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:

Vetoquinol SA

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 area:

praziquantel, combinations

Authorization status:

Authorised

Authorization date:

2017-09-08

Summary of Product characteristics

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Drontal Tasty Bone Wormer XL 525/504/175 mg tablets [IE]
Drontal Large Dog Tasty 525/504/175 mg tablets [BE, LU]
Drontal Dog Flavour XL 525/504/175 mg tablets [CZ, SK]
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 immature forms):
_Echinococcus granulosus _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_Echinococcus multilocularis _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_Dipylidium caninum _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_Taenia _
spp
_. _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_Mesocestoides _
spp
_. _
To help control infections caused by the protozoa
_Giardia _
spp, in puppies and adult dogs.
2
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
Do not use during the 1st and 2nd third 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 confirme