BENZAC*GEL 40G 10%

Benzac 5% gel
Benzac 10% gel
Benzoyl peroxide

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

What you need to know before taking the medicine
Do not use Benzac:
- If you are allergic to benzoyl peroxide or any of the other ingredients of this medicine (listed in paragraph 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Benzac.
Benzac is for external use only.
• Avoid contact with eyes, mouth, nostrils and other mucous membranes. If the medicine gets into the eye, wash 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 sun during the application of the product.
• In case of severe irritation, consult your doctor who will advise you to use Benzac less frequently, to temporarily stop or suspend the use of the medicine.
• Benzoyl peroxide can cause swelling and blisters on the skin; stop using 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 may experience a slight burning sensation on first application, and within a few days, slight redness and peeling of the skin may occur.
During the first weeks of treatment, most patients experience a sudden increase in peeling.
This is not dangerous and normally resolves within one or two days if treatment is temporarily stopped.
The use, especially if prolonged, of products for skin use can lead to sensitization. If this happens, immediately stop treatment and consult your doctor for appropriate therapy.
The oxidizing action of the gel can discolor dyed hair and colored clothing.

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

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

Very common side effects (may affect more than 1 in 10 people):
- Erythema (skin redness)
- Skin peeling (detachment 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 from the product)
- Itching
- Skin pain (pain, stinging pain)

Uncommon side effects (may affect up to 1 in 100 people):
- Allergic contact dermatitis from the product

Side effects with unknown frequency (frequency cannot be estimated from the available data)
- Swelling of the face and allergic reactions including hypersensitivity where the medicine is applied and a severe, rapidly occurring allergic reaction (anaphylaxis).

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.