Label: Information for the User

CICLOPIROX SERRA 80 mg/g NAIL ENAMEL MEDICAMENTOUS

Ciclopirox

Read this label carefully before starting to use the medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label.

1. What is Ciclopirox Serra and how it is used.

2. What you need to know before starting to use Ciclopirox Serra.

3. How to use Ciclopirox Serra.

4. Possible adverse effects.

5. Storage of Ciclopirox Serra.

6. Contents of the package and additional information

Ciclopirox Serra belongs to the group of external dermatological antifungals, medications for the treatment of infections caused by fungi.

Ciclopirox Serra is used in the treatment of nail fungal infections (onychomycosis) of hands and feet. The active ingredient, ciclopirox, penetrates the nail and kills the fungi.

Ciclopirox Serra should only be applied to the nails. Avoid contact with eyes and mucous membranes.

Due to the lack of clinical experience, Ciclopirox Serra is contraindicated in children.

Do not useCCiclopirox Serra

• if you are allergic (hypersensitive) to ciclopirox or to any of the other components of Ciclopirox Serra (see section 6).

• if you are under 18 years old.

Warnings and precautions

• Do not swallow.
• Avoid contact ofCiclopiroxSerra with the eyes and mucous membranes until it has dried.

• CiclopiroxSerra should only be applied locally.
• In case of allergic reaction, discontinue treatment and contact your doctor.
• In case you need to treat multiple nails or in case of diabetes or immunological disorders, consult your doctor as you may need additional oral treatment.

Use ofCCiclopirox Serrawith other medications

To date, there are no known interactions with other medications.

Inform your doctor or pharmacist if you are using, have used recentlyor may need to use anyother medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Due to the lack of clinical experience, treatment with Ciclopirox Serra is not recommended during pregnancy and breastfeeding.

Driving and operating machinery

Since the preparation does not affect the patient's attention, Ciclopirox Serra does not affect the ability to drive vehicles or operate machinery.

Follow exactly the administration instructions forCiclopirox Serraas indicated by your doctor. In case of doubt, consult your doctor or pharmacist. Remember to use your medication.

Your doctor will inform you of the duration of your treatment with Ciclopirox Serra. Do not discontinue treatment beforehand, as the medication would not be effective. If you estimate that the action of this medication is too strong or weak, inform your doctor or pharmacist.

Before starting treatment withCiclopirox Serra:

• remove all damaged parts of the nails, if possible using scissors, a nail clipper, or a nail file.

During the entire treatment:

• apply a thin layer ofCiclopirox Serrato the entire surface of all affected nails. Unless otherwise prescribed, Ciclopirox Serra will be applied every two days for the firstmonth. In the second month, the application may be reduced to at least two times a week, and from the third month onwards, the application may be performed once a week.
• at the same time, you should also remove as much damaged nail as possible.

Treatment duration:

The duration of treatment depends on the severity of the infection.

The minimum duration of treatment will be 3 months (nail fungus on the hands) and a maximum of 6 months (nail fungus on the feet).

If you have doubts about whether to continue or discontinue treatment, consult your doctor or pharmacist.

After each application of Ciclopirox Serra, the bottle must be kept tightly closed to prevent the solution from evaporating. To prevent the cap from sticking to the bottle, avoid getting the lacquer wet on the threads.

If you use more Ciclopirox Serra than you should

No adverse effects of overdosing with Ciclopirox Serra have been reported.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service at (91) 562 04 20, indicating the medication and the amount used.

If you forgot to use Ciclopirox Serra

Do not use a double dose to compensate for missed applications. Continue treatment as indicated in section 3 of this prospectus.

If you interrupt treatment with Ciclopirox Serra

If you discontinue treatment too soon, the fungus may recur. If you are unsure whether your nail condition has improved, consult your doctor or pharmacist.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Ciclopirox Serra may cause adverse effects, although not everyone will experience them.

In very isolated cases, redness and peeling of the skin around the nail that has come into contact with Ciclopirox Serra have been reported.

Prolonged use of the product may lead to sensitization phenomena, resulting in undesirable effects. In such cases, treatment should be interrupted and a healthcare professional consulted. If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Ciclopirox Serra should be kept at room temperature and protected from light (store the bottle well closed in its case after each application).

Do not use this medication after the expiration date indicated on the packaging, after CAD. The expiration date is the last day of the month indicated.

Once the packaging is opened, it should be used within a period of 6 months.

Keep this medication out of sight and reach of children.

Medications should not be thrown down the drains or in the trash.Deposit the containers and medications that you no longer need at the SIGRE collection pointof the pharmacy. In case of doubt, askyour pharmacist how to dispose of the containers and medications that you no longer need. In this way,you will help to protect the environment.

Composition of Ciclopirox Serra

The active ingredient is ciclopirox. One gram of medicated nail polish contains 80 mg of ciclopirox.

The other components are: methoxyethoxy polymer with 2-butenedioic acid, monobutyl ester; ethyl acetate and isopropyl alcohol.

Appearance of the product and contents of the packaging

Ciclopirox Serra is a topical solution, presented in a glass bottle containing3 gof transparent solution, provided with a brush.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Serra Pamies, S.A.

Ctra. Castellvell, 24

43206 REUS

(Tarragona)

Date of the last review of this leaflet: March 2013.

“The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”