POM-V
Prescription Required
Companion Animal
Modulis 100 mg/ml Oral Solution for Dogs
Active ingredient: Ciclosporin A
Form
Liquid
Species
Dogs
Manufacturer
Ceva Sante Animale
VMD MA No.
14966/3074
What it's used for
Symptomatic treatment of chronic allergic dermatitis in cats.
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Paying less for Ciclosporin A
-
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Prescription required
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Clinical information
Modulis 100 mg/ml Oral Solution for Dogs — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.
Symptomatic treatment of chronic allergic dermatitis in cats.
Before starting treatment, an evaluation of all alternative treatment options should
be made.
The mean recommended dose of ciclosporin is 5 mg/kg body weight corresponding
to 0.5 ml of solution for 10 kg of body weight.
The veterinary medicinal product will initially be given daily until a satisfactory
clinical improvement is seen. This will generally be the case within 4 weeks. If no
response is obtained within the first 8 weeks, the treatment should be stopped.
Once the clinical signs of atopic dermatitis are satisfactorily controlled, the
preparation can then be given every other day as a maintenance dose. The
veterinarian should perform a clinical assessment at regular intervals and adjust
the frequency of administration to the clinical response obtained.
AN: 01861/2025Page 5 of 8
In some cases where the clinical signs are controlled with every-other-day dosing,
the veterinarian can decide to give the veterinary medicinal product every 3 to 4
days. The lowest effective frequency of dosing should be used to maintain the
remission of clinical signs.
Adjunct treatment (e.g. medicated shampoos, essential fatty acids) may be
considered before reducing the dosing interval. Patients should be regularly re-
evaluated and alternative treatment options reviewed.
Treatment may be stopped when the clinical signs are controlled. Upon recurrence
of clinical signs, treatment should be resumed at daily dosing, and in certain cases
repeated treatment courses may be required.
The veterinary medicinal product should be given at least 2 hours before or after
feeding. The product is administered directly into the mouth.
Instructions for use
Push down and unscrew bottle top.
Insert the dosing syringe into the plastic adapter.
Turn the bottle/syringe upside down and slowly pull the
plunger down
until the white line on the plunger corresponds to the dose
prescribed by your veterinarian. The syringe is graduated in kg
and ml.
By pushing the plunger in, empty the contents of the syringe directly into the
mouth. Introduce the syringe either to the side of the mouth or over the tongue.
If necessary, wipe the outside of the syringe with a dry
tissue and dispose of used tissue immediately. Close the
bottle and insert the syringe into the specific cap to
protect from any contamination and to avoid any spillage
of remaining product.
For the 5 and 15 ml vials
Volume to be administered using 1 ml syringe: 0.05 ml/kg, i.e. 1 graduation/kg.
For the 30 and 50 ml vials
Volume to be administered using 2 ml syringe: 0.1 ml/2 kg, i.e. 1 graduation/2 kg
be made.
The mean recommended dose of ciclosporin is 5 mg/kg body weight corresponding
to 0.5 ml of solution for 10 kg of body weight.
The veterinary medicinal product will initially be given daily until a satisfactory
clinical improvement is seen. This will generally be the case within 4 weeks. If no
response is obtained within the first 8 weeks, the treatment should be stopped.
Once the clinical signs of atopic dermatitis are satisfactorily controlled, the
preparation can then be given every other day as a maintenance dose. The
veterinarian should perform a clinical assessment at regular intervals and adjust
the frequency of administration to the clinical response obtained.
AN: 01861/2025Page 5 of 8
In some cases where the clinical signs are controlled with every-other-day dosing,
the veterinarian can decide to give the veterinary medicinal product every 3 to 4
days. The lowest effective frequency of dosing should be used to maintain the
remission of clinical signs.
Adjunct treatment (e.g. medicated shampoos, essential fatty acids) may be
considered before reducing the dosing interval. Patients should be regularly re-
evaluated and alternative treatment options reviewed.
Treatment may be stopped when the clinical signs are controlled. Upon recurrence
of clinical signs, treatment should be resumed at daily dosing, and in certain cases
repeated treatment courses may be required.
The veterinary medicinal product should be given at least 2 hours before or after
feeding. The product is administered directly into the mouth.
Instructions for use
Push down and unscrew bottle top.
Insert the dosing syringe into the plastic adapter.
Turn the bottle/syringe upside down and slowly pull the
plunger down
until the white line on the plunger corresponds to the dose
prescribed by your veterinarian. The syringe is graduated in kg
and ml.
By pushing the plunger in, empty the contents of the syringe directly into the
mouth. Introduce the syringe either to the side of the mouth or over the tongue.
If necessary, wipe the outside of the syringe with a dry
tissue and dispose of used tissue immediately. Close the
bottle and insert the syringe into the specific cap to
protect from any contamination and to avoid any spillage
of remaining product.
