Drontal Plus XL Flavour Tablets for Dogs

Composition

Each tablet contains:

Active substances:

Febantel 525.0 mg

Pyrantel embonate 504.0 mg

Praziquantel 175.0 mg

Excipients:

Pale brown to brown oval shaped divisible tablet scored on both sides.

3

Pharmacological properties

The veterinary medicinal product contains anthelmintics active against roundworms and tapeworms. The veterinary medicinal product contains three active substances:

1. Febantel, a pro-benzimidazole.

2. Pyrantel embonate (pamoate), a tetrahydropyrimidine derivative, and

3. Praziquantel, a partially hydrogenated pyrazino-isoquinoline derivative.

4.1 ATCvet code: QP52AF30

4.2 Pharmacodynamics

In this fixed combination product pyrantel and febantel act synergistically against 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.

The spectrum of activity of praziquantel covers all important cestode species in dogs, in particular all Taenia spp, Dipylidium caninum, Echinococcus granulosus and Echinococcus multilocularis. Praziquantel acts against adult and immature forms of these parasites.

Praziquantel is very rapidly absorbed and distributed throughout the parasite. Both in vivo and in vitro 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.

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.

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 to 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.

4.3 Pharmacokinetics

No data available.

3

Target species

Dogs.

3

Indications

For the control of the following roundworms and tapeworms in adult dogs:

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

Hookworms: Uncinaria stenocephala, Ancylostoma caninum (adults)

Whipworms: Trichuris vulpis (adults)

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

3

Dosage

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

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 35 kg bodyweight as follows:

Dosages are as follows:

The veterinary medicinal product should be used to achieve accurate dosing in dogs weighing less than 17.5 kg.

Administration and Duration of Treatment

Oral administration: the tablet(s) can be given directly to the dog or disguised in food. No starvation is needed before or after treatment.

For routine treatment a single dose is recommended.

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

For routine control adult dogs should be treated every 3 months. In the event of a heavy roundworm infestation, a repeat dose should be given after 14 days.

3

Contraindications

Do not use simultaneously with piperazine compounds.

3

Adverse reactions

Dog:

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:

Any part-used tablets should be discarded.

Do not exceed the stated dose when treating pregnant bitches.

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 tablet 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.

3

Use during pregnancy, lactation or lay

Pregnancy:

Consult a veterinary surgeon before treating pregnant animals for roundworms.

Lactation:

This veterinary medicinal product may be used during lactation (see Section 3.9 below).

3

Interactions

Do not use simultaneously with piperazine.

Concurrent use with other cholinergic compounds is not recommended.

3

Overdose

The veterinary medicinal product is well tolerated in dogs. In safety studies doses of 5 x or greater gave rise to occasional vomiting.

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.

Since it contains praziquantel, the veterinary medicinal product is effective against Echinococcus multilocularis, which does not occur in the UK or Ireland but is becoming more common in some European countries. As a precautionary measure to prevent establishment of E multilocularis in the UK and Ireland, it is recommended that all dogs entering the country be treated with praziquantel.

3

Withdrawal period

Not applicable.

3

Incompatibilities

None known.

3

Immediate packaging

Container material:

- PCTFE/PVC-aluminium foil strip

- OPA/Alu/HDPE-aluminium foil strip

Container colour: White and silver

Container sizes: Cartons containing 2, 8, 48 and 96 tablets

Not all pack sizes may be marketed.

3

Storage

Do not store above 25ºC.

Any part used tablets should be discarded.

3

Shelf life

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

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

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.

Vm 08007/5044

8 DATE OF FIRST AUTHORISATION

31 March 2008

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

August 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.

Approved: 03 September 2026

3

Registration holder

Vetoquinol UK Limited

3