BENZAC 10% Gel

Зміст інструкції

1. Benzac 5% gel, 10% gel
   1. What is Benzac and what is it used for
   2. What you need to know before using Benzac
   3. How to use Benzac
   4. Possible side effects
   5. How to store Benzac
   6. Contents of the pack and other information
2. Benzac 5% gel
   1. What is Benzac and what is it used for?
   2. What you need to know before using Benzac
   3. How to use Benzac
   4. Possible side effects
   5. How to store Benzac
   6. Contents of the pack and other information

Benzac 5% gel, 10% gel

benzoyl peroxide

Read this leaflet carefully before you start using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet, or as your doctor or pharmacist
has told you to.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if your symptoms do not improve or get worse.

Contents of this leaflet:

• 1. What Benzac is and what it is used for
• 2. What you need to know before you use Benzac
• 3. How to use Benzac
• 4. Possible side effects
• 5. How to store Benzac
• 6. Contents of the pack and other information

1. What is Benzac and what is it used for

Benzac contains the active ingredient benzoyl peroxide and belongs to a category of medicines used
for the local treatment of acne.
Benzac disinfects the skin; it also works in the presence of bacteria that cause acne.

2. What you need to know before using Benzac

Do not use Benzac:

• If you are allergic to benzoyl peroxide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before using Benzac.
Benzac is for external use only.

• Avoid contact with the eyes, mouth, corners of the nose and other mucous membranes. If the medicine gets into your eye, wash it thoroughly with water.
• Do not apply the product to skin with superficial lesions (abrasions) or irritated skin.
• Avoid exposure to ultraviolet rays (tanning lamps) and the sun during application of the product.
• In case of severe irritation, consult your doctor who will advise you to use Benzac less frequently, to temporarily interrupt or discontinue use of the medicine.
• Benzoyl peroxide may cause swelling and blisters on the skin; discontinue use of the medicine and consult your doctor if any of these symptoms occur.
• You should use caution when applying the medicine to the neck and other sensitive areas. You will probably feel a slight burning sensation with the first application and, within a few days, mild redness and flaking of the skin may occur. During the first few weeks of treatment, a sudden increase in flaking occurs in most patients. This is not dangerous and normally subsides within one or two days if treatment is temporarily interrupted.

The use, especially if prolonged, of products for topical use can lead to sensitization. If this
should happen, immediately stop treatment and consult your doctor to obtain suitable
therapy.
The oxidizing action of the gel can discolor dyed hair and colored clothing.

Children and adolescents
No data are available on efficacy and safety in children under 12 years of age.

Other medicines and Benzac
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Avoid the simultaneous use of harsh cleansers, products containing alcohol, anti-acne skin preparations and
medicines used in the treatment of acne containing substances that may increase the peeling
effect (i.e. the effect of removing the superficial layer of the skin) ,irritants or that cause skin dryness ,
such as those based on tretinoin, resorcinol, salicylic acid and sulfides, medicated cosmetics.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
There are no data on the effects of benzoyl peroxide, the active ingredient of Benzac, during pregnancy.
During pregnancy and breastfeeding, use the medicine only if absolutely necessary and under medical
supervision.
Breastfeeding
It is not known whether benzoyl peroxide passes into breast milk. For this reason, if you are breastfeeding,
use gel based on this active ingredient with caution and do not apply the preparation to the breast to avoid
accidental transfer to the infant.

Driving and operating machinery
Benzac does not impair the ability to drive vehicles or operate machinery.

Benzac 5% gel and Benzac 10% gel contain propylene glycol
Benzac 5% gel and Benzac 10% gel contain 4% propylene glycol, corresponding to 40 mg per
gram of gel.

3. How to use Benzac

Use this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

• Apply Benzac to the skin one or two times a day as needed.
• Spread a small amount of product onto the affected areas with your fingertips after thoroughly cleaning them with a mild cleanser and drying them carefully, massaging gently until

absorption. If you have sensitive skin, you should apply Benzac once a day or once every two days before going to bed.

• Use a small amount of product each time.
• Do not exceed the indicated doses without consulting your doctor.

If you use more Benzac than you should
In case of ingestion or accidental intake of an excessive dose of Benzac, immediately notify your doctor or go to the nearest hospital.
Do not apply too much product in an attempt to obtain faster or better results, as this may cause irritation.
If you have any doubts 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.
Adverse reactions from clinical studies all relate to skin disorders. They are reversible if the
treatment is reduced in frequency or stopped.

Very common side effects(may affect more than 1 in 10 people):

• Erythema (redness of the skin)
• Skin peeling (shedding of dead skin cells)
• Burning sensation on the skin
• Dry skin

Common side effects(may affect up to 1 in 10 people):

• Skin irritation (irritant contact dermatitis with the product)
• Itching
• Skin pain (pain, stinging pain)

Uncommon side effects(may affect up to 1 in 100 people):

• Allergic contact dermatitis with the product

Side effects with unknown frequency(frequency cannot be estimated based on available data):

• Swelling (tumefaction) of the face and allergic reactions including hypersensitivity where the medicine is applied and a serious, rapidly appearing allergic reaction (anaphylaxis).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Benzac

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Scad.
The expiry date refers to the last day of that month.
The expiry date refers to the medicine in intact packaging, correctly stored.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Benzac contains

• The active ingredient is benzoyl peroxide Benzac 5% gel100 g of gel contains 5 g of benzoyl peroxide

Benzac 10% gel
100 g of gel contains 10 g of benzoyl peroxide

• The other ingredients are: carbomer 940, methacrylic copolymer, glycerin, disodium edetate, dioctyl sodium sulfosuccinate, colloidal silica, propylene glycol (E1520), poloxamer 182, demineralized water.

