Ciclopirox Serra 80 mg/g medicated nail polish

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

CICLOPIROX SERRA 80 mg/g MEDICATED NAIL LACQUER

Ciclopirox

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

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

Leaflet contents

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

1. What Ciclopirox Serra is and what it is used for

Ciclopirox Serra belongs to the group of topical dermatological antifungals, medicines used to treat infections caused by fungi.

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

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

Ciclopirox Serra should be applied to the nails only. Contact with eyes and mucous membranes must be avoided.

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

Do not use Ciclopirox 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 of age.

Warnings and precautions

• Do not swallow.

• Avoid contact of Ciclopirox Serra with eyes and mucous membranes until it has dried.

• Ciclopirox Serra should only be applied locally.

• If an allergic reaction occurs, discontinue treatment and contact your doctor.

• If you need to treat multiple nails, or if you have diabetes or immune system disorders, consult your doctor, as you may require additional oral treatment.

Use of Ciclopirox Serra with other medicines

To date, no interactions with other medicines are known.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines

As this preparation does not affect the patient's attention, Ciclopirox Serra has no influence on the ability to drive or operate machinery.

3. How to use Ciclopirox Serra

Follow exactly the administration instructions for Ciclopirox Serra provided by your doctor. If in doubt, consult your doctor or pharmacist. Remember to use your medicine as directed.

Your doctor will determine the duration of your treatment with Ciclopirox Serra. Do not stop the treatment early, as the medicine will not be effective otherwise. If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

Before starting treatment with Ciclopirox Serra:

• remove all damaged nail parts, if possible using scissors, nail clippers, or a file.

During the entire treatment:

• apply a thin layer of Ciclopirox Serra to the entire surface of all affected nails. Unless otherwise prescribed, Ciclopirox Serra should be applied every two days during the first month. In the second month, application may be reduced to at least twice a week, and from the third month onward, once weekly.
• at the same time, remove as much of the damaged nail as possible.

Duration of treatment:

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

The minimum treatment duration is 3 months (for fingernail fungal infections) and up to 6 months (for toenail fungal infections).

If you have any doubts about whether you should continue treatment, consult your doctor or pharmacist.

After each application of Ciclopirox Serra, the bottle must be kept tightly closed to prevent evaporation of the solution. To avoid the cap sticking, avoid contact of the lacquer with the threaded part of the bottle.

If you use more Ciclopirox Serra than you should

There are no known effects of overdose with Ciclopirox Serra.

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

If you forget to use Ciclopirox Serra

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

If you stop treatment with Ciclopirox Serra

If you discontinue or interrupt treatment too early, the fungal infection may recur. If you are unsure whether the condition of your nails has improved, consult your doctor or pharmacist.

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

4. Possible adverse effects

Like all medicines, Ciclopirox Serra may cause side effects, although not everybody gets them.

Very rarely, redness and scaling 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 reactions, resulting in undesirable effects. In such cases, treatment must be discontinued and a physician should be consulted. If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Ciclopirox Serra

Ciclopirox Serra should be stored at room temperature and protected from light (keep the bottle tightly closed in its box after each use).

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

Once the container has been opened, it should be used within 6 months.

Keep this medicine out of the sight and reach of children.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Ciclopirox Serra

The active substance is ciclopirox. One gram of medicated nail lacquer contains 80 mg of ciclopirox.

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

Appearance of the medicinal product and contents of the package

Ciclopirox Serra is a solution for topical use, supplied in a glass bottle containing 3 g of clear solution, provided with a brush.

Marketing Authorization Holder and Manufacturer

Laboratorios Serra Pamies, S.A.

Ctra. Castellvell, 24

43206 REUS

(Tarragona)

Date of the most recent revision of this leaflet: March 2013.

“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”