Frusedale 40 mg Oral Tablets

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Furosemide

Available from:

Dechra Limited

ATC code:

QC03CA01

INN (International Name):

Furosemide

Pharmaceutical form:

Tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Dogs

Therapeutic area:

Cardio Vascular diuretic

Authorization status:

Authorized

Authorization date:

1998-08-14

Summary of Product characteristics

Revised: March 2022
AN: 02253/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Frusedale 40 mg Oral Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active ingredient
Furosemide (Frusemide)
40 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
White, circular, biconvex, flat-faced tablets with bevelled edges and
a
breakline.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats and dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of oedema associated with cardiac insufficiency,
renal
dysfunction and trauma in cats and dogs.
In animals with pulmonary oedema of cardiac origin, combined therapy
with
other medicinal products may be indicated.
4.3
CONTRAINDICATIONS
Do not use in animals with acute glomerular nephritis, renal failure
with anuria,
electrolyte deficiency disease or in animals that have received an
overdosage
of digitalis.
Do not use concurrently with aminoglycoside antibiotics.
Do not use in animals weighing less than 4 kg.
Revised: March 2022
AN: 02253/2021
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Do not exceed the recommended dosage.
Therapeutic efficacy may be impaired by increased intake of drinking
water. Where the animal’s condition permits, water intake should be
restricted during treatment with Frusedale 40 mg oral tablets.
Monitoring of plasma potassium levels is advisable during periods of
prolonged treatment of combined therapy with cardiac glycosides.
Potassium supplements may be necessary.
ii.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Wear gloves, or wash your hands immediately after handling the
tablets.
iii.
Other precautions
None.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
During the post-authorisation period and following use of the product
in dogs
displaying signs of cardiac disease, lethargy, mal