Axopirox
Poland
Table of Contents
Package leaflet: Information for the user
Axopirox, 80 mg/g, medicinal nail lacquer
Ciclopiroxum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor, pharmacist, or nurse.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
- If there is no improvement after 4 weeks of treatment, or if you feel worse, contact your doctor.
Contents of the leaflet
- What Axopirox is and what it is used for
- Important information before using Axopirox
- How to use Axopirox
- Possible side effects
- How to store Axopirox
- Contents of the pack and other information
1. What Axopirox is and what it is used for
Axopirox is a medicinal nail lacquer intended for application to the nail. It contains the active substance ciclopirox, which belongs to a group of antifungal medicines. Ciclopirox penetrates the nail plate and exerts a fungicidal effect against all major microorganisms causing fungal nail infections.
Axopirox is indicated for the treatment of fungal nail infections (onychomycosis).
2. Important information before using the medicine Axopirox
When not to use Axopirox
- if the patient is allergic to ciclopirox or to 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 treatment with Axopirox, consult a doctor or pharmacist.
Topically applied medicines, especially when used long-term, may cause allergic reactions or adverse effects. In such cases, treatment with Axopirox should be discontinued and appropriate recommended therapy initiated.
Avoid contact of the medicine with eyes and mucous membranes.
During treatment, do not use nail polish or any other cosmetic nail products.
Children and adolescents
Due to lack of clinical experience, Axopirox should not be used in children and adolescents.
Axopirox with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Axopirox with food, drink and alcohol
Not applicable.
Pregnancy, breastfeeding and fertility
Axopirox is generally contraindicated during pregnancy and breastfeeding.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Axopirox has no effect on the ability to drive or operate machinery.
3. How to use Axopirox
This medicine should always be used exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is intended for topical application to the nail.
Unless otherwise advised by your doctor, apply a thin layer of Axopirox medicine once daily to the affected nail.
Before the first application of Axopirox, remove as much as possible of the diseased nail, for example with scissors, and as much as possible of the thickened layer using a disposable nail file (available for purchase, e.g. at a pharmacy or drugstore).
Throughout the entire treatment period, remove the nail lacquer once a week using a cotton swab soaked in alcohol (available for purchase, e.g. at a pharmacy or drugstore). At the same time, remove as much as possible of the thickened layer from the nail bed, always using a disposable nail file.
If the lacquer layer on the nail becomes damaged between applications, simply reapply Axopirox to the areas where the lacquer has come off.
The duration of treatment depends on the severity of the fungal infection. Do not use the medicine for longer than 6 months.
If there is no improvement after 4 weeks of treatment, or if the condition worsens, consult your doctor. Your doctor will decide whether further treatment is necessary.
After each use of the nail lacquer, it is recommended to close the bottle tightly to prevent the solution from drying out.
Avoid contact of the lacquer with the bottle neck to prevent the cap from sticking.
Use of a higher than recommended dose of Axopirox
Cases of overdose have not been reported.
Missed dose of Axopirox
Do not use a double dose to make up for a missed dose.
Continue treatment as directed by your doctor or as explained in section 3 ("How to use Axopirox").
Stopping the use of Axopirox
If you stop using Axopirox before the nail beds are clear or their appearance has significantly improved and healthy nails have not fully regrown, the fungi may not have been completely eradicated. In such a case, the condition of the nails may worsen again.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of adverse reactions 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 of the medicine with the skin adjacent to the nail may cause allergic contact dermatitis. Very rarely, redness and peeling of the skin have been observed.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.
5. How to store the medicine Axopirox
Keep the medicine out of the sight and reach of children.
No special storage instructions are required for this medicine.
Shelf life after first opening the bottle: 6 months.
Keep the bottle tightly closed to prevent evaporation of the contents.
Do not use this medicine after the expiry date stated on the packaging following EXP.
The expiry date refers to the last day of the stated month.
This medicine is flammable. Store away from heat sources and open flames.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Package contents and other information
What Axopirox contains
The active substance is ciclopirox. 1 gram of the nail lacquer contains 80 mg of ciclopirox.
The other ingredients are: ethyl acetate, isopropyl alcohol, methoxyethylene polymer with monobutyl ester of 2-butenedioic acid (1:1).
What Axopirox looks like and contents of the pack
Axopirox is a colourless, clear to pale yellow solution.
The packaging consists of an amber glass bottle with a cap fitted with a brush, contained in a cardboard box.
Pack size:
3.3 ml (3 g) or 6.6 ml (6 g). The pack does not contain disposable nail files or alcohol-impregnated swabs.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa 30 Street
02-867 Warsaw
Poland
Manufacturers
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 medicinal product is authorised in the European Economic Area countries 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