POM-V
Prescription Required
Companion Animal
Atopica 100 mg/ml Oral Solution for Cats and Dogs
Active ingredient: Ciclosporin A
Form
Liquid
Species
Cats
Dogs
Manufacturer
Elanco GmbH
VMD MA No.
52127/5136
What it's used for
Symptomatic treatment of chronic allergic dermatitis in cats. Treatment of chronic manifestations of atopic dermatitis in dogs.
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Clinical information
Atopica 100 mg/ml Oral Solution for Cats and Dogs — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 26 Mar 2026.
Symptomatic treatment of chronic allergic dermatitis in cats.
Treatment of chronic manifestations of atopic dermatitis in dogs.
Treatment of chronic manifestations of atopic dermatitis in dogs.
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
Do not use in animals 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 “Special precautions for
Revised: September 2025
AN: 01408/2025Page 2 of 14
use” and “Interaction with other medicinal products and other forms of
interaction”).
Do not use in cats infected with FeLV or FIV.
Do not use in dogs less than six months of age or less than 2 kg in weight.
excipients.
Do not use in animals 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 “Special precautions for
Revised: September 2025
AN: 01408/2025Page 2 of 14
use” and “Interaction with other medicinal products and other forms of
interaction”).
Do not use in cats infected with FeLV or FIV.
Do not use in dogs less than six months of age or less than 2 kg in weight.
Cats:
Very common
(>1 animal / 10 animals treated):
Digestive tract disorders (Vomiting,
Diarrhoea)
.
Common
(1 to 10 animals / 100 animals
treated):
Lethargy
, Anorexia
, Weight loss
;
Hypersalivation
;
Lymphopenia
.
Very rare
(<1 animal / 10,000 animals treated,
including isolated reports):
Leucopenia, Neutropenia,
Thrombocytopenia;
Diabetes mellitus.
generally mild and transient and do not require the cessation of the treatment.
²generally resolve spontaneously after treatment is stopped or following a
decrease in the dosing frequency
Side effects may be severe in individual animals.
Dogs:
Uncommon
(1 to 10 animals / 1,000 animals
treated):
Digestive tract disorders (Hypersalivation,
Vomiting, Mucous stool, Loose stool,
Diarrhoea)
.
Rare
(1 to 10 animals / 10,000 animals
treated):
Lethargy
, Anorexia
;
Hyperactivity
;
Gingival hyperplasia
2,3
;
Skin reactions (such as Verruciform lesions,
Hair change)
;
Pinnal reddening
, Pinnal oedema
;
Muscle weakness
, Cramp
.
Very rare
(<1 animal / 10,000 animals treated,
including isolated reports):
Diabetes mellitus
.
generally mild and transient and do not require the cessation of the treatment
generally resolve spontaneously after treatment is stopped
mild to moderate
mainly in West Highland White Terriers
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 the national
competent authority via the national reporting system. See also section 16 of
the package leaflet for respective contact details.
Very common
(>1 animal / 10 animals treated):
Digestive tract disorders (Vomiting,
Diarrhoea)
.
Common
(1 to 10 animals / 100 animals
treated):
Lethargy
, Anorexia
, Weight loss
;
Hypersalivation
;
Lymphopenia
.
Very rare
(<1 animal / 10,000 animals treated,
including isolated reports):
Leucopenia, Neutropenia,
Thrombocytopenia;
Diabetes mellitus.
generally mild and transient and do not require the cessation of the treatment.
²generally resolve spontaneously after treatment is stopped or following a
decrease in the dosing frequency
Side effects may be severe in individual animals.
Dogs:
Uncommon
(1 to 10 animals / 1,000 animals
treated):
Digestive tract disorders (Hypersalivation,
Vomiting, Mucous stool, Loose stool,
Diarrhoea)
.
Rare
(1 to 10 animals / 10,000 animals
treated):
Lethargy
, Anorexia
;
Hyperactivity
;
Gingival hyperplasia
2,3
;
Skin reactions (such as Verruciform lesions,
Hair change)
;
Pinnal reddening
, Pinnal oedema
;
Muscle weakness
, Cramp
.
