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Components:
Benzoyl Peroxide
Method of action:
Accelerating Wound Healing, Antiacne, Drying, Keratolytic
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Medically reviewed by Fedorchenko Olga Valeryevna, Pharmacy-Provisor. Last updated on 2019.11.17

Name of the medicinal product

Aczo

Therapeutic indications

The information provided in Therapeutic indications of Aczo is based on data of another medicine with exactly the same composition as the Aczo of the medicine (Benzoyl Peroxide). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Aczo directly from the package or from the pharmacist at the pharmacy.
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The product is indicated for use in the topical treatment of acne vulgaris.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Aczo is based on data of another medicine with exactly the same composition as the Aczo of the medicine (Benzoyl Peroxide). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Aczo directly from the package or from the pharmacist at the pharmacy.
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Treatment should normally begin with Aczo Aquagel 2.5. The reaction of the skin to benzoyl peroxide differs in individual patients. The higher concentration in Aczo Aquagel 5 or 10 may be required to produce a satisfactory response.

Adults and adolescents

Apply a thin film to the whole of the affected area once daily preferably after washing and drying the skin.

If excessive dryness or peeling occurs application should be temporarily interrupted as per physician instruction or patient tolerability.

Maximum lesion reduction may be expected after approximately eight to twelve weeks of drug use. Continued use is normally required to maintain a clinical response.

Elderly Patients

There are no specific recommendations for use in the elderly.

Paediatric Population

Safety and effectiveness of topical benzoyl peroxide in children under the age of 12 has not been established.

Contraindications

The information provided in Contraindications of Aczo is based on data of another medicine with exactly the same composition as the Aczo of the medicine (Benzoyl Peroxide). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Aczo directly from the package or from the pharmacist at the pharmacy.
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Patients with a known hypersensitivity to any of the ingredients.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Aczo is based on data of another medicine with exactly the same composition as the Aczo of the medicine (Benzoyl Peroxide). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Aczo directly from the package or from the pharmacist at the pharmacy.
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Avoid contact with the eyes, eyelids, mouth, lips and other mucous membranes. Contact with broken skin should be avoided. Care should be taken when applying the product to the neck and other sensitive areas.

During the first few weeks of treatment a sudden increase in peeling and reddening will occur in most patients and will normally subside in a day or two if treatment is temporarily discontinued.

Patients should be advised that excessive application will not improve efficacy, but may increase the risk of skin irritation.

Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy may occur, which sometimes may be severe, especially with the use of peeling, desquamating, or abrasive agents.

If severe local irritancy occurs (e.g. severe erythema, severe dryness and itching, severe stinging/burning sensation), benzoyl peroxide should be discontinued.

As benzoyl peroxide may cause increased sensitivity to sunlight, sunlamps should not be used and deliberate or prolonged exposure to sunlight should be avoided or minimised. When exposure to strong sunlight cannot be avoided, patients should be advised to use a sunscreen product and wear protective clothing.

The product may bleach hair and coloured or dyed fabrics. Avoid contact with hair, fabrics, furniture or carpeting.

Aczo 10 Aquagel contains propylene glycol. Propylene glycol may cause skin irritation.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Aczo is based on data of another medicine with exactly the same composition as the Aczo of the medicine (Benzoyl Peroxide). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Aczo directly from the package or from the pharmacist at the pharmacy.
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Not Relevant

Undesirable effects

The information provided in Undesirable effects of Aczo is based on data of another medicine with exactly the same composition as the Aczo of the medicine (Benzoyl Peroxide). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Aczo directly from the package or from the pharmacist at the pharmacy.
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Adverse reactions are classified by System Organ Class. Adverse reactions that occurred either during clinical studies or that were spontaneously reported are presented below:

Very common >1/10

Common >1/100 to <1/10

Uncommon >1/1000 to <1/100

Rare >1/10000 to <1/1000

Very rare <1/10000

Not known* (cannot be estimated from the available data).

Immune System Disorders

Not known: Allergic reactions, including application site hypersensitivity and anaphylaxis

Skin and Subcutaneous Tissue Disorders

Very Common: Peeling, application site erythema

Common: Dryness, pruritus and contact sensitisation reactions

Uncommon: Burning sensation

Not known: Application site rash

General Disorders and Administration Site Conditions

Not known: Application site discoloration and application site reactions such as irritation and pain

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at:www.mhra.gov.uk/yellowcard.

