Drontal Plus Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Febantel; Pyrantel embonate ; Praziquantel

Available from:

Bayer Animal Health GmbH

ATC code:

QP52AA51

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:

praziquantel, combinations

Authorization status:

Authorised

Authorization date:

1990-10-12

Summary of Product characteristics

Health Products Regulatory Authority
22 June 2020
CRN009RCY
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Drontal Plus Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES
MG PER TABLET
Febantel
150
Pyrantel embonate
144
Praziquantel
50
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Pale yellow.
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
_Echinococcusmultilocularis_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 PRECAUTION(S) 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
22 June 2020
CRN009RCY
Page 2 of 4
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
In the interests of good hygiene, persons administering the tablet
directly to the dog or by adding it to the dog’s food, should
wash their hands afterwards.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
In very rare cas