MICOTEF CREAM CUT 30G 2%

MICOTEF 2% CREMA CUTANEA

active ingredients

100 g skin cream contain: Active ingredient: miconazole............................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................. methyl p–hydroxybenzoate, propile p–hydroxybenzoate. For the full list of excipients, see paragraph 6.1.

Excellent

Lecithin, cholesterol, propylene glycol, butylhydroxytoluene, methylp–hydroxybenzoate, p–hydroxybenzoate propile, chloride sodium, sodium hydroxide, sodium edetate, citric acid monohydrate, ipromellose, purified water.

Therapeutic indications

Skin and nail infections caused by dermatophytes and Candida. For its antibacterial activity on Grams–positive, MICOTEF Cutanea cream can be used for treating mycosis with superinfections supported by such microorganisms.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients.

Population

1. INFO CUTANEE Apply on the lesion 1 cm of cream (or more depending on the lesion extension) 1–2 times a day, then smear with your fingers. 2. INFECT UNGUEAL Cut your nails as short as possible. Apply some cream 1–2 times a day on the infected nail, then smear with your fingers; cover the nail with a non-perforated occlusive bandage. Continue the treatment uninterruptedly, even after the fall of the infected nail (mostly after 2–3 weeks), until its complete regrowth and definitive healing of injuries (usually after 2 months or more).

Conservation

This medicine does not require any special precaution for conservation.

Warnings

Preparations for topical use, especially when used for prolonged treatment, can give rise to awareness phenomena. If this happens, it is necessary to stop treatment and establish suitable therapy. Avoid contact with eyes. Carefully wash your hands after each application, unless the treatment interests the same hands. It is advisable to apply the following hygienic measures to avoid sources of infections or reinfections: • keep towels and underwear for personal use in order to avoid the infection of other people; • regularly change garments that come into contact with the infected area to avoid re-infecting; • disinfection of socks and shoes. MICOTEF Cutanea cream does not spot skin or clothing. This medicine contains methyl p–hydroxybenzoate, propile p–hydroxybenzoate as excipients, so it can cause allergic reactions (also delayed)

Interactions

It is known that systemic miconazole inhibits CYP3A4/2 C9. Since, following local application, the presence of the drug in the blood is limited (see paragraph 5.2 Pharmactical Properties) the interactions considered relevant from a clinical point of view are very rare. However, in patients treated with oral anticoagulants, such as warfarin, care should be taken and monitor anticoagulant action. The efficacy and side effects of other drugs (e.g. oral and phenytoin hypoglycemizers), if administered at the same time to miconazole, may be increased and, therefore, special caution is required.

Effects

It is possible to follow the topical use that occasionally occur phenomena of local sensitization or irritation, which impose the interruption of treatment. The use, especially if prolonged, of the product can give rise to phenomena of sensitization. In this case it is necessary to stop treatment and establish suitable therapy. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

In general, excessive use of MICOTEF Cream can cause skin irritation that generally disappears with the interruption of therapy. In the case of accidental ingestion of high quantities of MICOTEF Cream to adopt, if necessary, an appropriate gastric emptying method. There is no specific antidote.

MICOTEF Cream, applied by topical means, is minimally absorbed in the systemic circle. However, although there is no evidence of embryotoxicity or teratogenicity in animals, the potential risks of prescription MICOTEF Cream during pregnancy should be evaluated compared to potential therapeutic benefits. Food Miconazole, applied by topical means, is minimally absorbed in the systemic circle and is not known if the miconazole is excreted in human milk. We recommend caution in using topical products containing miconazole during breastfeeding.

Source: Farmadati