Micotef 2% Miconazole Skin Cream 30g

NAME
MICOTEF 2% SKIN CREAM

PHARMACOTHERAPEUTIC CATEGORY
Topical antifungals.

ACTIVE PRINCIPLES
Miconazole.

EXCIPIENTS
Lecithin, cholesterol, propylene glycol, butylhydroxytoluene, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sodium chloride, sodium hydroxide, sodium edetate, citric acid monohydrate, hypromellose, purified water.

INDICATIONS
Skin and nail infections caused by dermatophytes and Candida; due to its antibacterial activity on Gram-positive, the drug can be used for the treatment of mycoses with superinfections sustained by these microorganisms.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients.

DOSAGE
Skin infections: apply 1 cm of cream to the lesion (or more depending on the extent of the lesion) 1-2 times a day, then spread with your fingers. Nail infections: cut infected nails as short as possible. Apply a little cream 1-2 times a day on the infected nail, then spread with your fingers; cover the nail with a non-perforated occlusive dressing. Continue the treatment without interruption, even after the fall of the infected nail (mostly after 2-3 weeks), until its complete regrowth and the definitive healing of the lesions (usually after 2 months or more).

STORAGE
This medicinal product does not require any special storage conditions.

WARNINGS
Preparations for topical use, especially if used for prolonged treatments, can give rise to sensitization phenomena. If this happens, it is necessary to interrupt the treatment and institute an appropriate therapy. Avoid contact with eyes. Wash hands carefully after each application, unless the treatment affects the hands themselves. It is advisable to apply the following hygienic measures to avoid the sources of infections or reinfections: keep towels and underwear for personal use in order to avoid the infection of other people; regularly change clothing that comes into contact with the infected area to avoid re-infection; disinfection of socks and shoes. The medicine does not stain skin or clothing. This medicine contains methyl p-hydroxybenzoate, propyl p-hydroxybenzoate as excipients, therefore it can cause allergic reactions (even delayed).

INTERACTIONS
Systemically administered miconazole is known to inhibit CYP3A4 / 2C9. Since, following local application, the presence of the drug in the blood is limited, interactions deemed relevant from a clinical point of view are very rare. However, in patients treated with oral anticoagulants, such as warfarin, caution and anticoagulant action should be monitored. The efficacy and undesirable effects of other drugs (e.g. oral hypoglycemic agents and phenytoin), when administered concomitantly with miconazole, may be increased and special caution is therefore required.

SIDE EFFECTS
It is possible, following topical use, that local sensitization or irritation phenomena occasionally occur, requiring the interruption of treatment. The use, especially if prolonged, of the product can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute a suitable therapy. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
The drug, applied topically, is minimally absorbed into the systemic circulation. However, although there is no evidence of embryotoxicity or teratogenicity in animals, the potential risks of prescribing the drug during pregnancy must be weighed against the potential therapeutic benefits. Miconazole, applied topically, is minimally absorbed into the systemic circulation and it is not known whether miconazole is excreted in human milk. Caution is advised in the use of topical products containing miconazole during breastfeeding.