For the 5 and 15 ml vials
Volume to be administered using 1 ml syringe: 0.05 ml/kg, i.e. 1 graduation/kg.
For the 30 and 50 ml vials
Volume to be administered using 2 ml syringe: 0.1 ml/2 kg, i.e. 1 graduation/2 kg
Do not use in cases of hypersensitivity to ciclosporin or to any of the excipients.
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 3.5 “Special precautions for use” and
3.8 “Interaction with other medicinal products”).
AN: 01861/2025Page 2 of 8
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 3.5 “Special precautions for use” and
3.8 “Interaction with other medicinal products”).
AN: 01861/2025Page 2 of 8
Dogs:
Common
(1 to 10 animals / 100 animals
treated):
Mucous stool
, soft stool
Uncommon
(1 to 10 animals / 1,000
animals treated):
Hyperactivity
Skin lesion
(verruciform lesion, hair change)
Muscle weakness
, musculoskeletal cramp
Rare
(1 to 10 animals / 10,000
animals treated):
Vomiting
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Diarrhoea
Lethargy
, anorexia
Gingival hyperlasia
Pinnal irritation
Diabetes mellitus
1
These signs are mild and transient and generally do not require the cessation of
the treatment.
These signs are mild and transient and generally do not require the cessation of
the treatment.
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 the package leaflet for respective contact
details.
Common
(1 to 10 animals / 100 animals
treated):
Mucous stool
, soft stool
Uncommon
(1 to 10 animals / 1,000
animals treated):
Hyperactivity
Skin lesion
(verruciform lesion, hair change)
Muscle weakness
, musculoskeletal cramp
Rare
(1 to 10 animals / 10,000
animals treated):
Vomiting
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Diarrhoea
Lethargy
, anorexia
Gingival hyperlasia
Pinnal irritation
Diabetes mellitus
1
These signs are mild and transient and generally do not require the cessation of
the treatment.
These signs are mild and transient and generally do not require the cessation of
the treatment.
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 the package leaflet for respective contact
details.
Consideration should be given to the use of other measures and/or treatment 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 due to the decrease
in antitumor immune response. 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
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. 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.
Irritation to eyes is unlikely. As precautionary measure avoid contact with eyes. In
case of contact, rinse thoroughly with clean water. Wash hands and any exposed
skin after use.
AN: 01861/2025Page 3 of 8
Special precautions for the protection of the environment:
Not applicable.
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 due to the decrease
in antitumor immune response. 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
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. 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.
Irritation to eyes is unlikely. As precautionary measure avoid contact with eyes. In
case of contact, rinse thoroughly with clean water. Wash hands and any exposed
skin after use.
AN: 01861/2025Page 3 of 8
Special precautions for the protection of the environment:
Not applicable.
Various substances are known to competitively inhibit or induce the enzymes
involved in the metabolism of ciclosporin, in particular cytochrome P450 (CYP 3A
4). In certain clinically justified cases, an adjustment of the dosage of the
veterinary medicinal product may be required. Ketoconazole at 5-10 mg/kg is
known to increase the blood concentration of ciclosporin in dogs up to five-fold,
which
is
considered
to
be
clinically
relevant.
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 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 (e.g. ivermectin and milbemycin) could decrease the
efflux of such drugs from blood-brain barrier cells, potentially resulting in signs of
Central nervous system toxicity.
Ciclosporin can increase the nephrotoxicity of aminoglycoside antibiotics and
trimethoprim. The concomitant use of ciclosporin is not recommended with these
active ingredients.
Particular attention must be paid to vaccination (see sections 3.3
“Contraindications” and 3.5 “Special precautions for use”). Concomitant use of
immunosuppressive agents: see section 3.5 “Special precautions for use”.
involved in the metabolism of ciclosporin, in particular cytochrome P450 (CYP 3A
4). In certain clinically justified cases, an adjustment of the dosage of the
veterinary medicinal product may be required. Ketoconazole at 5-10 mg/kg is
known to increase the blood concentration of ciclosporin in dogs up to five-fold,
which
is
considered
to
be
clinically
relevant.
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 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 (e.g. ivermectin and milbemycin) could decrease the
efflux of such drugs from blood-brain barrier cells, potentially resulting in signs of
Central nervous system toxicity.
Ciclosporin can increase the nephrotoxicity of aminoglycoside antibiotics and
trimethoprim. The concomitant use of ciclosporin is not recommended with these
active ingredients.
Particular attention must be paid to vaccination (see sections 3.3
“Contraindications” and 3.5 “Special precautions for use”). Concomitant use of
immunosuppressive agents: see section 3.5 “Special precautions for use”.
Keep the bottle in the outer carton.
Storage in the refrigerator should be avoided.
The product contains fat 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.
Storage in the refrigerator should be avoided.
The product contains fat 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.
Not applicable
4.
4.
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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