Package leaflet: Information for the user

TIOCONAZOLE IPSO PHARMA 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, contact 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 notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What TIOCONAZOLO IPSO PHARMA is and what it is used for

TIOCONAZOLO IPSO PHARMA 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 any improvement or if you notice worsening of symptoms after a short period of treatment.

2. What you need to know before using TIOCONAZOLE IPSO PHARMA

Do not use TIOCONAZOLE IPSO PHARMA

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 IPSO PHARMA.
TIOCONAZOLE IPSO PHARMA may cause allergic reactions (sensitization phenomena),
especially if used for prolonged periods.
Children and adolescents
There are no data available on the safety and efficacy of TIOCONAZOLE IPSO PHARMA in
children and adolescents.
Other medicines and TIOCONAZOLE IPSO PHARMA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
No interactions of TIOCONAZOLE IPSO PHARMA with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
Do not use TIOCONAZOLE IPSO PHARMA 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
This medicine has no known effect on the ability to drive and use machinery.

3. How to use TIOCONAZOLO IPSO PHARMA

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 TIOCONAZOLO IPSO PHARMA 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 TIOCONAZOLO IPSO PHARMA 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 TIOCONAZOLO IPSO PHARMA than you should
Cases of overdose have not been reported.
In case of accidental ingestion/ingestion of TIOCONAZOLO IPSO PHARMA, 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 gets them.
Very rare side effects (may affect up to 1 in 10,000 patients):

Mild and transient local skin irritation.

Stop treatment and contact 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 IPSO PHARMA

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 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. Pack contents and other information

What TIOCONAZOLE IPSO PHARMA contains

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

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