Hquin 40 mg/g cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
HQUIN 40 mg/g cream
Hydroquinone
Read the entire leaflet carefully before you start using 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, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- 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.
Leaflet contents
- What HQUIN is and what it is used for
- What you need to know before using HQUIN
- How to use HQUIN
- Possible adverse effects
- How to store HQUIN
- Contents of the pack and other information
1. What HQUIN is and what it is used for
HQUIN contains hydroquinone, which is a locally-acting depigmenting active substance.
This medicine works by gradually reducing the overproduction of melanin that causes dark skin spots.
HQUIN is indicated in adults and children over 12 years of age for lightening small dark spots on the skin, such as melasma and chloasma, senile lentigo, and freckles.
2. What you need to know before using HQUIN
Do not use HQUIN:
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If you are allergic to hydroquinone or to any of the other components of this medicine (listed in section 6).
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If you are undergoing treatment for any chemical hyperpigmentation such as ochronosis (asymmetrical black-blue spots mainly on the face and neck) and colloidal degeneration (colloidal milium), whether of occupational or cosmetic origin.
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On open wounds, mucous membranes, irritated skin, or sunburns.
Warnings and precautions
Consult your doctor or pharmacist before starting to use HQUIN.
- This product should only be applied to intact skin and over small surface areas.
- Avoid contact with eyes and mucous membranes. In case of accidental eye contact, rinse thoroughly with water to prevent possible opaque spots on the cornea, and consult your doctor. If contact occurs with the lips, a bitter taste and slight anesthetic effect in the area may be noticed.
- If the pigmented area is very extensive, treatment should be carried out in separate cycles.
- During treatment with HQUIN, it is essential to protect the treated area from sunlight, as even minimal sun exposure may reactivate melanin production. It is advisable to use a high-protection sunscreen and reapply it every 2 or 3 hours during sun exposure.
- HQUIN must not be used to prevent sunburns.
- In individuals with very dark skin, the effects of hydroquinone may be less noticeable.
- In some individuals, especially those with sensitive skin, hypersensitivity reactions may occur. To prevent this, it is advisable to apply a small amount of the product to the inner forearm for at least 24 hours. If irritation occurs, do not use this medicine.
- In some cases, temporary skin darkening or irritation may occur; if this persists, treatment should be discontinued.
- Depigmentation is not immediate, as hydroquinone only interferes with the formation of new melanin, and the effect is temporary. Once treatment is stopped, melanin production resumes. Depigmentation may last between 2 and 6 months after treatment ends. The darker the lesions, the sooner repigmentation occurs.
- Discontinue use of this medicine if the product develops a blackish discoloration.
Children and adolescents
Do not use in children under 12 years of age.
Use of HQUIN with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Concomitant use of hydroquinone with peroxides (e.g., hydrogen peroxide, benzoyl peroxide, etc.) may cause temporary skin discoloration in the area where both products are applied, due to oxidation of hydroquinone. This temporary discoloration resolves by discontinuing one of the products and washing the application area with mild soap.
Use of HQUIN with food, drinks, and alcohol
No interactions between HQUIN and food or drinks are known.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 during pregnancy and breastfeeding when strictly necessary, as determined by a physician.
Driving and using machines
No effects on the ability to drive or operate machinery have been reported.
HQUIN contains butylhydroxyanisole and butylhydroxytoluene
This medicine may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxyanisole and butylhydroxytoluene.
3. How to use HQUIN
Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
HQUIN is for external use only.
Adults and children over 12 years of age
Apply a thin layer of cream only to small hyperpigmented areas, always avoiding contact with eyes and mucous membranes.
Wash hands thoroughly with soap after applying the product, as hydroquinone may cause brown stains on the nails, which disappear over time.
Begin with one application per day for 10 to 15 days, exclusively on the area of skin with excess pigmentation. After this period, increase the frequency to two applications per day, one in the morning and one at night.
If no improvement is observed after two months of treatment, treatment should be discontinued and you should consult your doctor.
The recommended duration of treatment is 60 to 90 days.
This medicine must not be used under any circumstances for longer than 6 consecutive months.
Use in children and adolescents
Do not use in children under 12 years of age due to lack of safety and efficacy data in this population.
If you use more HQUIN than you should
Because it is for external use, systemic intoxication is unlikely.
In case of accidental ingestion, serious manifestations of systemic toxicity similar to those of phenol may occur. Oral ingestion of 5–15 g of hydroquinone may cause tremors, convulsions, and hemolytic anemia. Gastric lavage is recommended.
In case of overdose or accidental ingestion,
contact the Toxicology Information Service at telephone number 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 missed doses. Continue treatment with the recommended dose.
If you stop using HQUIN
Your doctor will determine the duration of your treatment with HQUIN. Do not discontinue treatment prematurely, as you may not achieve the desired effects.
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 can cause adverse effects, although not everyone experiences them.
The following adverse effects have been observed with the use of this medicine:
Uncommon (may affect up to 1 in 100 people): swelling and redness of the skin (erythema) and stinging.
Rare (may affect up to 1 in 1,000 people): increased skin sensitivity. If used for very prolonged treatments, a reaction of cutaneous hyperpigmentation (skin discoloration) may occur, especially if the treated area is exposed to sunlight.
Very rare (may affect up to 1 in 10,000 people): skin discoloration (leucoderma). With prolonged treatment (more than 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.
Systemic adverse effects have not been reported.
If you consider any of the effects you experience to be severe or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.
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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 tightly closed after each use to protect it from light.
Store below 25 °C.
Do not use this medicine after the expiry date stated on the carton and container after EXP. The expiry date refers to the last day of the month indicated.
Do not use HQUIN if a dark discoloration is observed, even if it is within the expiry date.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE POINT at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of HQUIN
- The active substance is hydroquinone. Each gram of cream contains 40 mg of hydroquinone.
- The other components (excipients) are: cetyl alcohol and polyoxyethylene cetearyl alcohol, polysorbate 20, octyl methoxycinnamate, white vaseline, macrogol stearate, glycerol monostearate 40-55, liquid paraffin, kojic dipalmitate, butyl methoxydibenzoylmethane, polysorbate 80, kojic acid, butylhydroxyanisole (E-320), butylhydroxytoluene (E-321), sodium metabisulfite (E-223), disodium edetate and purified water.
Appearance of the product and contents of the pack
HQUIN is presented as a white, 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 most recent revision of this leaflet: November 2016