CARBODERM-DARNYTSIA®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KARBODERM-DARNYTSIA® (CARBODERM-DARNITSA)

Composition:

Active substance: urea;

1 g of cream contains urea 100 mg;

Excipients: cetylpyridinium chloride, propylene glycol, mineral oil, cetylstearyl alcohol, purified water.

Pharmaceutical form. Cream.

Main physicochemical characteristics: homogeneous white odourless cream.

Pharmacotherapeutic group.

Emollient and protective agents. Urea. ATC code D02AE01.

Pharmacological properties.

Pharmacodynamics.

Carboderm-Darnitsya**®** cream exerts hydrating, keratolytic, antipruritic, antibacterial, and antifungal effects. With the use of the cream, manifestations of hyperkeratosis are reduced, the skin is softened and moisturized, its elasticity is increased, and re-epithelialization of superficial lesions is improved. Urea at a concentration of 10% exerts bactericidal and fungicidal effects due to cetylpyridinium chloride contained in the medicinal product. Thanks to the weak local anesthetic effect of urea, the medicinal product provides antipruritic action.

Pharmacokinetics.

High-molecular-weight polymeric substances of the ointment base retain urea at the site of application, preventing its transdermal absorption; thus, urea does not enter the systemic circulation.

Clinical characteristics.

Indications.

For the treatment of skin disorders associated with increased formation of keratinized epithelium.

The medicinal product is indicated for the treatment of psoriasis (in stationary stage with significant infiltration), seborrhea, keratomycoses, hyperkeratoses, hyperkeratotic forms of eczema, and ichthyosis.

Contraindications.

The use of Carbodyne-Darnytsia**®** cream is contraindicated in cases of hypersensitivity to urea or to any of the other components of the cream, as well as in dermatoses accompanied by pronounced exudation.

Interaction with other medicinal products and other forms of interaction.

There is no information available regarding interactions between Carbodyne-Darnytsia**®** cream and other medicinal products. However, it should be noted that simultaneous use of the cream with other ointments or creams may lead to enhanced absorption of active ingredients contained in these products (particularly corticosteroids).

Concomitant use of other medicinal products containing urea and its derivatives is not recommended.

Special precautions for use.

Avoid contact of the medicinal product with eyes and mucous membranes.

To prevent effects on healthy tissues, it is advisable to apply the cream without exceeding the boundaries of the affected area.

Do not use for treatment of acute inflammation of injured skin.

Propylene glycol may cause skin irritation.

Cetyl stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

Use during pregnancy or breastfeeding.

The medicinal product should be used during pregnancy or breastfeeding only as prescribed by a physician.

Ability to influence reaction rate while driving or operating machinery.

The medicinal product does not affect reaction speed while driving or operating machinery.

Dosage and Administration.

The medicinal product should be used for the treatment of adults.

The cream dosage should be individually prescribed by a physician depending on the type of disease, severity of lesions, and size of the affected area. Apply a thin layer of cream (on average, a strip 1–4 cm long) to the affected area of skin twice daily. For enhanced therapeutic efficacy, occlusive dressings may be used.

The duration of treatment, which may average 1–2 weeks, is determined individually by the physician according to the type and severity of the disease, taking into account the regression of symptoms of infiltration and lichenification of the skin.

Children.

The medicinal product should not be prescribed to children due to lack of clinical experience.

Overdose.

Cases of overdose with Carbodylm-Darnytsia**®** have not been reported.

In case of accidental ingestion of a large amount of the medicinal product and the onset of intoxication symptoms, seek medical advice immediately.

Side effects.

In isolated cases, dermatological reactions may develop: skin redness, itching, stinging, and irritation. Local allergic reactions including contact dermatitis are possible.

Rarely, a burning sensation may occur, which is more likely to occur when an occlusive dressing is used.

If any adverse reactions occur, use of the medicinal product should be discontinued and medical advice must be sought immediately.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

30 g in a tube; 1 tube in a carton.

Availability.

Over-the-counter.

Manufacturer. JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's address and place of business.

13, Borispilska Street, Kyiv, 02093, Ukraine.