Patient Information Leaflet

PIGMENTASA 40 MG/G CREAM

Contents of the leaflet:

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

Pigmentasacontains hydroquinone, which is a depigmenting active ingredient with local action.

Pigmentasaacts through a double mechanism. On the one hand, hydroquinone is able to depigment the skin by gradually reducing the production of excess melanin that causes dark skin spots. On the other hand, the medication incorporates a combination of sunscreens that prevent darkening (repigmentation) induced by sunlight.

This medication is indicated for adults and children over 12 years old for the reduction of the color of small dark skin spots (cutaneous hyperpigmentations) such as melasma and chloasma, senile lentigo, and freckles.

No use Pigmentasa

• If you are allergic to hydroquinone or any of the other components of this medication (listed in section 6).
• In case of chemical hyperpigmentation such as ochronosis and colloid degeneration (milium colloid), both of professional and cosmetic origin.
• On open wounds, mucous membranes, eczematous or irritated skin, sunburns.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Pigmentasa.

• Avoid contact with the eyes and mucous membranes. In case of accidental contact with the eyes, perform a thorough washing with plenty of water to prevent possible opacification of the cornea. In case of contact with the lips, you may notice a bitter taste and a mild anesthetic effect in the area.
• If the pigmented area is very extensive, it should be treated in different cycles.
• Protect the treated area from the sun during treatment with hydroquinone, as minimal sun exposure can reactivate melanin production. It is recommended to use a high-protection sunscreen during the day.
• This product cannot be used to prevent sunburns.
• If you have very dark skin, the effects of hydroquinone may be less visible.
• If you have sensitive skin, hypersensitivity reactions may occur. To prevent this, it is advisable to apply a small amount of the product to the inner side of the forearm for at least 24 hours. If a strong irritation occurs, you should discontinue use of this product.
• In some cases, a temporary darkening or irritation of the skin may occur; if it persists, treatment should be interrupted.

Depigmentation is not immediate, as hydroquinone only interferes with the formation of new melanin, and it is only temporary, as when treatment is interrupted, melanin production resumes. Depigmentation may be maintained between 2 and 6 months after completing treatment. The darker the lesions, the sooner they repigment.

Children and Adolescents

Do not use in children under 12 years old.

Use of Pigmentasa with Other Medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Do not use simultaneously topical preparations with peroxides (e.g. hydrogen peroxide, benzoyl peroxide, etc.) on the same skin area where you are applying Pigmentasa, as it may cause temporary skin discoloration due to oxidation of hydroquinone. This temporary discoloration is eliminated by interrupting the use of one of these medications and washing the application area with a mild soap.

Pregnancy, Lactation, and Fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The safety of Pigmentasa 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 Machines

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

Pigmentasa contains cetearyl alcohol, cetanol, methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216) and propylene glycol.

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

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

This medication contains 10 mg of propylene glycol per gram of cream.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.

In case of doubt, consult your doctor or pharmacist again.

Pigmentasais a topical medication (exclusively for the skin).

Use in children

Do not use in children under 12years.

Adults and children over 12 years

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

Apply a thin layer of the cream, only on small hyperpigmented areas, avoiding contact with the eyes and mucous membranes at all times.

Start with one application per day for 10or15days exclusively on the spot and continue the treatment with two daily applications, one in the morning and one at night. You must wash your hands with soap after applying the product, as hydroquinone can cause brown stains on the nails that disappear over time.

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

The recommended duration of treatment is 60to90days.

This medication should not be used in any case for more than 6months.

Your doctor will indicate the duration of your treatment withPigmentasa.Do not suspend the treatment beforehand, as you will not achieve the desired effects.

If you estimate that the action ofPigmentasais too strong or too weak, inform your doctor or pharmacist.

If you use more Pigmentasa than you should

Due to its topical use, it is unlikely that you will experience cases of intoxication.

In case of accidental ingestion, serious systemic toxicity manifestations similar to those of phenol may occur. Ingestion of 5‑15g of hydroquinone causes tremors, convulsions, and hemolytic anemia. It is recommended to perform a gastric lavage.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 915620420, indicating the medication and the amount used.

If you forgot to use Pigmentasa

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

If you interrupt the treatment withPigmentasa

Your doctor will indicate the duration of your treatment with Pigmentasa. Do not suspend the treatment beforehand, as you will not achieve the desired effects.

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

Like all medications,this medicationmay cause adverse effects, although not everyone 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: black-blue discoloration of cartilage, tendons, and some facial areas (ochronosis) and skin depigmentation (leucodermia).

In the event of adverse reactions being observed, treatment should be suspended.

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 national notification system:www.notificaRAM.es.

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

Keep this medication out of the sight and reach of children.

Keep the container perfectly closed after each application to protect it from light.

Do not usethis medicationafter the expiration date that appears on the container after CAD. The expiration date is the last day of the month indicated.

Do not usethis medicationif 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 containers and medicines you no longer need at the SIGREpoint of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Pigmentasa

• The active principle is hydroquinone. Each gram of cream contains 40mg of hydroquinone.

• The other components (excipients) are: cetostearyl alcohol emulsifying agent type B, ethylhexyl methoxycinnamate, cetyl alcohol, cetoestearyl ether of macrogol, isopropyl myristate, polisorbate 20, decyl oleate, butyl methoxydibenzoylmethane, propylene glycol, sodium metabisulfite (E-223), methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), disodium edetate, and purified water.

Appearance of the product and content of the packaging

Pigmentasais presented in the form of a white cream, in aluminum tubes of25grams.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Viñas, S.A.

Provenza, 386

08025-Barcelona

Spain

Last review date of this leaflet:November 2019

The detailed information of this medicine is available on the website ofthe Spanish Agencyof Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/