HQUIN 40 mg/g CREAM

Introduction

Leaflet: information for the patient

HQUIN 40 mg/g cream

Hydroquinone

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

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

Contents of the leaflet

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

1. What is HQUIN and what is it used for

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

This medicine acts by gradually reducing the production of excess melanin that causes dark spots on the skin.

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

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

Do not use HQUIN:

• If you are allergic to hydroquinone or any of the other components of this medicine (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 (colloid milium), 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.

• It should only be applied to intact skin and on small surfaces.
• Eye contact and mucous membrane contact should be avoided. In case of accidental eye contact, the eyes should be thoroughly rinsed with water to avoid possible production of opaque spots on the cornea, and a doctor should be consulted. In case of contact with the lips, a bitter taste and a slight 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.
• HQUIN cannot be used to prevent sunburn.
• In people with very dark skin, the effects of hydroquinone may be less visible.
• In some people, 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 that the area is irritated, do not use this medicine.
• In some cases, a temporary darkening or irritation of the skin 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 discontinued, melanin production resumes. Depigmentation can last between 2 and 6 months after treatment is completed. The darker the lesions are before treatment, the sooner they will repigment.
• Stop using this medicine if the product has acquired a dark color.

Children and adolescents

Do not use in children under 12 years old.

Using HQUIN with other medicines

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

The simultaneous use of hydroquinone with peroxides (such as 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 can be eliminated by discontinuing the use of one of these medicines and washing the application area with a mild soap.

Using HQUIN with food, drinks, and alcohol

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

Pregnancy and breastfeeding

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

Driving and using machines

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

HQUIN contains butylhydroxyanisole and butylhydroxytoluene

This medicine may produce local reactions on the skin (such as contact dermatitis) or eye and mucous membrane irritation because it contains butylhydroxyanisole and butylhydroxytoluene.

3. How to use HQUIN

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

HQUIN should only be used on the skin.

Adults and children over 12 years old

Apply a thin layer of cream, only on small hyperpigmented areas, always avoiding eye and mucous membrane contact.

Wash your hands with soap after applying the product, as hydroquinone can produce brown spots on the nails that disappear over time.

Start with one application per day, for 10 or 15 days, exclusively on the skin area that presents excess pigmentation. After this period, increase applications to twice daily, one in the morning and one at night.

If you do not observe improvement after two months of treatment, it should be discontinued and your doctor consulted.

The recommended treatment duration is 60 to 90 days.

This medicine should not be used for more than 6 months consecutively.

Use in children and adolescents

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

If you use more HQUIN than you should

Due to its external 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 the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use HQUIN

Do not apply a double dose to make up for forgotten doses. Continue treatment with the recommended dose.

If you stop treatment with HQUIN

Your doctor will indicate the duration of your treatment with HQUIN. Do not discontinue 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 everyone will experience them.

The following side effects have been observed after using this medicine:

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

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

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

No systemic side effects have been described.

If you consider that any of the effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting 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 Spanish Pharmacovigilance System for Human Use https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of HQUIN 40 mg/g cream

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

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

Store below 25 ºC.

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

Do not use HQUIN if you notice a dark color, even if it is within the expiration date.

Medicines should not be disposed of through wastewater or household waste. Deposit the containers and medicines you no longer need in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

HQUIN composition

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

Appearance of the product and package contents

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

Marketing authorization holder and manufacturer

Marketing authorization holder:

Galenicum Derma, S.L.U.

Ctra. N-1, Km 36,

28750 San Agustin del Guadalix (Madrid)

Spain

Manufacturer:

Mesoestetic Pharma group, s.l.

C/Tecnologia, 25

08840 – Viladecans (Barcelona)

Spain

Date of the last revision of this leaflet:November 2016