Atopica 25 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: June 2023
AN: 01270/2022 + 00836/2023
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Atopica 25 mg soft capsules for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
ACTIVE SUBSTANCE: Ciclosporin 25 mg
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCt

-tocopherol (E-307)
0.250 mg
Iron oxide black (E-172)
0.105 mg
Titanium dioxide (E-171)
2.120 mg
Carminic acid (E-120)
< 1.00 µg
Corn oil-mono-di-triglycerides
Ethanol (E-1510)
Gelatine (E-441)
Glycerol (E-422)
Propylene glycol (E-1520)
Macrogolglycerol hydroxystearate
Blue-gray oval soft capsules bearing the following imprint: NVR 25 mg.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs (weighing from 4 to 7.5 kg).
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of chronic manifestations of atopic dermatitis in dogs.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to ciclosporin or any 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.
Revised: June 2023
AN: 01270/2022 + 00836/2023
Page 2 of 7
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 3.5 “Special
precautions for use” and 3.8
“Interaction with other medicinal products and other forms of
interaction”).
3.4
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.
3.5
SPECIAL PRECAUTIONS FOR USE
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