PIGMENTASA 40 MG/G CREAM

Introduction

Package Leaflet: Information for the Patient

PIGMENTASA 40 MG/G CREAM

Contents of the Package Leaflet:

1. What is Pigmentasa and what is it used for
2. What you need to know before starting to use Pigmentasa
3. How to use Pigmentasa
4. Possible side effects
5. Storage of Pigmentasa
6. Package contents and additional information

1. What is Pigmentasa and what is it used for

Pigmentasa contains hydroquinone, which is a local depigmenting active ingredient.

Pigmentasa works through a dual mechanism. On the one hand, hydroquinone is able to depigment the skin by gradually reducing the production of excess melanin that causes dark spots on the skin. On the other hand, the medicine incorporates a combination of sun filters that prevent darkening (repigmentation) induced by sunlight.

This medicine is indicated for adults and children over 12 years old to reduce the color of small dark spots on the skin (cutaneous hyperpigmentation) such as melasma and chloasma, senile lentigo, and freckles.

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

Do not use Pigmentasa

• If you are allergic to hydroquinone or any of the other components of this medicine (listed in section 6).
• In case of chemical hyperpigmentation such as ochronosis and colloid degeneration (colloid milium), both professional and cosmetic in 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, you should rinse with plenty of water to avoid possible production of opaque spots on the cornea. In case of contact with the lips, you may notice a bitter taste and a slight 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 even 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 sunburn.
• 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 arm for at least 24 hours. If a strong irritation occurs, you should discard the use of this product.
• In some cases, a temporary darkening or irritation of the skin may appear; if it persists, the 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 the treatment is interrupted, melanin production resumes. Depigmentation can last between 2 and 6 months after finishing the treatment. The darker the lesions are before, the sooner they will repigment.

Children and Adolescents

Do not use in children under 12 years old.

Using Pigmentasa with Other Medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Do not use topical preparations containing peroxides (such as hydrogen peroxide, benzoyl peroxide, etc.) simultaneously on the same skin area where you are applying Pigmentasa, as a temporary skin discoloration may occur due to the oxidation of hydroquinone. This temporary discoloration can be eliminated by interrupting the use of one of these medicines and washing 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 medicine.

The safety of Pigmentasa in human pregnancy has not been established. Therefore, this medicine should only be used during pregnancy and breastfeeding when strictly necessary according to medical criteria.

C

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

Pigmentasa contains cetearyl alcohol, cetyl alcohol, methylparaben (E-218), and propylparaben (E-216), and propylene glycol.

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

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

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

3. How to Use Pigmentasa

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

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

Pigmentasa is a topical medicine (for use exclusively on the skin).

Use in Children

Do not 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.

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

Start with one application per day for 10 or 15 days, exclusively on the spot, and continue the treatment with two daily applications, one in the morning and one at night. You should wash your hands with soap after applying the product, as hydroquinone can cause brown spots on the nails that disappear over time.

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

The recommended duration of treatment is 60 to 90 days.

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

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

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

If You Use More Pigmentasa Than You Should

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

In case of accidental ingestion, serious manifestations of systemic toxicity similar to those of phenol may occur. The oral ingestion of 5-15 g of hydroquinone produces tremors, convulsions, and hemolytic anemia. Gastric lavage is recommended.

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 medicine and the amount used.

If You Forget to Use Pigmentasa

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

If You Interrupt the Treatment with Pigmentasa

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

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects listed below are classified by frequency and by organ system. The frequency categories are defined as follows: 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 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 sensitization) and skin spots (cutaneous hyperpigmentation).

Very rare: blue-black discoloration of cartilages, tendons, and some areas of the face (ochronosis) and skin discoloration (leucodermia).

In case of appearance of adverse reactions, the treatment should be suspended.

Reporting of Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package 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 medicine.

5. Storage of Pigmentasa

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

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

Do not use this medicine after the expiration date stated on the container after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Place the containers and medicines you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Pigmentasa

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

• The other ingredients (excipients) are: cetearyl alcohol emulsifier type B, ethylhexyl methoxycinnamate, cetyl alcohol, cetearyl glucoside, isopropyl myristate, polysorbate 20, decyl oleate, butyl methoxydibenzoylmethane, propylene glycol, sodium metabisulfite (E-223), methylparaben (E-218), propylparaben (E-216), disodium edetate, and purified water.

Appearance of the Product and Package Contents

Pigmentasa is presented as a white cream, in aluminum tubes of 25 grams.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Viñas, S.A.

Provenza, 386

08025-Barcelona

Spain

Manufacturer

Laboratorios Viñas, S.A.

Torrente Vidalet, 29

08012 Barcelona

Spain

Laboratorios Viñas, S.A.

Polígono Industrial Can Rosés, Avenida Can Rosés, s/n,

08191 Rubí

Spain

Date of the Last Revision of this Package Leaflet:July 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/