Ezi-Wormer Plus XL Tablets for Dogs

Composition

Each tablet contains:

Active substances:

Praziquantel 175 mg

Pyrantel 175 mg (equivalent to 504 mg pyrantel embonate)

Febantel 525 mg

Excipients:

For the full list of excipients, see section 6.1.

6.1 List of excipients

Lactose monohydrate,

Microcrystalline cellulose,

Magnesium stearate,

Colloidal anhydrous silica,

Croscarmellose sodium,

Sodium laurilsulfate

Pork flavour

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Pharmaceutical form

Tablet

A yellow coloured oblong tablet with a breakline on both sides.

The tablets can be divided into halves.

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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:

1. Febantel, a probenzimidazole

2. Pyrantel embonate (pamoate), a tetrahydropyrimidine derivative

3. Praziquantel, a partially hydrogenated pyrazinoisoquinoline derivative

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 caninum and 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 Taenia spp., Dipylidium caninum, Echinococcus granulosus and 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.

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Target species

Dogs.

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Indications

In adult 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: Echinococcus species, (E. granulosus, E. multilocularis), Taenia species, (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum (adult and immature forms).

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Dosage

For oral administration only.

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 Ezi-Wormer Plus XL tablet per 35 kg bodyweight. Dogs of > 35 kg bodyweight should be given 1 Ezi-Wormer Plus XL tablet plus the appropriate quantity of Ezi-Wormer Plus tablets equivalent to 1 tablet per 10 kg bodyweight.

Dogs weighing approx 17.5kg bodyweight should be given ½ Ezi-Wormer Plus XL tablet.

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

If there is a risk for re-infestation, the advice of a veterinarian should be sought regarding the need for and the frequency of repeat administration.

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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.

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Adverse reactions

Slight and transient digestive tract disorders such as vomiting and/or diarrhoea may occur in very rare spontaneous reports. Nonspecific signs such as lethargy, anorexia or hyperactivity can accompany these signs in individual cases.

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).

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Warnings

Special precautions for use in animals

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

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.

Other precautions

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.

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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. Use of 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.

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Interactions

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

Concurrent use with other cholinergic compounds can lead to toxicity.

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Overdose

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

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Special warnings

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.

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

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

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Withdrawal period

Not applicable.

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Incompatibilities

Not Applicable

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Immediate packaging

The product is presented in:

Blister packs made up of PVC/PE/PCTFE with 20µm hard tempered aluminium foil with 2, 4, 5, 6, 8, 10, 12, 14, 16, 18 or 20 tablets per blister. The blisters are packed into cartons containing either 2, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 30, 32, 36, 40, 42, 44, 48, 50, 52, 56, 60, 64, 68, 70, 72, 76, 80, 84, 88, 92, 96, 98, 100, 104, 106, 108, 112, 116, 120, 140, 150, 180, 200, 204, 206, 208, 250, 280, 300, 500 or 1000 tablets.

Not all pack sizes may be marketed.

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Storage

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

Each time an unused half tablet is stored, it should be returned to the open blister space and inserted back into the outer carton.

Keep the blister in the outer carton.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 5 years

Unused half tablet must be used within 14 days.

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Disposal of unused product

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

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Additional information

Vm 40162/4018

9 DATE OF FIRST AUTHORISATION

04 March 2016

10 DATE OF REVISION OF THE TEXT

March 2021

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Registration holder

C&H Generics Limited c/o Michael McEvoy and Co

Seville House

New Dock Street

Galway

Ireland

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