CICLOPIROX SERRA 80 mg/g NAIL LACQUER MEDICATED

Introduction

Package Leaflet: Information for the User

CICLOPIROX SERRA 80 mg/g MEDICATED NAIL VARNISH

Ciclopirox

Read the package leaflet carefully before starting to use the medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

Contents of the package leaflet

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

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

Ciclopirox Serra belongs to the group of topical antifungal dermatological medicines, used for the treatment of fungal infections.

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.

2. What you need to know before you start using Ciclopirox Serra

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

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

Do not useCiclopirox Serra

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

• if you are under 18 years old.

Warnings and precautions

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

• Ciclopirox Serra should only be applied locally.
• In case of allergic reaction, stop the treatment and contact your doctor.
• In case you need to treat several nails or if you have diabetes or immune system disorders, consult your doctor as you may need additional oral treatment.

Using Ciclopirox Serra with other medicines

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

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Pregnancy and breastfeeding

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

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

Driving and using machines

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

3. How to use Ciclopirox Serra

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

Your doctor will indicate the duration of your treatment with Ciclopirox Serra. Do not stop the treatment before, as the medicine may not be effective. If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

Before starting treatment with Ciclopirox Serra:

• remove all damaged parts of the nails, if possible using nail scissors, nail clippers or a nail 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, the application can be reduced to at least twice a week, and from the third month onwards, the application can be done once a week.
• at the same time, you should also remove as much of the damaged part of the nails as possible.

Duration of treatment:

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

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

If you are in doubt about whether you should continue or not the treatment, consult your doctor or pharmacist.

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

If you use more Ciclopirox Serra than you should

No effects of overdose with Ciclopirox Serra are known.

In case of overdose or accidental ingestion, consult your doctor, pharmacist or call the Toxicology Information Service, telephone (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 forgotten applications. Continue with the treatment as indicated in section 3 of this package leaflet.

If you stop using Ciclopirox Serra

If you stop or interrupt the treatment too early, the fungal infection may reappear. If you are not sure if 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 side effects

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

In very rare 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 discontinued and a doctor consulted. If you think any of the side effects are serious or if you notice any side effects not listed in this package leaflet, tell your doctor or pharmacist.

5. Storage of Ciclopirox Serra

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

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

Once the packaging is 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. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ciclopirox Serra

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

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

Appearance and packaging of the product

Ciclopirox Serra is a solution for cutaneous use, presented in a glass bottle containing 3 g of transparent solution, provided with a brush.

Marketing authorisation holder and manufacturer

Laboratorios Serra Pamies, S.A.

Ctra. Castellvell, 24

43206 REUS

(Tarragona)

Date of last revision of this package leaflet: March 2013.

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”