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

Composition:

Active substance: fladexan;

1 g of ointment contains 20 mg of fladexan, calculated as 30% flavonoid content;

Excipients: white soft paraffin, propylene glycol, stearic acid, emulsifier No. 1, methylparaben (E 218), propylparaben (E 216), purified water.

Pharmaceutical form. Ointment.

Main physicochemical properties: ointment of light brown to dark brown color, with a specific odor.

Pharmacotherapeutic group. Dermatological agents. ATC code D11AX.

Pharmacological Properties.

Pharmacodynamics. A medicinal product of plant origin containing fladexan – an extract from the herb of Desmodium canadense of the legume family.

The drug exhibits local anti-inflammatory, analgesic, and antipruritic effects, possesses antiallergic and desensitizing properties, demonstrates antiviral activity against the viruses causing vesicular herpes (common herpes) and zoster – Herpes simplex and Herpes zoster, and also stimulates reparative processes in the skin.

Pharmacokinetics. When applied to the skin, the components of the ointment are not detected in blood serum.

Clinical characteristics.

Indications. For local treatment of all forms and stages of psoriasis, allergic and atopic dermatitis (especially during the subacute phase and the remission phase), perioral and seborrheic dermatitis, neurodermatitis, photodermatoses, toxidermias, as well as vesicular herpes (herpes) in various locations (labial, buccal, nasal, auricular, genital) and herpes zoster.

Contraindications. Hypersensitivity to the components of the medicinal product.

Interaction with other medicinal products and other forms of interaction. Data not available.

Special precautions for use.

Due to the presence of methylparaben (E 218) and propylparaben (E 216) in the formulation, the medicinal product may cause allergic reactions (possibly delayed).

Propylene glycol may cause skin irritation.

Use during pregnancy or breastfeeding. The medicinal product can be used during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery. Treatment with this medicinal product does not affect the ability to drive or operate machinery.

Method of Administration and Dosage.

Apply externally, locally, to adults and children.

Various types of dermatitis, herpes simplex, and herpes zoster. Apply a thin layer of the ointment, gently rubbing it in, to the affected area of skin 2–4 times daily, preferably starting at the first signs of the disease. Treatment duration is 5–14 days.

Psoriasis. Apply the ointment to the affected skin area once or twice daily under waxed paper. Treatment course lasts 10–30 days or longer, especially in cases of large plaque forms.

Depending on the therapeutic response and in cases of relapses, the treatment course may be repeated 2–3 times or more.

Children. The medicinal product may be used in children.

Overdose. Cases of overdose have not been reported.

Side effects.

In some cases, a burning sensation may occur, which disappears after temporary discontinuation of the drug.

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature from 2 °C to 8 °C. Keep out of reach of children.

Packaging. 10 g or 15 g in a tube in a box.

Prescription status. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's address. 22, Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.