Very rare
(<1 animal / 10,000 animals treated,
including isolated reports):
Diabetes mellitus
.
generally mild and transient and do not require the cessation of the treatment
generally resolve spontaneously after treatment is stopped
mild to moderate
mainly in West Highland White Terriers
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 the national
competent authority via the national reporting system. See also section 16 of
the package leaflet for respective contact details.
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 use in animals
Clinical signs of atopic or allergic 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 or allergic
dermatitis.
A complete clinical examination should be performed before treatment.
It is recommended to clear any infection including 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.
While ciclosporin does not induce tumours, it does inhibit T-lymphocytes and
Therefore, treatment with ciclosporin may lead to an increased incidence of
clinically apparent malignancy due to the decrease in antitumor immune
response. The potentially increased risk of tumour progression must be weighed
against the clinical benefit. If lymphadenopathy is observed in cats and dogs
being treated with ciclosporin, further clinical investigations are recommended
and treatment discontinued if necessary.
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 cats and dogs.
Closely monitor creatinine levels with severe renal insufficiency.
Particular attention must be paid to vaccination. Treatment with the product may
result in decreased immune response to vaccination. It is recommended not to
vaccinate with inactivated vaccines during treatment or within a two-week
Revised: September 2025
AN: 01408/2025Page 3 of 14
interval before or after administration of the product. For live vaccines see also
section “Contraindications”.
It is not recommended to use immunosuppressive agents concomitantly.
Cats:
Allergic dermatitis in cats can have various manifestations, including
eosinophilic plaques, head and neck excoriation, symmetrical alopecia and/or
miliary dermatitis. The immune status of the cats to FeLV and FIV infections
should be assessed before treatment.
Cats that are seronegative for T. gondii may be at risk of developing clinical
toxoplasmosis if they become infected while under treatment. In rare cases this
can be fatal. Potential exposure of seronegative cats or cats suspected to be
seronegative to Toxoplasma should therefore be minimised (e.g. keep indoors,
avoid raw meat or scavenging). Ciclosporin was shown to not increase T. gondii
oocyte shedding in a controlled laboratory study. In cases of clinical
toxoplasmosis or other serious systemic illness, stop treatment with ciclosporin
and initiate appropriate therapy.
Clinical studies in cats have shown that decreased appetite and weight loss
may occur during ciclosporin treatment. Monitoring of body weight is
recommended. Significant reduction in body weight may result in hepatic
lipidosis. If persistent, progressive weight loss occurs during treatment it is
recommended to discontinue treatment until the cause has been identified.
The efficacy and safety of ciclosporin has neither been assessed in cats less
than 6 months of age nor weighing less than 2.3 kg.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Accidental ingestion of this product may lead to nausea and/or vomiting. To
avoid accidental ingestion, the product must be used and kept out of reach of
children. Do not leave unattended filled syringe in the presence of children. Any
uneaten medicated cat food must be disposed of immediately and the bowl
washed thoroughly. In case of accidental ingestion, particularly by a child, seek
medical advice immediately and show the package leaflet or the label to the
physician.
Ciclosporin can trigger hypersensitivity (allergic) reactions. People with known
hypersensitivity to ciclosporin should avoid contact with the product.
This veterinary medicinal product may cause irritation in case of eye contact.
Avoid contact with eyes. In case of contact, rinse thoroughly with clean water.
Wash hands and any exposed skin after administering the veterinary medicinal
product.
Revised: September 2025
AN: 01408/2025Page 4 of 14
to control moderate to severe pruritus when initiating therapy with ciclosporin.
Special precautions for use in animals
Clinical signs of atopic or allergic 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 or allergic
dermatitis.
A complete clinical examination should be performed before treatment.
It is recommended to clear any infection including 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.
