Skylocalm 5.4 mg Film-coated Tablets for Dogs

Dogs:
Very common
(>1 animal / 10 animals treated):
pyoderma, skin lump, papillomaCommon
(1 to 10 animals / 100 animals treated):
lethargy, lipoma, polydipsia,
increased appetite
nausea, vomiting, diarrhoea, anorexia
histiocytoma, fungal skin infection,
pododermatitis
otitis
lymphadenopathy
cystitis
aggression
Very rare
(<1 animal / 10,000 animals treated,
including isolated reports):
anaemia, lymphoma, convulsion
Treatment-related clinical pathology changes were restricted to an increase in mean
serum cholesterol and a decrease in mean leukocyte count, however, all mean
values remained within the laboratory reference range. The decrease in mean

Revised: April 2024AN: 02338/2023
leukocyte count observed in oclacitinib-treated dogs was not progressive, and
affected all white blood cell counts (neutrophil, eosinophil and monocyte counts)
except lymphocyte counts. Neither of these clinical pathology changes appeared
clinically significant.
Regarding susceptibility to infection and neoplastic conditions, see section 4.5.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian,
to either the marketing authorisation holder or its local representative or the national
competent authority via the national reporting system. See also the last section of
the package leaflet for respective contact details.