Spironolactone Ceva (spironolactone) - QC03DA01

Updated on site: 21-Sep-2017

Medication name: Spironolactone Ceva
Substance: spironolactone
Manufacturer: Ceva Sante Animale

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.

EMEA 2007