SCHOLLMED ONICOMCOD 2,5ML 5%

SCHOLLMED ONICOMIC

active ingredients

1 ml contains 55.74 mg of amorolphine hydrochloride (equivalent to 50 mg of amorolphine). Excipients with known effects: Alcohol (ethanol) 55.4% p/p For the full list of excipients, see paragraph 6.1.

Excellent

Ammonium methacrylate copolymer type A (Eudragit RL 100), Triacetin, Butile acetate, Acetate ethyl, Ethanol anidro.

Therapeutic indications

Treatment of cases of a slight entity of distal and lateral subungueal Onicomycosis, caused by dermatophytes, yeasts and moulds that involve no more than two nails in adult subjects.

Contraindications

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

Population

Population Apply the product on the nails of your feet or your hands, once a week. Special popularity Seniors There are no specific recommendations on the dosage for use in elderly patients. Pediatric population Schollmed Onicomicosi is not recommended for use in children and adolescents under the age of 18 due to lack of data on safety or effectiveness. Method of administration 1. Before starting the first treatment of Schollmed Onicomicosi, it is essential that the affected areas of the nail (particularly nail surfaces) are lied as accurately as possible using the supplied nail file. The surface of the nail must therefore be cleaned and degreased using a cleansing tampon filled with alcohol. Before repeating the application of Schollmed Onicomicosi the affected nails must be lied as described above and then cleaned with a clean tampon, to remove any layers of residual enamel. Attention: the flaws used for the affected nails should not be used for healthy nails. 2. With one of the reusable brushes provided, apply the nail polish on the entire surface of the affected nails. Allow the enamel to dry for 3-5 minutes. After use, clean the spatula with the same detergent pad used, first, for cleaning nails. Keep the bottle closed. For each nail to be treated, immerse the spatula in the enamel without rubbing it on the edge of the bottle. The duration of the treatment depends essentially on the intensity and location of the infection. In general, six months of therapy (hand nails) and nine to twelve months (foot nails). A treatment control is recommended at intervals of about three months.

Conservation

Schollmed Onicomicosi must be kept at a temperature below 30°C. Keep the bottle away from heat sources. Keep the bottle vertically and well closed after use.

Warnings

Avoid any contact of the enamel with eyes, ears and mucosa. Patients with predisposition to fungal nail infections should contact the doctor. These conditions include peripheral circulatory disorders, diabetes mellitus and immunosuppression. Patients with nail dystrophy and destroyed ointment plate should contact the doctor. In case of use of organic solvents (diluents, aquaragia, etc.) it is good to wear waterproof gloves to protect the layer of amorolphine applied on the nails. During treatment with amorolphine should not be used cosmetic enamels or artificial nails. After using the product, a systemic or local allergic reaction could potentially occur. If this happens, the use of the product must be interrupted immediately and the advice of the doctor must be requested. This medicine contains alcohol (ethanol) 55.4% p/p. It can cause burning sensation on damaged skin. Remove the product carefully using an enamel solvent. The product should not be reapplied.

Interactions

Interaction studies have not been carried out. The use of artificial cosmetic enamels or nails must be avoided during treatment.

Effects

Adverse reactions to the drug are rare. Nail pathologies may occur (alteration of the color of the nails, broken nails, nail fragility). These reactions can also be associated with the same person.

Classification for systems and organs	Frequency	Reaction
Immune system disorders	Frequency not known*	Hypersensitivity (systematic allergic reaction) *
Pathologies of skin and subcutaneous tissue	Rare (≥1/10.000,	Nail pathologies, alteration of the color of the nails, onicoclasia (broken nails), onicoressi (uncial brotherhood)
	Very rare (	Feeling of skin burning
	Frequency not known	Erythema*, itching*, contact dermatitis*, hives*

*post-marketing experience 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: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

Following the topic administration of amorolfina 5% medicated enamel, systemic overdose reactions are not expected. In case of accidental ingestion, appropriate measures must be taken for symptomatic treatment.

Pregnancy

Few cases of exposure to topical use of amorolfina have been reported in pregnant women during the post-authorization period, so the potential risk is not known. Animal studies have shown reproductive toxicity at high oral doses. Amorolphine should not be used during pregnancy unless it is strictly necessary.

Food

The experience with the use of amorolfina during lactation is limited. It is not known whether amorolfina is excreted in breast milk. Amorolphine should not be used during breastfeeding unless it is strictly necessary.

Source: Farmadati