Melanase 20 mg/g cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Melanasa 20 mg/g cream
hydroquinone
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or as directed 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve after 2 months.
Contents of the leaflet
- What Melanasa is and what it is used for
- What you need to know before using Melanasa
- How to use Melanasa
- Possible adverse effects
- How to store Melanasa
- Contents of the pack and other information
1. What Melanasa is and what it is used for
Melanasa is a topical cream medication whose active ingredient, hydroquinone, acts by gradually reducing the overproduction of melanin that causes dark skin spots.
This medicine is indicated for lightening small dark spots that occasionally appear on the skin, such as freckles and age spots in adults and children over 12 years of age.
2. What you need to know before using Melanasa
This medicine is for topical use only, so it should be applied exclusively to the skin areas with pigmentation spots that you wish to treat. 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 medicine (listed in section 6).
- On open wounds.
- On irritated skin.
- On mucous membranes or sunburned skin.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Melanasa.
- You should apply the product only on intact skin and on small surface areas.
- Avoid contact of the product with eyes and mucous membranes. If accidental contact with the eyes occurs, rinse thoroughly with plenty of water and consult your doctor. In case of contact with the lips, you may experience a bitter taste and a slight anesthetic effect in the area.
- Treated areas must not be exposed to sunlight (even on cloudy days) or to ultraviolet (UVA) lamps.
- This medicine must not 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, application of the product may cause an allergic reaction. To prevent this, apply a small amount of the product to the inner forearm for at least 24 hours. If you observe irritation at the site, do not use this medicine.
- In some cases, temporary skin darkening or irritation may occur. If this persists, discontinue treatment.
Note that lightening of pigmented spots in the affected skin area is not immediate and is only temporary, since melanin production resumes when treatment is stopped, and the effect may last between 2 and 6 months after treatment ends.
In some cases, pigmentation spots may not completely disappear with treatment.
Children and adolescents
Do not use in children under 12 years of age.
Other medicines and Melanasa
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Do not use topical preparations containing peroxides (e.g., hydrogen peroxide, benzoyl peroxide, etc.) on the same skin area where Melanasa is being applied, as this may cause temporary skin darkening in the area where both products are used together. If this occurs, discontinue use of one of the medicines and wash 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 Melanasa in human pregnancy has not been established. Therefore, this medicine should only be used during pregnancy and breastfeeding if strictly necessary, as determined by a physician.
Driving and operating machinery
No effects on the ability to drive or operate machinery have been reported.
Melanasa contains cetearyl alcohol, cetyl alcohol, hydrogenated poloxyl castor oil, methylparaben (E-218), and propylparaben (E-216).
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetearyl alcohol and cetyl alcohol.
This medicine may cause skin reactions because it contains hydrogenated poloxyl castor oil.
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 instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
Melanasa is a topical medication (for use on the skin only).
Use in children
Its use is not recommended in children under 12 years of age.
Adults and children over 12 years of age
Before using the tube for the first time, unscrew the brown cap, remove and discard the white ring, and then screw the cap back on.
Wash the affected area of skin and dry it afterwards.
Apply a small amount of the product twice daily (morning and night), exclusively to the pigmented spot, until the desired effect is achieved. Several weeks of treatment may be necessary. You must wash your hands thoroughly with soap after applying the product, as hydroquinone may cause brown stains on the nails, which disappear over time.
Under no circumstances should you use the product for longer than 6 months.
If you do not observe improvement after 2 months of treatment, you should discontinue use and consult your doctor.
Apply a high-protection sunscreen or cover the area with clothing, as the treated area of skin must be protected from sunlight during and after treatment to prevent the spots from reappearing.
Discontinue application of Melanasa when the spots disappear.
If you feel that 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 topical use, cases of intoxication are unlikely.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount used.
If you forget to use Melanasa
Do not apply a double dose to make up for missed doses. Continue treatment as recommended.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
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 and system. Frequency categories are defined by the following convention: very common (affects more than 1 in 10 people); common (affects up to 1 in 100 people); uncommon (affects up to 1 in 1,000 people); rare (affects between 1 and 10 in 10,000 people); very rare (affects less than 1 in 10,000 people); frequency not known (cannot be estimated from available data).
Uncommon: skin inflammation and redness (erythema) and stinging.
Rare: increased skin sensitivity (increased cutaneous sensitivity) and skin discoloration (cutaneous hyperpigmentation).
Very rare: blue-black discoloration of cartilage, tendons, and some areas of the face (ochronosis) and skin depigmentation (leukoderma).
Reporting of 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 leaflet. You may also report them directly through the national reporting system: www.notificaRAM.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Melanasa
Keep out of the sight and reach of children.
Keep the tube tightly closed to protect it from light.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Do not use this medicine if you observe dark discoloration, even if it is within the validity period.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Additional Information
Composition of Melanasa
- The active substance is hydroquinone. Each gram of cream contains 20 mg of hydroquinone.
- The other components (excipients) are: emulsifying cetyl alcohol esters and stearates type B, ethylhexyl methoxycinnamate, isopropyl myristate, polyoxyethylene cetyl alcohol, decyl oleate, hydrogenated and polyoxyethylene castor oil, butyl methoxydibenzoylmethane, cetyl alcohol, propylene glycol (E-1520), tocopheryl acetate, sodium metabisulfite (E-223), methylparaben (E-218), propylparaben (E-216), disodium edetate, lactic acid (E-270) and purified water.
Appearance of the medicinal product and contents of the container
Melanasa is presented as a white cream in aluminum tubes of 15 and 30 grams.
Only some container sizes may be marketed.
Marketing Authorization Holder
Laboratorios Viñas, S.A.
Provenza, 386
08025 Barcelona
Spain
Manufacturer responsible for batch release:
Laboratorios Viñas, S.A.
Torrente Vidalet, 29 - 08012 Barcelona
Spain
Date of the most recent review of this leaflet: March 2021
Detailed and up-to-date 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/