Label: information for the user

DexULac 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 you should not give it 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.

1. What isDexULacand how it is used

2. What you need to know before starting to useDexULac

3. How to useDexULac

4. Possible adverse effects

5. Storage ofDexULac

6. Contents of the package and additional information

DexULac80mg/g nail polish medicamentosois an effective antifungal agent (broad-spectrum antimycotic agent) for topical use on fingernails, toenails, and adjacent skin.

It is used for the treatment of mild to moderate fungal infections of the nails (onychomycosis) caused by filamentous fungi and/or other fungi that could be cured with ciclopirox.

The active ingredient ciclopirox prevents the growth of fungi and destroys them, so that the appearance of the nails improves.

Do not useDexULac:

• If you are allergic to ciclopirox or any of the other components of this medication (listed in section 6).
• In children and adolescents under 18 years of age since there is not enough experience in this age group.

Warnings and precautions

Consult your doctor or pharmacist before starting to useDexULac80mg/g nail polish medicamentoso.

In case of sensitization, stop treatment and consult your doctor.

As with all topical treatments for onychomycosis, if multiple nails (more than 5 nails) are affected, in the case of altered more than two-thirds of the nail plate, and in cases of predisposing factors, such as diabetes and immune disorders, consult your doctor for the possible addition of an oral therapy to your nail polish.

If you are diabetic, be careful when cutting your nails.

Avoid contact with the eyes and mucous membranes.

This medication is only for external use.

Do not use nail polish or any other type of cosmetic product for nails on treated nails.

Children and adolescents

DexULac80mg/g nail polish medicamentosois contraindicated in children and adolescents under 18 years of age (see section 2 “Do not useDexULac80mg/g nail polish medicamentoso”).

Other medications andDexULac

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pregnancy and lactation

Pregnancy

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

The treatment with DexULac80mg/g nail polish medicamentosowill only be performed, if necessary, after the responsible doctor has carefully evaluated the benefits against the possible risks.

Lactation

It is not known if ciclopirox passes into human breast milk. The treatment with DexULac80mg/g nail polish medicamentosowill only be performed, if necessary, after the responsible doctor has carefully evaluated the benefits against the possible risks.

Driving and operating machines

No special precautions are required.

DexULac80mg/g nail polish medicamentosocontains Sodium lauryl sulfate

This medication contains 9.3 mg of sodium lauryl sulfate in each ml of solution.

Sodium lauryl sulfate may cause local skin reactions (such as itching or burning sensation) or increase skin reactions caused by other medications when applied to the same area.

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.

Form of administration:

Cutaneous use (only for use on nails and adjacent skin).

DexULac is only for use in adults.

The recommended dose is to apply a thin layer once a day to the infected nail(s).

To do this, the nails must be clean and dry. The medicated nail polish will be applied over the entire surface of the nails and in a 5 mm radius of the surrounding skin. If possible, DexULac should also be applied underneath the nail.

Allow the medication to dry for about 30 seconds.

The nail(s) should not be washed for at least 6 hours after application, therefore, it is recommended to apply at night before going to bed. After this time, normal hygiene practices can be continued.

This medication does not need to be removed with solvents or abrasive products (e.g., nail file), simply wash the nails carefully with water. Occasionally, due to inadequate nail washing, a white layer may appear on the surface of the nail after several days of treatment. A thorough washing with neutral soap and, if necessary, a nail brush or sponge, will help to remove it. In the event of accidental removal by washing, DexULac can be reapplied. It is recommended to trim the nails regularly to remove the infected parts of the nail.

Treatment should continue until the problem has disappeared, meaning until the nail(s) is/are clean or almost clean and the healthy nail(s) has/have grown back. Normally, complete healing of hand nails is achieved in about 6 months and foot nails in approximately 9 to 12 months.

If a hand or foot nail is wide or severely affected, it may be recommended to use oral treatment. Consult your doctor in these cases.

If you consider that the effect of this medication is too strong or weak, inform your doctor or pharmacist.

If you use more DexULac than you should:

Up to now, no cases of overdose have been described.

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 DexULac:

Do not use a double dose to compensate for the missed doses. Continue treatment as recommended by your doctor or as explained in point 3 of this leaflet (How to use DexULac). In the case of not using the medicated nail polish for several days, the effectiveness may be reduced.

If you interrupt treatment with DexULac:

If you interrupt treatment with DexULac before your nail(s) is/are clean or almost clean, the fungi may not have disappeared.

In this case, the nail situation may worsen again.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Very rare adverse effects(may affect up to 1 in 10,000):

• redness, scales, itching, and burning at the application site

Unknown (frequency cannot be estimated from available data):

• skin eruption and eczemaat the application site
• (transient) nail discoloration (this reaction may also be due to the underlying fungal infection of the nail).

The adverse effects were of mild intensity and short duration.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products 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 reach and sight of children.

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

Store the bottle in the outer packaging to protect it from light..

Keep the bottle perfectly closed to prevent the contents from evaporating.

This product is flammable. Keep away from heat and flames.

After the first opening of the 7 ml bottle, use within 6 months.

After the first opening of the 10 ml bottle, use within 12 months.

Medications should not be disposed of through drains or in the trash. Deposit empty containers and unused medications at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of unused containers and medications. By doing so, you will help protect the environment.

What DexULac contains

The active ingredient is ciclopirox. One gram of medicated nail polish contains 80 mg of ciclopirox.

The other components are: hydroxypropyl-β-cyclodextrin, poloxamer 407, sodium lauryl sulfate, ethyl acetate, ethanol, and purified water.

What it looks likeDexULac 80mg/gand contents of the packaging:

DexULac 80mg/g medicated nail polishis a transparent, colorless or slightly yellowish solution supplied in transparent glass bottles with screw-top caps provided with an applicator.

The packaging sizes are 7 ml and 10 ml.

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer responsible

LABORATORIO REIG JOFRE, S.A

Gran Capitán, 10 – 08970 Sant Joan Despí, Barcelona

Spain

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

Portugal: DexULac 80mg/g medicated nail polish for fingernails
Spain: DexULac 80mg/g medicated nail polish

Last review date of this leaflet:July2019

The 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/