Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Praziquantel; Pyrantel embonate
Bayer Animal Health GmbH
QP52AA51
Praziquantel; Pyrantel embonate
30/345 mg/tablet
Tablet
CAM: Companion Animal Medicine as defined in relevant national legislation
praziquantel, combinations
Authorised
2004-08-06
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 XL 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 a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to yellowish, ellipsoid, biconvex, unscored tablet. 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. 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. 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 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 Any part-used tablets should be discarded. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Mild and transient digestive tract disorders such as hypersalivation and Read the complete document