Fungiconazole 400 mg, 20 tablets is a product containing Ketoconazole used for the treatment of fungal infections caused by Microsporum canis, Microsporum gypseum, Trichophyton mentagrophytes in dogs.

Each tablet contains:

• Active substance: Ketoconazole 400 mg.

Flavored, round tablets with brown dots, divisible into two and four equal parts.

Indications: Treatment of fungal infections caused by: Microsporum canis, Microsporum gypseum, Trichophyton mentagrophytes.

Contraindications:

• Do not administer to animals with liver failure.
• Do not administer in case of known hypersensitivity to the active substance or to any of the excipients.

Adverse reactions:

• In rare cases, at standard doses, neurological symptoms may be observed - apathy, ataxia, tremors (for example, the dog may appear passive, unstable and/or may have muscle spasms), hepatotoxicity (liver damage), vomiting, anorexia (severe lack of appetite) and/or diarrhea.
• Ketoconazole has anti-androgenic and anti-glucocorticoid effects; it inhibits the conversion of cholesterol to steroid hormones such as testosterone and cortisol, depending on the dose administered and the time. See also section 12 for effects in male breeding dogs.
• If you notice any serious reactions or other effects not mentioned in this leaflet, please inform your veterinarian.

Target species: Dogs.

Administration:

• 10 mg ketoconazole per kg body weight per day, by oral administration. This corresponds to 1 tablet per 20 kg body weight per day.
• It is recommended that samples are collected from the animal once a month during treatment and that the antifungal product is discontinued after two negative cultures. When mycological follow-up is not possible, treatment should be continued for an adequate period of time to ensure mycological cure. If lesions persist after 8 weeks of treatment, the medication should be re-evaluated by the responsible veterinarian.

Recommendations for correct administration:

• The product should preferably be taken with food to maximize absorption.
• The tablets can be divided into two or four equal parts to ensure proper administration. Place the tablet on a flat surface with the score lines facing up and the convex (rounded) side facing the surface.
• Two equal parts: Apply gentle vertical pressure with your thumbs on both sides of the tablet to break it in half.
• Four equal parts: Apply slight vertical pressure with the tip of your thumb on the middle of the tablet to break it into quarters.

Waiting time: Not applicable.

Special precautions for storage:

• Keep out of sight and reach of children.
• This veterinary medicinal product does not require any special storage conditions.
• Shelf life in use of divided tablets (halves/quarters): 3 days.
• Do not use this veterinary medicinal product after the expiry date which is stated on the carton.

Special warnings:

• Although this occurs rarely, repeated use of ketoconazole may induce cross-resistance to other azole products.
• Special precautions for use in animals:
• Treatment with ketoconazole causes suppression of testosterone levels and increases in progesterone levels and may affect reproductive efficiency in male dogs during treatment and for several weeks after treatment.
• Treatment of ringworm should not be limited to treating the infected animal(s). It should also include disinfection of the environment, as spores can survive in the environment for long periods of time. Other measures include frequent vacuuming, disinfection of grooming equipment, and removal of all potentially contaminated materials that cannot be disinfected, which will minimize the risk of reinfection or spread of infection.
• It is recommended to combine systemic treatment with topical treatment.
• In case of long-term administration, liver function should be carefully monitored. If clinical signs suggestive of liver dysfunction occur, treatment should be discontinued immediately.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

• People with known hypersensitivity to the active substances should avoid contact of the skin and mucous membranes with the medicinal product.
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• In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
• Wash your hands after use.
• The halves (half/quarter) of the tablet should be kept in the original blister and can be used for the next administration. Keep the blister in the outer carton in order to prevent access by children.

Gestation and lactation:

• Studies in laboratory animals have demonstrated the existence of teratogenic and embryotoxic effects.
• The safety of the product has not been established in bitches during pregnancy or lactation.
• Use during pregnancy is not recommended.
• Interactions with other medicinal products or other forms of interaction:
• The product should not be administered together with antacids and/or H2 receptor antagonists (cimetidine/ranitidine) or proton pump inhibitors (e.g. omeprazole), as the absorption of ketoconazole may be altered (absorption requires an acidic environment).
• Ketoconazole is a substrate and a potent inhibitor of cytochrome P450 3A4 (CYP3A4). This may result in decreased clearance of drugs metabolized by CYP3A4, thereby altering plasma concentrations. Cytochrome P450 inducers may increase the rate of ketoconazole metabolism. Relevant interactions with veterinary medicinal products include cyclosporines, macrocyclic lactones (ivermectin, selamectin, milbemycin), midazolam, cisapride, amlodipine, fentanyl, macrolide antibiotics (clarithromycin, erythromycin), digoxin, anticoagulants and phenobarbital.
• Ketoconazole inhibits the conversion of cholesterol to cortisol and thus may influence the dosing of trilostane/mitotane in dogs treated concomitantly for hyperadrenocorticism.
• Do not administer any other medication to your dog without first consulting your veterinarian.

Overdose (symptoms, emergency procedures, antidote):

• In cases of overdose, the following effects may be observed: anorexia (severe lack of appetite), vomiting, pruritus (itching), alopecia (hair loss) and increased levels of some liver enzymes (ALT and ALP).

Incompatibilities: Not applicable.
Special precautions for the disposal of unused product or waste materials, if any:
Any unused veterinary medicinal product or waste materials derived from the use of such products should be disposed of in accordance with local requirements.

Currently, product safety information is not available.

Currently, manufacturer information is not available.

Currently, information about the person responsible is not available.

Size: Small, Medium, Large

Age: Junior, Adult, Senior

Presentation type: Tablet

Action: Treating fungus in dogs

Pieces Set: 20 pieces

Brand Name: LeVet

Product Code: 6422966111561

Quantity: 20 Tablets