Benzac Gel 5% 40g gel

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Skin disinfection. It also has antiseptic activity against P. acnes.

ACTIVE INGREDIENTS

100 g of gel contains:

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

Excipient with known effects: Propylene glycol (E1520) For the complete list of excipients, see paragraph 6.1 Rinse-off formulation 100 g of gel contain:

Active ingredient: BENZAC 5% gel.

Benzoyl Peroxide: 5 g.

For the full list of excipients, see section 6.1

EXCIPIENTS

BENZAC 5% gel and BENZAC 10% gel Carbomer 940, Methacrylic copolymer, Glycerin, Disodium Edetate, Dioctyl sodium sulfosuccinate, Colloidal silica, Propylene glycol (E1520), Poloxamer 182, Demineralised water. BENZAC 5% gel - rinse-off formulation Acryl Copolymer, Carbomer 940, Sodium C14-C16 Olefin Sulphonate, Glycerol, Sodium Hydroxide, Demineralised Water.

CONTRAINDICATIONS AND SIDE EFFECTS

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

DOSAGE

BENZAC 5% gel e BENZAC 10% gel: Apply Benzac locally on the skin, favoring its penetration with a light massage. Applications must be made once or twice a day, as needed, by spreading a small amount of Benzac with the fingertips on the affected parts, previously thoroughly cleaned with a mild detergent and dried carefully, massaging lightly until absorbed. People with sensitive skin should apply the gel once a day or once every two days before going to bed. BENZAC 5% gel (rinse-off formulation): Apply the gel once or twice a day to the affected area. Moisten the application area. Place the required amount of BENZAC 5% gel on your fingertips and spread it on the various parts of the skin with a circular motion, as if washing. Skin contact time should be as short as possible (1 to 5 minutes) to minimize the risk of undesirable effects (see section 4.8). Rinse thoroughly with water and dry.

CONSERVATION

Do not store Benzac above 25°C

WARNINGS

Benzac is for external use only. The use, especially if prolonged, of products for skin use can give rise to sensitization phenomena; in this case, stop treatment and consult your doctor to institute suitable therapy. Probably, at the first application you may feel a slight burning sensation and, within a few days, slight redness and peeling of the skin may occur. During the first weeks of treatment, a sudden increase in desquamation occurs in most patients. This is not dangerous and normally subsides within a day or two if treatment is temporarily stopped. Patients should be directed to use the drug less frequently, to temporarily discontinue or discontinue use, if severe irritation occurs. Benzoyl peroxide may cause swelling and blistering of the skin; if any of these symptoms occur, the medicine should be stopped. Avoid contact with eyes, mouth, corners of the nose and other mucous membranes. If the medicine gets into the eye, wash with plenty of water. Caution should be used when applying the medicine to the neck and other sensitive areas. The oxidizing action of the gel can discolor dyed hair and colored clothing. Do not apply to abraded or irritated skin. Avoid exposure to the sun and ultraviolet rays while applying benzoyl peroxide. Pediatric population: No efficacy and safety data are available in children under 12 years of age. Benzac 5% gel and Benzac 10% gel contain propylene glycol Benzac 5% gel and Benzac 10% gel contain 4% propylene glycol, corresponding to 40 mg for each gram of gel.

INTERACTIONS

Avoid the simultaneous 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 sulphides, medicated cosmetics.

SIDE EFFECTS

The adverse reactions resulting from clinical studies are all related to skin disorders. They are reversible if treatment is reduced in frequency or stopped. The frequency of adverse reactions is divided into the following categories: Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000); Very rare (<1/10,000); Not known (frequency cannot be estimated from the available data). Adverse reactions are shown in the table below:

Pathologies of the skin and subcutaneous tissue.

Very common: erythema, skin exfoliation (desquamation), skin burning sensation, skin dryness.

Common: Skin irritation (irritant contact dermatitis), pruritus, skin pain (pain, stinging).

Uncommon: allergic contact dermatitis.

Cases of facial swelling and allergic reactions, including application site hypersensitivity and anaphylaxis, have been reported (frequency not known) from post-marketing pharmacovigilance data. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Benzac is for cutaneous use only. Excessive application of the product does not lead to faster or better results but may cause irritation. If severe irritation develops, treatment should be discontinued and appropriate symptomatic therapy instituted.

PREGNANCY AND BREASTFEEDING

Fertility, pregnancy: There are no safety concerns regarding the effects of benzoyl peroxide, applied to the skin, on reproductive function, fertility, teratogenicity, or peri- and post-natal development, in animals. Generalized clinical use for the skin treatment of acne vulgaris, for several decades, at concentrations of up to 10% w/w of benzoyl peroxide has never been associated with such effects. In any case, the drug should be administered in cases of real need under the direct supervision of a doctor. Breastfeeding: It is not known whether benzoyl peroxide is excreted in animal or human milk. Because many drugs are excreted in breast milk, caution should be exercised when benzoyl peroxide gel is used by women who are breastfeeding. The preparation must not be applied to the breast to avoid accidental transfer to the infant.

EFFECTS ON DRIVING ABILITY

Benzac does not affect the ability to drive or use machines.