Do not use in animals used for, or intended for use in breeding.

Do not use the product in dogs suffering from hypoadrenocorticism, hyperkalaemia or hyponatraemia.

Do not administer spironolactone in conjunction with NSAIDs to dogs with renal insufficiency.

Kidney function and serum potassium levels should be evaluated before initiating combined treatment with spironolactone and ACE inhibitors. Unlike in humans, an increased incidence of hyperkalaemia was not observed in clinical trials performed in dogs with this combination. However, in dogs with renal impairment regular monitoring of renal function and serum potassium levels is recommended as there may be an increased risk of hyperkalaemia.

Dogs treated concomitantly with spironolactone and NSAIDs should be correctly hydrated.

As spironolactone has an antiandrogenic effect, it is not recommended to administer the product to growing dogs.

As spironolactone undergoes extensive hepatic biotransformation, care should be taken when using the product to treat dogs with hepatic dysfunction.

May cause skin sensitisation: persons known to be allergic to spironolactone should not handle the product. Wash hands after use. In the event of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

A reversible prostatic atrophy is often observed in entire male dogs.

Do not use during pregnancy and lactation.

In clinical studies, Prilactone® was co-administered with furosemide and pimobendan without evidence of associated adverse reactions.

Spironolactone decreases digoxin elimination and hence raises digoxin plasma concentration. As the therapeutic index for digoxin is very narrow, it is advisable to monitor closely dogs receiving both digoxin and spironolactone.

The administration of either deoxycorticosterone or NSAIDs with spironolactone may lead to a moderate reduction of the natriuretic effects (reduction of urinary sodium excretion) of spironolactone.

Concomitant administration of spironolactone with ACE-inhibitors and other potassium-sparing drugs (as angiotensin receptor blockers, ß-blockers, calcium channels blockers, etc.) may potentially lead to hyperkalaemia.

Spironolactone may cause both induction and inhibition of cytochrome P450 enzymes and could therefore affect the metabolism of other drugs utilizing these metabolic pathways.

In case of an accidental massive ingestion by a dog, there is no specific antidote or treatment. It is therefore recommended to induce vomiting, lavage the stomach (depending on risk assessment) and monitor electrolytes. Symptomatic treatment, e.g., fluid therapy, should be provided.

Keep out of reach and sight of children. For animal treatment only.