Anthelmin Plus Flavour Tablets for Dogs

Composition

Each tablet contains:

Active substances:

Praziquantel 50 mg

Pyrantel embonate 144 mg

Febantel 150 mg

Excipients:

Yellow coloured, round, biconvex tablets with visible darker spots, cross-scored on one side.

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Pharmacological properties

4.1 ATCvet code: QP52AC55

4.2 Pharmacodynamics

The veterinary medicinal product contains anthelmintics active against roundworms and tapeworms. The veterinary medicinal product contains three active substances: febantel, pyrantel embonate (pamoate) and praziquantel, a partially hydrogenated pyrazino-isoquinoline derivative used widely as an anthelmintic for both human and veterinary use. Pyrantel acts as a cholinergic agonist. Its mode of action is to stimulate nicotinic cholinergic receptors of the parasite, induce spastic paralysis and thereby allow removal from the gastro-intestinal (GI) system by peristalsis.

With 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 polymerization. Formation of microtubules is thereby prevented, resulting in disruption to structures vital to the normal functioning of the helminth. Glucose uptake, in particular, is affected, leading to depletion in cell ATP. The parasite dies upon exhaustion of its energy reserves, which occurs 2 – 3 days later.

Praziquantel is very rapidly absorbed 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 contraction and paralysis. There is an almost instantaneous tetanic contraction of the parasite musculature and a rapid vacuolisation of the syncytial tegument. This rapid contraction has been explained by changes in divalent cation fluxes, especially calcium.

In this fixed combination veterinary medicinal product pyrantel and febantel act synergistically against all relevant nematodes (ascarids and hookworms) in dogs. In particular, the activity spectrum covers Toxocara canis, Toxascaris leonina, Uncinaria stenocephala and Ancylostoma caninum. The spectrum of activity of praziquantel covers also cestode species in dogs, in particular all Taenia spp. and Dipylidium caninum. Praziquantel acts against adult and immature forms of these parasites.

4.3 Pharmacokineticso

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.

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. Because of the low systemic absorption of pyrantel pamoate, there is very little danger of adverse reactions/toxicity in the host. Following absorption, pyrantel pamoate is quickly and almost completely metabolised into inactive metabolites that are excreted rapidly in the urine.

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

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Target species

Dogs (weighing at least 2 kg).

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Indications

For the treatment of mixed infections with the following roundworms and tapeworms in adult dogs and puppies:

Nematodes

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

Hookworms: Uncinaria stenocephala, Ancylostoma caninum (adults)

Cestodes

Tapeworms: Taenia spp., Dipylidium caninum

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Dosage

For oral use.

Dosage

The recommended dose rates are: 15 mg/kg bodyweight febantel, 14.4 mg/kg pyrantel and 5 mg/kg praziquantel. This is equivalent to 1 tablet per 10 kg bodyweight. Tablets may be halved/quartered to allow accuracy of dosing.

Administration and Duration of Treatment

The tablet(s) can be given directly to the dog or disguised in food. No restriction of access to food is required either before or after administration of the veterinary medicinal product.

To ensure a correct dosage, body weight should be determined as accurately as possible.

Puppies may be wormed with this veterinary medicinal product from 2 weeks of age and every 2 weeks until 12 weeks of age. Thereafter they should be treated at 3 monthly intervals until 6 months of age.

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

For adult dogs, a single dose should be used. The advice of a veterinarian should be sought regarding the need for and frequency of repeat treatment.

In the event of a heavy roundworm infestation, a repeat dose should be given after 14 days.

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Contraindications

Do not use simultaneously with piperazine compounds.

Do not exceed the stated dosage when treating pregnant bitches.

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

Do not use in dogs younger than 2 weeks of age and/or weighing less than 2 kg.

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Adverse reactions

Dogs:

*Transient.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Any part-used tablets should be discarded.

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

In the interests of good hygiene, persons administering the tablet directly to a dog or by adding it to the dog's food, should wash their hands afterwards.

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

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy:

Do not use in bitches during the first two-thirds of pregnancy.

Consult a veterinary surgeon before treating pregnant animals for roundworms.

Lactation:

Can be used during lactation (see Sections 3.3 and 3.9).

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Interactions

Do not combine with piperazine as the anthelmintic effects of pyrantel and piperazine (used in many worming products for dogs) may be antagonized.

Concurrent use with other cholinergic compounds can lead to toxicity.

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Overdose

Benzimidazoles possess wide safety margin. Pyrantel is not absorbed systematically to any extent. Praziquantel also has a wide safety margin, of up to five times the recommended dose.

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Special warnings

Fleas serve as intermediate hosts for one common type of tapeworm – Dipylidium caninum. Tapeworm infestation is certain to re-occur 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.

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Withdrawal period

Not applicable.

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Incompatibilities

Not applicable.

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Immediate packaging

OPA/Al/PVC-Al blister: 2 tablets (1 blister with 2 tablets), in a box.

OPA/Al/PVC-Al blister: 4 tablets (2 blisters with 2 tablets), in a box.

OPA/Al/PVC-Al blister: 10 tablets (1 blister with 10 tablets), in a box.

OPA/Al/PVC-Al blister: 30 tablets (3 blisters with 10 tablets), in a box.

OPA/Al/PVC-Al blister: 50 tablets (5 blisters with 10 tablets), in a box.

OPA/Al/PVC-Al blister: 100 tablets (10 blisters with 10 tablets), in a box.

OPA/Al/PVC-Al blister: 300 tablets (30 blisters with 10 tablets), in a box.

Not all pack sizes may be marketed.

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Storage

This medicinal product does not require any special storage conditions.

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Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life of the divided tablets: use immediately.

Half/quarter tablets should be discarded.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 01656/4015

8 DATE OF FIRST AUTHORISATION

07 March 2011

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

January 2026

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Registration holder

KRKA d.d, Novo mesto

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