CICLOPOLI

CICLOPOLI against nail fungus active ingredient nail polish

Important notes (mandatory information)

Ciclopoli against nail fungus 8% active ingredient nail polish. Active ingredient: Ciclopirox. Area of application: for the treatment of fungal nail infections (onychomycosis) caused by filamentous fungi and/or other fungi that can be treated with Ciclopirox.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist!


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Ciclopoli against nail fungus 8% active ingredient nail polish for use from 18 years of age
Active ingredient: Ciclopirox

Read the entire package leaflet carefully before you start using this medicine, as it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or 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 notice any side effects, contact 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 for fingernails or 12 months for toenails, contact your doctor.

What this package leaflet contains

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

1. WHAT IS CICLOPOLI AGAINST NAIL FUNGUS AND WHAT IS IT USED FOR?

Ciclopoli against nail fungus is a broad-spectrum fungicidal medicine (broad-spectrum antimycotic). It is used to treat fungal nail infections (onychomycosis) caused by filamentous fungi and/or other fungi that can be treated with Ciclopirox. The active ingredient Ciclopirox prevents the fungi from growing and kills them. This improves the appearance of your nails.

2. WHAT SHOULD YOU CONSIDER BEFORE USING CICLOPOLI AGAINST NAIL FUNGUS?

Ciclopoli against nail fungus must not be used:

• if you are hypersensitive (allergic) to Ciclopirox or any of the other ingredients of this medicine listed in section 6;
• in children and adolescents under 18 years of age, as sufficient experience in this age group is not available.

Warnings and precautions

Please talk to your pharmacist before using Ciclopoli against nail fungus. Please discontinue treatment in case of an allergic reaction (sensitisation) and consult your doctor for advice.

Use of Ciclopoli against nail fungus together with other medicines

Tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.

Pregnancy and

breastfeeding

Ask your doctor or pharmacist for advice before taking/using any medicine.

Pregnancy

Treatment with Ciclopoli against nail fungus should only be carried out after careful consideration of the benefits and risks by the treating doctor if treatment is urgently required.

Breastfeeding

It is not known whether Ciclopirox passes into breast milk in humans. Treatment with Ciclopoli against nail fungus should only be carried out after careful consideration of the benefits and risks by the treating doctor if treatment is urgently required.

Driving and operating machinery

No special precautions are required.

Ciclopoli against nail fungus contains cetyl stearyl alcohol

Cetyl stearyl alcohol can cause local skin irritation (e.g. contact dermatitis).

3. HOW TO USE CICLOPOLI AGAINST NAIL FUNGUS?

Always use Ciclopoli against nail fungus exactly as described in this package leaflet. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, Ciclopoli against nail fungus is applied in a thin layer once a day to the affected nail(s). The nails should be clean and dry. The active ingredient nail polish is applied to the entire nail surface and 5 mm of the surrounding skin. If possible, Ciclopoli against nail fungus should also be applied under the free edge of the nail. Let Ciclopoli against nail fungus dry for about 30 seconds. Treated nails must not be washed for at least 6 hours, so it is recommended to apply the product in the evening before going to bed. You can then resume normal hygiene measures. Ciclopoli against nail fungus does not need to be removed with a solvent or abrasive (e.g. by filing the nails), washing the nails with water is sufficient. If Ciclopoli against nail fungus has been accidentally removed by washing, it can be reapplied. Regular removal of loose nail material from the affected nail, e.g. by cutting the nails, is recommended. Treatment must be continued until the symptoms have completely subsided, i.e. until the nails are clear or almost clear and the nail plate has grown back healthy. Complete healing of fingernails usually takes about 6 months, that of toenails about 9 to 12 months. If a fingernail or toenail is severely affected, or if several nails are affected, additional therapy with an oral medicine may be advisable. In these cases, please consult your doctor. Please talk to your doctor or pharmacist if you have the impression that the effect of Ciclopoli against nail fungus is too strong or too weak.

If you have used more Ciclopoli against nail fungus than you should

No cases of overdose have been reported to date.

If you forget to use Ciclopoli against nail fungus

If you forget to use it once, do not use a double dose to make up for it. Continue treatment as recommended by your doctor or as explained in section 3 of this package leaflet ("How to use Ciclopoli against nail fungus?"). If you have not used the active ingredient nail polish for several days, the effect may be impaired.

If you stop using Ciclopoli against nail fungus

If you stop treatment with Ciclopoli against nail fungus before the nail(s) is/are clear or almost clear, the fungus may not have disappeared yet. In this case, the condition of your nails may worsen again. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

General disorders and administration site conditions

Very rare: redness, scaling, burning and itching at the treated sites.
The reported side effects were mild and of short duration.

Reporting of side effects

If you get 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, Department of Pharmacovigilance, 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 CICLOPOLI AGAINST NAIL FUNGUS?

Keep this medicine out of the reach of children. Do not refrigerate. At temperatures below 15°C, the active ingredient nail polish may gel; slight flocculation or a slight deposit may form on the bottom of the bottle. This can be dissolved by rubbing the bottle between your hands for about 1 minute. The solution will then be clear again. This does not affect the quality of the product or its effectiveness. Before use, check whether the solution is clear (transparent) again by checking the bottom of the bottle. After use, please close the bottle tightly so that the contents do not evaporate. Do not leave the bottle open. Store the bottle in the folding box to protect the product from light. When stored as directed, Ciclopoli against nail fungus has a shelf life of 6 months after first opening. Caution: Flammable. Keep away from heat and open flame. Do not use the medicine after the expiry date which is stated on the folding box and the bottle after "Use by". The expiry date refers to the last day of the month indicated. Do not dispose of medicines in wastewater or household waste (regional differences). 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 Ciclopoli against nail fungus contains

The active ingredient is Ciclopirox. One gram of Ciclopoli against nail fungus contains 80 mg of Ciclopirox. The other ingredients are: ethyl acetate, ethanol 96%, cetyl stearyl alcohol (Ph. Eur.) [vegetable], hydroxypropyl chitosan and purified water.

What Ciclopoli against nail fungus looks like and contents of the pack

Ciclopoli against nail fungus is a clear, colourless to slightly yellowish solution. Ciclopoli against nail fungus is available in glass vials with screw caps and an inserted brush. Pack sizes are 3.3 ml and 6.6 ml.

Pharmaceutical entrepreneur

Taurus Pharma GmbH
Benzstr. 11
D-61352 Bad Homburg
Tel.: 06172/139683,
Fax: 06172/171550
info@tauruspharma.de

Manufacturer

Alfa Wassermann S.p.A.
Via Enrico Fermi, 1
65020 Alanno (PE)
Italy

or

Doppel Farmaceutici s.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (PC)
Italy

This leaflet was last revised in May 2014.

Source: Information from the package leaflet
Status: 10/2017
Active ingredient: Ciclopirox. Area of application: for the treatment of fungal nail infections (onychomycosis) caused by filamentous fungi and/or other fungi that can be treated with Ciclopirox.