European Medicines Agency Veterinary Medicines

EMEA/V/C/105

EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PRILACTONE EPAR summary for the public

What is PRILACTONE?

PRILACTONE tablets contain the active substance spironolactone (10 mg, 40 mg or 80 mg). The tablets are scored to make them easier to break if smaller doses are needed.

What is PRILACTONE used for?

PRILACTONE is used to treat dogs that have congestive heart failure because of faulty heart valves. When the heart valves are faulty, the heart is not able to pump blood as efficiently as before. As a result, blood can accumulate in the veins and fluid can leak out into the tissues, leading to the heart being unable to deliver oxygen-rich blood to the body adequately. PRILACTONE is used in combination with ‘standard therapy’ (other heart medicines, including diuretic support where necessary).

PRILACTONE is given to the dog once daily, with food (either mixed in the food, or immediately after feeding). The dose to use is 2 mg per kilogram of the dog’s body weight. The appropriate number of tablets, half tablets or quarter tablets to give according to the dog’s size is given in the Package Leaflet.

How does PRILACTONE work?

The active substance in PRILACTONE, spironolactone, blocks the actions of a hormone called aldosterone in the kidneys, heart and blood vessels. By blocking aldosterone, spironolactone causes the kidneys to excrete salt and fluids, but retain potassium, and hence it improves heart function. It is accepted there are also other ways in which spironolactone works on the heart and blood vessels in congestive heart failure (although these mechanisms of action have not yet been fully demonstrated in dogs).

How has PRILACTONE been studied?

PRILACTONE has been studied in the laboratory, as well as in three studies in dogs with heart valve diseases, which were treated in various veterinary practices or clinics across Europe (‘clinical studies‘). In these clinical studies, the animal owners gave either PRILACTONE tablets or placebo (dummy tablets without any active ingredient) to their dogs, once daily, at a dose of 2 mg/kg with food. PRILACTONE tablets were given with food because this results in more of the active substance being absorbed from the tablets. All dogs also received ‘standard therapy’ (generally another medicine

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belonging to the group called ‘ACE-inhibitors’ and if needed a diuretic). Treatment continued for up to 15 months.

What benefit has PRILACTONE shown during the studies?

The results of the studies showed that dogs with congestive heart failure caused by faulty heart valves that were given PRILACTONE tablets in addition to another heart medicine (‘standard therapy’), had a longer survival time than the dogs that received the standard therapy plus placebo tablets. In a long term study, the dogs treated with PRILACTONE also showed less deterioration of their heart disease compared to the dogs which were treated only with ‘standard therapy’.

What is the risk associated with PRILACTONE?

PRILACTONE was generally well tolerated when administered daily at the recommended dose for up to 15 months in dogs with heart failure.

As spironolactone can reduce the levels of some male hormones, male dogs which have not been neutered may show a shrinking of the prostate gland. However, this is reversible. For the same reasons, PRILACTONE tablets should not be used in growing dogs. They should also not be given to animals with high blood potassium levels (hyperkalaemia) or low blood sodium levels (hyponatraemia), or to animals with hypoadrenocorticism (a disease that results from the reduction in corticosteroid secretion from the adrenal gland). PRILACTONE tablets should not be given to dogs with poor kidney function that are being given medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). As spironolactone is broken down in the liver, the tablets should be used with caution in dogs with liver disease.

PRILACTONE tablets should not be used in dogs used for, or intended for use in breeding, as it has been demonstrated that spironolactone might cause harm to newborn or young laboratory animals.

For a full list of all side effects reported with PRILACTONE, and for a list of all interactions with other medicines, see the Package Leaflet.

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

Anyone handling PRILACTONE should wash their hands afterwards. PRILACTONE may cause skin sensitisation, so people who know that they are allergic to spironolactone should not handle the product. In case someone accidentally swallows PRILACTONE tablets, medical advice should be sought immediately and the Package Leaflet or the label should be shown to the physician.

Why has PRILACTONE been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of PRILACTONE outweigh its risks for use in combination with standard therapy (including diuretic support, where necessary) for the treatment of congestive heart failure caused by valvular regurgitation in dogs, and recommended that PRILACTONE be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Other information about PRILACTONE:

The European Commission granted a marketing authorisation valid throughout the European Union for PRILACTONE to CEVA SANTE ANIMALE on 20 June 2007. Information on the prescription status of this product may be found on the outer package.

This summary was last updated in June 2007.

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