Thiomex

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TIO-MEX (THIOMEX)

Composition:

Active substance: tioconazole;

1 g of cream contains tioconazole 10 mg;

Excipients: polysorbate 60, sorbitan stearate, cetyl alcohol, octyldodecanol, cetyl esters wax, benzyl alcohol, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: homogeneous white cream, free from lumps and foreign particles.

Pharmacotherapeutic group. Antifungal agents for topical use. Tioconazole. ATC code D01AC07.

Pharmacological properties.

Pharmacodynamics.

Thioconazole is a broad-spectrum antifungal agent with additional antibacterial activity against several Gram-positive microorganisms, including Staphylococcus spp. and Streptococcus spp. In in vitro studies, it has demonstrated fungicidal activity against dermatophytes, yeasts, and other pathogenic fungi. The mechanism of action of thioconazole involves inhibition of enzymes essential for fungal membrane synthesis, leading to altered membrane permeability. In clinical studies, thioconazole has proven effective in the treatment of common anthropophilic and zoophilic dermatomycoses, particularly those caused by Trichophyton rubrum and T. mentagrophytes, as well as candidiasis, pityriasis versicolor, and erythrasma caused by the bacterial infection Corynebacterium minutissimum. Symptomatic relief of skin infections is observed within the first few days of treatment with thioconazole.

Pharmacokinetics.

Systemic absorption following topical application is negligible.

Clinical characteristics.

Indications.

Thiomex is indicated:

• for local treatment of dermatomycoses (tinea pedis, tinea manuum, pityriasis versicolor) caused by fungi sensitive to the drug (dermatophytes and yeasts);
• for use in the nail bed following keratolytic extraction in onychomycosis caused by dermatophytes.

Contraindications.

The medicinal product is contraindicated in patients with hypersensitivity to the active substance, antifungal agents of the imidazole group, or to any excipient.

Interaction with other medicinal products and other forms of interaction.

Information on interactions is not available.

Special precautions for use

Thiomex cream is not intended for ophthalmological use.

The medicinal product contains cetostearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).

Thiomex cream contains 10 mg of benzyl alcohol in each gram. Benzyl alcohol may cause allergic reactions and slight local irritation.

Use during pregnancy or breastfeeding

Pregnancy

Systemic absorption following topical application has been shown to be minimal. Adequate and well-controlled studies in pregnant women have not been conducted. Thiocanozole should be used during pregnancy only if the physician considers that the potential benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding period

It is unknown whether the medicinal product penetrates into breast milk. Since most drugs penetrate into breast milk, breastfeeding should be discontinued during the use of Thiomex cream.

Ability to influence reaction rate while driving or operating machinery

There is no information regarding the effect on reaction rate while driving or operating machinery.

Method of Administration and Dosage

Dosage

In most patients with tinea infections, the usual duration of treatment is 7 days. However, treatment of severe cases of tinea pedis, especially the chronic hyperkeratotic type, may require prolongation of therapy up to 6 weeks.

The usual duration of treatment for dermatomycoses at other sites, candidiasis, and erythrasma is 2–4 weeks.

For onychomycosis, the required duration of treatment after keratolytic debridement may last 6 months or even 1 year.

The duration of treatment necessary to achieve therapeutic effect varies for each patient and depends on the causative microorganism and the site of infection.

When using the medicinal product Thiomex in elderly people, patients with hepatic insufficiency, or patients with renal insufficiency, dose adjustment and special safety measures are not required, as systemic absorption of thiocanozole after topical application is negligible according to pharmacokinetic data (see section "Pharmacokinetics").

Method of Administration

Thiomex cream should be carefully applied to the affected and surrounding areas 1–2 times daily, in the morning and/or evening. For intertriginous areas, the cream should be applied moderately and spread well to avoid tissue maceration.

Children

The safety and efficacy of the medicinal product in children have not been established.

Overdose

Overdose with topical application of thiocanozole is unlikely due to negligible systemic absorption. In case of accidental oral ingestion, gastrointestinal symptoms may occur. Appropriate measures for gastric lavage should be taken.

Adverse Reactions

Thioconazole is well tolerated following topical application. The most common adverse effect is local irritation (including local allergic reactions), which usually occurs during the first week of treatment and is reversible. Systemic allergic reactions are uncommon. However, if hypersensitivity reactions occur during the use of thioconazole, treatment should be discontinued and appropriate therapy should be initiated.

Adverse reactions are listed by system organ class and frequency: common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), and not known (cannot be estimated from available data).

Immune system disorders.

Not known: allergic reactions.

Skin and subcutaneous tissue disorders.

Not known: bullous eruptions, contact dermatitis, dry skin, nail changes (including nail discoloration, paronychia, nail inflammation and pain), pruritus, skin irritation, skin peeling, urticaria, dermatitis, rash.

Nervous system disorders.

Not known: paraesthesia.

General disorders and administration site conditions.

Common: peripheral edema.

Not known: pain.

Shelf life.

3 years.

After first opening of the tube, the medicinal product is suitable for use for 1 year.

Storage conditions.

The medicinal product does not require special storage conditions. Keep out of reach of children.

Packaging.

30 g of cream in a tube, 1 tube in a cardboard box.

Prescription status.

Prescription only.

Manufacturer.

Laboratorios Basi – Industria Farmaceutica, S.A. / Laboratorios Basi – Industria Farmaceutica, S.A.

Manufacturer's address.

Parque Industrial Manuel Lourenco Ferreira, Lotes 8, 15 e 16, Mortagua, 3450-232, Portugal.

Marketing Authorization Holder.

UAB “Farmlyga” / UAB “Farmlyga”.

Address of the Marketing Authorization Holder.

Antakalnio g. 48A-304, Vilnius, Republic of Lithuania.