DEXULAC 80 MG/G MEDICINAL NAIL POLISH

Introduction

Package Leaflet: Information for the User

DexULac 80 mg/g Medicinal Nail Varnish

Ciclopirox

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again. If you have any questions, ask your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is DexULac and what is it used for
2. What you need to know before using DexULac
3. How to use DexULac
4. Possible side effects
5. Storage of DexULac
6. Package Contents and Additional Information

1. What is DexULac and what is it used for

DexULac 80mg/g Medicinal Nail Varnish is an effective antifungal agent (broad-spectrum antimycotic agent) for topical use on fingernails, toenails, and adjacent skin.

It is used to treat 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.

2. What you need to know before using DexULac

Do not useDexULacif:

• 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, as there is insufficient experience in this age group.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use DexULac 80mg/g Medicinal Nail Varnish.

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

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

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

Avoid contact with eyes and mucous membranes.

This medication is for external use only.

Do not use nail polish or other cosmetic products for the nails on the treated nails.

Children and Adolescents

DexULac 80mg/g Medicinal Nail Varnish is contraindicated in children and adolescents under 18 years of age (see section 2 "Do not use DexULac 80mg/g Medicinal Nail Varnish").

Other Medications and DexULac

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

Pregnancy and Breastfeeding

Pregnancy

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

Treatment with DexULac 80mg/g Medicinal Nail Varnish will only be carried out if necessary, after the responsible doctor has carefully evaluated the benefits against the possible risks.

Breastfeeding

It is not known whether ciclopirox passes into human breast milk. Treatment with DexULac 80mg/g Medicinal Nail Varnish will only be carried out if necessary, after the responsible doctor has carefully evaluated the benefits against the possible risks.

Driving and Using Machines

No special precautions are required.

DexULac 80mg/g Medicinal Nail Varnish contains Sodium Lauryl Sulfate

This medication contains 9.3 mg of sodium lauryl sulfate per 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.

3. How to use DexULac

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

Method of administration:

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

DexULac is for use in adults only.

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 medicinal nail varnish will be applied to the entire surface of the nail and to about 5 mm of the surrounding skin. If possible, DexULac should also be applied under 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, so it is recommended to apply it at night before bedtime. 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), it is sufficient to wash the nails carefully with water. Sometimes, due to inadequate washing of the nails, a white layer may appear on the surface of the nail after several days of treatment. A thorough wash with neutral soap and, if necessary, a nail brush or sponge, will help remove it. In case of accidental removal by washing, DexULac can be reapplied. It is recommended to regularly trim the nails to remove the infected parts.

Treatment should continue until the problem has disappeared, which means until the nail(s) are clean or almost clean and the healthy nail(s) have grown back. Normally, complete healing of fingernails is achieved in about 6 months and toenails in about 9 to 12 months.

If a fingernail or toenail is wide or severely affected, oral treatment may be recommended. Consult your doctor in these cases.

If you think the effect of this medication is too strong or too weak, tell your doctor or pharmacist.

If you use more DexULac than you should:

To date, no cases of overdose have been reported.

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

If you forget to use DexULac:

Do not use a double dose to make up for forgotten doses. Continue with the treatment as your doctor recommended or as explained in point 3 of this package leaflet (How to use DexULac). If you do not use the medicinal nail varnish for several days, the effectiveness may be reduced.

If you stop using DexULac:

If you stop using DexULac before your nail(s) are clean or almost clean, the fungi may not have disappeared.

In this case, the condition of the nails may worsen again.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

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

Unknown frequency (cannot be estimated from available data):

• skin rash and eczema at the application site.
• (transient) discoloration of the nail (this reaction may also be due to the fungal nail disease itself).

Side effects were of mild intensity and short duration.

Reporting of Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency: https://www.notificaram.es/. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of DexULac

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

Do not use the medication after the expiration date stated 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 tightly closed to prevent evaporation of the contents.

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

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

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

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

What contains DexULac

The active ingredient is ciclopirox. One gram of medicinal nail varnish contains 80 mg of ciclopirox.

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

What DexULac 80mg/g looks like and package contents:

DexULac 80mg/g Medicinal Nail Varnish is a clear, colorless or slightly yellow solution supplied in transparent glass bottles with screw caps provided with a brush.

Package sizes are 7 ml and 10 ml.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIO REIG JOFRE, S.A.

Gran Capitán, 10 – 08970 Sant Joan Despí, Barcelona

Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Portugal: DexULac 80mg/g Medicinal Nail Varnish

Spain: DexULac 80mg/g Medicinal Nail Varnish

Date of the last revision of this package leaflet:July2019

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/