While ciclosporin does not induce tumours, it does inhibit T-lymphocytes and
Therefore, treatment with ciclosporin may lead to an increased incidence of
clinically apparent malignancy due to the decrease in antitumor immune
response. The potentially increased risk of tumour progression must be weighed
against the clinical benefit. If lymphadenopathy is observed in cats and dogs
being treated with ciclosporin, further clinical investigations are recommended
and treatment discontinued if necessary.
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 cats and dogs.
Closely monitor creatinine levels with severe renal insufficiency.
Particular attention must be paid to vaccination. Treatment with the product may
result in decreased immune response to vaccination. It is recommended not to
vaccinate with inactivated vaccines during treatment or within a two-week
Revised: September 2025
AN: 01408/2025Page 3 of 14
interval before or after administration of the product. For live vaccines see also
section “Contraindications”.
It is not recommended to use immunosuppressive agents concomitantly.
Cats:
Allergic dermatitis in cats can have various manifestations, including
eosinophilic plaques, head and neck excoriation, symmetrical alopecia and/or
miliary dermatitis. The immune status of the cats to FeLV and FIV infections
should be assessed before treatment.
Cats that are seronegative for T. gondii may be at risk of developing clinical
toxoplasmosis if they become infected while under treatment. In rare cases this
can be fatal. Potential exposure of seronegative cats or cats suspected to be
seronegative to Toxoplasma should therefore be minimised (e.g. keep indoors,
avoid raw meat or scavenging). Ciclosporin was shown to not increase T. gondii
oocyte shedding in a controlled laboratory study. In cases of clinical
toxoplasmosis or other serious systemic illness, stop treatment with ciclosporin
and initiate appropriate therapy.
Clinical studies in cats have shown that decreased appetite and weight loss
may occur during ciclosporin treatment. Monitoring of body weight is
recommended. Significant reduction in body weight may result in hepatic
lipidosis. If persistent, progressive weight loss occurs during treatment it is
recommended to discontinue treatment until the cause has been identified.
The efficacy and safety of ciclosporin has neither been assessed in cats less
than 6 months of age nor weighing less than 2.3 kg.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Accidental ingestion of this product may lead to nausea and/or vomiting. To
avoid accidental ingestion, the product must be used and kept out of reach of
children. Do not leave unattended filled syringe in the presence of children. Any
uneaten medicated cat food must be disposed of immediately and the bowl
washed thoroughly. In case of accidental ingestion, particularly by a child, seek
medical advice immediately and show the package leaflet or the label to the
physician.
Ciclosporin can trigger hypersensitivity (allergic) reactions. People with known
hypersensitivity to ciclosporin should avoid contact with the product.
This veterinary medicinal product may cause irritation in case of eye contact.
Avoid contact with eyes. In case of contact, rinse thoroughly with clean water.
Wash hands and any exposed skin after administering the veterinary medicinal
product.
Revised: September 2025
AN: 01408/2025Page 4 of 14
Various substances are known to competitively inhibit or induce the enzymes
involved in the metabolism of ciclosporin, in particular cytochrome P450 (CYP
3A4). In certain clinically justified cases, an adjustment of the dosage of the
veterinary medicinal product may be required. The compound class of azoles
(e.g. ketoconazole) is known to increase the blood concentration of ciclosporin
in cats and dogs, which is considered to be clinically relevant. Ketoconazole at
5-10 mg/kg is known to increase the blood concentrations in dogs up to five-
fold. During concomitant use of ketoconazole and ciclosporin the veterinarian
should consider as a practical measure to double the treatment interval if the
dog is on a daily treatment regime. Macrolides such as erythromycin may
increase the plasma levels of ciclosporin up to twofold. Certain inducers of
cytochrome P450, anticonvulsants and antibiotics (e.g. trimethoprim/
sulfadimidine) may lower the plasma concentration of ciclosporin.
Ciclosporin is a substrate and an inhibitor of the MDR1 P-glycoprotein
transporter. Therefore, the co-administration of ciclosporin with P-glycoprotein
substrates such as macrocyclic lactones could decrease the efflux of such
drugs from blood-brain barrier cells, potentially resulting in signs of CNS toxicity.
