Prac-tic - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Prac-tic spot-on solution for dogs

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder:

Elanco GmbH

Heinz-Lohmann-Str. 4

27472 Cuxhaven

Germany

Manufacturer for the batch release :

Elanco France S.A.S.

26, Rue de la Chapelle

68330 Huningue

France

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Prac-tic 56.25 mg spot-on solution for very small dogs

Prac-tic 137.5 mg spot-on solution for small dogs

Prac-tic 275 mg spot-on solution for medium dogs

Prac-tic 625 mg spot-on solution for large dogs

Pyriprole

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

One ml contains 125 mg pyriprole as a colourless to yellow, clear solution for external application to the skin.

One pipette delivers:

The solution also contains 0.1 % Butylhydroxyto­luene (E321)

• 4. INDICATION(S)

Treatment and prevention of flea infestation (Ctenocephalides canis and C. felis.).

Treatment and prevention of tick infestation (Ixodes ricinus, Ixodes scapularis, Dermacentor variabilis, Dermacentor reticulatus, Rhipicephalus sanguineus, Amblyomma americanum ).

Treatment and prevention of flea infestation: Prac-tic is effective against new infestations with fleas for a minimum duration of 4 weeks.

Treatment and prevention of tick infestation: Prac-tic is effective against ticks for 4 weeks.

• 5. CONTRAINDI­CATIONS

Do not use in dogs less than 8 weeks of age or weighing less than 2 kg.

Do not use in case of known hypersensitivity to phenylpyrazole class compounds or to any of the excipients.

Do not use on sick animals or on animals recovering from disease.

The veterinary medicinal product is specifically developed for dogs.

Do not use in cats, as this could lead to overdosing.

Do not use in rabbits.

• 6. ADVERSE REACTIONS

On very rare occasions the following have been reported:

• – application site and skin reactions :pruritus (itchy skin), hair change, dermatitis (inflammation of the skin), erythema (redness of skin), alopecia (loss of hair), fur discoloration and greasy appearance of hair.

• – neurological reactions: ataxia (lack of coordination) and convulsions.

• – systemic reactions: lethargy (drowsiness).

• – digestive tract reactions: emesis (vomiting) and diarrhoea.

Those signs are usually transient and disappear within 24 hours of the application; if they take longer to disappear consult your veterinarian.

A brief period of hypersalivation (drooling) may occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within minutes without treatment. Correct application will minimise licking of the application site.

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 side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Dog

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

For spot-on use for external application to the dog’s skin.

Dosage Table

The recommended minimum dose is 12.5 mg pyriprole per kg bodyweight, equivalent to 0.1 ml spot-on solution per kg bodyweight.

Within each weight range the entire contents of the correct size pipette should be deposited on the dog’s skin.

Flea treatment and prevention

Pyriprole kills fleas within 24 hours after contact. One treatment prevents future flea infestation for 4 weeks.

Tick treatment and prevention

Pyriprole kills ticks within 48 hours after application. One treatment is effective against ticks for 4 weeks.

ADVICE ON CORRECT ADMINISTRATION

For application on the skin only.

Remove one pipette from the package. Hold the pipette in an upright position. Tap the narrow part of the pipette to ensure the contents are in the main body of the pipette. Snap-off the top of the pipette along the scored line.

Part the coat on the back of the animal between the shoulder blades until the skin is visible. Place the tip of the pipette on the skin and squeeze it gently several times at one or two spots to empty the contents onto the skin. Ensure the product is deposited on the skin. Apply the 5 ml pipette to 2–3 spots down the backline of large dogs so as to prevent run-off.

The dogs should be accurately weighed before the treatment to ensure the correct pipette size is used.

Not applicable.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children. Do not use after the expiry date stated on the pipette after “EXP”.

Keep the pipettes in the original blister package until ready to use, in order to protect from light.

Do not store above 25°C.

• 12. SPECIAL WARNING(S)

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

People with known allergies to the phenylpyrazole class of compounds or any of the excipients should avoid contact with the product.

Avoid the contents coming into contact with your fingers. Wash your hands after use and wash off any product in contact with your skin with soap and water. If the product accidentally gets in your eyes, rinse them carefully with water. If eye irritation persists seek medical advice and show the package leaflet or the label to the doctor

If you come into contact with the product, it may happen that your skin and mucosa become numb and irritated but these conditions usually disappear spontaneously.

If you or anybody else accidentally swallows this product, seek medical advice immediately and show this leaflet or the label to your doctor.

Do not smoke, eat or drink while handling the product.

As a precautionary measure, direct contact with the treated dogs should be avoided and children should not be allowed to play with treated dogs until the application site is dry. It is therefore recommended to treat dogs in the evening. Recently treated dogs should not be allowed to sleep in the same bed as their owners, especially children.

This veterinary medicinal product is for the treatment of ticks and adult fleas. All dogs in a household should be treated at the same time.

Special precautions for use in animals

Following treatment, ticks will drop off from the dog within 24 to 48 hours after coming into contact with the animal; however, single ticks might remain on the animal. For this reason, a transmission of infectious diseases by ticks cannot be completely excluded.

In cases of heavy infestation prior to treatment, the dog’s surrounding should be vacuumed and treated with a suitable insecticide.

Apply only to the skin surface and on intact skin.

The product is for skin application on dogs only; do not put in your dog’s mouth. Take care to avoid the veterinary medicinal product coming into contact with your dog’s eyes.

Consult a veterinary surgeon if it is intended to use the product on dogs with other products or medication

Do not give the product by mouth as this can lead to an overdose, or any other route.

The safety of the product has not been established in breeding dogs, including pregnant or lactating dogs. If you suspect your dog may be pregnant or if your bitch is nursing puppies or if you want to treat a breeding dog, contact your veterinarian for advice before use.

Overdose (symptoms, emergency, procedures, antidotes):

Mild neurological signs such as slight incoordination and unsteadiness were observed in some animals treated once a month. Those signs disappeared within 3 hours following administration.

In one out of 8 dogs the following transient adverse effects were observed: tremors (shaking), ataxia (lack of coordination), panting and convulsions. These signs disappeared within 18 hours following administration.

Following an overdose on a single occasion the following adverse effects were seen: vomiting, anorexia (loss of appetite), reduced body weight, muscle tremors, seizures, unsteadiness, laboured breathing. All signs resolved within 48 hours, with the exception of the loss of appetite.

An overdose of the product may cause a sticky and tangled appearance of hair at the treatment spot for up to 24 hours.

In case of an overdose contact your veterinary surgeon

Apply the dose to an area where your dog cannot lick it off and do not allow your dog or other animals lick each other following treatment.

Dogs should not be bathed or shampooed from 48 hours before treatment. Immersion of your dog in water or shampooing within 24 hours after treatment may reduce the efficacy of the product. If you want to wash your dog, leave at least one day between treatment and shampooing.

When administering the product, try to avoid wetting the fur as this will lead to a sticky and tangled appearance. However, should this happen it will disappear within 24 hours.

The solvent in Prac-tic may stain certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.

Prac-tic should not enter water courses, as this may be dangerous for fish and other aquatic organisms.

Medicines should not be disposed of via wastewater or household waste.

These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency

• 15. OTHER INFORMATION