LicoForte 40 mg/g gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Licoforte 40 mg/g gel
hydroquinone
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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- 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.
Leaflet contents
- What Licoforte is and what it is used for
- What you need to know before using Licoforte
- How to use Licoforte
- Possible side effects
- How to store Licoforte
- Contents of the pack and other information
1. What Licoforte is and what it is used for
Licoforte contains hydroquinone, which is a locally-acting depigmenting active substance. Licoforte works by gradually reducing the overproduction of melanin that causes dark spots on the skin.
Licoforte is indicated in adults and children over 12 years of age for lightening dark skin spots such as melasma and chloasma, senile lentigo, and freckles.
2. What you need to know before using Licoforte
Do not use Licoforte:
- if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
- if you are undergoing treatment for any chemical hyperpigmentation such as ochronosis (asymmetrical black-blue spots mainly on the face and neck) and colloidal degeneration (colloid milium), whether of occupational or cosmetic origin.
- on open wounds, mucous membranes, irritated skin, or sunburns.
Warnings and precautions:
- This product should only be applied to intact skin and on small areas.
- Avoid contact with eyes and mucous membranes. In case of accidental contact with the eyes, rinse thoroughly with plenty of water to prevent possible formation of opaque spots on the cornea, and consult your doctor. If contact occurs with the lips, a bitter taste and slight anesthetic effect in the area may be noticed.
- If the pigmented area is very large, treatment should be performed in separate cycles.
- During treatment with Licoforte, it is essential to protect the treated area from sunlight, as even minimal sun exposure may reactivate melanin production. 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.
- Licoforte must not be used to prevent sunburns.
- In individuals with very dark skin, the effects of Licoforte may be less noticeable.
- 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 forearm for at least 24 hours. If irritation occurs, do not use this medicine.
- In some cases, temporary darkening or irritation of the skin may occur; if this persists, treatment should be discontinued.
- Depigmentation is not immediate, as hydroquinone only interferes with the formation of new melanin, and is temporary, since melanin production resumes once treatment is stopped. Depigmentation may last between 2 and 6 months after treatment ends. The darker the lesions, the faster repigmentation occurs.
- Stop using this medicine if the product has turned blackish in color.
Children and adolescents
Do not use in children under 12 years of age.
Use of Licoforte with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Concurrent use of hydroquinone with peroxides (e.g., hydrogen peroxide, benzoyl peroxide, etc.) may cause temporary darkening of the skin area where both products are applied together, due to oxidation of hydroquinone. This temporary discoloration resolves by discontinuing one of the products and washing 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 Licoforte in human pregnancy has not been established. Therefore, this medicine should only be used during pregnancy and breastfeeding when strictly necessary, as determined by a physician.
Driving and use of machinery
No effects on the ability to drive or operate machinery have been reported.
Licoforte contains 96% ethanol, propylene glycol (E-1520), and butylated hydroxytoluene
This medicine contains 40 mg of propylene glycol (E-1520) per gram of gel. Propylene glycol (E-1520) may cause skin irritation.
This medicine contains 175 mg of alcohol (ethanol) per 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 butylated hydroxytoluene (E-321).
3. How to use Licoforte
Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Licoforte is a topical medicine (for use on the skin only).
Adults and children over 12 years of age
Apply a thin layer of gel only to the area of skin affected by the pigmentation spot, avoiding contact with the eyes and mucous membranes at all times.
Wash hands thoroughly with soap after applying the product, as hydroquinone may cause brown stains on the nails, which disappear over time.
Begin with one application per day for 10 to 15 days, applied exclusively to the pigmented spot, and then continue treatment with two daily applications, one in the morning and one in the evening.
If no improvement is observed after 2 months of treatment, treatment should be discontinued and you should consult your doctor.
The recommended duration of treatment is 60 to 90 days.
This medicine must not under any circumstances be used for longer than 6 months.
Your doctor will determine the duration of your treatment with Licoforte. Do not stop treatment prematurely, as you may not achieve the desired effects.
Use in children and adolescents
Do not use in children under 12 years of age due to lack of data on safety and efficacy in this population.
If you use more Licoforte than you should
Due to its external use, cases of intoxication are unlikely.
In case of accidental ingestion, serious manifestations of systemic toxicity similar to those of phenol may occur. Oral ingestion of 5–15 g of hydroquinone may cause tremors, convulsions, and hemolytic anemia. Gastric lavage is recommended.
In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Licoforte
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 produce adverse effects, although not everyone experiences them.
The adverse effects listed below are classified according to frequency and by organ systems. 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 1,000 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 available data).
Uncommon: skin inflammation and redness (erythema) and stinging.
Rare: 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: skin discoloration (leucoderma). With prolonged treatment (more than 6 months) and high doses, the appearance of asymmetric black-blue spots mainly on the face and neck (ochronosis) has been observed, particularly in individuals of black race.
Systemic adverse effects have not been reported.
If you consider any of the effects you experience to be severe, or if you notice any adverse effects not mentioned 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 they are possible adverse effects 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 Licoforte
Keep this medicine out of the sight and reach of children.
Keep the tube tightly closed after each use to protect it from light.
Do not use Licoforte 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, after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE POINT at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the container and other information
Composition of Licoforte:
- The active substance is hydroquinone. Each gram of gel contains 40 milligrams of hydroquinone.
- The other components (excipients) are: ethanol 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 contents of the container
Licoforte is presented as a transparent gel with a slight alcoholic odor, in 30-gram tubes.
Marketing Authorization Holder and Manufacturer Responsible
Industrial Farmacéutica Cantabria, S.A.
Barrio Solía 30
La Concha de Villaescusa
39690 Cantabria (Spain)
Date of the most recent review 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/