Package Insert: Information for the User

Licoforte 40 mg/g Gel

Hydroquinone

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

• Keep this package insert, as you may need to refer to it again.
  If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone and should not be given 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 package insert. See section 4.

1. What is Licoforte and how is it used

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

3. How to use Licoforte

4. Possible adverse effects

5. Storage of Licoforte

6. Contents of the package and additional information

Licoforte contains hydroquinone, which is a depigmenting active ingredient with local action.Licoforte acts by gradually reducing the excessive production of melanin that causes dark skin spots.

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

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 (milia colloid) both of professional and cosmetic origin.
• on open wounds, mucous membranes, irritated skin, and sunburns.

Warnings and precautions:

• Only apply the product to intact skin and in small areas.
• Avoid contact with the eyes and mucous membranes. In case of accidental contact with the eyes, perform a thorough rinse with plenty of water to prevent possible opacification of the cornea, and consult a doctor. In case of contact with the lips, a bitter taste and a mild anesthetic effect in the area may be noticed.
• 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 minimal sun exposure can reactivate melanin production. Treated areas should not be exposed to the sun (even on cloudy days) or ultraviolet lamps (UVA). It is recommended to use a high-protection sunscreen and apply it every 2 or 3 hours during sun exposure time.
• Licoforte cannot be used to prevent sunburns.
• In people with very dark skin, the effects of Licoforte may be less visible.
• In some individuals, 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 forearm for at least 24 hours. If you notice irritation in the area, do not use this medication.
• In some cases, temporary darkening or skin irritation may occur; if it persists, treatment should be discontinued.
• Depigmentation is not immediate, as hydroquinone only interferes with the formation of new melanin, and it is only temporary, as when treatment is stopped, melanin production resumes. Depigmentation may be maintained between 2 and 6 months after treatment completion. The darker the lesions, the sooner they repigment.
• Stop using this medication if the product has acquired a dark brown color.

Children and adolescents:

Do not use in children under 12 years old.

Use of Licoforte with other medications:

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

The simultaneous use of hydroquinone with peroxides (e.g., hydrogen peroxide, benzoyl peroxide, etc.) may produce temporary darkening in the skin area where they have been applied together, due to the oxidation of hydroquinone. This temporary coloration is eliminated by stopping 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machinery:

No effects on the ability to drive and operate machinery have been described.

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 injured skin.

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

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

Licoforte is a topical medication (exclusively for the skin).

Adults and children over 12 years old

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

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

Start with one application per day for 10 or 15 days, exclusively 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 interrupted and the doctor consulted.

The recommended treatment duration is 60 to 90 days.

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

Your doctor will indicate the duration of your treatment with Licoforte, do not suspend the 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 absence 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 systemic toxicity cases will occur.

In case of accidental ingestion, serious manifestations of systemic toxicity similar to those of phenol may occur. Ingestion of 5-15 g ofhydroquinoneproduces tremors, convulsions, and hemolytic anemia. A stomach lavage is recommended.

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

If you forgot to use Licoforte

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

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

The adverse effects listed below are classified according to their frequency and by organ and system. 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 fewer than 1 in 10,000 patients); frequency not known (cannot be estimated from available data).

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

Rare: more sensitive skin. If used in very prolonged treatments, a skin hyperpigmentation reaction (skin discoloration) may occur, especially if the treated area is exposed to the sun.

Very rare: skin decoloration (leucodermia). In prolonged treatments (more than 6 months) and at high doses, the appearance of asymmetrical black-blue spots mainly on the face and neck (ochronosis) has been observed, especially in individuals of black race.

No systemic adverse effects have been described.

If you consider any of the effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist even if they are possible adverse effects not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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 a dark coloration is observed, even if it is within the expiration date.

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

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines that you no longer need at the PICKUP POINT of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Licoforte:

• The active principle is hydroquinone. Each gram of gel contains 40 milligrams of hydroquinone.
• The other components (excipients) are: ethanol at 96 percent, glycolic acid, propylene glycol (E-1520), poliquaternium–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.

Appearance of the product and content of the packaging

Licoforte is presented in the form of a transparent gel with a light alcoholic odor, in tubes of 30 grams.

Holder of the marketing authorization and responsible for manufacturing

Industrial Farmacéutica Cantabria, S.A.

Barrio Solía 30

La Concha de Villaescusa

39690 Cantabria (Spain)

Date of the last review of this leaflet:June 2021

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/