Drontal Plus XL Flavour Tablets for Dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Praziquantel; Pyrantel embonate ; Febantel

Available from:

Bayer Animal Health GmbH

ATC code:

QP52AF30

INN (International Name):

Praziquantel; Pyrantel embonate ; Febantel

Dosage:

175, 504, 525 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:

2009-03-20

Summary of Product characteristics

Health Products Regulatory Authority
19 June 2020
CRN009RDT
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Drontal Plus XL Flavour Tablets for Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
mg per tablet
Febantel
525.0
Pyrantel embonate
504.0
Praziquantel
175.0
EXCIPIENTS:
Artificial beef flavour irradiated
408.0
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
Pale brown to brown oval shaped divisible tablet scored on both sides.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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).
4.3 CONTRAINDICATIONS
Do not use simultaneously with piperazine compounds.
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.
Since it contains praziquantel, the 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.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Any part-used tablets should be discarded.
Do not exceed the stated dose when treating pregnant bitches.
Health Products Regulatory Authority
19 June 2020
CRN009RDT
Page 2 of 4
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
MEDICINAL