Fungisol

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FUNGISOL (FUNGISOL)

Composition:

Active substance: naftifine hydrochloride;

1 ml of solution contains 10 mg of naftifine hydrochloride;

Excipients: propylene glycol, ethanol (96%), purified water.

Pharmaceutical form. Topical solution.

Main physicochemical characteristics: clear solution, colorless to light yellow.

Pharmacotherapeutic group.
Antifungal agents for dermatological use. ATC code: D01AE22.

Pharmacological properties.

Pharmacodynamics.

Fungisole is an antifungal agent of the allylamine class. Its active component is naftifine hydrochloride, whose mechanism of action is associated with inhibition of ergosterol synthesis.

Naftifine is active against dermatophytes such as Trichophyton, Epidermophyton, and Microsporum, as well as against yeasts (Candida), molds (Aspergillus), and other fungi (e.g., Sporothrix schenckii). Against dermatophytes and Aspergillus species, naftifine exerts a fungicidal effect in vitro; against yeast fungi, it demonstrates either fungicidal or fungistatic activity depending on the microbial strain.

Fungisole also exhibits antibacterial activity against both gram-positive and gram-negative microorganisms, which may cause secondary bacterial infections alongside mycotic lesions.

In addition, Fungisole possesses potent anti-inflammatory properties.

Pharmacokinetics.

Naftifine hydrochloride is rapidly absorbed and forms stable antifungal concentrations in various layers of the skin. Approximately 4% of the applied dose is absorbed through the skin, resulting in very low systemic exposure to the active substance. Only trace amounts of naftifine are detectable in blood plasma and urine. The active substance is almost completely metabolized; metabolites have no antifungal activity and are excreted in feces and urine. The elimination half-life is 2 to 4 days.

Clinical characteristics.

Indications.

Topical treatment of fungal infections caused by pathogens sensitive to naftifine:

• fungal infections of the skin and skin folds;
• interdigital mycoses;
• fungal infections of the nails;
• cutaneous candidiasis;
• pityriasis versicolor;
• inflammatory dermatomycoses, with or without pruritus.

Contraindications.

Hypersensitivity to naftifine, propylene glycol, or to any of the excipients. The product must not be applied to wound surfaces. Do not use for treatment of the eyes.

Interaction with other medicinal products and other forms of interaction.

Interaction studies have not been conducted.

Special precautions for use.

Apply the medication topically only for skin and nail disorders!

The product contains ethanol; therefore, avoid contact of the solution with eyes and open wounds.

The solution contains propylene glycol, which may cause skin irritation.

Use during pregnancy or breastfeeding.

Data on the use of naftifine in pregnant women are lacking or limited. Animal studies do not indicate any direct or indirect harmful effects of the drug on reproductive function. The medication may be used during pregnancy or breastfeeding only if clearly necessary, following careful assessment of the benefit-risk ratio determined by the physician.

Ability to influence reaction rate when driving or operating machinery.

No effect.

Method of Administration and Dosage

Fungisol solution should be applied to the affected skin area and adjacent surrounding areas once daily after thorough cleansing and drying, covering approximately 1 cm of healthy skin around the periphery of the affected area.

Duration of treatment:
For dermatomycoses – 2–4 weeks (if necessary, up to 8 weeks);
For candidiasis – 4 weeks;
For nail infections – up to 6 months.

For fungal nail infections, the drug is recommended to be applied twice daily. Prior to the first application, the affected portion of the nail should be trimmed as much as possible using scissors or a nail file (to facilitate this procedure, nails may be softened with a special agent as directed by a physician).

To prevent relapses, treatment with the drug should be continued for at least 2 weeks after the main symptoms of the disease have disappeared.

Children

There is insufficient data regarding the efficacy and safety of Fungisol in children; therefore, the drug is not recommended for use in this age group.

Overdose

Acute overdose with topical application of naftifine has not been reported.

Systemic intoxication following external application of the drug is unlikely due to minimal absorption of the active ingredient through the skin.

In case of accidental ingestion, symptomatic treatment should be initiated.

Side effects.

The frequency of adverse reactions is defined as follows: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000), very rare (< 1/10000), frequency not known (cannot be calculated from available data).

Skin and subcutaneous tissue disorders: frequency not known – contact dermatitis, erythema.

General disorders: frequency not known – local reactions may occur in isolated cases: dry skin, redness and burning sensation, erythema, itching, local irritation.

Shelf life. 30 months.

After opening the bottle, the solution should not be stored for more than 2 months.

Storage conditions.

No special storage conditions required. Keep out of reach of children.

Packaging.

10 ml, 20 ml of solution in a bottle; 1 bottle per cardboard box.

Classification.

Over-the-counter (without prescription).

Manufacturer.

Jadran-Galenski Laboratorij d.d.

Manufacturer's address and location of operations.

Svilno 20, 51000 Rijeka, Croatia.