Medicinal Products

AMOROLFINE SANDOZ 5%

Generic drug from Loceryl
Therapeutic class: Dermatology
active ingredients: Amorolfine
laboratory: Sandoz

Medicated nails nail polish
bottle of 250 ml
All forms

Indication

Treatment of moderate distal and lateral subungual onychomycosis, caused by dermatophytes, yeasts or molds, affecting no more than two fingernails in adults.

Dosage AMOROLFINE SANDOZ 5% Medicated Nail Polish 250 ml bottle

Treatment of moderate distal and lateral subungual onychomycosis, caused by dermatophytes, yeasts or molds, affecting no more than two fingernails in adults.

Against indications

Hypersensitivity to the active substance or to any of the excipients listed under Composition .

Adverse effects Amorolfine Sandoz

Undesirable effects are rare.

Ungular anomalies (eg discolouration of nail color, brittle nail, fragile nail) have been reported. However, these reactions can be linked directly to onychomycosis.

The undesirable effects presented below are classified by system organ and in order of frequency. Frequency classification uses the following convention: very common effects (≥1 / 10), frequent ((≥1 / 100; <1/10), not very frequent ((≥1 / 1000, <1/100), rare ((≥1 / 10 000, <1/1 000), very rare (<1 / 10, 000), undetermined frequency (can not be estimated on the basis of available data)

Class of organ systems

FrÚquence

Undesirable effects

Skin and subcutaneous tissue disorders

Rare (≥1 / 10, 000,

<1/1000)

Ungusting anomalies of nail polish (dyschromias), fragile, brittle nails (onychorrhexis)

Very rare

(<1 / 10, 000)

Sensation of skin burns

Indeterminate Frequency

Erythema, pruritus, contact dermatitis, urticaria, blister

Declaration of suspected undesirable effects

The declaration of undesirable effects suspected after authorization of the drug is important. It allows continuous monitoring of the beneficial / risk ratio of the drug. Healthcare professionals declare any suspected adverse effects via the national system of declaration: National Agency for the Safety of Medicines and Health Products (ANSM) and the Network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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