AXOPIROX 80 mg /G Varnish

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Axopirox, 80 mg/g, medicinal nail lacquer
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Axopirox and what is it used for
4. Important information before using Axopirox
   1. When not to use Axopirox
   2. Warnings and precautions
   3. Children and adolescents
   4. Axopirox and other medicines
   5. Axopirox with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
5. How to use Axopirox
   1. Using more than the recommended dose of Axopirox
   2. Missing a dose of Axopirox
   3. Stopping the use of Axopirox
6. Possible side effects
   1. Reporting side effects
7. How to store Axopirox
8. Package contents and other information
   1. What Axopirox contains
   2. What Axopirox looks like and what the package contains
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicine is authorized for sale in the member states of the European Economic Area under the following names:

Leaflet attached to the packaging: patient information

Axopirox, 80 mg/g, medicinal nail lacquer

Ciclopirox

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 4 weeks, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Axopirox and what is it used for
• 2. Important information before using Axopirox
• 3. How to use Axopirox
• 4. Possible side effects
• 5. How to store Axopirox
• 6. Package contents and other information

1. What is Axopirox and what is it used for

Axopirox is a medicinal nail lacquer. It contains the active substance ciclopirox, which belongs to the group of antifungal medicines. Ciclopirox penetrates the nail plate and has a fungicidal effect on all major microorganisms that cause nail fungus. Axopirox is indicated for the treatment of fungal nail infections (onychomycosis).

2. Important information before using Axopirox

When not to use Axopirox

• if the patient is allergic to ciclopirox or any of the other ingredients of this medicine (listed in section 6);
• in children and adolescents, due to insufficient experience in this age group;
• during pregnancy and breastfeeding.

Warnings and precautions

Before starting to use Axopirox, the patient should discuss it with their doctor or pharmacist. Medicines used locally, especially for a long time, may cause allergic reactions or side effects. In such cases, the use of Axopirox should be stopped and appropriate treatment should be started. Contact between the medicine and the eyes or mucous membranes should be avoided. During treatment, nail polish or other cosmetic nail products should not be used.

Children and adolescents

Due to the lack of clinical experience, the medicine should not be used in children and adolescents.

Axopirox and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Axopirox with food, drink, and alcohol

This is not applicable.

Pregnancy, breastfeeding, and fertility

Axopirox is generally contraindicated during pregnancy and breastfeeding. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

Axopirox has no effect on the ability to drive or use machines.

3. How to use Axopirox

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The medicine is intended for local use on the nails. If the doctor does not recommend otherwise, a thin layer of Axopirox should be applied to the affected nail once a day. Before the first application of Axopirox, as much of the affected nail as possible should be removed, for example with nail clippers, and as much of the thickened layer as possible should be removed with a single-use nail file (available for purchase, e.g., in a pharmacy). Throughout the treatment period, the layer of lacquer should be removed once a week with a cotton swab soaked in alcohol (available for purchase, e.g., in a pharmacy). At the same time, as much of the thickened layer as possible should be removed from the nail plate, always using a single-use nail file. If the layer of lacquer on the nail is damaged between applications, it is sufficient to reapply Axopirox to the areas where the lacquer has come off. The duration of treatment depends on the severity of the fungal infection. The medicine should not be used for more than 6 months. If there is no improvement or the condition worsens after 4 weeks of treatment, the patient should consult their doctor. The doctor will decide whether further treatment is necessary. After each use of the lacquer, the bottle should be tightly closed to prevent the solution from drying out. Contact between the lacquer and the neck of the bottle should be avoided to prevent the cap from sticking.

Using more than the recommended dose of Axopirox

There have been no reports of overdose.

Missing a dose of Axopirox

A double dose should not be used to make up for a missed dose. Treatment should be continued as directed by the doctor or as described in section 3 ("How to use Axopirox").

Stopping the use of Axopirox

If the use of Axopirox is stopped before the nail plates are clean or their appearance has significantly improved and healthy nails have not grown out, it may turn out that the fungi have not been destroyed. In such a case, the condition of the nails may worsen again. If there are any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Axopirox can cause side effects, although not everybody gets them. The frequency of side effects is defined as follows: Very common: affects more than 1 in 10 patients. Common: affects 1 to 10 in 100 patients. Uncommon: affects 1 to 10 in 1,000 patients. Rare: affects 1 to 10 in 10,000 patients. Very rare: affects less than 1 in 10,000 patients. Not known: frequency cannot be estimated from the available data. In rare cases, contact between the medicine and the skin surrounding the nail may cause allergic contact dermatitis. Very rarely, redness and flaking of the skin have been observed.

Reporting side effects

If side effects occur, including any not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Axopirox

The medicine should be stored out of sight and reach of children. There are no special precautions for storage. Shelf life after first opening the bottle: 6 months. The bottle should be kept tightly closed to prevent the contents from evaporating. The medicine should not be used after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the specified month. The medicine is flammable. It should be kept away from heat sources and open flames. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Axopirox contains

The active substance of Axopirox is ciclopirox. 1 gram of lacquer contains 80 mg of ciclopirox. The other ingredients of the medicine are: ethyl acetate, isopropyl alcohol, methoxyethylene polymer with 2-butenedioic acid monobutyl ester (1:1).

What Axopirox looks like and what the package contains

Axopirox is a colorless, transparent to light yellow solution. The package contains a brown glass bottle with a cap equipped with a brush, in a cardboard box. Package size: 3.3 ml (3 g) or 6.6 ml (6 g). The package does not contain single-use nail files or cotton swabs soaked in alcohol.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma Sp. z o.o. ul. Baletowa 30 02-867 Warsaw

Manufacturer

Doppel Farmaceutici S.R.L. Via Martiri delle Foibe, 1 29016 Cortemaggiore (PC) Italy Qualimetrix S.A. Mesogeion Avenue 579, Agia Paraskevi 15343 Athens Greece

This medicine is authorized for sale in the member states of the European Economic Area under the following names:

Poland: Axopirox 8% w/w medicinal nail lacquer Slovakia: Ciclopirox Aristo 80mg/g liečivý lak na nechty Spain: Ciclonic 80mg/g barniz de uñas medicamentoso Hungary: Kitolak 8% gyógyszeres körömlakk Germany: Ciclopirox Dexcel 80mg/g wirkstoffhaltiger Nagellack Estonia: Ciclopirox Auxilia Date of last revision of the leaflet:October 2024