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Fladex (Ointment) Instructions for Use

Marketing Authorization Holder

Pharmaceutical Company Zdorovye, LLC (Ukraine)

ATC Code

D04AX (Other antipruritic drugs)

Dosage Form

Bottle Rx Icon Fladex Ointment for external use 2%: tubes 10 g or 15 g

Dosage Form, Packaging, and Composition

Ointment for external use 2% 100 g
Fla dexan (calculated on dry substance and content of the sum of flavonoids 30%) 2 g

10 g – aluminum tubes (1) – cardboard packs.
15 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Preparation with anti-inflammatory, antipruritic and antiviral action for external use

Pharmacotherapeutic Group

Antiviral agent for topical application

Pharmacological Action

It has local anti-inflammatory, antipruritic, antihistaminic, and desensitizing actions, and also stimulates reparative processes in the skin.

It has antiviral activity against Herpes simplex virus types 1 and 2 and Herpes zoster.

Pharmacokinetics

When applied externally, it is practically not absorbed through damaged skin into the systemic circulation.

Indications

As part of complex therapy: psoriasis; dermatitis (allergic, atopic, perioral and seborrheic); neurodermatitis; photodermatosis; toxidermia; herpes of various localization; shingles.

ICD codes

ICD-10 code Indication
B00 Herpesviral [herpes simplex] infections
B02 Zoster [herpes zoster]
L20.8 Other atopic dermatitis (neurodermatitis, eczema)
L21 Seborrheic dermatitis
L23 Allergic contact dermatitis
L24 Irritant contact dermatitis
L27 Dermatitis due to substances taken internally
L28.0 Lichen simplex chronicus (circumscribed neurodermatitis)
L40 Psoriasis
L56.2 Photocontact dermatitis [berloque dermatitis]
L71.0 Perioral dermatitis
ICD-11 code Indication
1E91.Z Herpes zoster, unspecified
1F00.Z Infections due to herpes simplex virus, unspecified
9A06.70 Atopic eczema of the eyelids
EA80.0 Infantile atopic eczema
EA80.1 Childhood atopic eczema
EA80.2 Adult atopic eczema
EA80.Z Atopic eczema, unspecified
EA81.Z Seborrheic dermatitis, unspecified
EA83.00 Lichen simplex of vulva
EA83.01 Lichen simplex of male genital organs
EA83.02 Lichen simplex of perianal area
EA83.0Z Lichen simplex of unspecified location
EA85.20 Atopic hand eczema
EA8Z Dermatitis or eczema, unspecified
EA90.Z Psoriasis, unspecified
ED90.1 Periorificial dermatitis
EH6Z Drug eruptions of unspecified type
EK00.Z Allergic contact dermatitis, unspecified
EK02.Z Irritant contact dermatitis, unspecified
EK20 Photoallergic reaction to fragrances or cosmetic products
EM0Z Unspecified skin disorder

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

The drug is applied externally.

For herpetic skin infection, the ointment is applied to the affected areas 4-6 times/day (including with a clean swab).

The course of treatment is at least 5 days (maximum – 10 days).

Therapy should be continued until a crust appears on the blisters, or until they are completely healed.

For psoriasis and dermatitis, the ointment is applied in a thin layer to the affected areas of the skin 1-2 times/day; the use of an occlusive dressing is possible.

The course of treatment is 10-30 days.

Adverse Reactions

Allergic reactions, hyperemia, dryness, skin peeling.

Contraindications

Hypersensitivity.

With caution pregnancy, lactation period.

Use in Pregnancy and Lactation

During pregnancy and lactation, the drug should be used with caution.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

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