Furosoral 10 mg Tablets for Cats and Dogs

Composition

Each tablet contains:

Active substances:

Furosemide 10 mg

Excipients:

Qualitative composition of excipients and other constituents

Lactose monohydrate

Maize starch

Cellulose, microcrystalline

Povidone

Crospovidone

Talc

Pregelatinized starch

Silicon dioxide

Colloidal anhydrous silica

Long chain partial glyceride

White to yellow-white round and convex tablet with a cross-shaped break line on one side and embossing 10 on the other side. Tablets can be divided into two or four equal parts.

3

Pharmacological properties

4.1 ATCvet code: QC03CA01

4.2 Pharmacodynamics

Furosemide is a derivate of sulfamoyl antranil acid and is a fast acting diuretic in humans and animals. It inhibits resorption of sodium and chloride ions in the kidneys mainly in the ascending Loop of Henle, but also in the proximal and distal renal tubules resulting in an increased water excretion. An isotonic or slightly hypotonic urine with unchanged or slightly acidic pH is produced. Excretion of potassium ions is only enhanced at very high doses.

Furosemide has no effect on carbonic anhydrase.

4.3 Pharmacokinetics

Furosemide is absorbed rapidly mostly in the stomach and upper small intestine Maximum concentrations were measured at 1.1 hour after oral administration in cats and at 0.8 hours in dogs. After a mean oral dose of 5.2 mg/kg, Cmax in cats was 8.8 µg/ml. After a mean oral dose of 1.9 mg/kg, Cmax in dogs was 0.9 µg/ml.

Metabolism of furosemide is very limited. It is predominantly excreted via the kidneys, whilst the rest is excreted via the gastrointestinal tract. Elimination half-life was 3.7 hours in cats and 2.4 hours in dogs.

3

Target species

Cats and dogs.

3

Indications

Treatment of hydrothorax, hydropericardium, ascites and oedema, particularly associated with cardiac insufficiency and renal dysfunction.

3

Dosage

Oral use.

The recommended starting dose is 2.5- 5 mg furosemide per kg bodyweight per day, corresponding to ½ - 1 tablet per 2 kg bodyweight. In severe oedematous or refractory cases, the daily dose may initially be doubled. For maintenance, daily dosage should be adapted to the lowest effective dose by the veterinarian depending on the clinical response of the dog/cat to the therapy.

If treatment is administered last thing at night this may result in inconvenient diuresis overnight.

To ensure a correct dosage, body weight should be determined as accurately as possible.

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 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.

Do not use in cases of hypersensitivity to furosemide, sulphonamides or to any of the excipients.

3

Adverse reactions

Cats and dogs:

Rare (1 to 10 animals / 10,000 animals treated): Soft stool1, Haemoconcentration2, dehydration3, Poor peripheral circulation2, Electrolyte disorder (incl. hypokalaemia, hyponatremia)3

1 Transient, mild, does not necessitate the withdrawal of treatment.

2 Due to the diuretic action of furosemide.

3 In cases of prolonged treatment.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3

Warnings

Special precautions for safe use in the target species:

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 to animals:

Furosemide has possible genotoxic properties and there is evidence of carcinogenicity in mice. Although there is inadequate evidence relating to these effects in humans, skin contact with or accidental ingestion of the product should be avoided. Wear impervious gloves during handling and administration of the product and wash hands thoroughly afterwards.

Each time an unused part-tablet is stored until next use, it should be returned to the open blister space and inserted back into the cardboard box. The product should be stored safely, out of the sight and reach of children. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

People with known hypersensitivity to furosemide and other ingredients in the product should avoid contact with the veterinary medicinal product. Do not handle this product if you know you are sensitive to sulphonamides as hypersensitivity to sulphonamides may lead to hypersensitivity to furosemide. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention. Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

3

Use during pregnancy, lactation or lay

Pregnancy and lactation:

Laboratory studies have shown evidence of teratogenic effects.

The safety of the veterinary medicinal product has not been established during pregnancy or lactation. However furosemide is excreted into milk.

In pregnant and lactating animals, use only according to the benefit/risk assessment by the responsible veterinarian.

A deleterious effect on lactation is to be expected, particularly if drinking water is restricted.

3

Interactions

In cats, do not use furosemide with ototoxic antibiotics.

Concurrent use with drugs affecting electrolyte balance (corticosteroids, other diuretics, amphotericin B, cardiac glycosides) requires careful monitoring. Concomitant use with aminoglycosides or cephalosporins may increase the risk of nephrotoxicity.

Furosemide may increase the risk of sulfonamide cross-reactivity.

Furosemide may alter insulin requirements in diabetic animals.

Furosemide may reduce the excretion of NSAIDs.

The dose regimen may need to be reduced for long term treatment in combination with ACE inhibitors, depending upon the animal’s response to therapy.

3

Overdose

Doses higher than recommended may cause transitory deafness, electrolyte and water balance problems, CNS effects (lethargy, coma, seizures) and cardiovascular effects (hypotension, heart rhythm disorders, collapse), especially in old and weakened animals. Treatment is symptomatic.

3

Special warnings

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.

3

Withdrawal period

Not applicable.

3

Incompatibilities

Not applicable.

3

Immediate packaging

Cardboard box of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 25, 50, or 100 Aluminium-PVDC/PVC blisters with 10 tablets each, respectively corresponding to 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 250, 500, or 1000 tablets per box.

Cardboard box of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 25, 50, or 100 Aluminium-PVDC/PE/PVC blisters with 10 tablets each, respectively corresponding to 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 250, 500, or 1000 tablets per box.

Cardboard box containing 10 separate cardboard boxes, each containing 1 blister of 10 tablets.

Not all pack sizes may be marketed.

3

Storage

This veterinary medicinal product does not require any special storage conditions.

Any unused tablet portion should be returned to the open blister.

3

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life of divided tablets: 3 days.

3

Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

3

Additional information

7 MARKETING AUTHORISATION NUMBER

Vm 41821/4020

8 DATE OF FIRST AUTHORISATION

21 January 2015

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

May 2026

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved 23 June 2026

3

Registration holder

Le Vet. Beheer B.V.

3