Furosoral 10 mg tablets for cats and dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Furosemide

Available from:

Le Vet Beheer B.V.

ATC code:

QC03CA01

INN (International Name):

Furosemide

Dosage:

10 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Dogs

Therapeutic area:

furosemide

Therapeutic indications:

Cardiovascular

Authorization status:

Authorised

Authorization date:

2015-02-20

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Furosoral 40 mg tablets for cats and dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains:
ACTIVE SUBSTANCE:
Furosemide 40 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to yellow-white round and convex tablet with a cross-shaped
break line on one side. Tablets can
be divided into two or four equal parts.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats and dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of hydrothorax, hydropericardium, ascites and oedema,
particularly associated with cardiac
insufficiency and renal dysfunction.
4.3
CONTRAINDICATIONS
Do not use in animals 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,
sulphonamides or any of the excipients.
Do not use in acute glomerular nephritis.
Do not use in patients that have received excessive doses of cardiac
glycosides.
Do not use in combination with other loop diuretics
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.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Furosemide should be used with caution in the 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 commencement with diuretics and ACE
inhibitors renal function and
hydration status should be monitored.
Furosemide should be used with caution in patients with nephrotic
syndrome.
Special precautions to be taken by the person administering the
veterinary medicinal product