MICLAST 80 mg/g MEDICINAL NAIL POLISH

Introduction

Package Leaflet: Information for the User

Miclast 80 mg/g Medicinal Nail Varnish

Ciclopirox

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What Miclast 80 mg/g Medicinal Nail Varnish is and what it is used for
2. What you need to know before using Miclast 80 mg/g Medicinal Nail Varnish
3. How to use Miclast 80 mg/g Medicinal Nail Varnish
4. Possible side effects
5. Storage of Miclast 80 mg/g Medicinal Nail Varnish
6. Package Contents and Additional Information

1. What Miclast 80 mg/g Medicinal Nail Varnish is and what it is used for

This medication is a varnish that contains the active ingredient ciclopirox: a topical antifungal agent.

Miclast 80 mg/g Medicinal Nail Varnish is indicated in adults for the treatment of mild to moderate fungal infections of the nails (onychomycosis) of the hands and feet. The active ingredient, ciclopirox, penetrates the nail and kills the fungi.

2. What you need to know before using Miclast 80 mg/g Medicinal Nail Varnish

Do not use Miclast 80 mg/g Medicinal Nail Varnish

• if you are allergic to ciclopirox or any of the other components of this medication (listed in section 6).

Warnings and Precautions

• Do not swallow.
• Avoid contact of Miclast 80 mg/g Medicinal Nail Varnish with the eyes and mucous membranes until it has dried.
• Miclast 80 mg/g Medicinal Nail Varnish should only be applied locally.
• Do not apply nail polish or any other cosmetic varnish to the treated nails.
• In case of an allergic reaction, discontinue treatment immediately, carefully remove the nail varnish with a solvent, and contact your doctor.
• In case a nail comes off during cleaning, and especially if you have diabetes or immunological disorders, consult your doctor.
• In case you need to treat several nails (more than 5) or if you have diabetes or immunological disorders, consult your doctor as you may need additional oral treatment.

Other Medications and Miclast 80 mg/g Medicinal Nail Varnish

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medication.

Use of Miclast 80 mg/g Medicinal Nail Varnish with Food and Drinks

Not applicable.

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 medication.

Pregnancy

This medication can be used in pregnant women.

Breastfeeding

There is not enough information on the excretion of ciclopirox in breast milk. A risk to newborns cannot be excluded. You should not use Miclast 80 mg/g Medicinal Nail Varnish during breastfeeding.

Driving and Using Machines

Miclast 80 mg/g Medicinal Nail Varnish does not affect the ability to drive or use machinery.

Important Information about Some Components of Miclast 80 mg/g Medicinal Nail Varnish

Not applicable.

3. How to Use Miclast 80 mg/g Medicinal Nail Varnish

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Method of Administration

Topical use.

For external use only. This medication is for use in adults only.

The recommended dose is one application per day, preferably in the evening.

After each use, follow the storage instructions (see section 5).

Before starting treatment with Miclast 80 mg/g Medicinal Nail Varnish:

• it is recommended to remove loose parts of the affected nails using scissors, nail clippers, or a nail file.

During the entire treatment:

• apply a thin layer of Miclast 80 mg/g Medicinal Nail Varnish to the entire surface of the affected nails, once a day, preferably at night,
• Miclast 80 mg/g Medicinal Nail Varnish should be applied to the entire nail,
• once a week, before applying Miclast 80 mg/g Medicinal Nail Varnish, remove the varnish layer from the nails with a nail polish remover,
• at the same time, it is recommended to remove loose parts of the affected nails,
• do not apply common nail polish or any other cosmetic varnish to the treated nails,
• depending on the severity of your condition (extensive involvement of one or several nails of the hands and feet), consult your doctor as you may need additional oral treatment.

Duration of Treatment

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

The duration of treatment is usually 3 months for fungal infections of the nails of the hands and 6 months for fungal infections of the nails of the feet.

The duration of treatment should not exceed 6 months.

If you are unsure whether you should continue or discontinue treatment, consult your doctor or pharmacist.

If You Use More Miclast 80 mg/g Medicinal Nail Varnish Than You Should

Not applicable.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested).

If You Forget to Use Miclast 80 mg/g Medicinal Nail Varnish

Do not take a double dose to make up for forgotten doses. Continue treatment as indicated in section 3 of this package leaflet.

If You Interrupt Treatment with Miclast 80 mg/g Medicinal Nail Varnish

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Frequency Not Known(cannot be estimated from available data)

• You may experience contact dermatitis (skin rash like eczema)
• General allergic reactions (hypersensitivity) that can be severe, including swelling (edema), itching (pruritus), skin rash, itchy rash (urticaria), and difficulty breathing (dyspnea). If you experience any of these side effects, discontinue treatment immediately and consult a doctor as soon as possible.

Reporting Side Effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Miclast 80 mg/g Medicinal Nail Varnish

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

Do not use this medication after the expiration date stated on the packaging and bottle. The expiration date is the last day of the month indicated.

Store in the original packaging to protect from light.

After opening, keep the bottle tightly closed in the outer packaging.

After the first opening of the bottle, use the product within 3 months.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Miclast 80 mg/g Medicinal Nail Varnish

• The active ingredient is:Ciclopirox

Each gram of medicinal nail varnish contains 80 mg (80 mg/g) of ciclopirox.

• The other components are:

Ethyl acetate, isopropyl alcohol, copolymer of methyl vinyl ether and maleic acid monobutyl ester.

Appearance of Miclast 80 mg/g Medicinal Nail Varnish and Package Contents

Miclast 80 mg/g Medicinal Nail Varnish is a clear, slightly viscous liquid, colorless to slightly yellowish-brown.

Miclast 80 mg/g Medicinal Nail Varnish is packaged in a colorless glass bottle with a white screw cap provided with a brush (LDPE).

Package sizes: 1 bottle of 3 ml, 2 bottles of 3 ml.

Not all package sizes may be marketed.

Marketing Authorization Holder

PIERRE FABRE IBÉRICA, S.A.

C/ Ramón Trias Fargas, 7-11,

08005 Barcelona - Spain

Manufacturer

PIERRE FABRE MEDICAMENT PRODUCTION

Site de cahors

Le Payrat

46000 Cahors, France

This medication is authorized in the Member States of the European Economic Area under the following names:

Miclast: Germany, Spain

Mycosten: Belgium

Roxolac: Italy

Date of the Last Revision of this Package Leaflet: March 2025.

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