Contra-indications
None

Special warnings for each target species
In dogs with BPH associated with prostatitis, the product can be administered concurrently with antimicrobials

Special precautions for use
Special precautions for use in animals
A transient reduction of plasma cortisol concentration may occur; this may continue for several weeks after administration. Appropriate monitoring should be implemented in dogs under stress (e.g. postoperative) or those with hypoadrenocorticism. The response to an ACTH stimulation test may also be suppressed for several weeks after administration of osaterone.
Use with caution in dogs with a history of liver disease, as safety of use of the product in these dogs has not been thoroughly investigated, and as treatment of some dogs with liver disease has resulted in reversible elevation of ALT and ALP in clinical trials.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after administration.
In the case of accidental ingestion by a person, seek medical advice immediately and show the package leaflet or the label to the physician.
A single oral dose of 40 mg osaterone acetate in human males was followed by a sporadic decrease in FSH, LH and testosterone, reversible after 16 days. There was no clinical effect. In female laboratory animals, osaterone acetate caused serious adverse effects on reproductive functions. Therefore, women of child-bearing age should avoid contact with, or wear disposable gloves, when administering the product.

Adverse reactions
A transient increase in appetite occurs very commonly.
Transient behavioural changes such as increased or decreased activity, or more sociable behaviour, are common.
Other adverse reactions, including transient vomiting and/or diarrhoea, polyuria/polydipsia, lethargy or feminisation syndrome including mammary gland hyperplasia occur uncommonly.
A transient reduction in plasma cortisol occurs in most treated animals.
In clinical trials, treatment with the veterinary medicinal product was not discontinued and all dogs recovered without any specific therapy.

Use during pregnancy, lactation orlay
Not applicable

Interactions
None known

Amounts to be administered and administration route
For oral use.
Tablets can be given either directly into the mouth or with food. The maximum dose should not be exceeded.
The onset of clinical response to treatment is usually seen within 2 weeks. The clinical response persists for at least 5 months after treatment.
Re-evaluation by the veterinarian should take place 5 months after treatment or earlier if clinical signs recur. A decision to retreat at this or at a later time point should be based on veterinary examination taking into account the risk benefit profile of the product. If clinical response to treatment is considerably shorter than expected, a re-evaluation of the diagnosis is necessary.

Overdose
An overdose study (up to 1.25 mg/kg bodyweight for 10 days, repeated one month later) did not show undesirable effects except for a decrease of cortisol plasma concentration.

Withdrawal periods
Not applicable.