Label: Information for the Patient

HQUIN 40 mg/g Cream

Hydroquinone

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
  If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

HQUIN contains hydroquinone, which is an active ingredientwith local depigmenting action.

This medication actsby gradually reducing the production of excess melanin that causesdark skin spots.

HQUIN is indicated for adults and children over 12 years old for the reduction ofthe color of small dark skin spots such as melasma and chloasma, senile lentigo and freckles.

No use HQUIN:

• If you are allergic to hydroquinone or any of the other components of this medication (listed in section 6).

• If you are receiving treatment for any chemical hyperpigmentation such as ochronosis (asymmetric black-blue spots mainly on the face and neck) and colloid degeneration (milia colloid), both professional and cosmetic.

• On open wounds, mucous membranes, irritated skin, and sunburns.

Warnings and precautions

Consult your doctor or pharmacist before starting to use HQUIN.

• Only apply the product to intact skin and in small areas.
• Avoid contact with the eyes and mucous membranes. In case of accidental contact with the eyes, wash thoroughly with water to prevent possible opaque spot formation on the cornea, and consult a doctor. In case of contact with the lips, a bitter taste and a mild anesthetic effect in the area may be noticed.
• If the pigmented area is very extensive, it should be treated in different cycles.
• During treatment with HQUIN, it is essential to protect the treated area from the sun, as even minimal sun exposure can reactivate melanin production. It is recommended to use a high-protection sunscreen and apply it every 2 or 3 hours during sun exposure time.
• HQUIN cannot be used to prevent sunburns.
• In people with very dark skin, the effects of hydroquinone may be less visible.
• In some individuals, especially those with sensitive skin, hypersensitivity reactions may occur. To prevent this, it is advisable to apply a small amount of product to the forearm for at least 24 hours. If you notice the area is irritated, do not use this medication.
• In some cases, temporary darkening or skin irritation may occur; if it persists, treatment should be discontinued.
• Depigmentation is not immediate, as hydroquinone only interferes with the formation of new melanin, and it is only temporary, as when treatment is stopped, melanin production resumes. Depigmentation may be maintained between 2 and 6 months after treatment completion. The darker the lesions, the sooner they repigment.
• Stop using this medication if the product has turned a dark brown color.

Children and adolescents

Do not use in children under 12 years old.

Use of HQUIN with other medications

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

The simultaneous use of hydroquinone with peroxides (e.g., hydrogen peroxide, benzoyl peroxide, etc.) may produce a temporary coloration of the skin area where they have been applied together, due to the oxidation of hydroquinone. This temporary coloration is eliminated by stopping the use of one of these medications and washing the application area with a mild soap.

Use of HQUIN with food, drinks, and alcohol

No interactions of HQUIN with any food or drink are known.

Pregnancy and breastfeeding

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

The safety of HQUIN 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 driving and operating machinery have been described.

HQUIN containsbutylhydroxyanisoleandbutylhydroxytoluene

This medication may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxyanisole and butylhydroxytoluene.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

HQUIN should be used exclusively on the skin.

Adults and children over 12 years old

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

Wash your hands with soap after applying the product, as hydroquinone may cause brown stains on the nails that disappear over time.

Begin with one application per day, for 10 or 15 days, exclusively on the area of the skin with excess pigmentation. After this period of time, increase the applications to two per day, one in the morning and one at night.

If you do not observe improvement after two months of treatment, the treatment should be interrupted and you should consult your doctor.

The recommended duration of treatment is 60 to 90 days.

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

Use in children and adolescents

Do not use in children under 12 years old, due to the absence of data on safety and efficacy in this population.

If you use more HQUIN than you should

Due to its external 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 5-15 g ofhydroquinoneproduces tremors, convulsions, and hemolytic anemia. It is recommended to perform a stomach lavage.

In case of overdose or accidental ingestion,

consult the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested

If you forgot to use HQUIN

Do not apply a double dose to compensate for the missed doses. Continue treatment with the recommended dose.

If you interrupt treatment with HQUIN

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

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 everyone will experience them.

The following adverse effects have been observed after using this medication:

Rare (may affect up to 1 in 100 people): inflammation and redness of the skin (erythema) and itching.

Uncommon (may affect up to 1 in 1,000 people): increased skin sensitivity. If used in very prolonged treatments, a skin hyperpigmentation reaction (skin discoloration) may occur, especially if the treated area is exposed to the sun.

Very rare(may affect up to 1 in 10,000 people):skin depigmentation (leucodermia). In prolonged treatments (over 6 months) and at high doses, the appearance of asymmetrical black-blue spots mainly on the face and neck (ochronosis) has been observed, especially in individuals of black race.

No systemic adverse effects have been described.

If you consider any of the effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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 Spanish System for Pharmacovigilance of Medicinal Products for Human Usehttps://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.

Store below 25 °C

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

Do not use HQUIN if a dark coloration is observed, even if it is within the expiration date.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the PICKUP POINT of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help to protect the environment.

Composition of HQUIN

• The active ingredient is hydroquinone. Each gram of cream contains 40 mg of hydroquinone.
• The other components (excipients) are: cetyl alcohol and polyoxyl 40 stearate, polysorbate 20, octyl methoxycinnamate, white petrolatum, stearyl macrogol, glyceryl monostearate 40-55, liquid paraffin, kójic dipalmitate, butyl methoxydibenzoylmethane, polysorbate 80, kójic acid, butylated hydroxyanisole (E-320), butylated hydroxytoluene (E-321), sodium metabisulfite (E-223), disodium edetate, and purified water.

Appearance of the product and contents of the packaging

HQUIN is presented as a white and opaque cream in 30-gram tubes.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Galenicum Derma, S.L.U.

Ctra. N-1, Km 36,

28750 San Agustin del Guadalix (Madrid)

Spain

Responsible for manufacturing:

Mesoestetic Pharma group, s.l.

C/Tecnologia, 25

0884 – Viladecans (Barcelona)

Spain

Last review date of this leaflet:November 2016