Active ingredients: Benzoyl peroxide
BENZAC 5% gel
BENZAC 10% gel
BENZAC CLEAN 5% gel
Why is Benzac used? What is it for?
WHAT IS IT
Benzac is a drug for the local treatment of acne manifestations.
WHY IT IS USED
BENZAC is used for skin disinfection. It also performs antiseptic activity against P. acnes
Contraindications When Benzac should not be used
BENZAC must not be used in case of hypersensitivity to the active substance (benzoyl peroxide) or to any of the excipients of the product.
Precautions for use What you need to know before taking Benzac
BENZAC is for external use only.
Avoid contact with eyes and other mucous membranes.
Do not apply to skin with abrasions or irritations; avoid exposure to ultraviolet rays and the sun when applying the product.
There are no data on efficacy and safety in children below 12 years.
Interactions Which drugs or foods can modify the effect of Benzac
"Please inform your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription."
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 peeling effect, irritants or that cause dry skin, such as those based on tretinoin, resorcinol, acid salicylic and sulfides, medicated cosmetics.
Warnings It is important to know that:
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 institute a suitable therapy. The oxidizing action of the gel can discolour dyed hair and colorful clothing.
When it can be used only after consulting your doctor
Pregnancy and breastfeeding.
What to do during pregnancy and breastfeeding
"Ask your doctor or pharmacist for advice before taking any medicine'.
There are no data on the effects of benzoyl peroxide, the active ingredient of BENZAC, in pregnancy.
During pregnancy and breastfeeding, the drug should therefore be taken only in case of real need and under medical supervision.
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 gel or lotions are used by breastfeeding women. The preparation should not be applied to the breast to avoid accidental transfer to the infant.
Dose, Method and Time of Administration How to use Benzac: Posology
BENZAC 5% gel and BENZAC 10% gel
How much Use a small amount of the product each time. Do not exceed the indicated doses without doctor's advice.
When and for how long
Apply Benzac locally on the skin, favoring its penetration with a light massage. Applications should take place once or twice a day, as needed.
Like
Spread a small amount of product with your fingertips on the affected parts previously thoroughly cleaned with a mild detergent, massaging lightly until absorbed.
BENZAC CLEAN 5% gel
How much Use a small amount of the product each time. Do not exceed the indicated doses without doctor's advice.
When and for how long
Apply Benzac once or twice a day on the affected area, then rinse and dry. Do not use for prolonged treatments; after a short period of treatment without appreciable results consult your doctor.
Like
Moisten the area of application: bring the necessary amount of Benzac on the fingertips and spread it on the various parts of the skin in a circular motion, as if washing.
Overdose What to do if you have taken too much Benzac
"In case of accidental ingestion / intake of an excessive dose of Benzac, notify your doctor immediately or go to the nearest hospital".
Excessive application of the product does not lead to better results but can lead to irritation.
Side Effects What are the side effects of Benzac
The frequency of adverse reactions is divided into the following categories:
Very common (≥ 1/10) 16fi11 (Package leaflet authorized following Renewal, Determination dated 21/04/2011 and shelf life reduction 5% and 10%) Common (≥ 1/100, <1/10) Uncommon (≥ 1 / 1,000 to <1/100) Rare (≥ 1 / 10,000 to <1 / 1,000) Very rare (<1 / 10,000) Not known (cannot be estimated from the available data). Adverse reactions are shown in the table below:
Cases of facial swelling and hypersensitivity reactions (with frequency not known) have been reported from post-marketing pharmacovigilance data.
'Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects ".
"If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist."
Expiry and Retention
Expiry: See the expiry date printed on the package
The expiry date refers to the product in intact packaging, correctly stored
BENZAC 5% gel and BENZAC 10% gel: 2 years
BENZAC CLEAN 5% gel: 18 months
Warning: do not use the medicine after the expiry date shown on the package.
BENZAC 5% gel, BENZAC 10% gel and BENZAC CLEAN 5% gel: do not store above 25 ° C
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Keep this medicine out of the reach and sight of children.
It is important to always have the information on the medicine available, so keep both the box and the package leaflet.
COMPOSITION
BENZAC 100 g of gel contain:
Active ingredient BENZAC 10% gel BENZAC 5% gel Benzoyl peroxide 10 g 5 g
Excipients Carbomer 940, Methacrylic Copolymer, Glycerin, Disodium Edetate, Dioctyl Sodium Sulfosuccinate, Colloidal Silica, Propylene glycol, Poloxamer 182, Demineralized water.
Active ingredient BENZAC Clean 5% gel Benzoyl peroxide 5 g 16fi11 (leaflet authorized following Renewal, Resolution dated 21/04/2011 and variation of 5% and 10% shelf life reduction)
Excipients Acryl copolymer, Carbomer 940, Sodium C14-C16 Olefin Sulfonate, Glycerol, Sodium Hydroxide, demineralized water
HOW IT LOOKS
BENZAC comes in the form of a gel for cutaneous use.
BENZAC 5% gel and BENZAC 10% gel The contents of the package are 40 g of gel.
BENZAC Clean 5% gel The contents of the package are 100 g of gel.
