Afloderm

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

AFLODERM, 0.5 mg/g, cream

Alclometasone dipropionate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. 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 pack 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 topically in dermatology. Alclometasone dipropionate has anti-inflammatory, antipruritic, immunosuppressive, and vasoconstrictive effects.
Indications
Afloderm is indicated for the topical treatment of inflammatory and pruritic skin diseases that respond to corticosteroids, 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 tuberculosis of the skin,
• 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 instituted.

Warnings and precautions

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

Children

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

Afloderm and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No studies have been conducted on interactions with other topical 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 their doctor or pharmacist before using this medicine.
Pregnancy
Afloderm should only be used in pregnant women when the expected benefits to the mother outweigh the potential risk to the fetus.
However, it should be used for a short period and limited to a small area of the body.
There are no results from studies on the safety of topical 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 potential risk of side effects in the infant and the benefits of treatment for the mother.
Afloderm should not be applied to the breast skin before breastfeeding.
It is not known whether topical corticosteroids, including alclometasone dipropionate, are absorbed through the skin to an extent that may pass into breast milk. 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 Afloderm

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 in each 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 exactly as prescribed by the 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. Occlusive dressings should not be used.
Afloderm should not be used for more than 3 weeks.

Use in children

Afloderm should not be used in children under 1 year of age, due to the lack of data on safety.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Using a higher dose of Afloderm than recommended

When using the medicine for a longer period, on large areas of the skin, or on damaged skin, and when using occlusive dressings, especially in children, due to increased absorption of the active substances into the bloodstream, there is a risk of their 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, the patient should immediately consult their doctor.
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

A double dose should not be used to make up for a missed dose.
In case of doubts about using the medicine, consult a doctor or pharmacist.

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 suppression of adrenal cortex function (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. Allergic reactions may also occur.
Frequency not known (cannot be estimated from the available data): blurred vision.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Afloderm

The medicine should be kept out of the sight and reach of children.
Store in 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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Afloderm contains

• The active substance of Afloderm is alclometasone dipropionate. 1 g of cream contains 0.5 mg of alclometasone dipropionate.
• The other ingredients of the medicine are: propylene glycol, chlorocresol, sodium dihydrogen phosphate dihydrate phosphoric acid 1%, white petrolatum, macrogol cetostearyl ether, cetostearyl alcohol, glycerol stearate with macrogol 100 stearate, sodium hydroxide, 1% solution, purified water.

What Afloderm looks like and contents of the pack

Afloderm is a cream.
The medicine is available in aluminum tubes with an inner protective layer (phenol-epoxy) with a protective membrane and an HDPE cap with a piercer, containing 20 g of cream, packed 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Czech Republic, the country of export:46/362/01-C

Parallel import authorization number: 135/23

Date of leaflet approval: 11.07.2023

[Information about the trademark]