Licofar 20 mg/g gel

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Licostrata 20 mg/g gel

hydroquinone

Read the entire package leaflet carefully before you start using this medicine, because it contains important information for you.

Always follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if there is no improvement after 2 months.

Contents of the package leaflet

1. What Licostrata is and what it is used for
2. What you need to know before using Licostrata
3. How to use Licostrata
4. Possible adverse effects
5. How to store Licostrata
6. Contents of the pack and other information

1. What Licostrata is and what it is used for

Licostrata contains hydroquinone as the active substance, which acts by gradually reducing the overproduction of melanin that causes dark skin spots.

This medicinal product is indicated in adults and children over 12 years of age for lightening small dark spots that occasionally appear on the skin, such as freckles and age spots.

2. What you need to know before using Licostrata

This medicine is for topical use only, so you must apply it exclusively to the skin patches. Do not ingest it.

Do not use Licostrata:

• If you are allergic to hydroquinone or to any of the other components of this medicine (listed in section 6).
  • On an open wound
  • On irritated skin
  • On mucous membranes or sunburned skin

Warnings and precautions:

• You should apply the product only on intact skin and on small areas.
• Avoid contact of the product with eyes and mucous membranes. If accidental contact with the eyes occurs, rinse thoroughly with plenty of water and consult your doctor. In case of contact with the lips, you may experience a bitter taste and a slight numbing sensation in the area.
• You must protect the treated area from sunlight. Treated areas must not be exposed to sunlight (even on cloudy days) or to ultraviolet (UVA) lamps. It is advisable to use a high-protection sunscreen and reapply it every 2 to 3 hours during sun exposure.
• This medicine must not be used to prevent sunburn.
• If you have very dark skin, you may not observe the effects of the product.
• If you have sensitive skin, applying the product may cause an allergic reaction. To prevent this, apply a small amount of the product to the inner forearm for at least 24 hours. If you notice irritation in the area, do not use this medicine.
• In some cases, skin spots may not completely disappear with treatment.
• The lightening of the skin spot in the affected area is not immediate and is only temporary, since melanin production resumes when treatment is stopped. The effect may last between 2 and 6 months after treatment ends.
• In some cases, temporary darkening or irritation of the skin may occur. If this persists, you must stop treatment.

Children and adolescents

Do not use in children under 12 years of age.

Use of Licostrata with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines on the same area of skin to be treated, including those obtained without a prescription.

Do not use topical preparations containing peroxides (for example: hydrogen peroxide, benzoyl peroxide...) on the same skin area where you are applying Licostrata, as this may cause temporary darkening of the skin where both products have been applied together. If this occurs, you must discontinue use of one of these medicines and wash the application area with a mild soap.

Pregnancy, breastfeeding, and fertility

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

The safety of Licostrata in human pregnancy has not been established. Therefore, this medicine should only be used during pregnancy and breastfeeding when strictly necessary, as determined by medical judgment.

Driving and using machines

No effects on the ability to drive or operate machinery have been reported.

Licostrata contains 96 percent ethanol, propylene glycol (E-1520), and butylhydroxytoluene (E-321).

This medicine contains 40 mg of propylene glycol (E-1520) in each gram of gel. Propylene glycol (E-1520) may cause skin irritation.

This medicine contains 175 mg of alcohol (ethanol) in each gram of gel (17.5% w/w). It may cause a burning sensation on damaged skin.

This medicine may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxytoluene (E-321).

3. How to use Licostrata

Follow exactly the instructions for use provided in this leaflet or those given by your doctor. If in doubt, consult your doctor or pharmacist again.

Licostrata is a cutaneous medication intended for external use only (on the skin).

Adults and children over 12 years of age

Wash the affected area of skin and dry it afterwards.

Apply a small amount of the product twice daily (morning and night), exclusively to the discolored spot, until the desired effect is achieved. Several weeks of treatment may be necessary.

Wash hands thoroughly with soap after applying the product, as hydroquinone may cause brown stains on the nails, which disappear over time.

Under no circumstances should the product be used for longer than 6 months.

If no improvement is observed after 2 months of treatment, treatment should be discontinued and medical advice sought.

Apply a high-protection sunscreen or cover the area with clothing, as the treated area of skin must be protected from sunlight during treatment and also after treatment, to prevent the spots from reappearing.

Discontinue application of Licostrata when the spots disappear.

If you feel that the effect of Licostrata is too strong or too weak, inform your doctor or pharmacist.

Use in children and adolescents

Do not administer this medicine to children under 12 years of age due to lack of safety and efficacy data in this population.

If you use more Licostrata than you should

Due to its external use, intoxication is unlikely.

In case of accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Licostrata

Do not apply a double dose to make up for missed doses. Continue treatment with the recommended dose.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

The adverse effects listed below are classified according to their frequency and by organ system.

Uncommon (may affect up to 1 in 100 patients): skin inflammation and redness (erythema) and stinging.

Rare (may affect up to 1 in 1,000 patients): increased skin sensitivity. If used in very prolonged treatments, a reaction of cutaneous hyperpigmentation (skin spots) may occur, especially if the treated area is exposed to sunlight.

Very rare (may affect up to 1 in 10,000 patients): skin discoloration (leucoderma).

In prolonged treatments (more than 6 months) and at high doses, the appearance of asymmetric black-blue spots, mainly on the face and neck (ochronosis), has been observed, primarily in individuals of black race.

If you consider any of the effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

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 mentioned 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 Licostrata

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

Keep the tube completely closed after each use to protect it from light.

Do not use Licostrata if a dark discoloration is observed, even if it is within the expiry date.

Do not use this medicine after the expiry date stated on the packaging and on the tube, following EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the PUNTO SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Licostrata:

• The active substance is hydroquinone. Each gram of gel contains 20 milligrams of hydroquinone.
• The other components (excipients) are: ethanol 96 percent, glycolic acid, propylene glycol (E-1520), poliquaternium-10, dipalmitoyl kojic acid, ammonium hydroxide, anhydrous citric acid (E-330), sodium metabisulfite (E-223), sodium sulfite heptahydrate (E-221), disodium edetate, butylhydroxytoluene (E-321), carbomer 941 and purified water.

Nature of the product and contents of the pack

Licostrata is presented as a transparent gel with a slight alcoholic odor, in 30-gram tubes.

Marketing Authorization Holder and Manufacturer

Industrial Farmacéutica Cantabria, S.A.,
Barrio Solía 30
La Concha de Villaescusa
39690 Cantabria (Spain)

Date of the most recent revision of this leaflet: June 2021

Detailed 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/