Lovacil 0.05 Nail Lacquer
PDF Leaflet Revision Date: 18 March 2025
Clinical Summary
Quick overview from the medicine insert
Indication
Treatment of onychomycoses caused by dermatophytes, yeasts, and moulds.
Dosage (summary)
Apply once or twice weekly; treatment duration is 6 months for fingernails, 9-12 months for toenails.
Special Populations
- Elderly population
- Paediatric population
Pregnancy & Breastfeeding
Avoid use during pregnancy and breastfeeding due to lack of experience.
Contraindications
- Hypersensitivity to amorolfine or excipients
Common side effects
- Hypersensitivity
- Skin burning sensation
- Nail discolouration
- Brittle nails
Counselling Points
- File affected nails before application
- Clean nails with alcohol swab before each use
- Do not use the same nail file for healthy nails
Serious warnings
- Avoid cosmetic lacquers during treatment
- Possible allergic reactions
Important Disclaimer
The Lovacil 0.05 Nail Lacquer professional information leaflet below is the property of Astral Pharma and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications:
Onychomycoses caused by dermatophytes, yeasts and moulds. Only little experience is available in cases where the nail matrix was involved.
4.2 Posology and method of administration:
Nail Lacquer: To be applied to affected finger or toe nails once or twice weekly. The patient should apply the nail lacquer as follows:
- Before the first application of LOVACIL Nail Lacquer, 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 LOVACIL Nail Lacquer, 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.
- 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.
- When working with organic solvents (thinners, white spirit, etc.) wear impermeable gloves in order to protect the LOVACIL Nail Lacquer 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 toe nails. A review of the treatment is recommended at intervals of approximately 3 months. Co-existent tinea pedis should be treated with appropriate antimycotic cream.
Special populations
- Elderly population
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 LOVACIL 5 % nail lacquer.
4.3 Contraindications:
LOVACIL 5% nail lacquer is contraindicated in patients who have shown hypersensitivity to amorolfine or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use:
Use of cosmetic lacquers or artificial nails should be avoided during treatment with LOVACIL Nail Lacquer. After applying LOVACIL nail lacquer, an interval of at least 10 min should be respected before application of any cosmetic nail lacquer. Before repeat application of LOVACIL nail lacquer, the cosmetic nail lacquer should be removed carefully.
LOVACIL 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 LOVACIL nail lacquer will be removed. A systemic or local allergic reaction could possibly occur after use of LOVACIL nail lacquer. If this happens, LOVACIL nail lacquer should be stopped immediately, and medical advice should be sought. Remove LOVACIL nail lacquer carefully by using a nail remover solution. LOVACIL nail lacquer should not be reapplied.
Paediatric population
Owing to the lack of clinical experience available to date, children should not be treated with LOVACIL Nail Lacquer.
4.5 Interaction with other medicines and other forms of Interaction:
No interaction studies have been performed. Use of artificial nails should be avoided during treatment with LOVACIL nail lacquer.
4.6 Fertility, pregnancy and lactation:
Pregnancy
No experience exists with pregnancy and the use of LOVACIL nail lacquer should therefore be avoided during pregnancy.
Breastfeeding
No experience exists with nursing and the use of LOVACIL nail lacquer should therefore be avoided during breastfeeding.
Fertility
No experience exists with fertility and the use of LOVACIL nail lacquer should therefore be avoided during pregnancy.
4.7 Effects on ability to drive or use machines
The effect of LOVACIL nail lacquer on the ability to drive and use of machines is unknown.
4.8 Undesirable effects :
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*. |
Reporting of suspected adverse reactions
Reporting adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the u201cthe Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.
4.9 Overdose :
No systemic signs of overdose are expected following the topical application of LOVACIL Nail Lacquer. Should LOVACIL Nail Lacquer be ingested, treatment should be symptomatic and supportive.
