, skin and eyes should
be avoided. If the product is accidentally swallowed, seek medical advice immediately and show the package leaflet to the physician. 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. People with a known hypersensitivity (allergy) to insecticides or alcohol should avoid contact with the product. Avoid contents coming into contact with the fingers. If this occurs, wash hands with soap and water. After accidental exposure the eye should be rinsed carefully with pure 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 are not allowed to sleep with owners, especially children. Do not smoke, drink or eat during application.

Other Precautions: Fipronil and (S)-methoprene may adversely affect aquatic organisms. Dogs should not be allowed to swim in watercourses for 2 days after application. The alcohol carrier may have adverse effects on painted, varnished or other household surfaces or furnishings.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Fipronil and (S)-methoprene may adversely affect aquatic organisms.
Do not contaminate ponds, waterways or ditches with the product or empty containers.
For animal treatment only. Keep out of the sight and reach of children.

SPECIAL WARNING(S): For external use only.
Use during pregnancy and lactation: The product can be used during pregnancy and lactation.
Precautions: Animals should be weighed accurately prior to treatment. It is important to make sure that the 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. When treating infestations of parasites, all in-contact animals should be treated with an appropriate product at the same time. Do not use simultaneously with other flea products which are applied directly on to the animal.
Bathing/immersion in water within 2 days after application of the 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 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 product. Weekly bathing with a 2% chlorhexidine medicated shampoo did not affect efficacy against fleas during a 6 week long study. The duration of protection of the product is not affected by immersion in water or weekly shampooing with a 2% Chlorhexidine shampoo for up to 6 weeks when carried out 2 days after treatment. Avoid contact with the animal's eyes.
There may be an attachment of a few ticks. For this reason a transmission of infectious diseases cannot be completely excluded if conditions are unfavourable.
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.

Do not store above 30 °C. Store in the original package.
Do not use this veterinary medicinal product after the expiry date stated on the package after exp.
The expiry date refers to the last day of the month.