AFLODERM

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Afloderm, 0.5 mg/g, cream
Alclometasoni dipropionas
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Afloderm is and what it is 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 Afloderm is and what it is used for

Afloderm contains the active substance alclometasone dipropionate. Alclometasone is a synthetic, non-fluorinated corticosteroid with moderately potent activity, used topically in dermatology. Alclometasone dipropionate exerts anti-inflammatory, antipruritic, immunosuppressive, and vasoconstrictive effects.
Indications
Afloderm is indicated for the topical treatment of inflammatory and pruritic skin disorders responsive 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 to any of the other ingredients of this medicine (listed in section 6),
• in cutaneous tuberculosis,
• in viral skin infections, especially herpes simplex, vaccinia, or varicella,
• in acne, perioral dermatitis, or rosacea,
• in diaper dermatitis,
• in fungal or bacterial skin infections, unless appropriate specific treatment has been initiated simultaneously.

Warnings and precautions
Before using Afloderm, discuss it with your doctor, pharmacist, or nurse.
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If a skin allergic reaction (itching, burning, or redness) occurs after applying Afloderm, inform your doctor. The doctor will decide whether the medicine should be discontinued immediately.
Do not use occlusive dressings, as they may enhance absorption of the medicine through the skin.
Use on the face is not recommended due to the risk of dermatitis (resembling acneiform lesions), perioral dermatitis, skin atrophy, and acne.
Avoid contact of the medicine with eyes and mucous membranes. Do not apply to the eyes or around the eyes due to the risk of glaucoma and cataract.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
In case of skin infection, the doctor will initiate appropriate antibacterial or antifungal treatment.
Since corticosteroids can be absorbed through the skin, there is a risk of systemic adverse effects of corticosteroids, including suppression of adrenal cortex function, during treatment with Afloderm. Therefore, avoid use over large areas of the body, on damaged skin, in high doses, prolonged treatment, use in patients with liver function disorders, and in children.
Apply cream to the armpits and groin areas only when absolutely necessary due to increased absorption.
There are no data on the safety of using the medicine for longer than 3 weeks.

Children
Extreme caution should be exercised when using this medicine in children, due to the risk of systemic corticosteroid effects.
In children, because of the higher body surface area to body weight ratio compared to adults, the risk of systemic corticosteroid effects (including hypothalamic-pituitary-adrenal axis suppression, Cushing's syndrome, increased intracranial pressure) is greater than in adults. Long-term use of corticosteroids may also impair growth and development in children.

Afloderm and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to take.
No studies have been conducted on interactions with other topically applied medicines.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Use of Afloderm in pregnant women is permitted only when, in the opinion of the doctor, the benefit to the pregnant woman outweighs the potential risk to the fetus.
It should, however, be short-term and limited to small areas of the body.
There are no data from studies on the safety of topical corticosteroids in pregnant women. However, it is known that these substances may be absorbed through the skin.

Breastfeeding
The doctor will consider whether to discontinue breastfeeding or the use of Afloderm, taking into account the possibility of adverse effects in infants and the benefits of treatment for the mother.
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Do not apply the medicine to the breast skin before breastfeeding.
It is not known whether topically applied corticosteroids, including alclometasone dipropionate, are absorbed through the skin to such an extent that they can pass into breast milk. Systemically acting corticosteroids are known to pass into human milk.

Driving and operating machinery
There are no data on harmful effects of Afloderm on the ability to drive or operate machinery.

Important information about certain ingredients of the medicine
The medicine contains excipients such as cetostearyl alcohol, chlorocresol, and 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 your doctor has instructed. If in doubt, consult your
doctor or pharmacist.
Afloderm is intended for topical 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 daily. Do not use an occlusive dressing.
Do not use for longer than 3 weeks.
Use in children
Use in children under 1 year of age is not recommended due to lack of safety data.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Overdose of Afloderm
Prolonged use, application over large skin areas, use on damaged skin, application under occlusive
dressings, or use in children may lead to increased systemic absorption of the active substances,
resulting in overdose and general adverse effects typical of corticosteroids.
Symptoms of corticosteroid overdose may include suppression of the hypothalamic–pituitary–adrenal
axis, Cushing's syndrome, mild intracranial hypertension, growth and development retardation in
children, increased blood glucose levels (hyperglycemia), and glycosuria.
If more than the recommended dose has been used, consult your doctor immediately.
The doctor will decide whether to discontinue the medicine.
If symptoms such as fever, muscle pain, joint pain, or general weakness occur, the doctor may consider
administering a systemic corticosteroid.
Missed dose of Afloderm
Do not use a double dose to make up for a missed dose.
If you have any doubts regarding the use of this medicine, consult your doctor or pharmacist.
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4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Local adverse reactions to Afloderm cream occur more frequently when occlusive dressings (sealed coverings) are used.
Prolonged use of Afloderm cream may lead to systemic adverse effects characteristic of corticosteroids, including suppression of adrenal cortex function (see above - Use of doses higher than recommended of Afloderm).
Common (in 1–2% of patients): local symptoms such as itching, burning, redness, dry skin, skin irritation, and granular rash.
Very rare (in no more than 1 in 10,000 patients): folliculitis, acne-like changes, skin discoloration, perioral dermatitis, allergic contact dermatitis (burning, swelling, inflammatory blisters on the skin), secondary infections, skin atrophy, excessive sweating, striae, dilation of superficial blood vessels (especially on the face), and hypertrichosis. Additionally, allergic reactions may occur.
Frequency not known (cannot be estimated from available data): blurred vision.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Afloderm medicine

Keep the medicine out of the sight and reach of children.
Store below 30°C.
The shelf life after first opening the tube: 3 months when stored 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 stated month.
Medicines must 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 packaging and other information

What Afloderm contains

• The active substance is aclometasone dipropionate. 1 g of cream contains 0.5 mg of aclometasone dipropionate.
• Other ingredients are: propylene glycol
  chlorocresol
  disodium dihydrogen phosphate dihydrate
  phosphoric acid 1%
  white soft paraffin
  macrogol cetostearyl ether
  cetostearyl alcohol
  glyceryl stearate with macrogol 100 stearate
  sodium hydroxide 1% solution
  purified water.

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What Afloderm looks like and contents of the pack

The medicine is in the form of a cream.
The available pack consists of an aluminium tube with a protective membrane with an inner epoxyphenolic protective layer, and an HDPE cap, containing 20 g of cream, placed in a cardboard box.

For more detailed information, please contact the responsible party or the parallel importer.

Responsible party in the Czech Republic, 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, Poland

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

Czech Republic, country of export, marketing authorization number: 46/362/01-C
Parallel import authorization number: 291/23

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