MICLAST POLV CUT FL 30G 1%

MICLAST

active ingredients

Cream: A gram of cream contains 10 mg of cyclopirox olamine. Excipients with known effects: - cetilic alcohol (57.50 mg/g), - stearilic alcohol (57.50 mg/g) - benzilic alcohol (10 mg/g) Skin powder: A gram of skin powder contains 10 mg of cyclopirox olamine. Skin solution: A ml of skin solution contains 10 mg of cyclopirox olamine. For the full list of excipients, see paragraph 6.1.

Excellent

Cream: octyldodecanol, light liquid paraffin, stearilic alcohol, cetilic alcohol, mixed alcohol, polysorbate 60, stearate sorbitan, benzilic alcohol, lactic acid, purified water. Skin powder: anidra colloidal silica, pregelatinized corn starch. Skin solution: macrogol 400, isopropyl alcohol, purified water.

Therapeutic indications

Skin mycosis supported by sensitive mushrooms.

Contraindications

Hypersensitivity to olamin cyclopyrox or any of the excipients listed in paragraph 6.1. Powder should not be applied on open wounds.

Population

The different preparations allow the doctor to adopt the one most suitable for the individual case. Unless different medical prescription, posology is usually the following:Cream: apply 2 or 3 times a day on the skin lesions and let the preparation dry. Repeat the treatment until the skin lesions disappear (typically 2 weeks); to avoid relapses it is recommended to continue for 1-2 weeks. The cream is particularly suitable for glabrous and limited extension surfaces. Skin powder: sprinkle the affected areas 1-2 times a day and repeat the treatment until the skin lesions disappear; to avoid relapses it is recommended to continue for 1-2 weeks. It is recommended to use powder for prophylactic purposes and for disinfection of socks and shoes. Skin solution: apply 2-3 times a day, frying slightly and repeat the treatment until the disappearance of the skin lesions (typically 2 weeks); to avoid relapses it is recommended to continue for 1-2 weeks.

Conservation

MICLAST 1% skin powder: Store at temperature not exceeding 30°C. MICLAST 1% cream: Store at temperature not exceeding 30 ° C. MICLAST 1% cutaneous solution: no particular condition of conservation.

Warnings

Cream, skin solution and skin powder Avoid contact with eyes. The xolamine cyclopyro should be used with caution and under the direct control of the doctor: - in case of concomitant systemic antifungal treatment; - in subjects with anamnesi of immunosuppression; - in patients with a compromised immune system, such as those subjected to transplantation and those with HIV infection; - in diabetic subjects. The use, especially if prolonged, of products for topical use, can cause sensitization phenomena. In this case it is necessary to stop the treatment and take appropriate therapeutic measures. Hygienic measures recommended by the doctor must be strictly observed during treatment. In case of candidiasis, the use of acid soap is not recommended (acid pH promotes Candida proliferation). Cream Avoid contact of Miclast 1% cream with mucous membranes. Do not apply Miclast 1% cream on open wounds. Important information about some excipients: Cream: Miclast 1% cream contains: - cetilic alcohol and stearilic alcohol that can cause localized skin reactions (e.g. contact dermatitis) - Benzyl alcohol that can cause allergic reactions and due to topical use may cause mild local irritation.

Interactions

Interaction studies have not been carried out.

Effects

Cream and skin solution Summary table of adverse reactions The table below shows the adverse reactions according to the MedDRA Classification for Systems and Organs. The frequencies were defined according to the following convention: Very common (≥ 1/10); common (≥ 1/100,

Classification for systems and organs FrequencyUndesirable effectsImmune system disorders Not commonHypersensitivityPathologies of skin and subcutaneous tissue TownFeeling of skin burningFrequency not knownContact dermatitis, Eczema **Systemic pathologies and conditions for administration TownTransitional aggravation of the Eritema condition at the application site [Bleep] Prurito to the application site [Bleep]Not commonVesicles to the application site*

* requires termination of treatment ** They were reported during marketing. [Bleep] does not require treatment interruption Although no systemic effect has been reported, this possibility must be taken into account in patients subjected to prolonged treatment on vast surfaces, on skin, on mucosa or under occlusive bandage. Skin powder Summary table of adverse reactions The table below shows adverse reactions according to the MedDRA Classification for Systems and Organs. The frequencies were defined according to the following convention: Very common (≥ 1/10); common (≥ 1/100,

Classification for systems and organs FrequencyUndesirable effectsPathologies of skin and subcutaneous tissue Frequency not knownContact dermatitis, EczemaSystemic pathologies and conditions for administration Frequency not knownHypersensitivity to the application site Hypoesthesia to the application site Irritation to the application site Eritema to the application site Prurito to the application site

All these side effects were reported during the marketing. 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No known side effects.

Cream and skin solution

Pregnancy

There is no data or you have a limited number of data (less than 300 data on pregnancy) resulting from the use of cyclopirox olamina in pregnant women. Animal studies indicate no direct or indirect harmful effects than reproductive toxicity after oral, topical or subcutaneous administration of cyclopyrox olamine (see paragraph 5.3). As a precautionary measure, it is preferable to avoid the use of Miclast 1% cream and skin solution during pregnancy.

Food

There is insufficient information on excretion in breast milk of olamine cyclopyrox and its potential metabolites. You cannot exclude a risk for infants/ infants. Miclast 1% cream and skin solution should not be used during breastfeeding. Skin powder

Pregnancy

Effects are not expected during pregnancy, since systemic exposure to olamine cyclopyrox following the application is negligible. Miclast 1% cutaneous powder can be used during pregnancy.

Food

There are no effects on breast-milk breast-milk infants, since systemic exposure to olamine cyclopirox is negligible. Miclast 1% cutaneous powder can be used during lactation.

Fertility

Effects on male and female fertility after oral administration of cyclopirox olamin in dosage of up to 5 mg/kg/die have not been shown in experimental rat studies.

Source: Farmadati