Source Package Leaflet: AIFA (Italian Medicines Agency).Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
BENZAC GEL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of gel contain:
Active principle: BENZAC 10% gel BENZAC 5% gel
Benzoyl peroxide 10 g 5 g
Excipients: Propylene glycol
For the full list of excipients, see section 6.1. 100 g of gel contain:
Active principle: BENZAC CLEAN 5% gel
Benzoyl peroxide 5 g
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Gel
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Skin disinfection. It also has antiseptic activity against P. acnes.
04.2 Posology and method of administration
BENZAC 5% gel and BENZAC 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, massaging lightly until absorbed.
BENZAC CLEAN 5% gel: Apply the gel once or twice a day on the affected area. Moisten the application area. Bring the required amount of BENZAC CLEAN 5% gel on the fingertips and spread it on the various skin parts in a circular motion, as if washing. Rinse and dry.
04.3 Contraindications
Hypersensitivity to benzoyl peroxide or to any of the excipients.
04.4 Special warnings and appropriate precautions for use
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.
Avoid contact with eyes and other mucous membranes.
The oxidizing action of the gel can discolour dyed hair and colored clothing.
There are no data on efficacy and safety in children below 12 years.
Do not apply to abraded or irritated skin.
Avoid exposure to the sun and ultraviolet rays when applying benzoyl peroxide.
04.5 Interactions with other medicinal products and other forms of interaction
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 causing dry skin, such as those based on tretinoin, resorcinol, salicylic acid and sulphides, medicated cosmetics.
04.6 Pregnancy and lactation
There are no data in the published literature regarding the effects of benzoyl peroxide on reproductive function, fertility, teratogenicity, or peri- and postnatal development in animals. Widespread use for more than 30 years at concentrations up to 10% of benzoyl peroxide has never been associated with such effects on humans. In any case, the drug should be administered in cases of actual need under the direct supervision of the doctor.
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 gel or lotions are used by breastfeeding women. The preparation should not be applied to the breast to avoid accidental transfer to the infant.
04.7 Effects on ability to drive and use machines
The use of Benzac does not affect the ability to drive, nor the use of other machinery.
04.8 Undesirable effects
The frequency of adverse reactions is divided into the following categories: very common (≥ 1/10); common (≥ 1/100,
Adverse reactions are shown in the table below:
Skin and subcutaneous tissue disorders
Very common: erythema, skin exfoliation (peeling), skin burning sensation, dry skin
Common: skin irritation (irritative contact dermatitis), itching, skin pain (pain, stinging)
Uncommon: allergic contact dermatitis
Cases of facial swelling and hypersensitivity reactions (with frequency not known) have been reported from post-marketing pharmacovigilance data.
04.9 Overdose
Benzac is for cutaneous use only. Excessive application of the product does not lead to better results but can lead to irritation.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antiacne for topical use
ATC code: D10AE01
Benzoyl peroxide has been shown to possess a broad spectrum of antibacterial activity, particularly against Propionibacterium acnes, the microorganism present in abnormal quantities in the pilosebaceous units affected by acne. Furthermore, benzoyl peroxide has been shown to possess exfoliating and comedolytic activity in the treatment of acne.
05.2 Pharmacokinetic properties
Percutaneous penetration of benzoyl peroxide in rats, rabbits, monkeys and humans is low. When applied to the skin, most of the penetrating benzoyl peroxide is converted to benzoic acid, which enters the systemic circulation and is rapidly eliminated by the kidneys. There is no evidence of tissue accumulation, nor of systemic adverse reactions following the cutaneous application of Benzac administered according to the posology of clinical studies.
05.3 Preclinical safety data
Studies in animals treated with benzoyl peroxide via the skin have shown a skin irritation potential of minimal to moderate intensity. The low systemic exposure and rapid elimination of benzoic acid, the main degradation product of benzoyl peroxide, ensure that possible acute or chronic systemic toxicity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
BENZAC 5% gel and BENZAC 10% gel
Carbomer 940, Methacrylic copolymer, Glycerin, Disodium Edetate, Dioctyl sodium sulfosuccinate, Colloidal silica, Propylene glycol, Poloxamer 182, Demineralized water.
BENZAC CLEAN 5% gel
Acril Copolymer, Carbomer 940, Sodium C14-C16 Olefin Sulfonate, Glycerol, Sodium Hydroxide, Demineralized Water.
06.2 Incompatibility
Those common to all peroxides.
06.3 Period of validity
BENZAC 5% gel and BENZAC 10% gel: 2 years
BENZAC CLEAN 5% gel: 18 months
06.4 Special precautions for storage
BENZAC 5% gel, BENZAC 10% gel and BENZAC CLEAN 5% gel: do not store above 25 ° C
06.5 Nature of the immediate packaging and contents of the package
BENZAC 5% gel and BENZAC 10% gel: 40 g polyethylene tube
BENZAC CLEAN 5% gel: 100 g polyethylene tube
06.6 Instructions for use and handling
No special instructions
07.0 MARKETING AUTHORIZATION HOLDER
Galderma Italia S.p.A. - registered office in Milan - Commercial and administrative offices
Colleoni Business Center, Agrate Brianza (MB)
08.0 MARKETING AUTHORIZATION NUMBER
BENZAC 5% gel, 40 g tube: 032143024
BENZAC 10% gel, 40 g tube: 032143012
BENZAC CLEAN 5% gel, 100 g tube: 032143036
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
29 November 1995 / April 2011
10.0 DATE OF REVISION OF THE TEXT
April 2011/4
