LIBEO 10 MG CHEWABLE TABLETS FOR DOGS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FUROSEMIDE

Available from:

Ceva Santé Animale

ATC code:

QC03CA01

INN (International Name):

FUROSEMIDE

Dosage:

10 Milligram

Pharmaceutical form:

Tablets Chewable

Prescription type:

POM

Therapeutic group:

Canine

Therapeutic area:

Furosemide

Therapeutic indications:

Cardiovascular

Authorization status:

Authorised

Authorization date:

2016-04-22

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Libeo 10 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 330 mg contains:
ACTIVE SUBSTANCE:
Furosemide
10 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_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