Do not use in animals suffering from liver disease and/or poor kidney function.

(Information for the animal owner) If your dog becomes lethargic, develops vomiting or diarrhoea, or has a depressed appetite, stop treatment and consult your veterinary surgeon.

If you notice any serious effects or other effects not mentioned in the leaflet, please inform your veterinary surgeon.

(Information for the veterinary surgeon) Corticosteroid withdrawal syndrome or hypocortisolaemia should be distinguished from hypoadrenocorticism by evaluation of serum electrolytes.

Signs associated with iatrogenic hypoadrenocorticism, including weakness, lethargy, anorexia, vomiting and diarrhoea may occur, particularly if monitoring is not adequate. Signs are generally reversible within a variable period following withdrawal of treatment. Acute Addisonian crisis (collapse) may also occur. Lethargy, vomiting, diarrhoea and anorexia have been seen in dogs treated with Trilostane in the absence of evidence of hypoadrenocorticism.

There have been occasional isolated reports of adrenal necrosis in treated dogs which may result in hypoadrenocorticism.

Subclinical renal dysfunction may be unmasked by treatment with the product.

Treatment may unmask arthritis due to a reduction in endogenous corticosteroid levels.

A small number of reports have been received of sudden death during Trilostane treatment.

Other mild, rare, adverse effects include ataxia, hypersalivation, bloating, muscle tremors and skin changes.

Special warnings:

(Information for the animal owner) If your dog is being treated with any other medications advise your veterinary surgeon prior to the use of Vetoryl.

Do not use in pregnant or nursing bitches or in any animals intended for breeding.

Tell your veterinary surgeon if your dog is suffering from concurrent illnesses, especially liver disease, kidney disease, anaemia or diabetes mellitus.

Tell your veterinary surgeon if you intend to breed from your dog or your dog is pregnant or nursing.

(Information for the veterinary surgeon) The product should be used with extreme caution in dogs with pre-existing anaemia as further reductions in packed-cell volume and haemoglobin may occur. Regular monitoring should be undertaken.

As the majority of cases of hyperadrenocorticism are diagnosed in dogs between the ages of 10-15 years, other pathological processes are frequently present. It is particularly important to screen cases for primary hepatic disease and renal insufficiency as the product is contraindicated in these cases.

Dogs should be monitored at regular intervals for diabetes mellitus. The presence of diabetes mellitus and hyperadrenocorticism together requires specific monitoring.

If a dog has previously been treated with Mitotane, its adrenal function will have been reduced. Experience in the field suggests that an interval of at least one month should elapse between cessation of Mitotane and the introduction of Trilostane. Close monitoring of adrenal function is advised, as dogs may be more susceptible to the effects of Trilostane.

Close monitoring during treatment should be carried out. Particular attention should be paid to liver enzymes, electrolytes, urea and creatinine.

In the event of a non-stimulatory ACTH stimulation test during monitoring, treatment should be stopped for 7 days and then re-started at a lower dose. Repeat the ACTH stimulation test after a further 14 days. If the result is still non-stimulatory, stop treatment until clinical signs of hyperadrenocorticism recur. Repeat the ACTH stimulation test one month after re-starting treatment.

Interactions: The possibility of interactions with other medicinal products has not been specifically studied. Given that hyperadrenocorticism tends to occur in older dogs, many will be receiving concurrent medication.

In clinical studies, no interactions were observed. The risk of hyperkalaemia developing should be considered if Trilostane is used in conjunction with potassium-sparing diuretics or ACE inhibitors. The concurrent use of such drugs should be subject to a risk-benefit analysis by the veterinary surgeon, as there have been a few reports of deaths (including sudden death) in dogs when treated concurrently with Trilostane and an ACE inhibitor.

(Information for the animal owner) If an overdose of the product is given consult your veterinary surgeon immediately.

(Information for the veterinary surgeon) Overdose may lead to signs of hypoadrenocorticism. There were no mortalities following chronic administration at 3 x the maximum recommended dose to healthy dogs, however mortalities may be expected if higher doses are administered to dogs with hyperadrenocorticism. There is no specific antidote for Trilostane. Treatment should be withdrawn and supportive therapy, including corticosteroids, correction of electrolyte imbalances and fluid therapy may be indicated depending on clinical signs.

In cases of acute overdosage, induction of emesis followed by administration of activated charcoal may be beneficial.

Any iatrogenic adrenocortical insufficiency is usually quickly reversed following cessation of treatment. However in a small percentage of dogs, effects may be prolonged. Symptomatic treatment or appropriate replacement therapy should be initiated. Following a one week withdrawal of Trilostane treatment, treatment should be reinstated at a reduced dose rate.

Symptomatic treatment of hypocortisolaemia may be required.

Operator warnings: Trilostane may decrease testosterone synthesis and has anti-progesterone properties.

Women who are pregnant or are trying to become pregnant should avoid handling the capsules.

Wash hands with soap and water following accidental exposure and after use.

The content of the capsules may cause skin and eye irritation and sensitisation. Do not divide or open capsules: in the event of accidental breakage of the capsules and contact of the granules with the eyes or skin, wash immediately with plenty of water. If irritation persists, seek medical advice.

In the event of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician.

People with known hypersensitivity to Trilostane or any of the excipients should avoid contact with the product.

General precautions: For animal treatment only.