Leaflet: information for the user

Licostrata 20 mg/g gel

hydroquinone

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

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 2 months.

1. What is Licostrata and what it is used for

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

3. How to use Licostrata

4. Possible side effects

5. Storage of Licostrata

6. Contents of the pack and additional information

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

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

This medication is for topical use, so you must apply it exclusively on 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 sunburned skin

Warnings and precautions:

• Only apply the product on intact skin and in small areas.
• You must avoid contact of the product with the eyes and mucous membranes. If accidental contact with the eyes occurs, wash them with plenty of water and consult a doctor. In case of contact with the lips, you may notice a bitter taste and a mild anesthetic effect in the area.
• You must protect the treated area from the sun.Treated areas must not be exposed to the sun (even on cloudy days) or ultraviolet (UVA) lamps.It is recommended to use a high-protection sunscreen and apply it every 2 or 3 hours during sun exposure time.
• 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, the application of the product may cause an allergic reaction. To prevent it, apply a small amount of product to the inside of your forearm for at least 24 hours. If you notice the area is irritated, do not use this medication.
• In some cases, the spots may not disappear completely with treatment.
• The reduction of the spot color in the affected skin area is not immediate and is only temporary since, when treatment is interrupted, melanin production resumes, and the effect may last between 2 and 6 months after treatment is completed.
• In some cases, a temporary darkening or irritation of the skin may occur. If it persists, you must discontinue treatment.

Children and adolescents:

Do not use in children under 12 years old.

Use of Licostrata with other medications:

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

You must not use topical preparations containing peroxides (such as hydrogen peroxide, benzoyl peroxide...) on the same skin area where you are applying Licostrata, as it may cause temporary darkening in the skin area where they are applied together. If this occurs, you must discontinue use of one of these medications and wash 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 Licostrata 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.

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

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

This medication contains 175 mg of alcohol (ethanol) in each gram of gel (17.5% p/p). 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 of the medication contained in this leaflet or those indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Adults and children over 12 years old

Wash the affected area of the skin and dry it afterwards.

Apply a small amount of product 2 times a day (morning and night) exclusively on the spot, until you achieve the desired effect, which may take 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.

Do not use the product for more than 6 months.

If you do not observe improvement after 2 months of treatment, you must interrupt it and consult your doctor.

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

Stop applying Licostrata when the spots disappear.

If you estimate that Licostrata's action is too strong or too weak, inform 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 data on safety and efficacy in this population.

If you use more Licostrata than you should

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

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

If you forgot to use Licostrata

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 classification.

Possible Adverse Effects

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

Uncommon(may affect up to 1 in 1,000 patients): 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(may affect up to 1 in 10,000 patients): 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, mainly in individuals of black race.

If you consider that any of the effects you are experiencing are 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 it is a possible adverse effect 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 about 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 Licostrata 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.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the PHARMACY TAKE-BACK POINT. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Licostrata:

- The active principle is hydroquinone. Each gram of gel contains 20 milligrams of hydroquinone.

- The other components (excipients) are: ethanol at 96 percent, glycolic acid, propylene glycol (E-1520), poliquaternium-10, kójic acid dipalmitate, ammonium hydroxide, anhydrous citric acid (E-330), sodium metabisulfite (E-223), sodium heptahydrate sulfite (E-221), disodium edetate, butylhydroxytoluene (E-321), carbomer 941, and purified water.

Appearance of the product and contents of the packaging

Licostrata is presented in the form of a transparent gel with a light alcoholic odor, in 30-gram tubes.

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/