Drontal Plus XL Flavour Tablets for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Febantel, Praziquantel, Pyrantel Embonate

Available from:

Bayer plc

ATC code:

QP52AF30

INN (International Name):

Febantel, Praziquantel, Pyrantel Embonate

Pharmaceutical form:

Tablet

Prescription type:

NFA-VPS - Non-Food Animal – Veterinarian, Pharmacist, Suitably Qualified Person

Therapeutic group:

Dogs

Therapeutic area:

Anthelmintic anticestodal

Authorization status:

Authorized

Authorization date:

2008-03-31

Summary of Product characteristics

Revised: May 2017
AN: 00069/2017
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
Pyrantel embonate
Praziquantel
525.0
504.0
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.
Page 1 of 6
Revised: May 2017
AN: 00069/2017
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
I)
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Any part-used tablets should be discarded.
Do not exceed the stated dose when treating pregnant bitches.
II)
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
MEDICINAL PRODUCT TO ANIMALS
In case of accidental ingestion, seek medi