Summary of Product Characteristics

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Prazitel Plus Tablets For Dogs

Prazitel Plus (Denmark)

Prazitel Tablets For Dogs (Spain and Italy)

Strantel vet 150 mg/144 mg/50 mg Tablets for dogs (Sweden)

Strantel Tablets For Dogs (Germany and Norway)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Active substances:

Praziquantel	50 mg
Pyrantel	50 mg (equivalent to 144 mg pyrantel embonate)
Febantel	150 mg

Excipients:

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Tablet

A pale yellow tablet with a cross breakline on one side.

The tablets can be divided into equal halves or equal quarters.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs.

4.2 Indications for use, specifying the target species

In dogs: Treatment of mixed infections by nematodes and cestodes of the following species

Nematodes:

Ascarids:Toxocara canis, Toxascaris leonina(adult and late immature forms).

Hookworms:Uncinaria stenocephala, Ancylostoma caninum(adults).

Whipworms:Trichuris vulpis(adults).

Cestodes:

Tapeworms:Echinococcusspecies, (E. granulosus, E. multilocularis), Taeniaspecies,

(T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum(adult and immature forms).

4.3 Contraindications

Do not use simultaneously with piperazine compounds.

Do not use in animals with a known sensitivity to the active ingredients or to any of the excipients.

4.4 Special warnings for each target species

Fleas serve as intermediate hosts for one common type of tapeworm – Dipylidium caninum. Tapeworm infestation is certain to reoccur unless control of intermediate hosts such as fleas, mice, etc. is undertaken.

Tapeworm infestation is unlikely in pups less than 6 weeks of age.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.

4.5 Special precautions for use

Special precautions for use in animals

None.

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

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

In the interests of good hygiene, persons administering the tablets directly to the dog, or by adding them to the dog’s food, should wash their hands afterwards.

Echinococcosis represents a hazard for humans. As echinococcosis is a notifiable disease to the World Organisation for Animal Health (OIE), specific guidelines on the treatment and follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority.

4.6 Adverse reactions (frequency and seriousness)

In very rare cases, gastrointestinal disorders (diarrhoea, emesis) have been observed.

4.7 Use during pregnancy, lactation or lay

Teratogenic effects attributed to high doses of febantel have been reported in sheep and rats. No studies have been performed in dogs during early pregnancy.Useof the product during pregnancy should be in accordance with a benefit risk assessment by the responsible veterinarian. It is recommended that the product is not used in dogs during the first 4 weeks of pregnancy. Do not exceed the stated dose when treating pregnant bitches.

4.8 Interaction with other medicinal products and other forms of interaction

Do not use simultaneously with piperazine compoundsas the anthelmintic effects of pyrantel and piperazine may be antagonized.

Concurrent use with other cholinergic compounds can lead to toxicity.

4.9 Amounts to be administered and administration route

Single dose: For oral administration only.

To ensure administration of a correct dose, body weight should be determined as accurately as possible

The recommended dose rates are: 15mg/kg bodyweight febantel, 5 mg/kg pyrantel (equivalent to 14.4 mg/kg pyrantel embonate) and 5 mg/kg praziquantel. This is equivalent to 1 Prazitel Plus tablet per 10 kg (22 lbs) bodyweight.

The tablets can be given directly to the dog or disguised in food. No starvation is needed before or after treatment.

The advice of a veterinarian should be sought regarding the need for and the frequency of repeat administration.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

The combination of praziquantel, pyrantel embonate and febantel is well tolerated in dogs. In safety studies, a single dose of 5 times the recommended doseor greater gave rise to occasional vomiting.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anthelmintic, praziquantel combinations.

ATC vet code: QP52AA51

5.1 Pharmacodynamic properties

This product contains anthelmintics active against gastrointestinal roundworms and tapeworms. The product contains three active substances, as follows:

In this fixed combination, pyrantel and febantel act against all relevant nematodes (ascarids, hookworms, and whipworms) in dogs. In particular, the activity spectrum covers Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninumand Trichuris vulpis. This combination shows synergistic activity in the case of hookworms and febantel is effective against T. vulpis.

