ACTION AND MECHANISM

- Anti-acne. Topical antibacterial active against Propionibacterium acnes, a microorganism involved in acne vulgaris. It is also keratolytic and antiseborrheic, counteracting hyperkeratinization and excess sebum secretion associated with acne.

SPECIAL WARNINGS

- Assess the response to treatment after 3-4 weeks. In case of insufficient response, it may be necessary to increase the concentration.

- If a reaction occurs that suggests sensitivity to any of the components, discontinue application.

- People treated with benzoyl peroxide should protect their skin from ultraviolet radiation with sunscreens adapted to their phototype and/or with protective clothing.

SENIORS

There is no recommendation for use in these patients.

PATIENT ADVICE

- Do not apply to damaged skin, eyes, mouth or mucous membranes.

- Benzoyl peroxide can bleach hair or clothing.

- Avoid sun exposure and UV rays during treatment, as this could cause skin reactions due to the benzoyl peroxide. Protect your skin with sunscreen or clothing.

- Tell your doctor and/or pharmacist if skin irritation, blisters, or inflammation occur.

CONTRAINDICATIONS

- Hypersensitivity to benzoyl peroxide.

EFFECTS ON DRIVING

It does not present significant effects.

PREGNANCY

Animal safety : no data available on the effects of benzoyl peroxide on the fetus.

Safety in humans : There are no adequate and well-controlled studies in humans. Extensive experience exists in the treatment of acne vulgaris at concentrations up to 100 mg/g, without an observed increase in fetal effects. Its administration is only acceptable if there are no safer therapeutic alternatives and the benefits outweigh the potential risks.

Effects on fertility : no specific studies have been conducted in humans.

PHARMACOKINETICS

The percutaneous penetration of benzoyl peroxide is low; when applied to the skin, it is completely converted to benzoic acid which is rapidly eliminated in urine.

INDICATIONS

- [ACNE] of moderate severity.

INTERACTIONS

No interactions have been described, and due to its low absorption, none are expected. However, it would be advisable to avoid co-administration with azelaic acid and exfoliating, irritating, or drying cosmetics.

LACTATION

Animal safety : no data available.

Safety in humans : It is unknown whether this product is excreted in breast milk, and the potential consequences for the infant are also unknown. Use with caution during breastfeeding. Avoid applying it to the breast before breastfeeding.

CHILDREN

Benzoyl peroxide can be used in adolescents 12 years of age and older at the same doses as in adults. Its safety and efficacy have not been evaluated in children under 12 years of age, therefore its use is not recommended.

GUIDELINES FOR PROPER ADMINISTRATION

- "Benzac Wash" : Moisten the area to be treated. Apply a small amount of gel to your hands and wash the affected area. The contact time with the skin should be 1 to 5 minutes. Then rinse thoroughly with water and gently dry the area without rubbing. Wash your hands well after use.

POSOLOGY

- Adults and adolescents from 12 years of age: initially 1-2 applications per day to the affected area. In patients with very sensitive skin, it is advisable to start treatment with one application per day.

It is recommended to start with the lower concentration formulations. If there is insufficient response after 3-4 weeks, the higher concentration formulations can be used.

- Children < 12 years: not recommended.

Duration of treatment : improvement may be observed within 4-6 weeks, although longer periods may be necessary.

PRECAUTIONS

- Skin irritation. Skin irritation and peeling may occur at the start of treatment, which usually disappears 1-2 days after discontinuing treatment. It is recommended to start treatment on a small area of ​​skin and gradually increase the area. If skin irritation occurs, applications should be spaced out. Discontinue treatment and consult a doctor if severe irritation, blistering, or skin swelling occurs.

Use caution when using cosmetics with scaling, irritating or drying effects, as these may enhance the irritating effects of benzoyl peroxide.

[PHOTOSENSITIVITY REACTIONS]. Benzoyl peroxide has caused photosensitivity reactions in sun-exposed areas of skin. It is recommended to avoid sun exposure (including UVA tanning beds) during treatment and to protect the skin with appropriate sunscreens and/or protective clothing.

ADVERSE REACTIONS

Adverse reactions are usually local and disappear when treatment is discontinued.

Adverse reactions are described according to each frequency interval, being considered very common (>10%), common (1-10%), uncommon (0.1-1%), rare (0.01-0.1%), very rare (<0.01%) or of unknown frequency (cannot be estimated from the available data).

- Immune system disorders: frequency unknown [HYPERSENSITIVITY REACTIONS], with [ANAPHYLAXIS].

- Skin and subcutaneous tissue disorders: very common [DRY SKIN], [ERYTHEMA], [SKIN IRRITATION], [SKIN SCALING] and burning sensation; common [PRURITUS], skin pain, [IRRITATIVE CONTACT DERMATITIS]; uncommon [ALLERGIC CONTACT DERMATITIS]; frequency not known: swelling of the face, [PHOTOSENSITIVITY REACTIONS].

OVERDOSE

Symptoms : Excessive skin irritation may occur. There is no experience with accidental or intentional ingestion.

Measures to be taken :

- Antidote: there is no specific antidote.

- General elimination measures: none have been established.

- Monitoring: monitoring the patient does not appear to be necessary.

- Treatment: symptomatic, through the application of emollients, cold compresses and/or preparations with topical corticosteroids.