Sodium Oxybate 500mg/ml oral solution

PACKAGE LEAFLET:

Simparica chewable tablets for dogs.

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

Marketing authorisation holder and manufacturer responsible for batch release: Zoetis Belgium SA 

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

• Simparica 5 mg chewable tablets for dogs 1.3-2.5 kg
• Simparica 10 mg chewable tablets for dogs >2.5-5 kg
• Simparica 20 mg chewable tablets for dogs >5-10 kg
• Simparica 40 mg chewable tablets for dogs>10-20 kg
• Simparica 80 mg chewable tablets for dogs>20-40 kq
• Simparica 120 mg chewable tablets for dogs>40-60 kq

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

Each tablet contains:

Simparica chewable tablets

for dogs 1.3-2.5 kg            5mg

for dogs >2.5-5 kg.            10mg

for dogs >5-10 kg.             20mg

for dogs>10-20 kg.            40mg

for dogs >20-40 kg.           80mg

for dogs >40-60 kg.           120mg

Mottled brown coloured, square shaped chewable tablets with rounded edges. The number embossed on one side refers to the strength (mg) of tablet: "5", "10","20", "40', "80" or "120".

4. INDICATION(S)

For the treatment of tick infestations (Dermnacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus). The veterinary medicinal product has immediate and persistent tick killing activity for at least 5 weeks.

For the treatment of flea infestations (Ctenocephalides felis and Ctenocephalides canis). The veterinary medicinal product has immediate and persistent flea killing activity against new infestations for at least 5 weeks., The veterinary medicinal product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).

For the treatment of sarcoptic mange (Sarcoptes scabien).

For the treatment of ear mite infestations (Otodectes cynotis).

For the treatment of demodicosis (Demodex canis).

For reduction of the risk of infection with Babesia canis canis via transmission by Dermacentor reticulatus for 28 days after treatment. The effect is indirect due to the product's activity against the vector.

Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.

5. CONTRAINDICATIONS

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

6. ADVERSE REACTIONS

Mild and transient gastrointestinal signs such as vomiting and diarrhoea, and systemic disorders such as lethargy, anorexia/inappetence may occur in very rare cases based on post marketing safety experience.

These signs typically resolve without treatment. Neurological disorders such as tremor, ataxia or convulsion may occur in very rare cases based on post marketing safety experience. in most cases these signs are transient.

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

Dogs.

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

For oral use.

The veterinary medicinal product should be administered at a dose of 2-4 mg/kg bodywNeiyght in accordance with the following table:

Bodyweight    Tablet strength      Dosage 

    1.3-2.5.                5.                             One

    >2.5-5.                 10.                           One

    >5-10                   20.                           One

    >10-20.                40                            One

    >20-40.                80.                           One

    >40-60.                120                          One

    >60. Appreciate combination of tablets

Use appropriate combination of available strengths to achieve the recommended dose of 2-4 mg/kg. The tablets should not be divided.

Tablets can be administered with or without food.

Treatment schedule:

For optimal control of flea and tick infestations, the veterinary medicinal product should be administered at monthly intervals and continue throughout the flea and/or tick season based on the local epidemiological situation.

For the treatment of ear mite infestations (Otodectes cynotis) a single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may requires second treatment.

For the treatment of sarcoptic mange (caused by Sarcoptes SCabiei var.canis) a single dose should be administered at monthly intervals for two consecutive months.

For the treatment of demodicosis (caused by Demodex canis) the administration of a single dose once monthly for three consecutive months is efficacious and leads to a marked improvement of clinical signs. Treatment should be continued until skin scrapings are negative on at least two consecutive occasions one month apart. As demodicosi is a multi-factorial disease, it is advisable to also treat any underlying disease appropriately.

9. ADVICE ON CORRECT ADMINISTRATION

Simparica tablets are chewable and palatable and readily consumed by dogs when offered by the owner. If the tablet is not taken up voluntarily by the dog it can also be given with food or directly into the mouth.

