Lyrecol 5 %

LYRECOL 5 % medicated nail lacquer is indicated for the treatment of onychomycoses caused by dermatophytes, yeasts and moulds. (Limited experience is available in cases where the nail matrix was involved).

Posology

Onychomycoses

LYRECOL 5 % medicated nail lacquer should be applied to affected finger or toenails once or twice weekly.

Special populations

Elderly

There are no specific dosage recommendations for use in elderly patients.

Paediatric population

Owing to a lack of clinical experience to date, children should not be treated with LYRECOL 5 % medicated nail lacquer.

Method of administration

The patient should apply LYRECOL 5 % medicated nail lacquer as follows:

Step 1: Before the first application of LYRECOL 5 %, it is essential that the affected areas of nail (particularly the nail surfaces) should be filed down as thoroughly as possible using a disposable nail file supplied. The surface of the nail should then be cleansed and degreased using an alcohol-soaked swab (as supplied). Before repeating application of LYRECOL 5 %, the affected nails should be filed down again as required, and must at all times first be cleansed with an alcohol soaked swab to remove any remaining lacquer. Caution: Nail files used for affected nails must not be used for healthy nails.

Step 2: With the applicator supplied, apply the nail lacquer to the entire surface of the affected nails and allow it to dry for approximately 3-5 minutes. For each nail to be treated, dip the applicator into the nail lacquer without wiping off any of the lacquer on the bottle neck. After use, clean the applicator with the same pre-soaked swab used before for nail cleansing. Keep the bottle tightly closed.

Step 3: When working with organic solvents (thinners, white spirit, etc.) wear impermeable gloves in order to protect the LYRECOL 5 % on the nails. Treatment should be continued without interruption until the nail is regenerated and the affected areas are finally cured. The required duration of treatment depends essentially on intensity and localisation of the infection and on growth rate of the nails, but in general, it is six months for fingernails and nine to twelve months for toenails. A review of the treatment is recommended at intervals of approximately 3 months. Co-existent tinea pedis should be treated with an appropriate antimycotic cream.

LYRECOL 5 % medicated nail lacquer is contraindicated in:

• Patients with known hypersensitivity to amorolfine or to any of the excipients (see section 6.1);

Use of cosmetic lacquers or artificial nails should be avoided during treatment with LYRECOL 5 % medicated nail lacquer. After applying LYRECOL 5 % medicated nail lacquer, an interval of at least 10 min should be respected before application of any cosmetic nail lacquer. Before repeat application of LYRECOL 5 % medicated nail lacquer, the cosmetic nail lacquer should be removed carefully. LYRECOL 5 % medicated nail lacquer should not be applied on the skin around the nail. Avoid contact of the lacquer with eyes, ears and mucous membranes. When organic solvents are used impermeable gloves shall be used otherwise LYRECOL 5 % medicated nail lacquer will be removed. A systemic or local allergic reaction could possibly occur after use of LYRECOL 5 % medicated nail lacquer. If this happens, LYRECOL 5 % medicated nail lacquer should be stopped immediately, and medical advice should be sought. Remove LYRECOL 5 % medicated nail lacquer carefully by using a nail remover solution. LYRECOL 5 % medicated nail lacquer should not be reapplied.

Paediatric population

Owing to the lack of clinical experience available to date, children should not be treated with LYRECOL 5 % medicated nail lacquer.

No interaction studies have been performed. Use of artificial nails should be avoided during treatment with LYRECOL 5 % medicated nail lacquer.

Pregnancy

No experience exists with pregnancy and the use of LYRECOL 5 % medicated nail lacquer should therefore be avoided during pregnancy.

Breastfeeding

No experience exists with nursing and the use of LYRECOL 5 % medicated nail lacquer should therefore be avoided during breastfeeding.

Fertility

No experience exists with fertility and the use of LYRECOL 5 % medicated nail lacquer should therefore be avoided during pregnancy.

The effect of LYRECOL 5 % medicated nail lacquer on the ability to drive and use of machines is unknown.

a. Tabulated summary of adverse reactions

System Organ Class Frequency Undesirable effect

Immune system disorders Frequency unknown Hypersensitivity* (systemic allergic reaction)

Skin and subcutaneous tissue disorders Less frequent Skin burning sensation. Nail disorder, nail discolouration, broken nails, brittle nails. However, these reactions can also be linked to the onychomycosis itself. Frequency unknown Erythema*, pruritus*, urticaria*, blister*, contact dermatitis*.

* Post-marketing experience

b. Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

No systemic signs of overdose are expected following topical application of LYRECOL 5 % nail lacquer. In case of accidental oral ingestion, appropriate symptomatic measures should be taken if needed.