CREMA 20G 0.25%

ONILAQARE 0.25% CREMA

active ingredients

100 g 0.25% cream contain: active ingredient: amorolfina hydrochloride 278.8 mg equal to amorolfina base 250 mg. Excipients with known effects: stearilic alcohol,

Excellent

Polyethyleneglycol 40 stearate, steariric alcohol, liquid paraffin, white vaseline, carboxypolymethylene, sodium hydroxide, sodium edetate, 2-phenoxethanol, purified water.

Therapeutic indications

Dermatomycosis caused by dermatophytes: Tinea pedis (foot of athlete), Tinea cruris, Tinea inguinalis, Tinea corporis, Tinea manuum. Skin cancer, Pityriasis versicolor.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1

Population

Apply once a day (in the evening) to the affected skin area. Treatment must be continued without interruption until complete healing, then continuing for several days. The duration of treatment depends on the fungus species and the location of the infection. In general the treatment should be protracted for at least two or three weeks. For mycosis on the feet, therapies of six weeks and more may be necessary. Onilaqare 0.25% cream is colorless and, after absorption or after drying, does not stain.

Conservation

Store at temperature

Warnings

Since clinical data are lacking, the use of Onilaqare 0.25% cream is not recommended, in children, and especially in infants. This medicine contains stearilic alcohol that can cause local skin reactions (e.g. contact dermatitis). After use of this medicine, a systemic or local allergic reaction may occur. In this case, stop the use of the medicine immediately and consult a medico.Rimuovere carefully the medicine during skin detersion. The medicinal product should not be reapplied.

Interactions

Interaction studies have not been carried out

Effects

The adverse reactions shown are listed in the following table for Classification for systems and organs and frequency. The frequency is defined as follows: very common (≥ 1/10); common (≥1/100, Classification for systems and organs according to Medra Frequency Reaction Immune system disorders Notable Hypersensitivity (allergic reaction (system)* Pathologies of skin and subcutaneous tissue Rare (≥ 1/10.000, Skin irritation, erythema, itching, skin burning sensation Very rare ( Contact dermatitis* * Post-marketing experiences 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.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

No known overdose symptoms following the topical application of amorolfina cream 0.25%. In case of accidental ingestion, if necessary, all appropriate measures should be taken to treat symptoms.

Adequate clinical data concerning the use of amorolfina during pregnancy and/or breastfeeding are not available. Animal studies showed reproductive toxicity (see paragraph 5.3). The potential risk in man is not known. Therefore the use of Onilaqare 0.25% cream should be avoided during pregnancy or lactation. Breeding women must avoid applying cream on the breast.

Source: Farmadati