Each tablet contains:

Praziquantel 50 mg

Pyrantel Embonate 144 mg (equivalent to 50 mg pyrantel)

Febantel 150 mg

For the full list of excipients, see "Pharmaceutical particulars" section.

Tablet

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

The tablets can be divided into halves or quarters.

For the treatment of mixed infections with roundworms, hookworms, whipworms, and tapeworms of the following species:

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

Hookworms (adults): Uncinaria stenocephala, Ancylostoma caninum.

Whipworms (adults): Trichuris vulpis.

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

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

Do not use simultaneously with piperazine compounds as piperazine may block the action of pyrantel embonate contained in this product. Other worming products may contain piperazine.

Do not use simultaneously with other deworming products without veterinary advice.

Do not exceed the stated dose.

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.

Dogs should also be prevented from scavenging or hunting as part of measures to prevent tapeworm reinfestation.

If your dog receives other veterinary medicinal products, check with a veterinary surgeon or pharmacist before using this product.

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.

Do not exceed the stated dose, especially when treating pregnant bitches.

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

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 either 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.

In very rare cases mild and transient digestive tract disorders such as vomiting and/or diarrhoea may occur. In individual cases these signs can be accompanied by nonspecific signs such as lethargy, anorexia, or hyperactivity.

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).

Consult a veterinary surgeon before treating pregnant animals.

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.

The product may be used in lactating bitches from two weeks after giving birth (see Section 'Amounts to be administered and administration route' below).

Do not use simultaneously with piperazine compounds as the anthelmintic effects of pyrantel and piperazine may be antagonized (see section 'Contraindications' above).

Concurrent use with other cholinergic compounds (e.g. neostigmine, propoxur, and bethanechol) can lead to toxicity.

For oral administration only.

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

1 tablet per 10 kg (22 lbs) bodyweight.

This is equivalent to 15 mg febantel, 14.4 mg pyrantel embonate and 5 mg praziquantel per kilo bodyweight.

It is important to follow the treatment recommendations as presented here. Do not deviate from the recommendations without the advice of your veterinary surgeon.

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

Not for use in dogs weighing less than 3 kg or less than 2 weeks of age.

Puppies should be treated at 2 weeks of age and every 2 weeks until 12 weeks of age.

Thereafter they should be treated at 3-month intervals. It is advisable to treat the bitch at the same time as the puppies.

For routine worm control adult dogs should be treated with a single dose every 3 months.

For the control of Toxocara, nursing bitches should be dosed 2 weeks after giving birth and every two weeks until weaning.

In case of suspected heavy roundworm infestation, please contact your veterinary surgeon for diagnosis and treatment recommendations.

If there is a risk of re-infestation (see section 'Special warnings for each target species'), the advice of a veterinarian should be sought regarding the need for and the frequency of repeat administration.

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.

Not applicable.

Pharmacotherapeutic group: Anthelmintic, praziquantel combinations.

ATC vet code: QP52AA51

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.

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.

Lactose monohydrate,

Microcrystalline cellulose,

Magnesium stearate,

Colloidal anhydrous silica,

Croscarmellose sodium,

Sodium laurilsulfate

Pork flavour

Not applicable

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

Discard any unused divided tablets.

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

The product is presented in either:

Individual strips composed of aluminium foil 30 µm with 30 gsm extruded polythene, containing 1, 2, 4, 6, or 8 tablets.

or

Individual blisters composed of 45 µm, soft temper aluminium foil and 25 µm hard temper aluminium foil, containing 1, 2 or 8 tablets.

The strips or blisters are packed into cartons containing either 1, 2, 4, 6, or 8 tablets.

Not all pack sizes may be marketed.

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

C&H Generics Ltd

C/o Michael McEvoy and Co

Seville House

New Dock Street

Galway Ireland

Vm 40162/4032

12 January 2021

March 2022