INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT UGRESOL (UGRESOL)

Composition:
Active substance: benzoyl peroxide;
1 ml of lotion contains 0.1 g of benzoyl peroxide.
Excipients: disodium edetate, carbomer 940, Brij 30, diisopropanolamine, purified water.

Pharmaceutical form:
Lotion.

Main physical and chemical properties:
White, creamy lotion, free from lumps or granules, with a characteristic weak odor of benzoyl peroxide.

Pharmacotherapeutic group:
Topical agents for acne treatment.
ATC code: D10AE01.

Pharmacological properties

Pharmacodynamics:
Benzoyl peroxide has antiseptic and keratolytic properties. It inhibits the growth of anaerobic microorganisms Propionibacterium in acne lesions (due to oxygen release) and promotes pore cleansing.

Pharmacokinetics:
The preparation penetrates the skin, where it is converted into benzoic acid.

Clinical characteristics

Indications:
Topical treatment and prevention of acne vulgaris in adults and children aged 12 years and older.

Contraindications:
Hypersensitivity to benzoyl peroxide or any of the other components of the preparation.
Children under 12 years of age.

Interaction with other medicinal products and other forms of interaction:
Concomitant use of Ugresol with other acne treatments containing resorcinol, salicylic acid, sulfur, tretinoin, alcohol, as well as with creams and lotions for or after shaving, medicated cosmetics, abrasive and medicated soaps, facial cleansers, may cause cumulative skin irritation and increased dryness.

Special precautions for use:
The preparation is intended for topical use only. Avoid contact with eyes and mucous membranes.
Possible discoloration of hair, eyebrows, and dyed fabrics.
To prevent allergic reactions, it is recommended to apply Ugresol to a small area of skin on the wrist and observe for 48 hours: if swelling or itching with pronounced hyperemia occurs, discontinue use.
During the first weeks of treatment, mild skin peeling and redness may occur, which usually resolve with time.
The preparation should not be used in elderly individuals.

Use during pregnancy or breastfeeding:
The preparation may be systemically absorbed. It is unknown whether benzoyl peroxide passes into breast milk. Studies on this subject have not been conducted.

Effect on ability to drive vehicles or operate machinery:
The preparation does not affect the ability to drive vehicles or operate machinery.

Dosage and administration:
Shake the bottle several times before use.
Apply a thin layer of the preparation to clean, dry skin affected by acne, gently rubbing in with fingertips until completely absorbed.
Begin treatment once daily, then gradually increase to 2–3 times daily.
In case of excessive dryness or peeling, reduce application to once daily or every other day.
Optimal therapeutic effect usually develops within 8–12 weeks after initiation of treatment.
For prevention, treatment may be continued once daily until sustained remission is achieved.
Duration of treatment should not exceed three months.
In severe cases, Ugresol may be combined with other acne treatments.

Children:
Contraindicated in children under 12 years of age.

Overdose:
Symptoms: excessive hyperemia, dryness, burning, itching, peeling, or swelling of the skin.
Treatment: wipe the skin with a gauze or cotton pad moistened with vegetable oil.
Symptoms require medical intervention only if they persist for a prolonged period and cause discomfort.
Occasionally, it may be necessary to use creams or ointments containing glucocorticoids.

Adverse reactions:
In individual cases, a few days after starting treatment, the preparation may cause irritation manifested by redness, peeling, or dryness of the skin, sensation of warmth, pricking, burning, and itching.
Very rare: skin eruptions, allergic contact dermatitis (burning, blistering, crusting, itching, redness, or swelling).
Mild irritation can be alleviated by reducing the frequency of application (once daily or every other day).
In case of severe irritation, discontinue use of the lotion.

Shelf life:
2 years.

Storage conditions:
Store out of reach of children at a temperature not exceeding 25°C.

Packaging:
30 ml in a bottle, 1 bottle in a cardboard box.

Category of supply:
Over-the-counter (without prescription).

Manufacturer:
Pharmascience Inc.

Manufacturer’s address and place of business:
6111 Royalmount Avenue, Suite 100, Montreal, Quebec H4P 2T4, Canada.