Drontal Plus Flavour Tablets for Dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Febantel; Pyrantel embonate ; Praziquantel

Available from:

Bayer Animal Health GmbH

ATC code:

QP52AF30

INN (International Name):

Febantel; Pyrantel embonate ; Praziquantel

Dosage:

150, 144, 50 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

CAM: Companion Animal Medicine as defined in relevant national legislation

Therapeutic area:

combinations of tetrahydropyrimidines

Authorization status:

Authorised

Authorization date:

2009-01-25

Summary of Product characteristics

Health Products Regulatory Authority
19 June 2020
CRN009RFJ
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Drontal Plus Flavour Tablets for Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
mg per tablet
Febantel
150.0
Pyrantel embonate
144.0
Praziquantel
50.0
EXCIPIENTS
Artificial beef flavour, irradiated
​
116.5
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
A light brown to brown, round, flat tablet, cross scored on one side
for oral administration to dogs.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the control of the following gastrointestinal tapeworms and
roundworms in dogs and puppies.
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., _Dipylidium caninum
_(adult and immature forms)
4.3 CONTRAINDICATIONS
Do not use simultaneously with piperazine compounds.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
As a precautionary measure to prevent establishment of _Echinococcus
multilocularis _in the UK and Ireland it is recommended
that all dogs and cats entering the country be treated with
praziquantel.
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
Any part used tablet should be discarded
Consult a veterinary surgeon before treating pregnant animals for
roundworms.
Do not exceed the stated dose when treating pregnant bitches.
Health Products Regulatory Authority
19 June 2020
CRN009RFJ
Page 2 of 4
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
In case of accidental ingestion, seek medical advice