Monobenzone Vis

Package Leaflet: Information for the Patient

MONOBENZONE VIS

200 mg/g ointment
Monobenzonum

Read the package leaflet carefully before using the medicine, as it contains important information for the patient

• -Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Monobenzone VIS and what is it used for
• 2. Important information before using Monobenzone VIS
• 3. How to use Monobenzone VIS
• 4. Possible side effects
• 5. How to store Monobenzone VIS
• 6. Package contents and other information

1. What is Monobenzone VIS and what is it used for

Monobenzone VIS is an ointment that contains the active substance monobenzyl ether of hydroquinone. The medicine weakens skin pigmentation after application.

Indications

The medicine is indicated for the treatment of hyperpigmentation (skin diseases with discoloration) caused by an excess of the melanin pigment and for depigmentation of normally pigmented skin areas in patients with vitiligo.

2. Important information before using Monobenzone VIS

When not to use Monobenzone VIS

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• discoloration spots, such as hyperpigmentation caused by an allergic reaction to light after using certain perfumes, melasma (chloasma) in pregnant women, hyperpigmentation caused by skin inflammation,
• cafe-au-lait spots, pigmented moles, melanomas, and discoloration changes caused by a pigment other than melanin.

Warnings and precautionsand
Before starting to use Monobenzone VIS, discuss it with your doctor.
During the use of the medicine, avoid excessive sun exposure.
During lifetime exposure to sunlight after using this medicine, use UV filter creams.
In people with excessively dry skin or a tendency to allergic reactions, the use of the medicine is not recommended.

Children and adolescents

There are no data on the use of the medicine in children and adolescents.

Monobenzone VIS and other medicines

There are no data.
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.

Pregnancy, breastfeeding, and fertility:

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine.
This medicine can be used during pregnancy or breastfeeding only if the doctor decides so.
Due to the content of the hydroquinone derivative, the use of the medicine during pregnancy is not recommended.
Caution should be exercised when using the medicine during breastfeeding, as it is not known whether the active substance contained in the medicine passes into breast milk.

Driving and using machines:

The effect of the medicine on the ability to drive and use machines is not known.

3. How to use Monobenzone VIS

This medicine should always be used as directed by your doctor.
In case of doubts, consult your doctor.
The medicine is intended for local use on the skin.
Usually, the discolored areas of the skin are smeared with Monobenzone 2 to 3 times a day, for no longer than 3 months. If satisfactory treatment results are not achieved after this time, the use of the medicine should be discontinued. After achieving a satisfactory degree of skin depigmentation, the medicine is used for maintenance treatment - usually 2 times a week.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Using a higher dose of Monobenzone VIS than recommended

In case of using a higher dose of the medicine than recommended, contact your doctor.

Missing a dose of Monobenzone VIS

Do not use a double dose to make up for a missed dose.

Stopping the use of Monobenzone VIS

In case of any further doubts related to the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are listed below by MedDRA system organ class and frequency.
Very common (≥ 1/10)
Common (≥ 1/100 to <1>Uncommon (≥ 1/1,000 to <1>Rare (≥ 1/10,000 to <1>Very rare (<1>Not known (frequency cannot be estimated from the available data)
Disorders of the skin and subcutaneous tissue(unknown frequency)
Transient itching or burning sensation, which usually disappears after a few days.
Burning, redness of the skin, irritation, exudative changes, permanent damage to melanocytes (skin pigment cells).
In case of persistent burning, redness of the skin, irritation, or exudative changes, contact your doctor, as these are indications to discontinue treatment.

Reporting suspected adverse reactions

If any side effects occur, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw,
Phone: +48 22 49-21-301
Fax: +48 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions can help gather more information on the safety of the medicine.

5. How to store Monobenzone VIS

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C, in a dry place.
Do not use this medicine after the expiry date stated on the packaging (tube and carton) after: "expiry date". The expiry date refers to the last day of the specified month.

6. Package contents and other information

What Monobenzone VIS contains

The active substance of the medicine is monobenzyl ether of hydroquinone.
1 g of ointment contains 200 mg of monobenzyl ether of hydroquinone.
The excipients are: glycerol 86%, anhydrous eucerin, white petrolatum, purified water.

What Monobenzone VIS looks like and what the package contains

Monobenzone VIS is an ointment.
The package contains an aluminum tube with 30 g of ointment, placed in a cardboard box.

Marketing authorization holder and manufacturer

Zakłady Chemiczno-Farmaceutyczne "VIS" Sp. z o.o.
ul. Św. Elżbiety 6a
41-905 Bytom
tel. (32) 2589555
Date of last update of the leaflet:23.01.2023