Description of the appearance of Benzac and contents of the pack
Benzac is presented in the form of a gel for topical use.

Benzac 5% gel
Polyethylene tube containing 15 g or 40 g of gel.

BENZAC 10% gel
Polyethylene tube containing 40 g of gel.

Marketing Authorisation Holder
Galderma Italia S.p.A., Via dell'Annunciata, 21 – 20121 Milano

Manufacturer
Laboratoires Galderma, 74540 Alby sur Chéran, France

Benzac 5% gel

benzoyl peroxide

Read this leaflet carefully before you start using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet, or as your doctor or pharmacist
has told you to.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if your symptoms do not improve or get worse.

Contents of this leaflet:

• 1. What Benzac is and what it is used for
• 2. What you need to know before you use Benzac
• 3. How to use Benzac
• 4. Possible side effects
• 5. How to store Benzac
• 6. Contents of the pack and other information

1. What is Benzac and what is it used for?

Benzac contains the active ingredient benzoyl peroxide and belongs to a category of medicines used
for the local treatment of acne.
Benzac disinfects the skin; it also works in the presence of bacteria that cause acne.

2. What you need to know before using Benzac

Do not use Benzac:

• If you are allergic to benzoyl peroxide or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before using Benzac.
Benzac is for external use only.

• Avoid contact with the eyes, mouth, corners of the nose and other mucous membranes. If the medicine gets into your eye, wash it thoroughly with water.
• Do not apply the product to skin with superficial lesions (abrasions) or irritated skin.
• Avoid exposure to ultraviolet rays (tanning lamps) and the sun during application of the product.
• In case of severe irritation, consult your doctor who will advise you to use Benzac less frequently, to temporarily interrupt or discontinue use of the medicine.
• Benzoyl peroxide may cause swelling and blisters on the skin; discontinue use of the medicine and consult your doctor if any of these symptoms occur.
• You should use caution when applying the medicine to the neck and other sensitive areas.

You will probably feel a slight burning sensation with the first application and, within a few days,
mild redness and flaking of the skin may occur.
During the first few weeks of treatment, most patients experience a sudden
increase in flaking. This is not dangerous and usually subsides within one or two days
if treatment is temporarily interrupted.
The use, especially if prolonged, of topical products can lead to sensitization. If this
should happen, immediately discontinue treatment and consult your doctor to obtain suitable
therapy.
The oxidizing action of the gel can discolor dyed hair and colored clothing.

Children and adolescents
No data are available on efficacy and safety in children under 12 years of age.

Other medicines and Benzac
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Avoid the concurrent use of harsh cleansers, alcohol-containing products, topical acne preparations and
medicines used in the treatment of acne containing substances that may increase the peeling
effect (i.e. the effect of removing the superficial layer of the skin) ,irritants or that cause skin dryness ,
such as those based on tretinoin, resorcinol, salicylic acid and sulfides, medicated cosmetics.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
There are no data on the effects of benzoyl peroxide, the active ingredient of Benzac, during pregnancy.
During pregnancy and breastfeeding, use the medicine only if absolutely necessary and under medical supervision.
Breastfeeding
It is not known whether benzoyl peroxide passes into breast milk. For this reason, if you are breastfeeding,
use gel based on this active ingredient with caution and do not apply the preparation to the breast to avoid
accidental transfer to the infant.

Driving and operating machinery
Benzac does not impair the ability to drive vehicles or operate machinery.

3. How to use Benzac

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• Apply Benzac once or twice a day to the affected area, then rinse thoroughly with water and dry. The contact time with the skin must be as short as possible (from 1 to 5 minutes) to minimize the risk of side effects (see section 4). Do not use for prolonged treatments; after a short period of treatment without appreciable results, consult your doctor.
• Moisten the application area: place the necessary amount of Benzac on your fingertips and spread it on the various parts of the skin with a circular motion, as if washing.
• Use a small amount of product each time.
• Do not exceed the indicated doses without consulting your doctor.

If you use more Benzac than you should
In case of ingestion or accidental intake of an excessive dose of Benzac, immediately inform your doctor or go to the nearest hospital.
Do not apply too much product in an attempt to obtain faster or better results, as this may cause irritation.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Adverse reactions from clinical studies all relate to skin disorders. They are reversible if the
treatment is reduced in frequency or stopped.

Very common side effects(may affect more than 1 in 10 people):

• Erythema (redness of the skin)
• Skin peeling (shedding of dead skin cells)
• Burning sensation on the skin
• Dry skin

Common side effects(may affect up to 1 in 10 people):

• Skin irritation (irritative contact dermatitis with the product)
• Itching
• Skin pain (pain, stinging pain)

Uncommon side effects(may affect up to 1 in 100 people):

• Allergic contact dermatitis with the product

Side effects with unknown frequency(frequency cannot be estimated based on available data)

• Swelling (tumefaction) of the face and allergic reactions including hypersensitivity where the medicine is applied and a serious, rapidly occurring allergic reaction (anaphylaxis).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Benzac

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Scad.
The expiry date refers to the last day of that month.
The expiry date refers to the medicine in intact packaging, correctly stored.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Benzac contains

• The active ingredient is benzoyl peroxide

100 g of gel contains 5 g of benzoyl peroxide

• The other ingredients are: acryl copolymer, carbomer 940, sodium C14-C16 olefin sulfonate, glycerol, sodium hydroxide, demineralized water.

Description of the appearance of Benzac and contents of the pack
Benzac is presented in the form of a gel for topical use.
Polyethylene tube containing 100 g of gel.

Marketing Authorisation Holder
Galderma Italia S.p.A., Via dell'Annunciata, 21 – 20121 Milano

Manufacturer
Laboratoires Galderma, 74540 Alby sur Chéran, France