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 local 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 section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Benzac.

Benzac is for external use only.
• Avoid contact with eyes, mouth, corners of the nose 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 the sun during product application.
• In case of severe irritation, consult your doctor who will advise you to use Benzac less frequently, to temporarily stop or discontinue the use of the medicine.
• Benzoyl peroxide can cause swelling and blistering of 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 may probably feel a slight burning sensation on first application and, within a few days, slight redness and skin flaking may occur.
During the first few weeks of treatment, a sudden increase in flaking occurs in most patients. This is not dangerous and normally resolves within one or two days if treatment is temporarily discontinued.

The use, especially if prolonged, of products for cutaneous use can give rise to sensitisation. If this should happen, stop treatment immediately and consult your doctor to obtain appropriate therapy.
The oxidising action of the gel can discolour dyed hair and coloured clothes.

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

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 treatment is reduced in frequency or discontinued.

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

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

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