Afloderm 0.5 mg/g cream and ointment (alclometasone) – atopic, irritant and allergic dermatitis

Afloderm contains alclometasone dipropionate, a non-fluorinated corticosteroid for topical use on the skin. Corticosteroids are used for their anti-inflammatory action – Afloderm prevents excessive skin reactions to various triggers that lead to inflammation, eczema and dermatitis.

In Serbia two forms of the same strength (0.5 mg/g) are authorised, in a 20 g tube: Afloderm cream, intended for acute, weeping lesions, and Afloderm ointment, intended for dry, scaly and thickened lesions in chronic skin conditions. Both are prescription-only.

What are Afloderm cream and ointment used for and how should they be applied to the skin?

Key facts about the medicine

What is Afloderm used for?

According to the approved leaflets, Afloderm cream and ointment are used to treat skin conditions that respond to topical corticosteroid treatment:

• atopic dermatitis;
• various forms of dermatitis, including irritant and allergic dermatitis.

The choice of form depends on the appearance of the lesions: the cream is used for acute, weeping lesions and the ointment for dry, scaly and thickened lesions of chronic dermatoses.

How is it used and dosed?

• Apply a thin layer, enough to cover the affected area, and rub in gently, two to three times a day.
• Apply to clean skin; wash your hands well before and after application.
• Do not cover the treated area with bandages, plastic or nappies unless your doctor tells you to, as more medicine is then absorbed through the skin.
• If there is no improvement after 2 weeks, see your doctor. According to the leaflet, as with other corticosteroids, use should be stopped before a follow-up examination.

Special patient groups

• Children: may be used in children over 1 year of age, as a thin layer 2–3 times a day, for the shortest possible time (2–3 weeks) and with extreme caution. Because of their larger skin surface relative to body weight, children absorb proportionally more medicine (risk of growth retardation, raised intracranial pressure and Cushing's syndrome). Use under nappies is not recommended.
• Adults and elderly: the official documentation does not specify a dose adjustment; avoid long-term use on large areas.

Contraindications – when the medicine must not be used

Do not use Afloderm cream or ointment in:

• hypersensitivity to the active substance or any of the excipients;
• acne, rosacea and perioral dermatitis;
• skin tuberculosis, viral skin infections (especially herpes simplex), chickenpox and vaccinia (reaction after vaccination);
• fungal or bacterial skin infections.

Precautions and warnings

• If itching, stinging and redness occur at the first application as a sign of an allergic reaction, stop using it immediately and contact your doctor.
• Long-term use on large skin areas, especially under occlusion, is not recommended; long-term treatment requires medical supervision because of increased absorption.
• Do not apply in or near the eye because of the possibility of cataract or glaucoma; contact your doctor if you have blurred vision or other visual disturbances.
• If a fungal or secondary bacterial skin infection develops, stop using the medicine and start appropriate treatment as advised by your doctor.
• The groin, armpits and perianal area are more prone to stretch marks – use in these areas should be as short as possible.
• The cream contains propylene glycol (may cause skin irritation), chlorocresol (may cause allergic reactions) and cetostearyl alcohol (may cause local skin reactions, e.g. contact dermatitis). The ointment contains propylene glycol monopalmitostearate, which may cause skin irritation.

Interactions with other medicines, alcohol and food

No interactions with other medicines are known. Tell your doctor or pharmacist about all medicines you use.

Pregnancy and breastfeeding

During pregnancy, topical use is allowed only when the doctor considers that the possible benefit to the mother outweighs the risk to the foetus – and then briefly and on a small area.

During breastfeeding the medicine may be used as decided by the doctor, but it must not be applied to the skin of the breasts before breastfeeding.

Driving and using machines

Afloderm cream and ointment have no influence on the ability to drive and use machines.

Possible side effects

At therapeutic doses, topical use very rarely leads to mild side effects; local reactions are more frequent under occlusion.

