LICOSTRATA 20 mg/g GEL

Introduction

Prospectus: Information for the User

Licostrata 20 mg/g Gel

Hydroquinone

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

Follow the administration instructions for the medication contained in this prospectus or as indicated by your doctor or pharmacist exactly.

• Keep this prospectus, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.
• You should consult a doctor if it worsens or does not improve after 2 months.

Prospectus Content

1. What Licostrata is and what it is used for
2. What you need to know before starting to use Licostrata
3. How to use Licostrata
4. Possible adverse effects
5. Storage of Licostrata
6. Package contents and additional information

1. What Licostrata is and what it is used for

Licostrata contains hydroquinone as the active ingredient, which acts by gradually reducing the production of excess melanin that causes dark spots on the skin.

This medication is indicated for adults and children over 12 years old to reduce the color of small dark spots that occasionally appear on the skin, such as freckles and age spots.

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

This medication is for topical use, so it should be applied exclusively to the skin spots. Do not ingest it.

Do not use Licostrata:

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

Warnings and precautions:

• It should only be applied to intact skin and on small surfaces.
• You should avoid contact between the product and the eyes and mucous membranes. If accidental contact with the eyes occurs, they should be rinsed with plenty of water and a doctor consulted. In case of contact with the lips, a bitter taste and a slight anesthetic effect in the area may be noticed.
• You must protect the treated area from the sun. 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.
• This medication cannot be used to prevent sunburn.
• If you have very dark skin, you may not notice 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 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, the spots do not completely disappear with treatment.
• The reduction in the color of the spot in the affected area of the skin is not immediate and is only temporary, as when treatment is interrupted, melanin production resumes, and the effect may last between 2 and 6 months after treatment ends.
• In some cases, temporary darkening or irritation of the skin may appear. If it persists, treatment should be interrupted.

Children and adolescents

Do not use in children under 12 years old.

Using Licostrata with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication on the same area of skin to be treated, including those purchased without a prescription.

Do not use topical preparations containing peroxides (such as hydrogen peroxide, benzoyl peroxide...) on the same area of skin where Licostrata is being applied, as this may cause temporary darkening in the area of skin where they have been applied together. If this occurs, use of one of these medications should be interrupted and the application area washed 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 Licostrata in human pregnancy has not been established. Therefore, this medication should only be used during 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 described.

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

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 Licostrata

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

Licostrata is a topical medication, exclusively for external use (on the skin).

Adults and children over 12 years old

Wash the affected area of skin and dry it afterwards.

Apply a small amount of product 2 times a day (morning and night) exclusively to the spot, until the desired effect is achieved, which may require several weeks of treatment.

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

Never use the product for more than 6 months.

If you do not notice improvement after 2 months of treatment, you should interrupt it and consult a doctor.

Apply a high-protection sunscreen to the spot or cover the area with clothing, as you must protect the treated area from the sun while using the product, as well as after treatment, to prevent the spots from reappearing.

Interrupt the application of Licostrata when the spots disappear.

If you think the effect of Licostrata is too strong or too weak, tell your doctor or pharmacist.

Use in children and adolescents

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

If you use more Licostrata than you should

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

In case of accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone: 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 forgotten doses. Continue treatment with the recommended dose.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not everyone experiences them.

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

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

Rare (may affect up to 1 in 1,000 patients): 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 (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, mainly in individuals of black race.

If you consider that any of the effects you are experiencing is serious 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 it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Licostrata

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

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. 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

Licostrata composition:

• The active ingredient is hydroquinone. Each gram of gel contains 20 milligrams of hydroquinone.
• The other components (excipients) are: 96% ethanol, glycolic acid, propylene glycol (E-1520), polyquaternium-10, kojic acid dipalmitate, 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.

Product appearance and package contents

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 last revision of this prospectus: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/