BENZAC GEL 40G 5%

BENZAC GEL

active ingredients

100 g gel contains:

Active ingredient:	BENZAC 10% gel	BENZAC 5% gel
Benzoyl Peroxide	10 g	5 g

Excipient with known effects: Propilen glycol (E1520) For the full list of excipients, see paragraph 6.1 Rinse formula 100 g gel contain:

Active ingredient	BENZAC 5% gel
Benzoyl Peroxide	5 g

For the full list of excipients, see paragraph 6.1

Excellent

BENZAC 5% gel and BENZAC 10% gel Carbomer 940, Methacrylic copolymer, Glycerin, Edetate disode, Diottil sodium sulphosuccinate, Silice colloidal, Propilen glycol (E1520), Poloxamer 182, Demineralized water. BENZAC 5% gel - rinsing formula Acril Copolimero, Carbomer 940, Sodium C14-C16 Olefina Sulfonato, Glicerolo, Sodium Hydroxide, Demineralized water.

Therapeutic indications

Skin disinfection. It also carries out antiseptic activity against P. acnes.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

BENZAC 5% gel and BENZAC 10% gel: Apply locally on the skin Benzac favoring penetration with light massage. Applications must take place one or two times a day, according to necessity, by laying with the tip of the fingers a small amount of Benzac on the interested parties previously cleaned thoroughly with a mild detergent and dried with care, massaging slightly until absorption. People with sensitive skin should apply the gel once a day or once every two days before going to bed. BENZAC 5% gel (resciacquo): Apply the gel once or twice a day on the affected part. Moisten the application area. Bring the necessary amount of BENZAC 5% gel on the tip of the fingers and spread it on the various cutaneous parts with circular movement, as if a washing was carried out. The contact time with the skin must be as short as possible (from 1 to 5 minutes) to minimize the risk of unwanted effects (see paragraph 4.8). Rinse thoroughly with water and dry.

Conservation

Non keeping Benzac at a temperature exceeding 25°C

Warnings

Benzac is only for external use. The use, especially if prolonged, of the products for skin use can give rise to phenomena of sensitization; in this case interrupt treatment and consult your doctor to establish suitable therapy. Probably, a slight burning sensation may be felt at the first application and, within a few days, a slight redness and skin dequamation may occur. During the first weeks of treatment, in most patients, a sudden increase in desquamation occurs. This is not dangerous and normally regress within one or two days if the treatment is temporarily stopped. Patients should be directed to use the drug less frequently, temporarily interrupt or suspend use, in case of severe irritation, Benzoyl peroxide can cause swelling and blisters on the skin; if any of these symptoms occur, the medicine must be stopped. Avoid contact with eyes, mouth, corners of the nose and other mucous membranes. If the medicine enters the eye, wash thoroughly with water. You should use caution when applying the medicine on the neck and other sensitive areas. The oxidizing action of the gel can discolor dyed hair and colored clothing. Do not apply on abraded or irritated skin. Avoid sun exposure and ultraviolet rays while applying benzoyl peroxide. Pediatric population: Efficiency and safety data are not available in children under 12 years. Benzac 5% gel and Benzac 10% gel contain glycol propylene Benzac 5% gel and Benzac 10% gel contain 4% glycol propylene, corresponding to 40 mg per gram of gel.

Interactions

Avoid the contemporary use of strong detergents, alcoholic products, anti-acne skin preparations and medicines used in the treatment of acne containing substances that can increase the effect peeling, irritants or that cause skin dryness, such as those based on tretinoin, resorcinol, salicylic acid and sulfides, medicated cosmetics.

Effects

Adverse reactions from clinical trials are all related to skin disorders. They are reversible if the treatment is reduced in frequency or interrupted. The frequency of adverse reactions is divided into the following categories: Very common (≥1/10) Common (≥1/100, Pathologies of skin and subcutaneous tissue Very common: erythema, skin exfoliation (desquamation), skin burning sensation, skin dryness Common: skin irritation (contact irritative dermatitis), itching, skin pain (sweet, pungent pain) Not common: contact allergic dermatitis Cases of facial swelling and allergic reactions have been reported, including hypersensitivity to the application site and anaphylaxis (frequently unknown) from post-marketing pharmacovigilance data. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.aifa.gov.it/content/segnalazioni-reazioni-avverse..

Overdosing

Benzac is only for skin use. Excessive application of the product does not lead to faster or better results but can cause irritation. In the event of severe irritation, treatment must be interrupted and appropriate symptomatic therapy must be established.

Fertility, pregnancy: There is no safety problem regarding the effects of benzoyl peroxide, applied at the cutaneous level, reproductive function, fertility, teratogenicity, or on the development of pears and post-Christmas, in animals. Generalized clinical use for skin treatment of acne vulgaris, for several decades, at concentrations of up to 10% p/p of benzoyl peroxide has never been associated with such effects. In any case, the drug should be administered in cases of actual need under the direct control of the drug medico.Allattamento: It is not known whether benzoyl peroxide is excreted in animal or human milk. Since many medicines are excreted in breast milk, it must be exercised caution when the peroxide of benzoyl content in gel is used by nursing women. The preparation should not be applied on the breast to avoid accidental transfer into the infant.

Source: Farmadati