ZALAÍN

Composition:

Active substance: sertaconazole nitrate;

1 tube (20 g) contains 0.4 g of sertaconazole nitrate;

Excipients: ethylene glycol and polyethylene glycol palmitostearate, lauromacrogol glycerides, glycerol isostearate, light mineral oil, methylparahydroxybenzoate (E 218), sorbic acid, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties:

Semi-solid white cream of liquid consistency, odorless or with a faint fatty odor.

Pharmacotherapeutic group. Antifungal agents for topical use.

ATC code D01A C14.

Pharmacological Properties.

Pharmacodynamics. Zalain is an antifungal agent, an imidazole derivative, with high fungicidal activity. Its mechanism of action involves inhibition of ergosterol synthesis and increased cell membrane permeability, leading to destruction of pathogens. It is effective against pathogenic yeast fungi (Candida albicans, Candida spp. and Malassezia furfur), dermatophytes (Trichophyton, Epidermophyton and Microsporum spp.), and pathogens causing infectious diseases of the skin and mucous membranes, including gram-positive strains (Staphylococcus, Streptococcus).

Pharmacokinetics. No systemic absorption occurs.

Clinical characteristics.

Indications.

For local treatment of fungal skin infections caused by dermatophytes and yeast fungi: tinea pedis, tinea cruris, dermatomycosis of smooth skin, trichophytia of the beard and mustache area, dermatomycosis of the hands, candidiasis, pityriasis versicolor.

Contraindications.

Hypersensitivity to any imidazole-derived antifungal agents in history or to any other component of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Not established. If simultaneous use of any other medicinal products is necessary, consult a physician.

Special precautions for use.

Zalain must not be used in ophthalmology. It must not be administered orally. If irritation or hypersensitivity reactions occur during use of the medicinal product, treatment should be discontinued and appropriate therapy initiated. The drug is contraindicated in patients with hypersensitivity to sertaconazole or to any other imidazole-derived antifungal agents due to possible cross-sensitivity.

Hands should be washed before applying Zalain cream to affected skin areas. The skin should be dry prior to application of the cream.

Patients should use acidic cleansing agents with caution, as an acidic environment promotes the proliferation of Candida spp.

Zalain contains methylparahydroxybenzoate (E 218), which may cause allergic reactions (possibly delayed).

Zalain contains sorbic acid, which may cause local skin reactions (e.g. contact dermatitis).

Use during pregnancy or breastfeeding.

After topical application of the drug in large amounts, no plasma levels were observed. Since the harmful effects of the drug on newborns or pregnant women have not been studied, the benefit-risk ratio for the woman and fetus/child should be carefully evaluated before prescribing Zalain during pregnancy or breastfeeding.

Ability to influence the speed of reactions while driving or operating machinery.

No influence.

Dosage and Administration

Apply the cream once or twice daily (preferably at night or morning and evening), in a thin, smooth and even layer, gently and uniformly over the affected area of the skin, extending approximately 1 cm beyond the lesion into the surrounding healthy skin.

The duration of treatment depends on the etiology and the site of infection. Generally, treatment should continue for approximately 4 weeks to achieve clinical remission with a negative result on microbiological follow-up testing, thus preventing relapse. However, in many cases, clinical recovery occurs earlier, between 2 and 4 weeks.

Children. There are no data available on use in pediatric patients.

Overdose.

Considering the concentration of the active ingredient and the recommended route of administration, intoxication is unlikely. However, in case of accidental ingestion, appropriate symptomatic therapy should be administered.

Side effects.

The product has shown good tolerability when applied to both intact and damaged skin.

Local reactions may include contact dermatitis (skin dryness, burning sensation, itching, urticaria). Hypersensitivity reactions and transient local erythematous reactions are possible, which do not require discontinuation of the product.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in a place inaccessible to children.

Packaging. 20 g in a tube; 1 tube per cardboard box.

Supply category. Over-the-counter (without prescription).

Manufacturer.

1. EGIS Pharmaceuticals PLC, Hungary.
2. Ferrer International, S.A., Spain.

Manufacturer's location and address of business operations.

1. 1165, Budapest, Bokenyfoldi ut. 118–120, Hungary.
2. Joan Buscalla, 1–9, 08173 Sant Cugat del Valles, Barcelona, Spain.