Afloderm

Package Leaflet: Information for the User

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Afloderm, 0.5 mg/g, cream

Alclometasone dipropionate

Before using the medicine, carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Afloderm and what is it used for
• 2. Important information before using Afloderm
• 3. How to use Afloderm
• 4. Possible side effects
• 5. How to store Afloderm
• 6. Contents of the packaging and other information

1. What is Afloderm and what is it used for

Afloderm contains the active substance alclometasone dipropionate. Alclometasone is a synthetic non-fluorinated corticosteroid with moderate potency, used locally in dermatology. Alclometasone dipropionate has anti-inflammatory, antipruritic, immunosuppressive, and vasoconstrictive effects.
Indications
Afloderm is indicated for the local treatment of inflammatory and pruritic skin diseases that respond to corticosteroid therapy, including atopic dermatitis, contact dermatitis, and psoriasis.

2. Important information before using Afloderm

When not to use Afloderm:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• in skin tuberculosis,
• in viral skin infections, especially in herpes simplex, chickenpox, and shingles,
• in acne, perioral dermatitis, rosacea,
• in diaper dermatitis,
• in fungal or bacterial skin infections, unless appropriate causal treatment has been initiated.

Warnings and precautions

Before starting treatment with Afloderm, discuss it with a doctor, pharmacist, or nurse.
Page 1 5
If a skin allergic reaction (itching, burning, or redness of the skin) occurs after using Afloderm, inform a doctor. The doctor will decide whether to discontinue the medicine immediately.
Do not use occlusive dressings, as they may enhance the absorption of the medicine through the skin.
It is not recommended to use the medicine on the face, due to the risk of skin inflammation (similar to acne-like changes), perioral dermatitis, skin atrophy, and rosacea.
Avoid contact with the eyes and mucous membranes. Do not use in the eyes or around the eyes, due to the possibility of glaucoma and cataracts.
If the patient experiences blurred vision or other vision disturbances, consult a doctor.
In case of skin infection, the doctor will initiate appropriate antibacterial or antifungal treatment.
Since corticosteroids are absorbed through the skin, there is a risk of systemic side effects of corticosteroids, including adrenal suppression, during treatment with Afloderm. Therefore, avoid using it on large areas of the body, damaged skin, using large doses, prolonged treatment, and using it in patients with liver function disorders and in children.
On the skin of the armpits and groin, use the cream only in cases where it is absolutely necessary, due to increased absorption.
There are no data on the safety of using the medicine for more than 3 weeks.

Children

Particular caution should be exercised when using the medicine in children, as there is a risk of systemic corticosteroid effects.
In children, due to the larger ratio of body surface area to body mass compared to adults, the risk of systemic corticosteroid effects (including disorders of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, increased intracranial pressure) is greater than in adults. Prolonged use of corticosteroids may also disrupt growth and development in children.

Afloderm and other medicines

Inform a doctor or pharmacist about all medicines currently being used or recently used by the patient, as well as any medicines the patient plans to use.
No studies have been conducted on interactions with other locally used medicines.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
Pregnancy
The use of Afloderm in pregnant women is allowed only when, in the doctor's opinion, the benefit to the pregnant woman outweighs the risk to the fetus.
However, it should be short-term and limited to a small area of the body.
There are no results of studies on the safety of local use of corticosteroids in pregnant women. However, it is known that these substances can be absorbed through the skin.
Breastfeeding
The doctor will consider whether to stop breastfeeding or using Afloderm, taking into account the possibility of side effects in children and the benefits of treatment for the mother.
Page 2 5
Do not use the medicine on the breast skin before breastfeeding.
It is not known whether locally used corticosteroids, including alclometasone dipropionate, are absorbed through the skin to an extent that they can pass into breast milk. Generally, systemic corticosteroids pass into breast milk.

Driving and using machines

There are no data on the harmful effects of Afloderm on the ability to drive and use machines.

