Onicter

Patient Information Leaflet

ONICOTER 78.22 mg/ml medicated nail lacquer

Please read all of this leaflet carefully before you start using this medicine, as 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 your symptoms worsen after 6 months for fingernails or 9 to 12 months for toenails.

Contents of this leaflet:

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

1. What ONICOTER is and what it is used for

ONICOTER contains the active substance terbinafine, which belongs to a group of medicines known as antifungals. It kills a wide range of fungi that can cause nail infections.
ONICOTER is used in adults to treat mild to moderate fungal infections of the nails.

1. Mild 2. Moderate 3. Severe

Consult your doctor if you do not notice any improvement in your nails, or if you notice a worsening after 6 months for fingernails and 9 to 12 months for toenails.

2. What you need to know before using ONICOTER

Do not use ONICOTER
if you are allergic to terbinafine or any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using ONICOTER if:
more than 3 nails are affected, or the infection involves more than half of the nail surface or the area near the cuticle,
you have diabetes,
you have disorders of the immune system,
you have circulatory problems (peripheral vascular disease),
you have severely damaged, infected or painful nails,
you have a skin condition (e.g. psoriasis),
you have yellow nail syndrome (swelling of the legs, respiratory problems and yellowish discoloration of the nail).

ONICOTER is for external use only.
Avoid contact with unaffected parts of the body until the nail lacquer has completely dried.
Accidental contact may cause irritation to the eyes or mucous membranes. In case of accidental contact with these areas, rinse thoroughly with running water.
Do not use nail polish or other cosmetic products intended for application on the nails and/or hands during treatment, as they may interfere with the effectiveness of ONICOTER.

Children and adolescents
ONICOTER must not be used in children and adolescents under 18 years of age due to the lack of clinical studies in this age group.

Other medicines and ONICOTER
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
When ONICOTER is used as directed, very little terbinafine is absorbed into the body after application to the nail, so it is unlikely to interfere with other medicines you may be taking.
Do not use other medicinal products on the affected areas during treatment with ONICOTER.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine. ONICOTER must not be used during pregnancy unless clearly necessary.
This medicine may pass into breast milk. If you are breastfeeding, ask your doctor for advice before using this medicine.
Do not allow children to come into contact with treated areas. Ensure that infants do not suck treated nails.

Driving and using machines
ONICOTER has no influence on the ability to drive or operate machinery.

ONICOTER contains alcohol (ethanol)
This medicine contains 616 mg of alcohol (ethanol) in each ml of medicated nail lacquer. It may cause a burning sensation on damaged skin.

3. How to use ONICOTER

Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you. If you have any doubts, consult your doctor or pharmacist.
For topical use on fingernails or toenails.

Instructions for use
Step 1: Before applying ONICOTER, remove any cosmetic nail polish or other cosmetic products from the nails and surrounding skin.
Step 2: Clean and thoroughly dry the affected areas.
Step 3: Unscrew the cap of the bottle.
Step 4: Dip the applicator into the nail lacquer.
Step 5: Using the applicator, apply a thin layer of ONICOTER over the entire surface of the affected nail, including a 5 mm area of surrounding skin, and, if possible, under the front edge of the nail and the skin beneath the nail.
Step 6: Wait approximately 30 seconds until the lacquer has completely dried before performing any activity.
Step 7: Close the bottle tightly.

Treated nails should not be washed or wetted for at least 6 hours. Therefore, it is recommended to apply ONICOTER in the evening before going to bed and after a shower or bath. After this time, normal hygiene practices may be resumed.

ONICOTER does not require a special solvent for removal. It can be easily removed by washing the nails with water. Filing the nail is not necessary.

Duration of treatment
For the first 4 weeks, apply ONICOTER once daily to the affected nails. After this period, apply ONICOTER once weekly.
Treatment should be continued until the treated nail appears clear or its appearance has significantly improved. In some cases, additional oral therapy may be necessary.
Generally, treatment duration is approximately 6 months for fingernails and about 9–12 months for toenails.

Contact your doctor if:

• the infection has not cleared after the treatment period.
• the infection does not respond adequately to treatment.
• you have a severe nail infection (more than half of the nail affected).
• three or more nails are affected.
• the area near the cuticle, from which the nail grows, is involved.

If ONICOTER is accidentally swallowed
Contact your doctor, pharmacist, or nearest hospital immediately if you or someone else has swallowed the medicated nail lacquer. If possible, bring the remaining medicine and this patient information leaflet with you.

If you forget to use ONICOTER
If you miss an application, apply ONICOTER as soon as possible and then continue treatment as before. If you remember only at the time of the next scheduled application, apply ONICOTER once and continue treatment as usual.
It is important to try to use ONICOTER at the correct times, as missed applications may reduce the effectiveness of treatment.

If you stop using ONICOTER
If you stop treatment with ONICOTER before the recommended treatment period is complete, the fungal infection may persist and the condition of your nails may worsen again.

If you have any questions 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 everyone experiences them.
Uncommon: may affect up to 1 in 100 people
redness and irritation of the skin at the application site

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist.
You may also report side effects directly through the national reporting system at the following address: https://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 ONICOTER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Keep the bottle tightly closed to prevent the nail polish from drying out.
Keep the bottle in the carton to protect the medicine from light.
This medicine is flammable. Keep it away from heat or open flame.
After first opening the bottle, use within 6 months.
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 ONICOTER contains
The active substance is terbinafine. One ml of medicated nail lacquer contains terbinafine hydrochloride
equivalent to 78.22 mg of terbinafine.
The other components are: ethanol (96%), hydroxypropyl-chitosan and purified water.

Description of the appearance of ONICOTER and contents of the pack
ONICOTER is a clear, colourless medicated nail lacquer, supplied in a transparent glass bottle with an applicator.
The applicator incorporates a short spatula attached to the screw cap of the bottle. The bottle cap serves both as a support and as a closure for the bottle.
Pack sizes: 3.3 ml and 6.6 ml.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Sandoz S.p.A.,
Largo Umberto Boccioni 1,
21040 Origgio (VA),
Italy

Manufacturer
Alfasigma S.p.A. (BS 2)
Via Enrico Fermi, 1
65020 Alanno (PE),
Italy

This medicinal product is authorized in the European Economic Area countries under the
following names:
Austria: Terbinafin Sandoz 78.22 mg/ml - wirkstoffhaltiger Nagellack
Bulgaria: EXOTERIN
Denmark: Terbinafin Sandoz
Finland: Terbinafin Sandoz 78.22 mg/ml lääkekynsilakka
Germany: Terbinafin - 1 A Pharma Nagellack gegen Nagelpilz 78.22 mg/ml wirkstoffhaltiger Nagellack
Italy: ONICOTER
Norway: Terbinafin Sandoz
Netherlands: Terbinafine Sandoz 78.22 mg/ml, nagellak
Czech Republic: Terbinafin Sandoz
Romania: Exoterfyn 78.22 mg/ml Lac de unghii medicamentos
Slovakia: Exoterin
Slovenia: Exoter 78.22 mg/ml zdravilni lak za nohte
Spain: Terbinafina Sandoz Care 78.22 mg/ml barniz de uñas medicamentoso
Sweden: Terbinafin Sandoz
Hungary: Exoterfyn gyógyszeres körömlakk