PATIENT INFORMATION LEAFLET

Melanasa 20 mg/g Cream

Hydroquinone

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those given 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.

Melanasa is a topical cream medication whose active ingredient, hydroquinone, acts by gradually reducing the excessive production of melanin that causes dark skin spots.

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

This medication is for topical use, so it must be applied exclusively to the skin spots that you want to treat. Do not ingest it.

Do not use Melanasa

• If you are allergic to the active ingredients or to 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

Consult your doctor or pharmacist before starting to use Melanasa.

• It must only be applied to intact skin and in small areas.
• It must be avoided to come into contact 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.
• The treated areas must not be exposed to the sun (even on cloudy days) or ultraviolet lamps (UVA).
• This medication cannot be used to prevent sunburns.
• 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 the product to the inside of the forearm 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 appear. If it persists, discontinue treatment.

Keep in mind that the reduction of skin spots in the affected area of the skin is not immediate and is only temporary since, when treatment is discontinued, melanin production resumes, and the effect may last between 2 and 6 months after treatment is completed.

In some cases, the spots may not completely disappear with treatment.

Children and adolescents

Do not use in children under 12 years old.

Other medications and Melanasa

Inform your doctor or pharmacist if you are using or have recently usedor may need to useany other medication.

Do not use topical preparations containing peroxides (such as hydrogen peroxide, benzoyl peroxide...) on the same skin area where Melanasa is being applied, as a temporary darkening may occur in the skin area where they are applied together. If this occurs, discontinue use of one of these medications and wash the application area with a mild soap.

Pregnancy and lactation 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 Melanasa in human pregnancy has not been established. 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.

Melanasacontains cetearyl alcohol, cetil alcohol, hydrogenated ricinoleic acid and polyoxylglycerides, methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetearyl alcohol and cetil alcohol.

This medication may cause skin reactions because it contains hydrogenated ricinoleic acid polyoxylglycerides.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

Followexactly theadministration instructionscontained in this leaflet or those indicated by yourdoctor or pharmacist.In case of doubt, ask yourdoctor or pharmacist.

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

Use in children

It is not recommended for use in children under 12 years old.

Adults and children over 12 years old

Before using the tube for the first time, you must unscrew the brown cap, remove and discard the white ring, and screw the cap back on.

Wash the affected skin area 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.You must wash your hands with soap after applying the product, as hydroquinone may cause brown stains on the nails that disappear over time.

Do not use the product for more than 6 months.

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

Apply a high-factor 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 the spots from reappearing.

Stop applying Melanasa when the spots disappear.

If you think Melanasa's action is too strong or too weak, inform your doctor or pharmacist.

If you use more Melanasa than you should

Due to its topical use, it is unlikely that you will experience poisoning symptoms.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forgot to use Melanasa

Do not make a double application to compensate for the missed doses. Continue treatment with the recommended dosage.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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: skin inflammation and redness (erythema) and itching.

Rare: increased skin sensitivity (increased cutaneous sensitivity) and skin spots (cutaneous hyperpigmentation).

Very rare: blue-black discoloration of cartilages, tendons, and some facial areas (ochronosis) and skin depigmentation (leucodermia)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the national notification system:www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

Keep the tube perfectly closed to protect it from light.

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

Do not use this medication if you observe a dark coloration, even if it is within the validity period.

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

Composition of Melanasa

• The active principle is hydroquinone. Each gram of cream contains 20 mg of hydroquinone.
• The other components (excipients) are: cetostearyl alcohol emulsifying agent type B, ethylhexyl methoxycinnamate, isopropyl myristate, cetostearyl alcohol polyoxylglycerides, decyl oleate, hydrogenated ricinoleic acid and polyoxylglycerides, butyl methoxydibenzoylmethane, cetyl alcohol, propylene glycol (E-1520), tocopherol acetate, sodium metabisulfite (E-223), methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), disodium edetate, lactic acid (E-270), and purified water.

Appearance of the product and contents of the container

Melanasa is presented in the form of a white cream, in aluminum tubes of 15 and 30 grams.

Only some sizes of packaging may be commercially available

Holder of the marketing authorization

Laboratorios Viñas, S.A.

Provenza, 386

08025 Barcelona

Spain

Responsible for manufacturing:

Laboratorios Viñas, S.A.

Torrente Vidalet, 29 - 08012 Barcelona

Spain

Last review date of this leaflet: March 2021

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