ONICOTER 78.22 MG/ML Medicated nail polish

Зміст інструкції

1. ONICOTER 78.22 mg/ml medicated nail polish
   1. What is ONICOTER and what is it 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

ONICOTER 78.22 mg/ml medicated nail polish

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet, or as your doctor or
pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms get worse after 6 months for fingernails and 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 is ONICOTER and what is it used for

ONICOTER contains the active substance terbinafine, which belongs to the group of medicines known
as antifungals. It kills a wide variety 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

Contact 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 affects 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 disorders of blood circulation (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, breathing problems and
yellowish discoloration of the nail).
ONICOTER is only for external use.
Avoid contact with unaffected parts of the body until the polish is completely dry.
Accidental contact may cause irritation to the eyes or mucous membranes. If accidental contact with
these areas occurs, rinse thoroughly with running water.
Do not use nail polishes or other cosmetic products that need to be applied to the nails and/or
hands during treatment, as they may affect the functioning of ONICOTER.

Children and adolescents
ONICOTER should 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
If ONICOTER is used as indicated, very little terbinafine is absorbed into the body after
application to the nail and therefore it is unlikely to interfere with any other medicines you are
taking.
Do not use other medicines on the affected areas while using ONICOTER.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, ask your
doctor or pharmacist for advice before using this medicine. ONICOTER should not be used during
pregnancy unless clearly necessary.
This medicine can pass into breast milk. If you are breastfeeding, ask your doctor
before using this medicine.
Do not allow children to come into contact with the treated areas. Make sure that babies do not
suck the treated nails.

Driving and operating machinery
ONICOTER has no influence on the ability to drive and operate machinery.

ONICOTER contains alcohol (ethanol)
This medicine contains 616 mg of alcohol (ethanol) in each ml of medicated nail polish. 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 told you. If you have any doubts, ask your doctor or pharmacist.
For topical use on the nails of the hands or feet.
Instructions for use
Step 1: Before applying ONICOTER, remove nail polish or other cosmetic products from the nails and adjacent skin.
Step 2: Clean and dry the affected areas thoroughly.
Step 3: Unscrew the cap of the bottle.
Step 4: Dip the applicator into the nail polish.
Step 5: Using the applicator, apply a thin layer of ONICOTER to the entire surface of the affected nail, 5 mm of surrounding skin and, if possible, under the front edge of the nail and the skin under the nail.
Step 6: Wait about 30 seconds until the polish is completely dry, before performing any activity.
Step 7: Close the bottle tightly.
Treated nails should not be washed or wetted for at least 6 hours. It is therefore recommended to apply it in the evening before going to bed and after showering or bathing. After this time, you can continue with your normal hygiene practices.
ONICOTER does not require a special solvent to be removed. It is easily removed by washing the nails with water. It is not necessary to file the nail.
Duration of treatment
For the first 4 weeks, apply ONICOTER to the affected nails once a day. After this period, apply ONICOTER once a week.
Treatment should be continued until the treated nail is clear or its appearance is significantly improved. In some cases, additional oral therapy may be necessary.
In general, the duration of treatment for fingernails is about 6 months while for toenails it is about 9-12 months.
Contact your doctor if:

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

If you accidentally ingest ONICOTER
Contact your doctor, pharmacist or the nearest hospital immediately if you or someone else has ingested medicated nail polish. If possible, bring the remaining medicine and this leaflet with you.
.

If you forget to use ONICOTER
If you forget an application, apply ONICOTER as soon as possible and then continue treatment as before. If you only remember it at the time of the next application, apply ONICOTER once and continue normally.
It is important to try to use ONICOTER at the correct times, as forgotten applications can reduce the effectiveness of treatment.
If you stop treatment with ONICOTER
If you stop treatment with ONICOTER before the end of the recommended period, the fungal infection may persist and the condition of your nails may worsen again.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the
national reporting system at 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 which is stated on the package and bottle after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Keep the bottle tightly closed to prevent the polish from drying out.
Keep the bottle in the package to protect the medicine from light.
This medicine is flammable. Keep it away from heat or open flame.
After first opening of the bottle, use within 6 months.
Do not dispose of any medicine in the drain or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ONICOTER contains
The active ingredient is terbinafine. One ml of medicated nail polish contains terbinafine hydrochloride
equivalent to 78.22 mg of terbinafine.
The other ingredients 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 polish, packaged 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 size: 3.3 ml and 6.6 ml.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area with the
following denominations:
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 78.22mg/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