Drontal

Main information

  • Trade name:
  • Drontal Dog Tasty Bone XL 525/ 504/ 175 mg Tablets
  • Pharmaceutical form:
  • Tablet
  • Prescription type:
  • NFA-VPS - Non-Food Animal – Veterinarian, Pharmacist, Suitably Qualified Person
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Drontal Dog Tasty Bone XL 525/504/175 mg Tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Dogs
  • Therapeutic area:
  • Anthelmintic anticestodal

Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Authorized
  • Authorization number:
  • 00010/4214
  • Authorization date:
  • 03-10-2017
  • Last update:
  • 19-01-2018

Summary of Product characteristics: dosage, interactions, side effects

Revised: January 2018

AN: 01693/2017

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

Drontal Dog Tasty Bone XL 525/504/175 mg tablets [IE, UK]

Drontal Plus Tasty XL 525/504/175 mg tablets for dogs [AT, DE]

Dronbits 525 mg/504 mg/175 mg tablets [FI, SE]

Drontaste 525/504/175 mg tablets [DK, IS, NO]

Drontal Chien XL 525/175/175 mg [FR]

Drontal Multi Aroma Carne XL 525/504/175 mg compresse per cani [IT]

Drontal Large Dog Tasty 525/504/175 mg tablets [NL]

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Active Substances

525 mg febantel

175 mg pyrantel equivalent to 504 mg pyrantel embonate

175 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

Page 1 of 6

Revised: January 2018

AN: 01693/2017

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 trimester 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. 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.

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 treated, including isolated reports).

Page 2 of 6

Revised: January 2018

AN: 01693/2017

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 trimester

of pregnancy. Do not use in pregnant dogs during the 1st and 2nd trimester of

pregnancy (see section 4.3).

A single treatment during the last trimester 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

antagonised 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 35 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

7-17.5

>17.5-35

>35-52.5

1 ½

>52.5-70

For each additional 17.5 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.

Part tablets should be discarded immediately or returned to the open blister until

used.

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 7 kg.

Page 3 of 6

Revised: January 2018

AN: 01693/2017

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 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.

Page 4 of 6

Revised: January 2018

AN: 01693/2017

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 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.

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

Major 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 after first opening the immediate packaging: 7 days

6.4

Special precautions for storage

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

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, 8, 24, 48 tablets.

Not all pack sizes may be marketed.

Page 5 of 6

Revised: January 2018

AN: 01693/2017

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

400 South Oak Way

Green Park

Reading

Berkshire

RG2 6AD

8.

MARKETING AUTHORISATION NUMBER

Vm 00010/4214

9.

DATE OF FIRST AUTHORISATION

03 October 2017

10.

DATE OF REVISION OF THE TEXT

January 2018

Approved: 10 January 2018

Page 6 of 6