Drontal Tasty Bone Wormer XL 525/504/175 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Febantel; Pyrantel embonate ; Praziquantel

Available from:

Bayer Limited

ATC code:

QP52AA51

INN (International Name):

Febantel; Pyrantel embonate ; Praziquantel

Dosage:

525,504,175 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

praziquantel, combinations

Therapeutic indications:

Anthelmintic

Authorization status:

Authorised

Authorization date:

2017-09-08

Summary of Product characteristics

Health Products Regulatory Authority
02 January 2018
CRN000WLX
Page 1 of 7
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Drontal Tasty Bone Wormer XL 525/504/175 mg tablets
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_
​
Tapeworms (adult and late immatureforms):
​_Echinococcus granulosus_
​
​_Echinococcus multilocularis_
​
​_Dipylidium caninum_
​
​_Taenia _spp_._
Health Products Regulatory Authority
02 January 2018
CRN000WLX
Page 2 of 7
​
​_Mesocestoides _spp_._
To help control infections caused by the protozoa _Giardia _spp, in
puppies and adult
dogs.
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.
In case your dog develops diarrhoea, please ask your veterinarian for
evaluation and
diagnosis to determine the cause before beginning treatment with this
product.
Diarrhoea can be caused by the protozoa _Giardia _spp. but this
disease should be
confirmed so as to exclude other pot