10. WITHDRAWAL PERIOD(S)

Not applicable.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

Do not use this veterinary medicinal product after the expiry date which is stated on the blister after EXP. The expiry date refers to the last day of that month.

12. SPECIAL WARNING(S)

Special warnings for each target species:

Transmission of B. anis canis cannot be completely excluded since D. reticulatus ticks have to attach to the host before being killed. As an acaricidal effect against D. reticulatus may take up to 48 hours, transnission of B. canis canis during the frst 48 hours cannot be incuded.

The use of the product should be based on the local epidemiological situation including knowledge of the prevalent tick species as transmission of B. canis by tick species other than D. reticulatus is possible should be part of an integrated control program to prevent the transmission of Babesia canis.

Special precautions for use in animals:

Puppies less than 8 weeks of age and/or dogs less than 1.3 kg bodyweight should not be treated unless so advised by a veterinarian.

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

Wash hands after handling the product. The accidental ingestion of the product may potentially result in adverse effects, such as transient excitatory neurological signs. To prevent children from accessing the product, only one chewable tablet at a time should be removed from the blister pack and only when required. The blister pack should be returned into the carton immediately after use and the carton should be stored out of the sight and reach of children. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician.

Pregnancy and lactation:

The safety of the veterinary medicinal product has not been established during pregnancy and lactation or in animals intended for breeding.

Laboratory studies in rats and rabbits have not produced any evidence any teratogenic effects. Use only accordingly to the benefit-risk assessment by the responsible veterinarian.

Interactions with other medicinal products and other forms of interaction

None known.

During clinical field trials, no interactions between Simparica chewable tablets for dogs and routinely used veterinary medicinal products were observed.

In laboratory safety studies, no interactions were observed when sarolaner was co-administered with milbemycin oxime, moxidectin and pyrantel pamoate. (In these studies efficacy was not investigated).

Sarolaner is highly bound to plasma proteins and might compete with other highly bound drugs such as non-steroidal anti-inflammatory drug (NSAIDs) and the cumarin derivative warfarin.

Overdose (symptoms, emergency procedures antidotes:

In a margin of safety study, the veterinary medicinal product was administered orally to & week old Beagle puppies at doses of 0, 1,3and 5 times the maximum exposure dose of 4 ng/ka at 28 day intervals for 10 doses. No adverse effects were observed at the maximum exposure dose of 4 mg/kg. In the overdose groups, transient and self-limiting neurological signs were observed in some animals: mild tremors at 3 times the maximum exposure dose and convulsions at 5 times the maximum exposure dose. All dogs recovered without treatment. 

Sarołaner is well tolerated in Collies with a deficient multi-drug resistance-protein 1 (MDR1-) following single oral administration at 5 times the recommended dose. No treatment-related clinical signs we observed.

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

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

11/11/2022.

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu)

15. OTHER INFORMATION

Sarolaner is an acaricide and insecticide belonging to the isoxazoline family. Sarolaner is active against adult fleas (Ctenocephalides felis and Ctenocephalides canis) as well as several tick species such as Dermacent reticulatus, bxodes hexagonus, Ixodes ricinus, Rhipicephalus sanguineus are the mites Demodex canis, Otodectes cynotis and Sarcoptes scabiei.

For fleas, the onset of efficacy is within 8 hours of attachment during the 28 day period after product administration. For ticks (/. ricinus), the ones of efficacy is within 12 hours of attachment during the 28 day period after product administration. Ticks on the animal prior to administration are killed within 24 hours.

The veterinary medicinal product kills newly emerged fleas on the dog before they can lay eggs and therefore it prevents environmental flea contamination in areas to which the dog has access.

For each strength, the chewable tablets are available in the following

pack sizes: carton with 1 blister of 1, 3 and 6 tablets, Not all pack sizes may be marketed.