Afloderm cream 0.05% 40g tube

Release form, composition and packaging

Cream for external use 0.05% white, homogeneous.

1 g

alclomethasone dipropionate 500 mcg

propylene glycol, chlorocresol, sodium dihydrogen phosphate dihydrate, phosphoric acid, cetostearyl alcohol (60% cetyl alcohol, 40% stearyl alcohol), macrogol cetostearate, macrogol glyceryl stearate, soft white paraffin, sodium hydroxide, purified water.

20 g - aluminum tubes (1) - cardboard packs.

40 g - aluminum tubes (1) - cardboard packs.

pharmachologic effect

Non-halogenated synthetic GCS for external use.

It has anti-inflammatory, anti-allergic, antipruritic and antiproliferative effects.

When applied to the surface of the skin in the focus of inflammation, it quickly and effectively reduces the severity of objective symptoms (erythema, edema, lichenification) and subjective sensations (itching, irritation, pain).

Indications for use

Dermatoses in which topical GCS therapy is effective (including on the face and in the anogenital region): atopic dermatitis, eczema, psoriasis, allergic and contact dermatitis, solar dermatitis, allergic reactions to insect bites.

Contraindications for use

Tuberculosis of the skin, cutaneous manifestations of syphilis, chickenpox, viral skin infections, skin reactions to vaccinations, open wounds, trophic ulcers, rosacea, acne vulgaris, children under 6 months of age, hypersensitivity to alclomethasone.

Dosage regimen

Applied externally 2-3 times / day or more, depending on the location.

Side effect

Possible: itching, burning, redness or dryness of the skin, irritation, rash.

Extremely rare: acne-like changes, hypopigmentation, prickly heat, folliculitis, striae, skin atrophy, hypertrichosis, allergic contact dermatitis, secondary skin infections.

Application during pregnancy and lactation

Use during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

In such cases, the application should be short-lived and limited to a small area of ��the skin.

There are no data on teratogenic action.

It can be used during lactation, but in such cases, do not apply to the skin of the breast before feeding.

special instructions

Should not be applied to the skin in the eye area (due to the possible development of glaucoma and cataracts), as well as to open wound surfaces.

If the course of the disease is complicated by the development of a secondary bacterial or fungal infection, then a specific antibacterial or antimycotic agent must be added.

Can be used in young children.

It should be borne in mind that in young children, skin folds and diapers can have an effect similar to that of an occlusive dressing, and, accordingly, increase the systemic absorption of the active substance.

In addition, in children, a high degree of systemic absorption is possible due to the ratio between the surface of the skin and body weight, as well as due to insufficient maturity of the epidermis.

Therefore, long-term use in young children is possible only under medical supervision.

Name ENG

AFLODERM

Clinical and pharmacological group

GCS for external use

ATX code

Alclometasone

Dosage

0.05% x 40g

Structure

1 g of cream contains: Active ingredient: alclomethasone dipropionate - 0.5 mg

Excipients: propylene glycol - 250 mg

chlorocresol - 1 mg

sodium dihydrogen phosphate dihydrate - 2.995 mg

phosphoric acid - 0.04 mg

cetostearyl alcohol (cetyl alcohol - 60%, stearyl alcohol - 40%) - 72 mg

macrogol cetostearate - 22.5 mg

macrogol glyceryl stearate - 30 mg

soft white paraffin - 210 mg

sodium hydroxide - qs

purified water - 410.96 mg.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 4 years

INN / Active ingredient

alclomethasone dipropionate

Specifications

Category

Psoriasis

Scope of the drug

Leather

Release form

Cream

Manufacturer country

Croatia

Package quantity, pcs

one

Scope of application

Dermatology

Way of introduction

On the skin

Vacation conditions

Without recipe

Brand name

Belupo

The amount of the dosage form in the primary package

40 g

Primary packaging type

Tuba

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Topical glucocorticosteroid

Anatomical and therapeutic characteristics

D07AB10 Alclomethasone

Dosage form

Cream for external use

Dosage (volume) of the substance in the preparation

alclomethasone dipropionate 500mcg

Expiration date in days

1460

The target audience

Adult

Package weight, g

55

Mode of application

:

The cream is recommended for the treatment of acute, incl.

weeping skin lesions.

The cream or ointment is evenly applied in a thin layer to the affected skin areas 2-3 times / day.

On areas with denser skin (for example, elbows, palms and feet), as well as places from which the drug is easily erased, Afloderm should be applied more often.

In children and during the period when the main symptoms subside, the drug can be used 1 time / day.

To prevent relapses in the treatment of chronic diseases, therapy should be continued for some time after the disappearance of all symptoms.

Information on technical characteristics, delivery set, country of manufacture