• Common (up to 1 in 10): itching, burning, redness, dry skin, irritation, papular rash.
• Very rare (up to 1 in 10,000): skin thinning (atrophy), stretch marks, inflammation of hair follicles, increased hair growth, allergic contact dermatitis, acne-like changes, white patches (hypopigmentation), miliaria, visible dilation of blood vessels (especially on the face), secondary skin infections.
• Not known: blurred vision.
• Systemic effects (adrenal suppression) may exceptionally occur with prolonged use on large skin areas.

Suspected side effects can be reported to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose: with prolonged use on large, damaged areas, under occlusion or in children, increased absorption and systemic effects may occur (in children growth retardation and raised intracranial pressure, Cushing's syndrome, high blood sugar and sugar in the urine). These effects are exceptional and usually reversible after stopping. If the medicine is swallowed accidentally, no side effects are expected, but contact your doctor if needed.
• Missed dose: apply it as soon as you remember and continue as prescribed; do not apply a double amount.
• Stopping treatment: the duration is decided by the doctor; if there is no improvement within 2 weeks, see your doctor.

Related information

• Atopic dermatitis – treatment and the best creams
• Dry skin – how to care for it and which cream is best

For additional care and support with eczema and dermatitis, see also the Eczema and Psoriasis – Care for Dry, Irritated and Atopic Skin category – products in this category do not replace the medicine you have been prescribed.

Composition, packaging and manufacturer

• Cream: 1 g contains 0.5 mg alclometasone dipropionate. Excipients: propylene glycol; chlorocresol; sodium dihydrogen phosphate dihydrate; concentrated phosphoric acid; cetostearyl alcohol; macrogol cetostearyl ether; glyceryl stearate and PEG-100 stearate; white soft paraffin; sodium hydroxide; purified water.
• Ointment: 1 g contains 0.5 mg alclometasone dipropionate. Excipients: hexylene glycol; propylene glycol monopalmitostearate; white soft paraffin; white wax.
• Pack: aluminium tube with polyethylene screw cap, 20 g, in a carton.
• Marketing authorisation holder: Predstavništvo Belupo, lijekovi i kozmetika d.d., Belgrade (Voždovac), Mosorska 1, Belgrade.
• Manufacturer: Belupo d.d., Ulica Danica 5, Koprivnica, Croatia.

Storage

• Store below 30 °C; shelf life of the unopened medicine is 3 years.
• After first opening: use within 3 months, store below 25 °C.
• Keep out of the sight and reach of children; return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

What is the difference between Afloderm cream and ointment?

Both contain the same strength of alclometasone (0.5 mg/g). The cream is intended for acute, weeping skin lesions and the ointment for dry, scaly and thickened lesions in chronic dermatoses. The excipients also differ.

Can Afloderm be used on a baby?

The medicine may be used only in children over 1 year of age, for the shortest possible time (2–3 weeks) and with extreme caution. Application under nappies is not recommended because nappies act as an occlusive dressing.

Can I apply Afloderm to my face?

It must not be applied in or near the eye, and it is contraindicated in acne, rosacea and perioral dermatitis. Use on the face is decided by the doctor.

How long can I use Afloderm?

The duration is decided by the doctor. If there is no improvement after 2 weeks, see your doctor; long-term use on large areas is not recommended. An opened tube can be used for up to 3 months.

Sources

• ALIMS – Patient leaflet Afloderm® 0.5 mg/g cream (approved May 2022, Serbian)
• ALIMS – Summary of Product Characteristics Afloderm® 0.5 mg/g cream (authorisation 515-01-03436-21-001, Serbian)
• ALIMS – Patient leaflet Afloderm® 0.5 mg/g ointment (approved May 2022, Serbian)
• ALIMS – Summary of Product Characteristics Afloderm® 0.5 mg/g ointment (authorisation 515-01-03437-21-001, Serbian)
• ALIMS – List of new authorisations and renewals 01.04.–30.06.2022 (Afloderm cream and ointment, 25.05.2022)

Sources checked on: 23 October 2026.