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.

Special precautions for safe use in the target species:
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 3.3 “Contraindications”.
It is not recommended to use other immunosuppressive agents concomitantly.
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.
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Special precautions for the protection of the environment:
Not applicable.