TIICONAZOLE PHARMEG

Package leaflet: Information for the user

TIOCONAZOLE PHARMEG 28% medicated nail lacquer

Please read all of this leaflet carefully before you start 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 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 notice any improvement or if you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

1. What TIOCONAZOLE PHARMEG is and what it is used for
2. What you need to know before using TIOCONAZOLE PHARMEG
3. How to use TIOCONAZOLE PHARMEG
4. Possible side effects
5. How to store TIOCONAZOLE PHARMEG
6. Contents of the pack and other information

1. What TIOCONAZOLO PHARMEG is and what it is used for

TIOCONAZOLO PHARMEG 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 active against bacteria and is therefore indicated for nail infections caused by both bacteria and fungi.

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

2. What you should know before using TIOCONAZOLE PHARMEG

Do not use TIOCONAZOLE PHARMEG

• 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 PHARMEG.
TIOCONAZOLE PHARMEG may cause allergic reactions (sensitization phenomena),
especially if used for long periods.
Children and adolescents
There are no data available on the safety and efficacy of TIOCONAZOLE PHARMEG in children
and adolescents.
Other medicines and TIOCONAZOLE PHARMEG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
No interactions between TIOCONAZOLE PHARMEG and other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before using this medicine.
Do not use TIOCONAZOLE PHARMEG if you are pregnant or breastfeeding, since,
although absorption of the medicine into the bloodstream 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 or operate machinery are known.

3. How to use TIOCONAZOLO PHARMEG

Use this medicine exactly as stated in this leaflet or according to your doctor’s or pharmacist’s instructions.
If you have any doubts, consult your doctor or pharmacist.
Apply TIOCONAZOLO PHARMEG to the infected nail and the surrounding area (periungual) twice daily, in the morning and evening, using the special brush attached to the cap.
The solvent contained in TIOCONAZOLO PHARMEG 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; therefore, there is no need to reapply.
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 TIOCONAZOLO PHARMEG than you should
No cases of overdose have been reported.
In case of accidental ingestion/ingestion of TIOCONAZOLO PHARMEG, 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 gets 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through 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 PHARMEG

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 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. Package contents and other information

What TIOCONAZOLE PHARMEG contains

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

Description of the appearance of TIOCONAZOLE PHARMEG and contents of the pack
The pack contains a 12 ml glass bottle with screw cap and a brush.
Marketing Authorization Holder
Pharmeg S.r.l. - Via dei Giardini, 34 – 85033 Episcopia (PZ)
Manufacturer
Doppel Farmaceutici S.r.l.– Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC)