Instructions for Thiomex cream 10 mg/g tube 30 g
Composition
active ingredient: tioconazole;
1 g of cream contains tioconazole 10 mg;
excipients: polysorbate 60, sorbitan stearate, cetostearyl alcohol, octyldodecanol, cetyl wax esters, benzyl alcohol, purified water.
Dosage form
Cream.
Main physicochemical properties: homogeneous white cream, without lumps and foreign particles.
Pharmacotherapeutic group
Antifungal agents for topical use. Tioconazole. ATX code D01A C07.
Pharmacological properties
Pharmacodynamics
Tioconazole is a broad-spectrum antifungal agent with antibacterial activity against several Gram-positive microorganisms, including Staphylococcus spp. and Streptococcus spp. In vitro studies have shown fungicidal activity against dermatophytes, yeasts and other pathogenic fungi. The mechanism of action of tioconazole is to inhibit enzymes required for the synthesis of fungal membranes, which leads to a change in their permeability. In clinical studies, tioconazole has shown efficacy in the treatment of all common, anthropophilic and zoophilic dermatomycoses, especially those caused by Trichophyton rubrum, T. mentagrophytes, as well as candidiasis, lichen planus and erythrasma, a bacterial infection caused by Corynebacterium minutissimum. When tioconazole is used, symptomatic relief of skin infections is observed within the first days of treatment.
Pharmacokinetics
Systemic absorption with external use is insignificant.
Indication
Thiomex is indicated for:
for topical treatment of dermatomycoses (dermatophytosis of the feet, mycosis of the hands, tinea versicolor) caused by fungi sensitive to the drug (dermatophytes and yeasts); for use in the nail bed after keratolytic extraction in onychomycosis caused by dermatophytes.
Contraindication
The drug is contraindicated in patients with hypersensitivity to the active substance, imidazole antifungal agents, or to any of the excipients.
Interaction with other medicinal products and other types of interactions
There is no information on interaction.
Application features
Thiomex cream is not intended for ophthalmic 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 minor local irritation.
Use during pregnancy or breastfeeding
Pregnancy
Systemic absorption has been shown to be negligible following topical administration. There are no adequate and well-controlled studies in pregnant women. Tioconazole 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 not known whether the drug passes into breast milk. Since most drugs pass into breast milk, breastfeeding should be discontinued while using Thiomex cream.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no information on the effect on reaction speed when driving vehicles or other mechanisms.
Method of administration and doses
Dosage
In most patients with tinea versicolor, the duration of treatment is usually 7 days, but in the treatment of severe cases of tinea pedis, especially the chronic hyperkeratic type, treatment may need to be extended to 6 weeks.
The duration of treatment for dermatomycoses of other localization, candidiasis, and erythrasma is usually 2–4 weeks.
In onychomycosis, the required duration of treatment after keratolytic extraction may be 6 months or even 1 year.
The duration of treatment required to achieve a therapeutic effect varies for each patient and depends on the causative microorganism and the location of the infection.
When using the drug Tiomex in elderly people, patients with hepatic insufficiency and patients with renal insufficiency, dose adjustment and special precautions are not required, since, according to pharmacokinetic data, systemic absorption of tioconazole when applied externally is insignificant (see section "Pharmacokinetics").
Method of application
Thiomex cream should be applied gently to the affected and adjacent areas 1-2 times a day, morning and/or night. On intertriginous areas, the cream should be applied sparingly and well distributed to avoid tissue maceration.
Children
The safety and efficacy of the drug in children have not been established.
Overdose
Overdose with topical application of tioconazole is unlikely, as systemic absorption is negligible. In case of accidental oral administration, gastrointestinal symptoms may occur. Appropriate measures should be taken to lavage the stomach.
Side effects
Tioconazole is well tolerated after topical application. The most common adverse event is local irritation (including local allergic reactions), which usually occurs within the first week of treatment and is reversible. Systemic allergic reactions are uncommon. However, if hypersensitivity reactions occur with tioconazole, 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 (≥1/10000, <1/1000), very rare (<1/10000) and frequency unknown (cannot be estimated from the available information).
From the immune system.
Frequency unknown: allergic reactions.
On the skin and subcutaneous tissue.
Frequency unknown: bullous eruptions, contact dermatitis, dry skin, nail changes (including nail discoloration, periungual inflammation, nail inflammation and pain), itching, skin irritation, skin peeling, urticaria, dermatitis, rash.
From the nervous system.
Frequency unknown: paresthesia.
General disorders and administration site conditions.
Common: peripheral edema.
Frequency unknown: pain.
Expiration date
3 years.
After the first opening of the tube, the medicine is suitable for use for 1 year.
Storage conditions
The medicine does not require any special storage conditions. Keep out of the reach of children.
Packaging
30 g of cream in a tube, 1 tube in a cardboard pack.
Vacation category
According to the recipe.
Producer
Laboratorios Basi – Industria Farmaceutica, SA / Laboratorios Basi – Industria Farmaceutica, SA
Location of the manufacturer and address of its place of business
Industrial Park Manuel Lourenco Ferreira, buildings 8, 15 and 16, Mortagua, 3450-232, Portugal / Parque Industrial Manuel Lourenco Ferreira, Lotes 8, 15 e 16, Mortagua, 3450-232, Portugal.
Applicant
CJSC "Farmlyga" / UAB "Farmlyga".
Applicant's location
Antakalnio g. 48A-304, Vilnius, Republic of Lithuania.
