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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/374036/2015

EMEA/V/C/003836

EPAR summary for the public

UpCard

Torasemide

This is a summary of the European public assessment report (EPAR) for UpCard. It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use UpCard.

For practical information about using UpCard, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

What is UpCard and what is it used for?

UpCard is a veterinary medicine used to treat signs of congestive heart failure in dogs. Congestive heart failure is a condition, usually of older dogs, where the heart fails to pump blood efficiently around the body leading to clinical signs such as exercise intolerance (inability to carry out physical activity), difficulty breathing and fluid retention.

UpCard contains the active substance torasemide.

How is UpCard used?

UpCard is available as tablets (0.75 mg, 3 mg, 7.5 mg and 18 mg) and can only be obtained with a prescription.

UpCard is given once daily, with or without food, with the dose adjusted to produce the required effect. Once signs of congestive heart failure have been controlled, if long-term treatment is required the lowest effective dose should be given.

For further information, see the package leaflet.

How does UpCard work?

Torasemide is a diuretic medicine. It works by increasing the elimination of salt and water in the urine. This decreases the overall blood volume, reducing the effort needed for the heart to pump blood and thereby improving its function.

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What benefits of UpCard have been shown in studies?

In a field study involving 251 dogs with congestive heart failure, treatment with UpCard was compared to a standard treatment with the diuretic furosemide. The main measure of effectiveness was response to treatment after about 3 months of treatment, scoring the difficulty breathing, cough frequency, exercise intolerance and fluid retention in the abdomen. The study showed UpCard to be at least as effective as furosemide for treatment of signs related to congestive heart failure.

What are the risks associated with UpCard?

The most common side effects with UpCard are kidney problems and increased thirst, water consumption and urine output, which may affect more than 1 in 10 dogs.

For the full list of restrictions and side effects reported with UpCard, see the package leaflet.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

Safety information has been included in the summary of product characteristics and the package leaflet for UpCard, including the precautions to be followed by healthcare professionals and animal owners or keepers.

People with known hypersensitivity (allergy) to torasemide or other sulphonamides should give the medicine with caution.

This product may increase urination and gastrointestinal disturbances if ingested.

Tablets should be kept in the blister packs until required, and the blisters should be kept in the outer carton.

In case of accidental ingestion, particularly by children, medical advice should be sought immediately and the package leaflet or label shown to the doctor.

Why is UpCard approved?

The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that UpCard's benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about UpCard

The European Commission granted a marketing authorisation valid throughout the EU for UpCard on 31/07/2015.

The full EPAR for UpCard can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. For more information about treatment with UpCard, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

This summary was last updated in June 2015.

UpCard

EMA/374036/2015