Medicinal Products

AMOROLFINE SANDOZ ADVICE 5%

Generic drug from Loceryl
Therapeutic Class: Diagnostic Products or Other Therapeutic Products
active ingredients: Amorolfine
laboratory: Sandoz

Medicated nail polish
bottle of 250 ml
All forms

Indication

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

Dosage AMOROLFINE SANDOZ CONSEIL 5% medicated nail varnish 250 ml bottle

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

Against indications

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

Adverse effects Amorolfine Sandoz Conseil

Adverse effects are rare.

Ungular abnormalities (eg fading of nail color, brittle nail, fragile nail) have been reported. However, these reactions can be directly related to onychomycosis.

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

Class of organ systems

Frà © quence

Inadmissible effects

Skin and subcutaneous tissue disorders

Rare (≥1 / 10, 000,

<1/1000)

Ungular abnormalities, nail discolouration (dyschromias), fragile nails, brittle (onychorrhexis)

Very rare

(<1 / 10, 000)

Sensation of skin burns

Unlimited frequency (can not be estimated based on available data)

Erythema, pruritus, contact dermatitis, urticaria, blister

Declaration of suspected untoward effects

The declaration of suspected adverse effects after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals disclose any suspected adverse effects via the national reporting system: National Agency for Drug and Health Product Safety (ANSM) and network Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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