Patient Information Leaflet: Instructions for Use

ONISID 28% Medicinal Nail Lacquer

Tioconazole
Please read this leaflet carefully before using this medicine because it contains important information for you.

Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.
Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not see any improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

What ONISID is and what it is used for
What you need to know before using ONISID
How to use ONISID
Possible side effects
How to store ONISID
Contents of the pack and other information

1. What ONISID is and what it is used for

ONISID contains the active substance tioconazole, which belongs to a group of antifungal medicines that act against fungi.
This medicine is indicated for the treatment of nail infections (onychomycosis) caused by dermatophytes and yeasts.
This medicine is also effective against bacteria and is therefore indicated for nail infections caused by both bacteria and fungi.

Consult your doctor if you do not notice improvement or if you observe worsening of symptoms after a short period of treatment.

2. What you need to know before using ONISID

Do not use ONISID

if you are allergic to tioconazole or to any of the other ingredients of this medicine (listed in section 6);
if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using ONISID.
ONISID may cause allergic reactions (sensitization phenomena), especially if used for long periods of time.

Children and adolescents
There are no data available on the safety and efficacy of ONISID in children and adolescents.

Other medicines and ONISID
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No interactions of ONISID with other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use ONISID if you are pregnant or breastfeeding, since, although absorption of the medicine into the blood after application to the nails is negligible, treatment may last for many months.

Driving and using machines
No effects of this medicine on the ability to drive and use machines are known.

3. How to use ONISID

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply ONISID to the infected nail and the surrounding area (periungual region) twice daily, in the morning and evening, using the brush provided in the cap.
The solvent contained in ONISID dries within 5 minutes, leaving a thin, transparent, oily film.
Even if this film is accidentally removed, do not worry, as this does not reduce the effectiveness of the medicine and therefore you do not need to reapply it.
Do not use an occlusive dressing.
Warning: Do not exceed the recommended doses without medical advice.
The duration of treatment required to achieve healing varies depending on your condition, the type of infection, and the extent of the affected area.
Generally, treatment may last on average up to 6 months, but may be extended up to one year.
If you use more ONISID than you should
Cases of overdose have not been reported.
In case of accidental ingestion/ingestion of ONISID, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Very rare side effects (may affect up to 1 in 10,000 patients):

Mild and transient local skin irritation.

Stop treatment and consult your doctor if you experience allergic reactions. Your doctor will advise you on appropriate therapy.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ONISID

Keep this medicine out of the sight and reach of children.
There are no special storage conditions for this medicine.
Do not use this medicine after the expiry date stated on the pack after “Exp”. The expiry date refers to the last day of that month.
This medicine can be used for up to 3 months after first opening.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ONISID contains

The active substance is thiocanazole. 100 g of medicated nail enamel contain 28 g of thiocanazole.
The other components are: undecylenic acid and ethyl acetate.

Description of the appearance of ONISID and contents of the pack
The pack contains a 12 ml glass bottle with screw cap and a brush.
Marketing Authorization Holder
Epifarma S.r.l. – Via San Rocco, 6 – 85033 Episcopia (PZ)
Manufacturer
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC)