Drontal Cat XL Film-coated Tablets

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Praziquantel, Pyrantel Embonate

Available from:

Bayer plc

ATC code:

QP52AA51

INN (International Name):

Praziquantel, Pyrantel Embonate

Pharmaceutical form:

Coated tablet

Prescription type:

NFA-VPS - Non-Food Animal – Veterinarian, Pharmacist, Suitably Qualified Person

Therapeutic group:

Cats

Therapeutic area:

Anthelmintic anticestodal

Authorization status:

Authorized

Authorization date:

2004-01-29

Summary of Product characteristics

Revised: May 2018
AN: 02090/2017
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Drontal Cat XL Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES
MG PER TABLET
Pyrantel embonate
345
Praziquantel
30
EXCIPIENTS
Titanium dioxide E171 (colouring agent)
2.60
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to yellowish, ellipsoid, 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 (see
also above): _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.
Until sufficient studies have been performed with this combination, 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.
Page 1 of 5
Revised: May 2018
AN: 02090/2017
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
i.
Special precautions for use in animals
None known.
ii.
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.
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 e