Big Cat Wormer Film-Coated 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:

30.0/345.0 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:

2009-03-20

Summary of Product characteristics

Health Products Regulatory Authority
19 June 2020
CRN009RF9
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Big Cat Wormer Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES
Pyrantel embonate
345
mg
Praziquantel
30
mg
EXCIPIENTS
Titanium dioxide E171 (colouring agent)
2.60
mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to yellowish, round, biconvex tablet, unscored.
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 taenaeformis._
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 the establishment of _E.
multilocularis _in the UK or Ireland, it is recommended that all
cats entering the country be treated with praziquantel.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None known.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
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.
Any part-used tablets should be discarded
Health Products Regulatory Authority
19 June 2020
CRN009RF9
Page 2 of 4
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Mild and transient digestive tract disorders such as hyperthyroidism
and/or vomiting and mild and transient neurological
disorders such as ataxia may occur in extremely rare case