Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FUROSEMIDE
Ceva Santé Animale
QC03CA01
FUROSEMIDE
40 Milligram
Tablets Chewable
POM
Canine
Furosemide
Cardiovascular
Authorised
2016-04-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Libeo 40 mg chewable tablets for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Chewable tablet. Clover shape beige tablet. The tablets can be divided into equal quarters. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of ascites and oedema, particularly associated with cardiac insufficiency. 4.3 CONTRAINDICATIONS Do not use the product in dogs suffering from hypovolaemia, hypotension or dehydration. Do not use in cases of renal failure with anuria. Do not use in cases of electrolyte deficiency. Do not use in cases of known hypersensitivity to furosemide, sulfonamides or any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Therapeutic efficacy may be impaired by increased intake of drinking water. Where the animal’s condition permits, water intake should be restricted to physiologically normal levels during treatment. One tablet of 1320 mg contains: ACTIVE SUBSTANCE: Furosemide 40 mg EXCIPIENTS: For the full list of excipients, see section 6.1. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 29/11/2016_ _CRN 7024759_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS As the tablets are flavoured, they should be stored in a safe place out of the reach of animals. Furosemide should be used with caution in case of pre-existing electrolyte and/or water imbalance, impaired hepatic function (may precipitate hepatic coma) and diabetes mellitus. In case of prolonged treatment, hydration status and serum electrolytes should be monitored frequently 1-2 days before and after comm Read the complete document