The spectrum of activity of praziquantel covers all important cestode species in dogs, in particular Taeniaspp., Dipylidium caninum, Echinococcus granulosusand Echinococcus multilocularis. Praziquantel acts against all adult and immature forms of these parasites.

Praziquantel is very rapidly absorbed through the parasite’s surface and distributed throughout the parasite. Both in vitro and in vivo studies have shown that praziquantel causes severe damage to the parasite integument, resulting in the contraction and paralysis of the parasites. There is an almost instantaneous tetanic contraction of the parasite musculature and a rapid vacuolization of the syncytial tegument. This rapid contraction has been explained by changes in divalent cation fluxes, especially calcium.

Pyrantel acts as a cholinergic agonist. Its mode of action is to stimulate nicotinic cholinergic receptors of the parasite, induce spastic paralysis of the nematodes and thereby allow removal from the gastrointestinal system by peristalsis.

Within the mammalian system, febantel undergoes ring closure, forming fenbendazole and oxfendazole. It is these chemical entities which exert the anthelmintic effect by inhibition of tubulin polymerisation. Formation of microtubules is thereby prevented, resulting in disruption of structures vital to the normal functioning of the helminth. Glucose uptake in particular is affected, leading to a depletion in cell ATP. The parasite dies upon exhaustion of its energy reserves, which occurs 2 – 3 days later.

5.2 Pharmacokinetic particulars

Perorally administered praziquantel is absorbed almost completely from the intestinal tract. After absorption, the drug is distributed to all organs. Praziquantel is metabolized into inactive forms in the liver and secreted in bile. It is excreted within 24 hours to more than 95% of the administered dosage. Only traces of non-metabolised praziquantel are excreted.

Following administration of the product to dogs, peak plasma concentrations of praziquantel were achieved by approximately 2.5 hours.

The pamoate salt of pyrantel has low aqueous solubility, an attribute that reduces absorption from the gut and allows the drug to reach and be effective against parasites in the large intestine. Following absorption, pyrantel pamoate is quickly and almost completely metabolized into inactive metabolites that are excreted rapidly in the urine.

Febantel is absorbed relatively rapidly and metabolized to a number of metabolites including fenbendazole and oxfendazole, which have anthelmintic activity.

Following administration of the product to dogs, peak plasma concentrations of fenbendazole and oxfendazole were achieved by approximately 7-9 hours.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose monohydrate,

Microcrystalline cellulose,

Magnesium stearate,

Colloidal anhydrous silica,

Croscarmellose sodium,

Sodium laurilsulfate

Pork flavour

6.2 Incompatibilities

Not applicable

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale:3 years

Discard any unused divided tablets immediately.

6.4. Special precautions for storage

This veterinary medicinal product does not require any special storage conditions

6.5 Nature and composition of immediate packaging

The product is presented in either:

Individual strips composed of aluminium foil 30 µm/30 gsm extruded polythene, containing 2, 4, 6, 8, 10, 12, 14, 16, 18 or 20 tablets.

or

Individual blisters composed of 45 µm, soft temper aluminium foil and 25 µm hard temper aluminium foil, containing 2 or 8 tablets.

The strips or blisters are packed into cartons containing either 2,4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 30, 32, 36, 40, 42, 44, 48, 50, 52, 56, 60, 70, 80, 84, 90, 98, 100, 104, 106, 120, 140, 150, 180, 200, 204, 206, 250, 280, 300, 500 or 1000 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials

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

7. MARKETING AUTHORISATION HOLDER

Chanelle Pharmaceuticals Manufacturing Limited,

Loughrea,

Co. Galway,

Ireland.

8. MARKETING AUTHORISATION NUMBER

Vm08749/4024

9. DATE OF FIRST AUTHORISATION

15 December 2009

10. DATE OF REVISION OF THE TEXT

July 2014

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

Approved: 18/07/2014