Each gram of Vitasilk 5% gel for external use contains:

active ingredient: Benzoyl peroxide – 50 mg;

For a full list of excipients see section List of excipients.

A white to off white homogenous gel with a specific odor.

Therapeutic indications

Topical therapy for the treatment of acne vulgaris.

For external use only.

Adults and children:

Before each application, the skin should be cleaned and dried. Apply in a thin layer once or twice daily or as directed to the affected areas. Persons with sensitive skin should be directed to apply the gel once daily before going to bed. The extent of any drying or peeling may be adjusted by modifying the dosage schedule.

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

For external use only.

Vitasilk may cause swelling and blistering of the skin, if any of these symptoms occur, medication has to be discontinued.

A mild burning sensation will probably be felt on first application and some reddening and peeling of the skin will occur within a few days. During the first weeks of treatment a sudden increase in peeling will occur in most patients. This is not harmful and will normally subside within a day or two if treatment is temporarily discontinued. If severe irritation occurs, patients should be directed to use the medication less frequently, to temporarily discontinue use or to discontinue use altogether.

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.

Benzoyl peroxide gel should not come into contact with the eyes, mouth, angles of the nose or mucous membranes. If the preparation enters the eye, wash thoroughly with water. Caution should be exercised when applying the drug to the neck and other sensitive areas.

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

Contact with any coloured material including hair and dyed fabrics may result in bleaching or discoloration.

Due to the risk of sensitisation, benzoyl peroxide gel should not be applied on damaged skin.

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed; however, drugs with desquamative, irritant and drying effects should not be used concurrently with benzoyl peroxide gel.

Pregnancy

There is no safety concern relating to the effects of cutaneously applied benzoyl peroxide on reproductive function, fertility, teratogenicity, embryotoxicity, or peri- and post- natal development from animal data. In widespread clinical use for the cutaneous treatment of acne vulgaris, at concentrations up to 10% w/w for several decades, benzoyl peroxide has never been associated with such effects. Vitasilk should only be used by a pregnant woman if clearly needed.

Breast-feeding

It is unknown whether benzoyl peroxide/metabolites are excreted in human milk. A risk to the new-borns/infants cannot be excluded. Caution should be exercised when benzoyl peroxide is administered to a nursing woman and the preparation should not be applied on the chest to avoid accidental transfer to the infant.

Vitasilk Gel has no or negligible influence on the ability to drive and use machines.

The adverse reactions resulting from clinical trials are all skin disorders. They are reversible when treatment is reduced in frequency or discontinued.

The following categories are used to indicate the frequency of occurrence of adverse effects:

Very common (≥1/10)

Common (≥1/100 to <1/10)

Uncommon (≥ 1/1,000 to <1/100)

Rare (≥1/10,000 to <1/1,000)

Very rare (<1/10,000)

Unknown (Frequency not assessable based on the available data).

They are presented in the table below:

Swelling face and allergic reactions, including application site hypersensitivity and anaphylaxis (not know frequency) have been reported during post-marketing surveillance.

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 Arpimed “LLC” by going to www.arpimed.com and fill out the appropriate form ″Report an adverse reaction or inefficiency of drug″. Hotline number: (+374 55) 05 79 86. And by using Scientific Centre of Drug and Medical Technology Expertise after academician E. Gabrielyan ″CJSC ″, going to the site: www.pharm.am in  ″Report about adverse effect of medicine″ section  and fill out the ″Report of adverse reaction or manufacturing problem of medicinal product″. Hotline numbers: +37410200505; +37496220505.

Benzoyl peroxide gel is a preparation indicated for topical treatment only. If the medication is applied excessively, no more rapid or better results will be obtained and severe irritation might develop. In this event, treatment must be discontinued and appropriate symptomatic therapy should be instituted.

Pharmacotherapeutic group: Anti-acne preparations for topical use.

ATC Code: D10AE01

Benzoyl peroxide is an established and effective keratolytic agent with antibacterial properties. It has been shown to be effective in reducing the local population of Propionibacterium acnes leading to a reduction in the production of irritant fatty acids in the sebaceous glands.

Not applicable. Vitasilk is a topical preparation.

In animal studies by the cutaneous route, benzoyl peroxide is associated with a minimal to moderate skin irritation potential including erythema and oedema. Phototoxic and photoallergic reactions have been reported for benzoyl peroxide therapy.

List of excipients

Propylene glycol

Carbomer 940

Sodium hydroxide

Water purified

Not applicable.

3 years.

Store at a temperature not above 25^oC, out of the reach of children, in original pack.

25 g of gel is filled into aluminum tube (inside package).

The tube packed and inserted with the leaflet into cardboard box (outer package).

Not applicable.