Overdose

The information provided in Overdose of Aczo is based on data of another medicine with exactly the same composition as the Aczo of the medicine (Benzoyl Peroxide). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Aczo directly from the package or from the pharmacist at the pharmacy.
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Symptoms and signs

Topically applied benzoyl peroxide is not generally absorbed in sufficient amounts to produce systemic effects.

Excessive application may result in severe irritation. In this event, discontinue use and wait until the skin has recovered.

Treatment

Cold compresses can provide relief from irritation due to excessive application.

Accidental ingestion of topical benzoyl peroxide should be managed clinically or as recommended by the National Poisons Centre, where available.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Aczo is based on data of another medicine with exactly the same composition as the Aczo of the medicine (Benzoyl Peroxide). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Aczo directly from the package or from the pharmacist at the pharmacy.
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Pharmacotherapeutic group: Benzoyl peroxide

ATC code: D10AE01

Mechanism of action

Benzoyl peroxide is a highly lipophilic oxidizing agent with bacteriocidal and keratolytic effects.

Pharmacodynamic effects

The effectiveness of benzoyl peroxide in the treatment of acne vulgaris is primarily attributable to its antibacterial activity, especially with respect to Propionibacterium acnes. The antibacterial activity of benzoyl peroxide is due to the release of active or free-radical oxygen capable of oxidising bacterial proteins. Benzoyl peroxide is also believed to be effective in the treatment of acne on account of its anti-inflammatory and mild keratolytic properties.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Aczo is based on data of another medicine with exactly the same composition as the Aczo of the medicine (Benzoyl Peroxide). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Aczo directly from the package or from the pharmacist at the pharmacy.
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Absorption/Distribution/Metabolism

Benzoyl peroxide is absorbed by the skin where it is metabolised to benzoic acid. Following topical application, less than 5% of the dose enters systemic circulation as benzoic acid.

Elimination

Benzoyl peroxide is excreted as benzoic acid in the urine.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Aczo is based on data of another medicine with exactly the same composition as the Aczo of the medicine (Benzoyl Peroxide). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Aczo directly from the package or from the pharmacist at the pharmacy.
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Benzoyl peroxide

Preclinical safety data

The information provided in Preclinical safety data of Aczo is based on data of another medicine with exactly the same composition as the Aczo of the medicine (Benzoyl Peroxide). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Aczo directly from the package or from the pharmacist at the pharmacy.
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Carcinogenesis/mutagenesis

Both the carcinogenicity and photocarcinogenicity of benzoyl peroxide have been extensively assessed in both mice and hamsters, by various routes of administration, in studies ranging from 42 to 100 weeks in duration. The overall conclusion is that benzoyl peroxide is considered to be generally recognized as a neither carcinogenic nor photocarcinogenic and safe in topical acne products at a concentration of 2.5% to 10%.

The genotoxicity of benzoyl peroxide was extensively assessed in vitro and in vivo. While in a few in vitro studies benzoyl peroxide showed weak mutagenicity, the overall genotoxicity profile did not indicate significant biological relevance.

Reproductive Toxicology

Fertility and Pregnancy

In a combined repeat- dose and reproduction/development toxicity study, benzoyl peroxide (250, 500 or 1,000 mg/kg/day) was administered orally to male rats for 29 days and female rats for 41-51 days. There were no treatment-related changes observed in the mating period, mating rate, conception rate, delivery rate, birth rate, pregnancy period, luteinization number, implantation number and the rate of losing embryos and foetuses after implantation. In pups, body weight was significantly decreased in the high-dose group. The no-observed-adverse-effect-level (NOAEL) for reproductive toxicities was considered to be 500 mg/kg/day.

Incompatibilities

The information provided in Incompatibilities of Aczo is based on data of another medicine with exactly the same composition as the Aczo of the medicine (Benzoyl Peroxide). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Aczo directly from the package or from the pharmacist at the pharmacy.
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None.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Aczo is based on data of another medicine with exactly the same composition as the Aczo of the medicine (Benzoyl Peroxide). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Aczo directly from the package or from the pharmacist at the pharmacy.
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There are no special instructions for use or handling of Aczo Aquagel 10.

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