Important information about some ingredients of the medicine

The medicine contains excipients such as cetostearyl alcohol, chlorocresol, propylene glycol.
Due to the presence of cetostearyl alcohol, the medicine may cause local skin reactions (e.g., contact dermatitis).
Due to the presence of chlorocresol, the medicine may cause allergic reactions.
The medicine contains 250 mg of propylene glycol per gram of product. Due to the presence of this excipient, the medicine may cause skin irritation.

3. How to use Afloderm

This medicine should always be used as directed by a doctor. In case of doubts, consult a doctor or pharmacist.
Afloderm is intended for use on the skin only.

Adults and children over 1 year of age

A thin layer of the medicine should be gently rubbed into the affected areas of the skin two or three times a day. Do not use occlusive dressings.
Do not use for more than 3 weeks.

Use in children

The use of Afloderm in children under 1 year of age is not recommended, due to the lack of data on safety.
If the effect of the medicine is too strong or too weak, consult a doctor.

Using a higher dose of Afloderm than recommended

During prolonged use, use on large areas of the skin, or on damaged skin, and in case of occlusive dressings, as well as in children, due to increased absorption of the active substances into the bloodstream, there may be an overdose and the occurrence of systemic side effects of corticosteroids.
Overdose symptoms characteristic of corticosteroids include suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, mild intracranial hypertension, growth and development disorders in children, increased blood sugar levels (hyperglycemia), and glycosuria.
In case of using a higher dose of the medicine than recommended, consult a doctor immediately. The doctor will decide whether to discontinue the medicine.
If symptoms such as fever, muscle pain, joint pain, and general weakness occur, the doctor will consider using a systemic corticosteroid.

Missing a dose of Afloderm

Do not use a double dose to make up for a missed dose.
In case of doubts about using the medicine, consult a doctor or pharmacist.
Page 3 5

4. Possible side effects

Like all medicines, Afloderm can cause side effects, although not everybody gets them.
Local side effects of Afloderm cream occur more frequently when using occlusive dressings.
Prolonged use of Afloderm cream may cause systemic side effects characteristic of corticosteroids, including adrenal suppression (see above - Using a higher dose of Afloderm than recommended).
Frequent (in 1-2% of patients) local side effects may include: itching, burning, redness, dryness of the skin, skin irritation, and papular rash.
Very rare (in less than 1 in 10,000 patients) side effects may include: folliculitis, acne-like changes, skin discoloration, perioral dermatitis, allergic contact dermatitis (burning, swelling, and inflammatory blisters on the skin), secondary infections, atrophic changes, striae, and telangiectasia. Additionally, allergic reactions may occur.
Unknown frequency (cannot be estimated from the available data): blurred vision.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Afloderm

Keep the medicine out of the sight and reach of children.
Store at a temperature below 30°C.
Shelf life after first opening the tube: 3 months when stored at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Afloderm contains

• The active substance is alclometasone dipropionate. 1 g of cream contains 0.5 mg of alclometasone dipropionate.
• Other ingredients are: propylene glycol

Page 4 5
chlorocresol
sodium dihydrogen phosphate dihydrate
1% phosphoric acid
white petrolatum
macrogol cetostearyl ether
cetostearyl alcohol
glycerol stearate with macrogol 100 stearate
sodium hydroxide solution 1%
purified water.

What Afloderm looks like and what the pack contains

The medicine is a cream.
The available packaging of the medicine is an aluminum tube with a protective membrane with an inner protective layer (epoxyphenol), an HDPE screw cap, containing 20 g of cream, placed in a cardboard box.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

Belupo s.r.o., Cukrová 14, 811 08 Bratislava, Slovakia

Manufacturer:

BELUPO lijekovi i kozmetika, d.d., Ulica Danica 5, 48 000 Koprivnica, Croatia

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Czech Republic, country of export, marketing authorization number: 46/362/01-C

Parallel import authorization number: 291/23

Date of approval of the leaflet: 18.12.2023

[Information about the trademark]
Page 5 5