EXOLIC

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT EKZOLIK® (EXOLIK)

Composition:

Active substance: naftifine hydrochloride;

1 g of cream contains 10 mg of naftifine hydrochloride;

Excipients: benzyl alcohol, sorbitan stearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60 (E 435), isopropyl myristate, sodium hydroxide, purified water.

Pharmaceutical form. Cream.

Main physicochemical characteristics: white, soft or slightly syrupy shiny cream with a slight characteristic odor.

Pharmacotherapeutic group.

Antifungal agents for dermatological use.

ATC code D01AE22.

Pharmacological Properties

Pharmacodynamics

Exolic® 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 fungicidal or fungistatic activity depending on the microbial strain.

Exolic® also exhibits antibacterial activity against gram-positive and gram-negative microorganisms that may cause secondary bacterial infections accompanying mycotic lesions.

In addition, Exolic® has 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 detected 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 2–4 days.

Clinical characteristics.

Indications.

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

• fungal skin infections and skin folds;
• interdigital mycoses;
• nail fungal infections (onychomycosis);
• cutaneous candidiasis;
• pityriasis versicolor;
• inflammatory dermatomycoses which may be accompanied by itching.

Contraindications.

Hypersensitivity to naftifine 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.

The medicinal product should be used for nail and skin disorders only as a topical application!

Exolic®, 1% cream contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

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 medicinal product should be used during pregnancy or breastfeeding only if clearly necessary, following careful assessment of the benefit-risk ratio as determined by a physician.

Breastfeeding mothers should avoid contact of the drug with the infant's skin and gastrointestinal tract.

Ability to influence reaction rate when driving or operating machinery.

Does not influence.

Method of Administration and Dosage

Exolic® cream should be applied to the affected skin area and adjacent regions once daily after thorough cleansing and drying of the skin, extending approximately 1 cm onto healthy skin around the perimeter 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 medication is recommended to be applied twice daily. Before the first application, the infected 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 softening agent as advised by a physician).

To prevent relapses, treatment with the medication should continue for at least 2 weeks after the main symptoms have disappeared.

Children.

There is insufficient data on the efficacy and safety of the drug in pediatric patients; therefore, Exolic® is not recommended for use in this age group.

Overdose.

Acute overdose with topical naftifine has not been reported.

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

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

Adverse Reactions

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 estimated from available data).

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

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

Reporting of adverse reactions after drug registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Shelf life after first opening — 4 weeks.

Do not use after the expiry date.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging.

15 g of cream in a tube, 1 tube per pack.

Supply category.

Over-the-counter.

Manufacturer.

PJSC "CHEMICAL PHARMACEUTICAL PLANT "CHERVONA ZIRKA".

Manufacturer's address and place of business.

1 Gordiienkivska Street, Kharkiv, Kharkiv Oblast, 61010, Ukraine.