CUTACNYL 5 % Topical gel T/40g

Benzoyl peroxide hydrated

Quantity corresponding to anhydrous benzoyl peroxide...................................................................5 g

For 100 g of gel

Excipient with known effect: propylene glycol

Acne vulgaris.

Cutacnyl 2,5 % and Cutacnyl 5 % will preferably be used in the following cases:

• early acne in adolescents,
• in patients with fragile skin, particularly children, fair-haired or red-haired subjects,
• at the start of treatment, during a trial period, to ensure good tolerance of the product,
• as maintenance therapy for blanched acne.

Dosage

To be adapted according to therapeutic response and individual tolerance (see section Warnings and precautions).

In general, 1 to 2 daily applications. In patients with sensitive skin it is recommended to apply the gel 1 times per day.

1 application every 2-3 days as maintenance therapy for Cutacnyl 2,5 % and Cutacnyl 5 %.

Method of administration

Cutacnyl should be applied in a thin layer over all affected areas of skin that has been cleansed and dried. Apply Cutacnyl with light massage using the fingertips until the product is fully absorbed.

Wash hands after using the product.

Store away from heat. Avoid proximity to a flame.

Hypersensitivity to benzoyl peroxide or to any of the excipients mentioned in section Composition.

For external use only.

Precise information provided to the patient may prevent premature and unjustified discontinuation of treatment.

Slight irritation is possible (mild burning sensation, redness and peeling of the skin), especially at the start of treatment. It does not indicate intolerance or allergy to the topical product as long as it remains moderate. It is nevertheless advisable to test individual sensitivity by preceding the start of treatment with a "test patch" (repeated applications to a small area of skin for 10 to 15 consecutive days).

To reduce these irritation phenomena:

• do not apply to skin already irritated by previous treatments or suffering from sunburn erythema,
• as a general rule, avoid concomitant use with other topical keratolytic or detergent therapies,
• use a mild soap bar (washing no more than twice a day), refrain from any cosmetic or other perfumed or alcohol-containing product,
• do not expose yourself repeatedly to the sun and UV rays,
• particular caution is recommended for subjects with fair skin and on certain more fragile skin areas (face, neck, décolletage, supraclavicular hollow),
• avoid contact with the eyes and eyelids, the mouth, the nostrils, the nose wings and the mucous membranes. In case of accidental application on mucous membranes (eyes, mouth, nostrils) or on the eyelids, rinse very thoroughly with water,
• if the irritation becomes troublesome, space out applications and/or use the less concentrated form,
• if troublesome irritation persists despite the precautions for use, treatment must be discontinued,
• due to the risk of sensitization, this medicine must not be applied to damaged skin (wound, skin erosion or acute skin inflammation),
• contact of CUTACNYL 5 PERCENT with a coloured material (such as dyed hair and fabrics) may cause it to bleach or discolour,
• this medicine contains propylene glycol and may cause skin irritation.

Cutacnyl may cause skin swelling and vesicles. If this symptom appears, treatment must be discontinued.

The data available to date do not suggest the existence of clinically significant interactions.

Pregnancy

There are no published reports in animals mentioning an effect of benzoyl peroxide on reproductive functions, fertility, teratogenicity, embryotoxicity or peri- and post-natal development. The wide use of benzoyl peroxide for acne over several decades at concentrations below 10 % has not been associated with this type of effect in humans. CUTACNYL gel should be used in pregnant women only if clearly necessary.

Breast-feeding

In the absence of data on the excretion of benzoyl peroxide into milk in animals or humans, and because many medicines are excreted into human milk, it is recommended to use benzoyl peroxide with caution in breastfeeding women, and the preparation must not be applied to the breast to avoid any transfer of product to the newborn.

Benzoyl peroxide has no or negligible effect on the ability to drive vehicles and use machines.

Adverse effects are listed by System Organ Class and by frequency using the following convention: 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), frequency not known (cannot be estimated from the available data).

Adverse effects are presented in the table below:

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 national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: www.ansm.sante.fr.

Benzoyl peroxide gel is indicated only for topical use. In the event of excessive application of the product, no systemic effect is expected. Excessive topical application of benzoyl peroxide does not give better results or faster results but can induce severe irritation. In this case, treatment must be discontinued and symptomatic treatment initiated.

In the event of accidental ingestion, appropriate symptomatic measures must be taken.

Pharmacotherapeutic class: ANTI-ACNE PREPARATIONS FOR TOPICAL USE, ATC code: D10AE01.

As currently understood, the pathogenesis of acne involves several factors:

• Seborrhoeic hypersecretion (dependent on androgens),
• Sebum retention, due to an abnormality in keratinisation of the infrainfundibulum of the pilosebaceous follicle, leading to the formation of comedones and microcysts (essential semiological elements),
• Inflammatory reaction induced by saprophytic germs (Propionibacterium acnes, Staphylococcus epidermidis...) and certain irritant components of sebum, leading to the formation of inflammatory papules, pustules and nodules.

Benzoyl peroxide acts essentially through antibacterial action on P. acnes, the main contributor to inflammatory phenomena; it is also moderately keratolytic and sebostatic.

The predominantly aqueous formula of the excipient (86 % water) reduces the risk of irritation sometimes observed at the start of treatment.

The extreme fineness of the microfine benzoyl peroxide particles gives dermal gels optimal homogeneity.

Benzoyl peroxide penetrates the skin where it is converted into benzoic acid, which passes into the systemic circulation.

Non-clinical data from conventional safety pharmacology, repeated-dose toxicology, genotoxicity, carcinogenesis and reproductive function studies did not reveal any particular risk for humans.

The well-known adverse effects of benzoyl peroxide include mild to moderate irritation after dermal application and a sensitising potential after a number of exposures. Benzoyl peroxide is rapidly and completely metabolised to benzoic acid in the skin, which after absorption is eliminated in the urine with limited systemic exposure.

2 years

Store at a temperature not exceeding 25 °C.

No special requirements.