MELANASA 20 mg/g CREAM

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Melanasa 20 mg/g cream

hydroquinone

Read all of 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 as indicated by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience 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 it worsens or does not improve after 2 months.

Contents of the package leaflet

1. What is Melanasa and what is it used for
2. What you need to know before you start using Melanasa
3. How to use Melanasa
4. Possible side effects
5. Storage of Melanasa
6. Contents of the pack and further information

1. What is Melanasa and what is it used for

Melanasa is a medicinal product in the form of a cream for cutaneous use, whose active principle, hydroquinone, acts by gradually reducing the production of excess melanin that causes dark spots on the skin.

This medicinal product 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.

2. What you need to know before you start using Melanasa

This medicinal product is for cutaneous use, so it should be applied exclusively to the skin spots to be treated. Do not ingest it.

Do not use Melanasa

• If you are allergic to the active substances or to any of the other components of this medicinal product (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 should only be applied to intact skin and on small surfaces.
• Avoid contact of the product with the eyes and mucous membranes. If accidental contact with the eyes occurs, rinse them with plenty of water and consult a doctor. In case of contact with the lips, you may notice a bitter taste and a slight anesthetic effect in the area.
• The treated areas should not be exposed to the sun (even on cloudy days) or to ultraviolet (UVA) lamps.
• This medicinal product 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 inner arm for at least 24 hours. If you notice that the area is irritated, do not use this medicinal product.
• In some cases, a temporary darkening or irritation of the skin may appear. If it persists, you should interrupt the treatment.

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

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

Children and adolescents

Do not use in children under 12 years old.

Other medicinal products and Melanasa

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

Do not use cutaneous preparations with peroxides (e.g., hydrogen peroxide, benzoyl peroxide...) on the same area of the skin where you are applying Melanasa, as a temporary darkening may occur in the area of the skin where they have been applied together. In case this happens, you should interrupt the use of one of these medicinal products 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 medicinal product.

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

Driving and use of machines

No effects on the ability to drive and use machines have been described.

Melanasacontains cetearyl alcohol, cetyl alcohol, hydrogenated and polyoxyethylene ricinoleate, methylparaben (E-218), and propylparaben (E-216).

This medicinal product may cause local reactions on the skin (such as contact dermatitis) because it contains cetearyl alcohol and cetyl alcohol.

This medicinal product may cause skin reactions because it contains hydrogenated and polyoxyethylene ricinoleate.

It may cause allergic reactions (possibly delayed) because it contains methylparaben (E-218) and propylparaben (E-216).

3. How to use Melanasa

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Melanasa is a medicinal product for cutaneous use (exclusively on 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 should unscrew the brown cap, remove and discard the white ring, and screw the cap back on.

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 to the spot, until the desired effect is achieved, which may require several weeks of treatment. You should wash your hands with soap after applying the product, as hydroquinone can cause brown spots on the nails that disappear over time.

Under no circumstances should you 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 your doctor.

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

Interrupt the application of Melanasa when the spots disappear.

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

If you use more Melanasa than you should

Due to its cutaneous use, it is unlikely that intoxication will occur.

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

If you forget to use Melanasa

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

If you have any other doubts about the use of this medicinal product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicinal products, this medicinal product can cause side effects, although not everybody gets them.

The side effects listed below are classified according to their frequency and the classification by organs and systems. 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 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 the 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 areas of the face (ochronosis) and skin discoloration (leucodermia)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of Melanasa

Keep out of the sight and reach of children.

Keep the tube perfectly closed to protect it from light.

Do not use this medicinal product after the expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

Do not use this medicinal product if you notice a dark color, even if it is within the validity period.

Medicinal products should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicinal products in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicinal products. This way, you will help protect the environment.

6. Further information

Composition of Melanasa

• The active substance is hydroquinone. Each gram of cream contains 20 mg of hydroquinone.
• The other components (excipients) are: cetearyl alcohol emulsifier type B, ethylhexyl methoxycinnamate, isopropyl myristate, cetearyl alcohol polyoxyethylene, decyl oleate, hydrogenated and polyoxyethylene ricinoleate, butyl methoxydibenzoylmethane, cetyl alcohol, propylene glycol (E-1520), tocopherol acetate, sodium metabisulfite (E-223), methylparaben (E-218), propylparaben (E-216), disodium edetate, lactic acid (E-270), and purified water.

Appearance of the product and contents of the packaging

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

Only some pack sizes may be marketed.

Marketing authorization holder

Laboratorios Viñas, S.A.

Provenza, 386

08025 Barcelona

Spain

Manufacturer

Laboratorios Viñas, S.A.

Torrente Vidalet, 29 - 08012 Barcelona

Spain

Date of the last revision of this leaflet: March 2021

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Medical Devices (AEMPS) http://www.aemps.gob.es/