Benzac 50 Mg/G Skin Gel 40 G

Benzac (50 Mg/G Cutaneous Gel 1 Tube 40 G)

Benzoyl Peroxide 50Mg/g

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.

PHARMACOKINETICS

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

INDICATIONS

- [ACNE] of moderate degree.

POSOLOGY

- Adults and adolescents from 12 years: initially 1-2 applications per day on 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 presentations. In case of insufficient response at 3-4 weeks, the higher concentration presentations can be used.

- Children < 12 years: not recommended.

Duration of treatment : improvement can be seen at 4-6 weeks, although longer periods may be necessary.

RULES FOR CORRECT ADMINISTRATION

- Topical gel: apply with the fingertips a thin film on freshly washed and dry skin. Avoid eyes, mouth, nostrils or mucous membranes. If it comes into contact with the eyes, rinse immediately with lukewarm water.

It should not be applied to damaged or eczematous skin, or to cuts or abrasions.

CONTRAINDICATIONS

- Hypersensitivity to benzoyl peroxide.

PRECAUTIONS

- Skin irritation. Skin irritation and peeling of the skin may appear at the start of treatment, which usually disappears within 1-2 days of stopping treatment. It is recommended to start the treatment in a small area of ​​skin, and gradually increase it. In case of skin irritation, administrations should be distanced. Discontinue treatment and consult a doctor if severe irritation occurs, or the appearance of blisters or skin edema.

Be careful if cosmetics with peeling, irritating or drying effects are used, as these can enhance the irritating effects of benzoyl peroxide.

- [PHOTOSENSITIVITY REACTIONS]. Benzoyl peroxide has given rise to photosensitivity phenomena in areas of skin exposed to the sun. It is recommended to avoid sunbathing (including UVA baths) during treatment, and protect the skin with suitable sunscreens and/or protective clothing.

ADVICE TO THE PATIENT

- Do not apply on damaged skin, eyes, mouths or mucosa.

- Benzoyl peroxide can discolor hair or clothing.

- Do not sunbathe or UVA rays during treatment, as you could have skin reactions as a result of benzoyl peroxide. Protect your skin with sunscreen or clothing.

- Warn your doctor and/or pharmacist if skin irritation or the appearance of blisters or inflammation appears.

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 that suggests sensitivity to any of the components occurs, stop the application.

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

INTERACTIONS

No interactions have been described and due to its low absorption, they are not to be expected. However, it would be advisable to avoid joint administration with azelaic acid and desquamating, irritating or drying cosmetics.

PREGNANCY

Animal Safety : No data is available on the effects of benzoyl peroxide on the fetus. 

Safety in humans : Adequate and well-controlled studies in humans are not available. There is extensive experience in the treatment of acne vulgaris at concentrations up to 100 mg/g, without an increased incidence of fetal effects having been observed. Its administration is only accepted if there are no safer therapeutic alternatives, and the benefits outweigh the possible risks.  

Effects on Fertility : No specific studies have been conducted in humans.

LACTATION

Safety in animals : no data available.

Safety in humans : It is unknown whether it is excreted in milk, and what consequences it could have for the nursing infant. It is advised to use with caution during lactation. Avoid application on the chest before breastfeeding the child.

CHILDREN

Benzoyl peroxide can be used in adolescents from 12 years of age, at the same doses as in adults. The safety and efficacy in children < 12 years have not been evaluated, so it is recommended to avoid its use.

ELDERLY

There is no recommendation for use in these patients.

EFFECTS ON DRIVING

It does not present significant effects.

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], [ERITEMA], [SKIN IRRITATION], [SKIN DESCAMATION] and burning sensation; common [PRURITIS], skin pain, [IRRITATIVE CONTACT DERMATITIS]; uncommon [ALLERGIC CONTACT DERMATITIS]; unknown frequency facial swelling, [PHOTOSENSITIVITY REACTIONS].

OVERDOSE

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

Measures to take :

- Antidote: there is no specific antidote.

- General elimination measures: not established.

- Monitoring: patient follow-up does not seem accurate.

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

Leaflet Benzac 50 Mg/G Cutaneous Gel 40 G