LICOFORTE 40 mg/g GEL

Introduction

Package Leaflet: Information for the User

Licoforte 40 mg/g Gel

Hydroquinone

Read the 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, consult 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 not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Licoforte and what is it used for

Licoforte contains hydroquinone, which is a local depigmenting active ingredient. Licoforte works by gradually reducing the production of excess melanin that causes dark spots on the skin.

Licoforte is indicated for adults and children over 12 years old for the reduction of the color of small dark spots on the skin, such as melasma and chloasma, senile lentigo, and freckles.

2. What you need to know before starting to use Licoforte

Do not use Licoforte:

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• if you are receiving treatment for any chemical hyperpigmentation, such as ochronosis (asymmetric black-blue spots mainly on the face and neck) and colloid degeneration (milium colloid) of professional or cosmetic origin.
• on open wounds, mucous membranes, irritated skin, and sunburns.

Warnings and Precautions:

• It should only be applied to intact skin and on small surfaces.
• Avoid contact with eyes and mucous membranes. In case of accidental contact with the eyes, wash with plenty of water to avoid possible production of opaque spots on the cornea, and consult a doctor. In case of contact with the lips, a bitter taste and a slight anesthetic effect may be noticed in the area.
• If the pigmented area is very extensive, it should be treated in different cycles.
• During treatment with Licoforte, it is essential to protect the treated area from the sun, as even minimal sun exposure can reactivate melanin production. The treated areas should not be exposed to the sun (even on cloudy days) or to ultraviolet (UVA) lamps. It is recommended to use a high-protection sunscreen and apply it every 2 or 3 hours during sun exposure.
• Licoforte cannot be used to prevent sunburn.
• In people with very dark skin, the effects of Licoforte may be less visible.
• In some people, especially those with sensitive skin, allergic reactions may occur. To prevent this, it is advisable to apply a small amount of the product to the inner arm for at least 24 hours. If you notice that the area is irritated, do not use this medication.
• In some cases, a temporary darkening or irritation of the skin may occur; if it persists, treatment should be discontinued.
• Depigmentation is not immediate, as hydroquinoneonly interferes with the formation of new melanin, and it is only temporary, as when treatment is discontinued, melanin production resumes. Depigmentation can last between 2 and 6 months after treatment is completed. The darker the lesions are before treatment, the sooner they will repigment.
• Stop using this medication if the product has acquired a dark color.

Children and Adolescents

Do not use in children under 12 years old.

Using Licoforte with Other Medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

The simultaneous use of hydroquinonewith peroxides (such as hydrogen peroxide, benzoyl peroxide, etc.) may produce a temporary darkening in the area of the skin where they have been applied together, due to the oxidation of hydroquinone. This temporary coloration can be eliminated by discontinuing the use of one of these medications and washing the application area with a mild soap.

Pregnancy, Breastfeeding, and Fertility

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

The safety of Licoforte in human pregnancy has not been established. Therefore, this medication should only be used in pregnancy and breastfeeding when strictly necessary according to medical criteria.

Driving and Using Machines

No effects on the ability to drive and use machines have been reported.

Licoforte contains ethanol 96%, propylene glycol (E-1520), and butylhydroxytoluene

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

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

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

3. How to Use Licoforte

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

Licoforte is a medication for external use only (on the skin).

Adults and Children Over 12 Years Old

Apply a thin layer of gel, only to the area of skin where the spot is, always avoiding contact with the eyes and mucous membranes.

Wash your hands with soap after applying the product, as hydroquinone can cause brown spots on the nails that disappear over time.

Start with one application per day for 10 to 15 days, only on the spot, and continue treatment with two daily applications, one in the morning and one at night.

If no improvement is observed after 2 months of treatment, it should be discontinued and the doctor consulted.

The recommended duration of treatment is 60 to 90 days.

This medication should not be used for more than 6 months in any case.

Your doctor will indicate the duration of your treatment with Licoforte; do not discontinue treatment beforehand, as you will not achieve the desired effects.

Use in Children and Adolescents

Do not use in children under 12 years old, due to the lack of data on safety and efficacy in this population.

If You Use More Licoforte Than You Should

Due to its external use, it is unlikely that intoxication will occur.

In case of accidental ingestion, serious manifestations of systemic toxicity similar to those of phenol may occur. The oral ingestion of 5-15 g of hydroquinoneproduces tremors, convulsions, and hemolytic anemia. Gastric lavage is recommended.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Use Licoforte

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

4. Possible Side Effects

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

The side effects listed below are classified according to their frequency and the classification by organs and systems. The frequency categories are defined by the following convention: very common (affects more than 1 in 10 patients); common (affects up to 1 in 100 patients); uncommon (affects up to 1 in 1000 patients); rare (affects between 1 and 10 in 10,000 patients); very rare (affects less than 1 in 10,000 patients); frequency not known (cannot be estimated from the available data).

Uncommon: skin inflammation and redness (erythema) and itching.

Rare: increased skin sensitivity. If used in very prolonged treatments, a cutaneous hyperpigmentation reaction (skin spots) may occur, especially if the treated area is exposed to the sun.

Very rare: 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, especially in individuals of black race.

No systemic side effects have been reported.

If you consider that any of the effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting Side Effects:

If you experience any type of side effect, 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 Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Licoforte

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

Keep the tube perfectly closed after each application to protect it from light.

Do not use Licoforte if you notice a dark color, even if it is within the expiration date.

Do not use this medication after the expiration date shown on the packaging and tube, after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE POINT in your pharmacy. 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

Licoforte Composition:

• The active ingredient is hydroquinone. Each gram of gel contains 40 milligrams of hydroquinone.
• The other components (excipients) are: ethanol 96%, glycolic acid, propylene glycol (E-1520), polyquaternium-10, ammonium hydroxide, anhydrous citric acid (E-330), sodium metabisulfite (E-223), anhydrous sodium sulfite (E-221), disodium edetate, butylhydroxytoluene (E-321), and purified water.

Product Appearance and Package Contents

Licoforte 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 Last Revision of this Package Leaflet:June 2021

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