BENZAC * GEL 40G 10%

BENZAC * GEL 40G 10%

Therapeutic indications

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

Dosage and method of use

BENZAC 5% gelAndBENZAC 10% gel: Apply Benzac locally on the skin favoring its penetration with a light massage. Applications must take place once or twice a day, as needed, spreading a small amount of Benzac with the fingertips on the affected parts, previously thoroughly cleaned with a mild detergent and carefully dried, 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 on the affected area. Moisten the application area. Bring the required amount of BENZAC 5% gel on the fingertips and spread it on the various skin parts in 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.

Contraindications

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

Side effects

Adverse reactions from clinical trials all relate 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,

Cases of facial swelling and allergic reactions, including application site hypersensitivity and anaphylaxis (frequency unknown) have been reported 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 ratio 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.

Special warnings

Benzac is for external use only. The use, especially if prolonged, of products for cutaneous use can give rise to sensitization phenomena; in this case, stop the treatment and consult the doctor to establish a suitable therapy. Probably, a slight burning sensation may be felt at the first application and, within a few days, a slight redness and peeling of the skin may occur. A sudden increase in desquamation occurs in most patients during the first few weeks of treatment. This is not dangerous and usually regresses within a day or two if treatment is temporarily stopped. Patients should be directed to use the drug less frequently, to temporarily stop or discontinue use, in case of severe irritation. Benzoyl peroxide can 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 it off with plenty of water. Caution should be exercised when applying the medicine to the neck and other sensitive areas. The oxidizing action of the gel can discolour dyed hair and colored clothing. Do not apply to abraded or irritated skin. Avoid exposure to the sun and ultraviolet rays when applying benzoyl peroxide.Pediatric population:There are no data on efficacy and safety in children below 12 years.Benzac 5% gel and Benzac 10% gel contain propylene glycolBenzac 5% gel and Benzac 10% gel contain 4% propylene glycol, corresponding to 40 mg per gram of gel.

Pregnancy and breastfeeding

Fertility, pregnancy: There is no safety concern with the effects of benzoyl peroxide applied to the skin on reproductive function, fertility, teratogenicity, or peri- and postnatal development in animals. The generalized clinical use for the cutaneous treatment of acne vulgaris, for several decades, at concentrations 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 the doctor. Lactation: It is not known whether benzoyl peroxide is excreted in animal or human milk. Since many drugs are excreted in breast milk, caution should be exercised when benzoyl peroxide contained in gel is used by breastfeeding women. The preparation should not be applied to the breast to avoid accidental transfer to the infant.

Expiration and retention

No.Do not store Benzac above 25 ° C

Interactions with other drugs

Avoid the simultaneous use of strong detergents, alcoholic products, acne skin preparations and medicines used in the treatment of acne containing substances that can increase the effectpeeling,irritants or that cause dry skin, such as those based on tretinoin, resorcinol, salicylic acid and sulphides, medicated cosmetics.

Overdose

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

Active principles

100 g of gel contain:

Excipient with known effect: Propylene glycol (E1520) For a full list of excipients, see section 6.1 Rinse-off formulation 100 g of gel contain:

For the full list of excipients, see section 6.1

Excipients

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