Label: information for the user

Miclast 80 mg/g medicated nail polish

Ciclopirox

Read this label carefully before starting to use this 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 should not be given to others, even if they 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. See section 4.

This medication is a nail polish that contains the active ingredient ciclopirox: an antifungal agent.

OTHER TOPICAL ANTIFUNGALS

Miclast 80 mg/g medicated nail polish, is used in the treatment of mild to moderate nail fungus (onychomycosis) of hands and feet. The active ingredient, ciclopirox, penetrates the nail and kills the fungi.

Do not use Miclast 80 mg/g medicated nail polish

• if you are allergic to ciclopirox or any of the other ingredients of this medicine (listed in section 6).
• if you are under 18 years old.

Warnings and precautions

• Do not swallow.
• Avoid contact of Miclast 80 mg/g medicated nail polish with the eyes and mucous membranes until it has dried.
• Miclast 80 mg/g medicated nail polish should only be applied locally.
• Do not apply nail polish or any other cosmetic varnish over treated nails.
• In case of an allergic reaction, stop treatment immediately, carefully remove the nail polish with a solvent, and contact your doctor.
• In case you need to treat multiple nails or have diabetes or immunological disorders, consult your doctor as you may need additional oral treatment.

Other medicines and Miclast 80 mg/g medicated nail polish

Inform your doctor or pharmacist if you are using or have used recently or might have to use any other medicine.

Use of Miclast 80 mg/g medicated nail polish with food and drinks

Not applicable.

Pregnancy and breastfeeding

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

Pregnancy

This medicine can be used in pregnant women.

Breastfeeding

There is not enough information about the excretion of ciclopirox in breast milk. A risk to newborns cannot be excluded. Do not use Miclast 80 mg/g medicated nail polish during breastfeeding.

Driving and operating machines

Miclast 80 mg/g medicated nail polish does not affect your ability to drive or use machinery.

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

Not applicable.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Administration Form

Cutaneous use.

For exclusive external use. This medication is exclusively for adults.

The recommended dose is a daily application, preferably in the afternoon.

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

Before starting treatment with Miclast 80 mg/g nail varnish:

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

During the entire treatment:

• Apply a thin layer of Miclast 80 mg/g nail varnish to all affected nails once a day, preferably at night,
• Miclast 80 mg/g nail varnish must be applied to the entire nail,
• Once a week, before applying Miclast 80 mg/g 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.

Treatment Duration

The treatment duration depends on the severity of the infection.

The treatment duration is usually 3 months for hand nail fungus to 6 months for foot nail fungus.

If you have doubts about whether to continue or not the treatment, consult your doctor or pharmacist.

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

Not applicable.

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

If you forgot to use Miclast 80 mg/g nail varnish

Do not take a double dose to compensate for the missed doses. Continue treatment as indicated in section 3 of this leaflet.

If you interrupt the treatment with Miclast 80 mg/g nail varnish

If you abandon or interrupt the treatment too soon, the fungus may reappear. If you are unsure if 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, this medication may produce adverse effects, although not all people will experience them.

You may suffer from contact dermatitis (skin eruption of the type eczema) and general allergic reactions, but the frequency of this adverse effect is unknown (it cannot be estimated from the available data).

Reporting Adverse Effects:

If you experienceany type of adverse effect, consult your doctor or pharmacist even if it ispossibleadverse effects that do not appear in this prospectus.You can also report them directly tothrough the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

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

Store in the original packaging, to protect it from light.

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

After the first opening of the bottle: 3 months.

Medicines should not be thrown down the drain or in the trash.Deposit the containers and medicines that you no longer need at the SIGRE collection point of the pharmacyin your area..If in doubt, ask your pharmacist how to dispose of the containers and medicines that you no longer need. In this way, you will help protect the environment.

C Composition of Miclast 80 mg/g medicated nail polish

• The active principle is: Ciclopirox

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

• The other components are:

Acetate of ethyl, isopropyl alcohol, methylvinyl ether-maleic anhydride copolymer, and monobutyl ester of maleic acid.

Appearance of Miclast 80 mg/g medicated nail polish, and contents of the packaging

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

Miclast 80 mg/g medicated nail polish is packaged in a colorless glass bottle with a white screw cap provided with a brush (LDPE).

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

Only some packaging sizes may be commercially available.

Marketing authorization holder

PIERRE FABRE IBÉRICA, S.A.

C/ Ramón Trias Fargas, 7-11,

08005 Barcelona - Spain

Responsible for manufacturing

PIERRE FABRE MEDICAMENT PRODUCTION

Site de cahors

Le Payrat

46000 Cahors, France

This medicine is authorized in the member states of the European Economic Area with the following names:

Miclast: Germany, Spain

Mycosten: Belgium

Roxolac: Italy

Last review date of this leaflet : August 2021.

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