In clinical studies with cats treated with ciclosporin and selamectin or
milbemycin, there did not appear to be an association between these drugs’
concomitant use and neurotoxicity.
Ciclosporin can increase the nephrotoxicity of aminoglycoside antibiotics and
trimethoprim. The concomitant use of ciclosporin is not recommended with
these active ingredients.
In dogs, no toxicological interactions between ciclosporin and prednisolone (at
anti-inflammatory doses) are expected.
Particular attention must be paid to vaccination (see section “Contraindications”
and “Special precautions for use”). Concomitant use of immunosuppressive
agents: see section “Special precautions for use”.
involved in the metabolism of ciclosporin, in particular cytochrome P450 (CYP
3A4). In certain clinically justified cases, an adjustment of the dosage of the
veterinary medicinal product may be required. The compound class of azoles
(e.g. ketoconazole) is known to increase the blood concentration of ciclosporin
in cats and dogs, which is considered to be clinically relevant. Ketoconazole at
5-10 mg/kg is known to increase the blood concentrations in dogs up to five-
fold. During concomitant use of ketoconazole and ciclosporin the veterinarian
should consider as a practical measure to double the treatment interval if the
dog is on a daily treatment regime. Macrolides such as erythromycin may
increase the plasma levels of ciclosporin up to twofold. Certain inducers of
cytochrome P450, anticonvulsants and antibiotics (e.g. trimethoprim/
sulfadimidine) may lower the plasma concentration of ciclosporin.
Ciclosporin is a substrate and an inhibitor of the MDR1 P-glycoprotein
transporter. Therefore, the co-administration of ciclosporin with P-glycoprotein
substrates such as macrocyclic lactones could decrease the efflux of such
drugs from blood-brain barrier cells, potentially resulting in signs of CNS toxicity.
In clinical studies with cats treated with ciclosporin and selamectin or
milbemycin, there did not appear to be an association between these drugs’
concomitant use and neurotoxicity.
Ciclosporin can increase the nephrotoxicity of aminoglycoside antibiotics and
trimethoprim. The concomitant use of ciclosporin is not recommended with
these active ingredients.
In dogs, no toxicological interactions between ciclosporin and prednisolone (at
anti-inflammatory doses) are expected.
Particular attention must be paid to vaccination (see section “Contraindications”
and “Special precautions for use”). Concomitant use of immunosuppressive
agents: see section “Special precautions for use”.
Store between 15°C and 30°C but preferably not below 20°C for more than one
month. Storage in the refrigerator should be avoided.
Keep the bottle in the outer carton.
The product contains oily components from natural origin which can become
solid at lower temperatures. A jelly-like formation may occur below 20°C which
is however reversible at temperatures up to 30°C. Minor flakes or a slight
sediment may still be observed. However, this does neither affect the dosing nor
the efficacy and safety of the product.
month. Storage in the refrigerator should be avoided.
Keep the bottle in the outer carton.
The product contains oily components from natural origin which can become
solid at lower temperatures. A jelly-like formation may occur below 20°C which
is however reversible at temperatures up to 30°C. Minor flakes or a slight
sediment may still be observed. However, this does neither affect the dosing nor
the efficacy and safety of the product.
medicine.
This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.
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Related Conditions
Same active ingredient
Other Products Containing Ciclosporin A
These products share the same active ingredient and may be suitable alternatives. Always consult your vet.
Atopica 10 mg Soft Capsules for Dogs
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capsule
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Atopica 10 mg Soft Capsules for Dogs
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capsule
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Atopica 100 mg Soft Capsules for Dogs
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capsule
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Atopica 100 mg Soft Capsules for Dogs
POM-VElanco GmbH
capsule
Dogs
Atopica 100 mg/ml Oral Solution for Cats and Dogs
POM-VElanco GmbH
liquid
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Dogs
Atopica 25 mg Soft Capsules for Dogs
POM-VElanco GmbH
capsule
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