Miclast 80 mg/g medicated nail lacquer

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Miclast 80 mg/g medicated nail lacquer

Ciclopirox

Read the entire leaflet carefully before you start using this medicine, because 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Miclast 80 mg/g medicated nail lacquer is and what it is used for
2. What you need to know before using Miclast 80 mg/g medicated nail lacquer
3. How to use Miclast 80 mg/g medicated nail lacquer
4. Possible side effects
5. How to store Miclast 80 mg/g medicated nail lacquer
6. Contents of the pack and other information

1. What Miclast 80 mg/g medicated nail lacquer is and what it is used for

This medicine is a nail lacquer containing the active substance ciclopirox: an antifungal agent for topical use.

Miclast 80 mg/g medicated nail lacquer is indicated in adults for the treatment of mild to moderate fungal infections of the nails (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 you start using Miclast 80 mg/g medicated nail lacquer

Do not use Miclast 80 mg/g medicated nail lacquer

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

Warnings and precautions

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

Other medicines and Miclast 80 mg/g medicated nail lacquer

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

Use of Miclast 80 mg/g medicated nail lacquer with food and drink

Not applicable.

Pregnancy and breastfeeding

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

Pregnancy

This medicine may be used in pregnant women.

Breastfeeding

There is insufficient information regarding the excretion of ciclopirox in breast milk. A risk to newborns cannot be excluded. Miclast 80 mg/g medicated nail lacquer should not be used during breastfeeding.

Driving and using machines

Miclast 80 mg/g medicated nail lacquer does not affect the ability to drive or operate machinery.

Important information about some of the components of Miclast 80 mg/g medicated nail lacquer

Not applicable.

3. How to use Miclast 80 mg/g medicated nail lacquer

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Method of administration

Cutaneous use.

For external use only. This medicine is intended for adult use only.

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

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

Before starting treatment with Miclast 80 mg/g medicated nail lacquer:

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

During the entire treatment:

• apply a thin layer of Miclast 80 mg/g medicated nail lacquer over the entire surface of the affected nails once daily, preferably at night,
• Miclast 80 mg/g medicated nail lacquer must be applied over the entire nail,
• once a week, before applying Miclast 80 mg/g medicated nail lacquer, remove the previous layer of lacquer from the nails using nail polish remover,
• at the same time, it is recommended to remove any loose parts of the affected nails,
• do not apply regular nail polish or any other cosmetic nail coating on the treated nails,
• depending on the severity of your condition (extensive involvement of one or more fingernails and/or toenails), consult your doctor, as you may require additional oral treatment.

Duration of treatment

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

Treatment duration is typically 3 months for fungal infections of the fingernails and up to 6 months for fungal infections of the toenails.

The treatment duration should not exceed 6 months.

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

If you use more Miclast 80 mg/g medicated nail lacquer than you should

Not applicable.

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

If you forget to use Miclast 80 mg/g medicated nail lacquer

Do not apply a double dose to make up for missed doses. Continue with the treatment as indicated in section 3 of this leaflet.

If you stop treatment with Miclast 80 mg/g medicated nail lacquer

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, this medicine may cause adverse effects, although not everybody will experience them.

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Miclast 80 mg/g medicated nail lacquer

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

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

Store in the original packaging to protect from light.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Miclast 80 mg/g medicated nail lacquer

• The active substance is: Ciclopirox

Each gram of medicated nail lacquer contains 80 mg (80 mg/g) of ciclopirox.

• The other components are:

Ethyl acetate, isopropyl alcohol, methylvinyl ether-maleic acid monobutyl ester copolymer.

Appearance of Miclast 80 mg/g medicated nail lacquer and contents of the pack

Miclast 80 mg/g medicated nail lacquer is a slightly viscous, transparent liquid, colourless to slightly yellowish-brown.

Miclast 80 mg/g medicated nail lacquer is packaged in a colourless glass bottle with a white screw cap equipped with a brush (LDPE).

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

Only certain pack 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 medicinal product is authorized in the European Economic Area member states under the following names:

Miclast: Germany, Spain

Mycosten: Belgium

Roxolac: Italy

Date of the most recent review of this leaflet: March 2025.

“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) https://www.aemps.gob.es/”