Atopica 10 mg Soft Capsules for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Ciclosporin A

Available from:

Elanco Europe Ltd

ATC code:

QL04AD01

INN (International Name):

Ciclosporin A

Pharmaceutical form:

Capsule, soft

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Anti Inflammatory immunosuppressive

Authorization status:

Authorized

Authorization date:

2003-10-06

Summary of Product characteristics

Revised: September 2020
AN: 00839/2020
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ATOPICA 10 mg soft capsules for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Ciclosporin
10.00 mg
EXCIPIENT(S):

-tocopherol (E-307)
0.10 mg
Titanium dioxide (E-171)
1.13 mg
Carminic acid (E-120)
< 1.00

g
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Soft capsule
Yellow-white oval capsules bearing the following imprint: NVR 10.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs (weighing from 2 to 4 kg)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of chronic manifestations of atopic dermatitis in dogs.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to ciclosporin or one of the
excipients.
For all capsule strengths, do not use in dogs less than six months of
age or
less than 2 kg in weight.
Do not use in cases with a history of malignant disorders or
progressive
malignant disorders.
Do not vaccinate with a live vaccine during treatment or within a
two-week
interval before or after treatment. (see also sections 4.5 “Special
precautions
for use” and 4.8 “Interaction with other medicinal products”).
Revised: September 2020
AN: 00839/2020
Page 2 of 7
4.4
SPECIAL WARNINGS
Consideration should be given to the use of other measures and/or
treatments
to control moderate to severe pruritus when initiating therapy with
ciclosporin.
4.5
SPECIAL PRECAUTIONS FOR USE
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 fung