SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Drontal Dog Tasty Bone 150/144/50 mg tablets [IE, UK]

Drontal Plus Tasty 150/144/50 mg tablets [AT, DE]

Dronbits 150/144/50 mg tablets [FI, SE]

Drontaste 150/144/50 mg tablets [DK, IS, NO]

Drontal Chien HP Comprimé 150/50/50 mg [FR]

Drontal Multi Aroma Carne 150/144/50 mg compresse per cani fino a 10kgs [IT]

Drontal Dog Tasty 150/144/50 mg tablets [NL]

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Active Substances

150 mg febantel

50 mg pyrantel equivalent to 144 mg pyrantel embonate

50 mg praziquantel

Excipients

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Tablet

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

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

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.

4.3 Contraindications

Do not use in case 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 4.7)

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 re-occur unless control of intermediate hosts such as fleas, mice etc. is undertaken.

4.5 Special precautions for use

Special precautions for use in animals

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.

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. Echinococcosisrepresents a hazard for humans. As Echinococcosisis 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 mild and transient digestive tract disorders (e.g. vomiting) may occur.

The frequency of adverse reactions is defined using the following convention:

- very rare (less than 1 animal in 10,000 animals, including isolated reports).

4.7 Use during pregnancy, lactation or lay

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 4.3).

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

4.8 Interaction with other medicinal products and other forms of interaction

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

4.9 Amounts to be administered and administration route

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:

Body weight (kg)	Tablet quantity
2-5	½
>5-10	1
>10-15	1 ½
>15-20	2

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.

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

10 times the recommended dose of the product was tolerated without signs of adverse reactions in dogs and pups.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anthelmintics, praziquantel combinations.

ATCvet code: QP52AA51.

5.1 Pharmacodynamic properties

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 Taeniaspecies, as well as Multiceps multiceps, Dipylidium caninum, Echinococcus granulosus andEchinococcus multilocularis. Praziquantel acts against all intestinal stage of these parasites.

Pyrantel acts as the nicotine, as a cholinergic agonist, 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 tubuline 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 thence to death.

5.2 Pharmacokinetic particulars

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 metabolized 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 metabolized and the parent compound/metabolites are excreted by urine.

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

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Maize starch

Lactose monohydrate

Microcrystalline cellulose

Povidone K25

Magnesium stearate

Sodium laurilsulfate

Colloidal anhydrous silica

Croscarmellose sodium

Meat flavour

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

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

Shelf life of half-tablets: 7 days

6.4. Special precautions for 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.

6.5 Nature and composition of 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.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

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

Bayer plc

Animal Health Division

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

8. MARKETING AUTHORISATION NUMBER

Vm 00010/4187

9. DATE OF FIRST AUTHORISATION

21 October 2014

10. DATE OF REVISION OF THE TEXT

July 2016

20 July 2016