MICLAST 80 mg/g medicated nail polish

Important notes (mandatory information)

Miclast 80 mg/g medicated nail polish. Active ingredient: Ciclopirox. Areas of application: for the treatment of mild to moderate nail fungus infections (onychomycosis) of the fingernails and toenails.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Miclast 80 mg/g medicated nail polish
Active ingredient: Ciclopirox

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If your symptoms worsen or do not improve after 6 months, contact your doctor.

What this package leaflet contains

1. WHAT IS MICLAST AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING MICLAST?
3. HOW TO USE MICLAST?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE MICLAST?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS MICLAST AND WHAT IS IT USED FOR?

This medicine is a varnish with an active ingredient against fungal infections. Other antimycotics (antifungal agents) for topical (external) use. Miclast is intended for the treatment of mild to moderate nail fungus infections (onychomycosis) of the fingernails and toenails. The active ingredient ciclopirox penetrates the nail and kills the fungi.

2. WHAT SHOULD YOU CONSIDER BEFORE USING MICLAST?

Miclast must not be used:

• if you are allergic to ciclopirox or any of the other ingredients of Miclast listed in section 6.
• in children and adolescents under 18 years of age.

Warnings and precautions:

• Do not ingest/swallow.
• Avoid contact with eyes and mucous membranes until Miclast has dried.
• Miclast should only be applied locally.
• Do not apply normal nail polish or other cosmetic varnishes to the treated nails.
• In case of an allergic reaction, discontinue treatment and contact your doctor.
• If several nails need to be treated or if you have diabetes mellitus or an immune system disorder, please consult your doctor. You may also need additional oral treatment (medicine to be taken by mouth).

Use of Miclast with other medicines

No interactions with other medicines are known to date. Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.

Use of Miclast with food and drink

Not applicable.

Pregnancy and breast-feeding

Ciclopirox can be used by pregnant and breastfeeding women. Ask your doctor or pharmacist for advice before taking/using any medicine.

Driving and using machines

Miclast has no influence on the ability to drive and use machines.

3. HOW TO USE MICLAST?

Dosage, type of application, frequency of

application

Type of

application

For application to the nails. For external use only. This medicine should only be used by adults. Always use the medicine exactly as described in this package leaflet or as directed by your doctor or pharmacist. Please ask your doctor or pharmacist if you are not sure. The recommended dose is one application daily, preferably in the evening.

Application

Remove the product from the stand. Put the stand back in the box. Remove the cover that covers the stand. Place the bottle in the stand. After each application, follow the storage instructions (see section 5). Before starting treatment with Miclast: remove as much of the diseased nail as possible with nail scissors, nail clippers or a nail file.

During treatment:

• once a day, preferably in the evening, cover all affected nails completely with a thin layer of Miclast,
• remove the layer of varnish at least once a week before applying Miclast with a commercially available nail polish remover,
• remove as much of the diseased nail as possible,
• avoid using cosmetic nail polish.

Duration of treatment

The duration of treatment depends on the severity of the infection. The duration of treatment is at least 3 months (nail fungus of the fingernails) and should not exceed 6 months (nail fungus of the toenails). If you are in doubt whether to continue treatment, please consult your doctor or pharmacist.

If you have used more Miclast than you should

Not applicable.

If you forget to use Miclast

Do not use twice the amount if you have forgotten the previous application. Continue treatment as described in section 3 of this package leaflet.

If you stop using Miclast

If you interrupt or stop treatment too early, the nail fungus may recur. If you are not sure whether the condition of your nail has improved, please consult your doctor or pharmacist.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Miclast can cause side effects, although not everybody gets them. Allergic contact dermatitis (rash such as eczema) may occur, but the frequency of this side effect is unknown.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MICLAST?

Keep this medicine out of the reach of children. Do not use the medicine after the expiry date which is stated on the carton and the bottle after "use by". The expiry date refers to the last day of the month indicated. Store in the original package to protect the contents from light. Keep the bottle tightly closed after opening to protect the contents from light. After first opening the bottle: 3 months. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Miclast contains

The active ingredient is: Ciclopirox. One gram of medicated nail polish contains 80 mg (8%) ciclopirox. The other ingredients are: ethyl acetate, 2-propanol (Ph.Eur.), poly(butyl hydrogen maleate-co-methoxyethylen) (1:1).

What Miclast looks like and contents of the pack

Colourless type III glass bottle with white screw cap and attached brush (LDPE). Pack size: 1 bottle with 3 ml

Pharmaceutical entrepreneur

Pierre Fabre Dermo-Kosmetik GmbH
Jechtinger Str. 13
D-79111 Freiburg

Manufacturer

Pierre Fabre medicament production
SITE DE CAHORS LE PAYRAT
46000 CAHORS, France

This package leaflet was last revised in June 2016.

Source: Package leaflet information
Status: 11/2017
Active ingredient: Ciclopirox. Areas of application: for the treatment of mild to moderate nail fungus infections (onychomycosis) of the fingernails and toenails.