Drontal Plus XL Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pyrantel embonate ; Praziquantel; Febantel

Available from:

Bayer Animal Health GmbH

ATC code:

QP52AC55

INN (International Name):

Pyrantel embonate ; Praziquantel; Febantel

Dosage:

175, 504, 525 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

CAM: Companion Animal Medicine as defined in relevant national legislation

Therapeutic area:

febantel, combinations

Authorization status:

Authorised

Authorization date:

2003-10-17

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 XL Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1 ACTIVE CONSTITUENTS
MG PER TABLET
Febantel
525.0
Pyrantel embonate
504.0
Praziquantel
175.0
2.2 RELEVANT CONSTITUENTS OF THE EXCIPIENTS
None
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Yellow oval shaped 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 tapeworms and roundworms in adult
dogs:
Ascarids:
_Toxocara canis, Toxascaris leonine_ (adult and late immature forms).
Hookworms:
_Uncinaria stenocephala_, _Ancylostoma canium_ (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
Fleas serve as intermediate hosts for one common type of
tapeworm-_Dipylidium caninum_. Tapeworm infestation is certain to
reoccur 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 Europena countries. As a
precautionary measure to prevent establishment of
_Echinococcus multilocularis_ in the UK and Ireland it is recommended
that all dogs entering the country be treated with
praziquantel.
Health Products Regulatory Authority
22 June 2020
CRN009RCY
Page 2 of 4
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTION(S) FOR USE IN ANIMALS
Any part-used tablets should be discarded.
Do not exceed the stated dosage when treating pregnant bitches
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
MEDICINAL PRODUCT TO ANIMALS
In the interests of good hygiene, persons administ