Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PROPENTOFYLLINE
Intervet Ireland Limited
QC04AD90
PROPENTOFYLLINE
50 mg/tablet
Film Coated Tablet
POM
Canine
Propentofylline
Cardiovascular
Authorised
1999-10-29
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Vivitonin 50 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Propentofylline 50 mg EXCIPIENTS: Titanium dioxide (E171) 0.359 mg Yellow ferric oxide (E172) 0.125 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. Orange yellow round tablets, quarter scored on one side, with ‘K50’ embossed on the other side of the tablets. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the improvement of peripheral and cerebral vascular blood circulation in dogs. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 05/10/2016_ _CRN 7024830_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS In the case of specific diseases (e.g. kidney disease), appropriate treatment should be administered. Consideration should be given to rationalising the medication of dogs already receiving treatment for congestive heart disease or bronchial disease. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Not applicable. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) In rare cases, symptoms of cardiac and cerebral over-stimulation (e.g. tachycardia and/or collapse) have been observed. In such cases, animals should be treated symptomatically. Allergic reactions (e.g. urticaria) may occur in rare cases and these necessitate discontinuation of the treatment. Vomiting has been observed on rare occasions, particularly at the commencement of Read the complete document