Atopica 10 mg Soft Capsules for Dogs

Consideration should be given to the use of other measures and/or treatments
to control moderate to severe pruritus when initiating therapy with ciclosporin.

Revised: April 2025
AN: 04197/2024Page 2 of 7

i) Special precautions for use in animals
Clinical signs of atopic dermatitis such as pruritus and skin
inflammation are not specific for this disease and therefore other
causes of dermatitis such as ectoparasitic infestations, other allergies
which cause dermatological signs (e.g. flea allergic dermatitis or food
allergy) or bacterial and fungal infections should be ruled out before
treatment is started. It is good practice to treat flea infestations before
and during treatment of atopic dermatitis.
It is recommended to clear bacterial and fungal infections before
administering the veterinary medicinal product. However, infections
occurring during treatment are not necessarily a reason for drug
withdrawal, unless the infection is severe.
A complete clinical examination should be performed before treatment.
As ciclosporin inhibits T-lymphocytes and though it does not induce
tumors, it may lead to increased incidences of clinically apparent
malignancy. Lymphadenopathy observed on treatment with ciclosporin
should be regularly monitored.
In laboratory animals, ciclosporin is liable to affect the circulating levels
of insulin and to cause an increase in glycaemia. In the presence of
suggestive signs of diabetes mellitus, the effect of treatment on
glycaemia must be monitored. If signs of diabetes mellitus are observed
following the use of the product, e.g. polyuria or polydipsia, the dose
should be tapered or discontinued and veterinary care sought. The use
of ciclosporin is not recommended in diabetic dogs. Closely monitor
creatinine levels in dogs with severe renal insufficiency.
Particular attention must be paid to vaccination. Treatment with the
veterinary medicinal product may interfere with vaccination efficacy. In
the case of inactivated vaccines, it is not recommended to vaccinate
during treatment or within a two-week interval before or after
administration of the product. For live vaccines see also section
“Contraindications”.
It is not recommended to use other immunosuppressive agents
concomitantly.
ii) 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 of the capsule or its contents, seek
medical advice immediately and show the package leaflet or the label
to the physician.

Revised: April 2025
AN: 04197/2024Page 3 of 7