Drontal Dog Tasty Bone 150/144/50 mg Tablets

Composition

Each tablet contains:

Active substances:

150 mg febantel

50 mg pyrantel equivalent to 144 mg pyrantel embonate

50 mg praziquantel

Excipients:

Qualitative composition of excipients and other constituents

Maize starch

Lactose monohydrate

Microcrystalline cellulose

Povidone K25

Magnesium stearate

Sodium laurilsulfate

Silica, colloidal anhydrous

Croscarmellose sodium

Meat flavour

A light-brown to brown bone shaped tablet scored on both sides that can be divided into halves.

3

Pharmacological properties

4.1 ATCvet code:

QP52AA51

4.2 Pharmacodynamics

The product is an anthelmintic containing as active substances the tetrahydropyrimidine derivative pyrantel (as the embonate salt), the pro- benzimidazole febantel and praziquantel, a partly hydrogenated pyrazinoisoquinoline derivative. It is effective against certain roundworms and tapeworms.

In this fixed combination pyrantel and febantel act synergistically against roundworms (ascarides, hookworms and whipworms) in dogs. In particular, the action spectrum covers Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninum, and Trichuris vulpis.

The spectrum of activity of praziquantel covers tapeworm species in dogs. In particular, it includes all Taenia species, as well as Dipylidium caninum, Echinococcus granulosus and Echinococcus multilocularis. Praziquantel acts against all intestinal stage of these parasites.

Pyrantel acts as a nicotinic agonist at acetylcholine receptors, causing spastic paralysis of roundworms via a depolarising neuromuscular block.

The anthelmintic efficacy of febantel is due to its ability to inhibit the polymerisation of tubulin to microtubuli. The resulting structural and functional metabolic disturbances exhaust the parasite’s energy reserves and kill it in 2-3 days.

Praziquantel is absorbed very rapidly through the parasite’s surfaces and is evenly distributed throughout their bodies. It causes severe damage of their integument, leading to disruption of metabolism and subsequently to death.

4.3 Pharmacokinetics

Praziquantel is absorbed almost completely in the small intestine following oral administration to dogs. Absorption is very rapid reaching maximum serum levels within 0.5 to 2 hours. After absorption, the drug is widely distributed through the body. Plasma protein binding is high. Praziquantel is rapidly metabolised in the liver leading to inactive metabolites. In dogs, metabolites are eliminated by urine (66 % of an oral dose) and via the bile (15%) in the faeces. Elimination half-life in dogs is about 3 hours.

Pyrantel (as embonate), being a low water-soluble compound, is poorly absorbed in the gastrointestinal tract, reaching the final parts of the intestine. The absorbed drug is extensively metabolised and the parent compound/metabolites are excreted by urine.

Febantel is a pro-drug that after oral administration and oral absorption is metabolised to fenbendazole and oxfendazole, the chemical entities exerting the anthelmintic effect. The active metabolites are excreted via faeces.

3

Target species

Dogs.

3

Indications

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

Roundworms:

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

Hookworms (adults): Uncinaria stenocephala, Ancylostoma caninum

Whipworms (adults): Trichuris vulpis

Tapeworms (adult and immature forms): Echinococcus granulosus, Echinococcus multilocularis, Dipylidium caninum, Taenia spp.

3

Dosage

For oral administration only.

Dosage

For treatment of dogs, 1 tablet per 10 kg body weight (15 mg febantel, 14.4 mg pyrantel embonate and 5 mg praziquantel/kg body weight).

Dosages are as follows:

For each additional 5 kg bodyweight, administer an additional half tablet.

Administration and Duration of Treatment

The tablets are flavoured and studies have shown that they are palatable and are taken voluntarily by the majority (88%) of dogs tested.

The tablets can be administered with or without food. Access to normal diet does not need to be limited before or after treatment.

Tablets should be given as a single administration.

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

Not for use in dogs weighing less than 2 kg.

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

3

Contraindications

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

Do not use during the 1st and 2nd third of pregnancy (see section 3.7).

3

Adverse reactions

Dogs:

Very rare (<1 animal / 10,000 animals treated, including isolated reports): Digestive tract disorders (e.g., vomiting and diarrhoea)1

Anorexia, Lethargy,

Hyperactivity.

1Mild and 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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3

Warnings

Special precautions for safe use in the target species:

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

To minimise the risk of reinfestation and new infestation, excreta should be collected and properly disposed of for 24 hours following treatment.

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

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

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

Special precautions for the protection of the environment:

Not applicable.

Other precautions:

Since it contains praziquantel, the product is effective against Echinococcus spp. which do not occur in all EU member states but are becoming more common in some. Echinococcosis represents a hazard for humans. As Echinococcosis is a notifiable disease to the World Organisation for Animal Health (WOAH), specific guidelines on the treatment and follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority.

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.

3

Use during pregnancy, lactation or lay

Pregnancy and lactation:

Teratogenic effects attributed to high doses of febantel administered during early pregnancy have been reported in rats, sheep and dogs.

The safety of the product has not been investigated during the 1st and 2nd third of pregnancy. Do not use in pregnant dogs during the 1st and 2nd third of pregnancy (see section 3.3).

A single treatment during the last third of pregnancy or during lactation has been demonstrated safe.

3

Interactions

The anthelmintic effects of this product and piperazine containing products may be antagonised when the two drugs are used together.

Concurrent use with other cholinergic compounds can lead to toxicity.

3

Overdose

No signs of adverse reactions were observed in safety studies in dogs and pups following administration of 10 times the recommended dose of the product.

3

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.

3

Withdrawal period

Not applicable.

3

Incompatibilities

Not applicable.

3

Immediate packaging

Container material: Blisters formed from PA/Alu/PE foil and sealed with Alu/PE foil.

Container sizes: Cartons containing 2, 4, 6, 24, 102, 312 tablets.

Not all pack sizes may be marketed.

3

Storage

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

After opening the blister, remaining half-tablets should be wrapped in aluminium foil and returned to the open blister.

3

Shelf life

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

Shelf life of half-tablets after first opening the immediate packaging: 7 days.

3

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.

3

Additional information

Vm 08007/5003

8 DATE OF FIRST AUTHORISATION

21 October 2014

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

April 2026

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product not subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

3

Registration holder

Vetoquinol UK Limited

3