BENZAC Gel 40g 5%

BENZAC Gel

active principles

100 g gel contain:

Active principle:	BENZAC 10% gel	BENZAC 5% gel
Benzoyl peroxide	10 g	5 g

Excipient with known effects: Propilen glycol (E1520) For the complete list of excipients, see section 6.1 Rinsing formulation 100 g of gels contain:

Active principle	BENZAC 5% gel
Benzoyl peroxide	5 g

For the complete list of excipients, see section 6.1

Eccepienti

BENZAC 5% gel e BENZAC 10% gel Carbomer 940, methacrylic copolymer, glycerin, edetated disodium, sodium sodium diottyl, colloidal silica, propylene glycol (E1520), Poloxamer 182, demineralized water. BENZAC 5% gel - rinsing formulation Acril Copolymer, Carbomer 940, sodium C14-C16 Olefina sulfonate, glycerol, sodium hydroxide, demineralized water.

Therapeutic indications

Cute disinfection. It carries out antiseptic activity also against Fr. Acnes.

Contraindications

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

Dosage

BENZAC 5% gel and BENZAC 10% gel: Apply locally on the Cute Benzac favoring the penetration with a light massage. The applications must take place once or twice a day, as needed, stretching a small amount of Benzac with the fingertips on the interested parties previously cleaned at the bottom with a bland cleanser and carefully drying, massaging slightly up to absorption. People with sensitive skin must apply the gel once a day or once every two days before going to bed. BENZAC 5% gel (rinsing formulation): Apply the gel once or twice a day on the interested part. During the application area. Bring the necessary amount of BENZAC 5% gel on your fingertips and spread it on the various skin parts with circular motion, as if you were making a wash. The contact time with the skin must be as short as possible (from 1 to 5 minutes) to minimize the risk of undesirable effects (see section 4.8). Rinse carefully with water and dry.

Storage

Do not store Benzac at a temperature above 25 ° C

Warnings

Benzac is only for external use. Use, especially prolonged, of skin use products can give rise to awareness-raising phenomena; In this case, interrupt the treatment and consult your doctor to set up a suitable therapy. Probably, at the first application, a slight burning feeling can be felt and, within a few days, a slight redness and a pitch of the skin may occur. During the first weeks of treatment, in most patients, a sudden increase in fencing. This is not dangerous and normally regresses within one or two days if the treatment is temporarily interrupted. Patients must be directed to using the drug less frequently, to stop temporarily or suspend their use, in the event of severe irritation, benzoyl peroxide can cause swelling and blisters on the skin; If any of these symptoms occurs, the medicine must be interrupted. Avoid contact with eyes, mouth, nose corners and other mucous membranes. If the medicine should enter the eye, wash thoroughly with water. Caution must be used when the medicine is applied to the neck and other sensitive areas. The oxidizing gel action can discolor dyed hair and colored garments. Do not apply on abrasa or irritated skin. Avoid exposure to the sun and ultraviolet rays during the application of benzoyl peroxide. Pediatric population: No effectiveness and safety data are available in children under the age of 12. Benzac 5% gel and Benzac 10% gel contain propylene glycol Benzac 5% Gel and Benzac 10% gel contain 4% of propylene glycol, corresponding to 40 mg for each gram of gel.

Interactions

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

Effects

Adverse reactions arising from clinical studies are all related to skin disorders. They are reversible if the treatment is reduced frequently or interrupted. 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 defined based on the available data). Adverse reactions are reported in the table below:

Cute and subcutaneous fabric pathologies

Very common: erythema, skin exfoliation (peeling), skin burn sensation, skin dryness

Municipality: skin irritation (irritative contact dermatitis), itching, skin pain (pain, pungent pain)

Uncommon: allergic contact dermatitis

Cases of face swelling and allergic reactions have been reported, including hypersensitivity to the application site and anaphylaxis (with non-note frequency) from post-marketing pharmacovigilance data. Reporting of adverse reactions suspects the reporting of suspected adverse reactions that occur after authorization from the medicine is important, as it allows continuous monitoring of the benefit / risk report of the medicine. Healthcare professionals are required to report any suspected adverse reactions through the national reporting system to the address www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdose

Benzac is only for skin use. The excessive product application does not lead to faster or better results but can lead to irritation. In the event that a serious irritation is developed, the treatment must be interrupted and an appropriate symptomatic therapy must be established.

Fertility, pregnancy: There is no safety problem related to the effects of benzoyl peroxide, applied at skin level, on reproductive function, fertility, teratogenicity, or for a peri and post-christmas development, in animals. The generalized clinical use for the skin treatment of the acne vulgaris, for several decades, at concentrations up to 10% p / p of benzoyl peroxide has never been associated with these effects. In any case the drug must be administered in cases of actual necessity under the direct control of the medico.Allattamento: It is not known if benzoyl peroxide is excreted in animal or human milk. Because many drugs are excreted in breast milk, caution must be exercised when benzoyal peroxide contained in gel is used by women breastfeeding. The preparation must not be applied on the breast to avoid accidental transfer in the infant.

Source: Phandates