Package leaflet: Information for the user

TIOCONAZOLE EG 28% medicated nail lacquer

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 you.
Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What TIOCONAZOLE EG is and what it is used for

TIOCONAZOLE EG contains the active substance tioconazolo, 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 also acts 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 notice worsening of symptoms after a short period of treatment.

2. What you need to know before using TIOCONAZOLE EG

Do not use TIOCONAZOLE EG

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 TIOCONAZOLE EG.
TIOCONAZOLE EG may cause allergic reactions (sensitization phenomena), especially when used for long periods.
Children and adolescents
There are no data available regarding the safety and efficacy of TIOCONAZOLE EG in children and adolescents.
Other medicines and TIOCONAZOLE EG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions between TIOCONAZOLE EG and other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Do not use TIOCONAZOLE EG if you are pregnant or breastfeeding, since, although absorption of the medicine into the bloodstream after application to the nails is negligible, the treatment may last for many months.
Driving and using machines
This medicine is not known to affect the ability to drive or use machinery.

3. How to use TIOCONAZOLE EG

Use this medicine exactly as stated in this leaflet or as instructed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply TIOCONAZOLE EG to the infected nail and the surrounding area (periungual) twice
daily, in the morning and evening, using the brush provided in the cap.
The solvent contained in TIOCONAZOLE EG 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 medicinal activity and therefore you do not need to reapply it.
Do not use an occlusive (non-breathable) dressing.
Caution: 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 TIOCONAZOLE EG than you should
No cases of overdose have been reported.
In case of accidental ingestion/ingestion of TIOCONAZOLE EG, inform your doctor immediately or
go to the nearest hospital.
If you have any doubts about how to use 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 people)

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 effects, 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 TIOCONAZOLE EG

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 packaging 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 any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TIOCONAZOLE EG contains

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

Description of the appearance of TIOCONAZOLE EG and contents of the pack
The pack contains a 12 ml glass bottle with a 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)