Trilotab 60 mg chewable tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Trilostane

Available from:

CP-Pharma Handelsgesellschaft mbH

ATC code:

QH02CA01

INN (International Name):

Trilostane

Pharmaceutical form:

Chewable tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

trilostane

Authorization date:

2023-09-22

Summary of Product characteristics

_ [Version 9,10/2022] _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Trilotab 60 mg chewable tablets for dogs
(NL/AT/BE/CZ/DE/ES/FR/HU/IE/IT/PL/PT/SK/UKNI)
Trilotab vet 60 mg chewable tablets for dogs (FI/ SE/ DK)
Trilotab vet chewable (EE/ LT/ LV)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Trilostane
60
mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Lactose monohydrate
Starch, pregelatinised
Hydroxypropylcellulose
Silica, colloidal hydrated
Sodium starch glycolate (Type A)
Magnesium stearate
Chicken flavour
Off-white to light brown with brown spots, round and convex tablet
with a cross-shaped break line on
one side. Tablets can be divided into 2 or 4 equal parts.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the treatment of pituitary-dependent and adrenal-dependent
hyperadrenocorticism (Cushing’s
disease and syndrome).
3.3
CONTRAINDICATIONS
Do not use in animals suffering from primary hepatic disease and/or
renal insufficiency.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
3.4
SPECIAL WARNINGS
An accurate diagnosis of hyperadrenocorticism is essential.
Where there is no apparent response to treatment, the diagnosis should
be re-evaluated. Dose increases
may be necessary.
Veterinarians should be aware that dogs with hyperadrenocorticism are
at increased risk of
pancreatitis. This risk may not diminish following treatment with
trilostane.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
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.
Subsequent close monitoring during treatment should be carried out.
Particular