BREVOXYL Cream Ref.[6450] Active ingredients: Benzoyl peroxide

Contact with the eyes, eyelids, mouth, lips, other mucous membranes and broken skin should be avoided. In case of accidental contact, rinse well with water. Care should be taken when applying the product to the neck and other sensitive areas.

This product contains propylene glycol alginate, stearyl alcohol and cetyl alcohol. Propylene glycol alginate may cause skin irritation. Stearyl alcohol and cetyl alcohol may cause local skin reaction (e.g. contact dermatitis).

During the first weeks of treatment, a sudden increase in peeling and reddening will occur in most patients and will normally subside in a day or two if treatment is temporarily discontinued.

Patients should be advised that excessive application will not improve efficacy, but may increase the risk of skin irritation.

Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy may occur, which sometimes may be severe, especially with the use of peeling, desquamating, or abrasive agents.

If severe, local irritancy occurs (e.g. severe erythema, severe dryness and itching, severe stinging/burning sensation), Brevoxyl should be discontinued.

As Brevoxyl may cause increased sensitivity to sunlight, sunlamps should not be used and deliberate or prolonged exposure to sunlight should be avoided or minimised. When exposure to strong sunlight cannot be avoided, patients should be advised to use a sunscreen product and wear protective clothing.

The product may bleach hair and coloured or dyed fabrics. Avoid contact with hair, fabrics, furniture or carpeting.

Concomitant application of Brevoxyl with tretinoin, isotretinoin, and tazarotene should be avoided since it may reduce their efficacy and increase irritation. If combination treatment is required, the products should be applied at different times of the day (e.g. one in the morning and the other in the evening).

Using Brevoxyl at the same time as topical sulphonamide-containing products may cause skin and facial hair to temporarily change colour (yellow/orange).

Fertility

There are no data on the effect of topical benzoyl peroxide on fertility.

Pregnancy

There are limited data on the use of topical benzoyl peroxide in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3.). No effects during pregnancy are anticipated since systemic exposure to benzoyl peroxide is very limited.

However, Brevoxyl should be used during pregnancy only if the expected benefit justifies the potential risk to the foetus.

Lactation

Percutaneous absorption of benzoyl peroxide is very limited; however, it is not known whether benzoyl peroxide is excreted in human milk after topical application.

Brevoxyl should be used during lactation only if the expected benefit justifies the potential risk to the infant.

If used during lactation, Brevoxyl should not be applied to the breast area to avoid accidental ingestion by the infant.

Not relevant.

Adverse reactions are classified by System Organ Class. Adverse reactions that occurred either during clinical studies or that were spontaneously reported are presented below.

Frequencies were defined as follows:

Very common ≥1/10
Common ≥1/100 to <1/10
Uncommon ≥1/1000 to <1/100
Rare ≥1/10000 to <1/1000
Very rare <1/10000
Not known (cannot be estimated from the available data)

Immune System Disorders

Not known: Allergic reactions, including application site hypersensitivity and anaphylaxis

Skin and subcutaneous tissue disorders

Very Common: Peeling, application site erythema

Common: Dryness, pruritus and contact sensitisation reactions

Uncommon: Burning sensation

Not known: Application site rash

General Disorders and Administration Site Conditions

Not known: Application site discoloration and application site reactions such as irritation and pain

Not applicable.