Drontal Cat Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Praziquantel; Pyrantel embonate

Available from:

Bayer Animal Health GmbH

ATC code:

QP52AA51

INN (International Name):

Praziquantel; Pyrantel embonate

Dosage:

20/230 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:

1995-09-22

Summary of Product characteristics

Health Products Regulatory Authority
22 June 2020
CRN009RDJ
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Drontal Cat Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1 ACTIVE CONSTITUENTS
MG PER TABLET
Pyrantel Embonate
230.0
Praziquantel
20.0
2.2 RELEVANT CONSTITUENTS OF THE EXCIPIENTS
Titanium Dioxide E171
1.8
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
White to yellowish scored coated tablet. The tablet can be divided
into equal halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of gastrointestinal roundworms and tapeworms:
_Toxocara cati, Toxascaris leonina, Dipylidium caninum, _
_Taenia taeniaeformis._
4.3 CONTRAINDICATIONS
Do not use simultaneously with piperazine compounds.
Not intended for use in kittens less than 6 weeks of age.
Do not use during pregnancy.
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.
As a precautionary measure to prevent establishment of _Echinococcus
multilocularis_ in the UK and Ireland, it is recommended
that all dogs and cats entering the country be treated with
praziquantel.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
In the interests of good hygiene, persons administering the tablets
directly to a cat, or by adding them to the cat's food, should
wash their hands afterwards.
Health Products Regulatory Authority
22 June 2020
CRN009RDJ
Page 2 of 4
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Mild and transient digestive tract disorders such as hypersalivation
and/or vomiting and mild and transient neurological
disorders such as ataxia may occur in extremely rare cases.
4.7 USE DURING PREGN