Dexulac 80 mg/g medicated nail lacquer
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
DexULac 80 mg/g medicated nail lacquer
Ciclopirox
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents
- What DexULac is and what it is used for
- What you need to know before using DexULac
- How to use DexULac
- Possible side effects
- How to store DexULac
- Contents of the pack and other information
1. What DexULac is and what it is used for
DexULac 80mg/g medicated nail lacquer is an effective antifungal agent (broad-spectrum antimycotic) 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 may be responsive to ciclopirox.
The active ingredient, ciclopirox, prevents fungal growth and destroys fungi, thereby improving the appearance of the nails.
2. What you need to know before using DexULac
Do not use DexULac:
- if you are allergic to ciclopirox or to any of the other ingredients of this medicine (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 medicated nail lacquer.
If signs of hypersensitivity occur, discontinue treatment and consult your doctor.
As with all topical treatments for onychomycosis, if multiple nails are affected (more than 5 nails), if more than two-thirds of the nail plate is altered, or in the presence of predisposing factors such as diabetes or immune disorders, consult your doctor to evaluate the possible need for adding an oral therapy to your nail lacquer treatment.
If you are diabetic, be cautious when trimming your nails.
Avoid contact with eyes and mucous membranes.
This medicine is for external use only.
Do not apply nail polish or any other cosmetic nail product on treated nails.
Children and adolescents
DexULac 80mg/g medicated nail lacquer is contraindicated in children and adolescents under 18 years of age (see section 2 “Do not use DexULac 80mg/g medicated nail lacquer”).
Other medicines and DexULac
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Treatment with DexULac 80mg/g medicated nail lacquer should only be carried out, if urgently needed, after the responsible physician has carefully evaluated the benefits versus the potential risks.
Breastfeeding
It is not known whether ciclopirox passes into human breast milk. Treatment with DexULac 80mg/g medicated nail lacquer should only be carried out, if urgently needed, after the responsible physician has carefully evaluated the benefits versus the potential risks.
Driving and using machines
No special precautions are required.
DexULac 80mg/g medicated nail lacquer contains Sodium Lauryl Sulfate
This medicine 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 may increase skin reactions caused by other medicines when applied to the same area.
3. How to use DexULac
Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Method of administration:
For topical use (only on the nails and adjacent skin).
DexULac is for use in adults only.
The recommended dose is to apply a thin layer once daily to the infected nail(s).
To do this, the nails must be clean and dry. The medicated nail lacquer should be applied to the entire surface of the nail(s) and to approximately 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; therefore, it is recommended to apply the product at night before going to bed. After this time, normal hygiene practices may be resumed.
This medicine 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 nail surface after several days of treatment. Thorough washing with neutral soap and, if necessary, a nail brush or sponge will help remove it. If the product is accidentally removed by washing, DexULac may be reapplied. Regular nail trimming is recommended to remove infected parts of the nail.
Treatment should continue until the problem has resolved, meaning until the nail(s) are clear or almost clear and healthy nail(s) have regrown. Complete healing typically takes about 6 months for fingernails and approximately 9 to 12 months for toenails.
If a fingernail or toenail is extensively or severely affected, oral treatment may be advisable. Consult your doctor in such cases.
If you think the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.
If you use more DexULac than you should:
Cases of overdose have not been reported to date.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20 (indicating the medicine and the amount ingested).
If you forget to use DexULac:
Do not use a double dose to make up for missed doses. Continue treatment as recommended by your doctor or as explained in section 3 of this leaflet (How to use DexULac). If the medicated nail lacquer is not used for several days, effectiveness may be reduced.
If you stop using DexULac:
If you stop treatment with DexULac before your nail(s) are clear or almost clear, the fungi may not have been eradicated.
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 adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Very rare adverse effects (may affect up to 1 in 10,000):
- redness, scaling, itching, and burning at the application site
Not known (frequency cannot be estimated from available data):
- skin rash and eczema at the application site
- (transient) nail discoloration (this reaction may also be due to the fungal nail disease itself).
The adverse effects were mild in intensity and of short duration.
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of DexULac
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the bottle after EXP. The expiry date refers to 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 away from heat and flames.
After first opening the 7 ml bottle, use within 6 months.
After first opening the 10 ml bottle, use within 12 months.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
What DexULac contains
The active substance is ciclopirox. One gram of medicated nail lacquer contains 80 mg of ciclopirox.
The other components are: hydroxypropyl-ß-cyclodextrine, poloxamer 407, sodium lauryl sulfate, ethyl acetate, ethanol and purified water.
What DexULac 80mg/g looks like and contents of the pack:
DexULac 80mg/g medicated nail lacquer is a clear, colourless or slightly yellow solution supplied in transparent glass bottles with screw caps fitted with a brush.
Pack sizes are 7 ml and 10 ml.
Only some pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Responsible
LABORATORIO REIG JOFRE, S.A
Gran Capitán, 10 – 08970 Sant Joan Despí, Barcelona
Spain
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Portugal: DexULac 80mg/g verniz para unhas medicamentoso
Spain: DexULac 80mg/g barniz de uñas medicamentoso
Date of the most recent review of this leaflet: July 2019
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/