Package leaflet: Information for the user

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

Keep this leaflet to be able to 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 another person, even if their symptoms are the same.
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What Afloderm is and what it is used for
Important information before using Afloderm
How to use Afloderm
Possible side effects
How to store Afloderm
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 conditions 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, and varicella,
in acne, perioral dermatitis, rosacea,
in diaper dermatitis,
in fungal or bacterial skin infections, unless appropriate causative treatment has been initiated simultaneously.

Warnings and precautions
Before starting treatment with Afloderm, discuss it with your doctor, pharmacist, or nurse.
If a skin allergic reaction (itching, burning, or redness of the skin) 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.
The use of this medicine on the facial skin 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 possibility of developing glaucoma and cataract.
If blurred vision or other visual disturbances occur, contact your 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 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 impaired liver function, and use in children.
Cream should be applied to the axillae and groin areas only when absolutely necessary due to increased absorption.
There are no data on the safety of use 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. Prolonged use of corticosteroids may also impair growth and development in children.

Afloderm and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
No studies have been conducted on interactions with other topically used medicines.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy
Afloderm may be used during pregnancy only if, in the opinion of the doctor, the benefit to the pregnant woman outweighs the potential risk to the fetus.
However, such use should be short-term and limited to a small area 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.
Do not apply the medicine to the skin of the breasts 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 the breast milk of nursing mothers.
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 vehicles or operate machinery.

Important information about some of the 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 directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Afloderm is intended for topical use only.
Adults and children over 1 year of age
Apply a thin layer of the medicine and gently rub it into the affected areas of 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.
Use of a higher than recommended dose of Afloderm
Prolonged use, application over large areas of skin or on damaged skin, use under occlusive dressings,
and 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
(HPA) axis, Cushing's syndrome, benign intracranial hypertension, growth and development
inhibition in children, increased blood glucose (hyperglycemia), and glycosuria.
If a higher than recommended dose has been used, seek immediate medical advice.
The doctor will decide whether treatment with the medicine should be discontinued.
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 apply a double dose to make up for a missed dose.
If you have any doubts regarding the use of the medicine, consult your doctor or
pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone experiences 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 typical of corticosteroids, including suppression of adrenal cortex function (see above - Use of doses higher than recommended).
Common (in 1–2% of patients): local symptoms such as itching, burning, erythema, 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), 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 or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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

Keep this medicine out of sight and reach of children.
Store at a temperature below 30°C.
After first opening the tube: use within 3 months if 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 indicated.
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 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 components of the medicine are: propylene glycol, chlorocresol, disodium dihydrogen phosphate dihydrate, phosphoric acid 1%, white soft paraffin, macrogol cetostearyl ether, cetostearyl alcohol, glyceryl stearate and polyethylene glycol 100 stearate, sodium hydroxide 1% solution, purified water.

What Afloderm looks like and contents of the pack
The medicine is in the form of a cream.
The available packaging is an aluminium tube with an internal protective layer (phenol-epoxy),
with a tamper-evident membrane and a HDPE cap with a plug, containing 20 g of cream,
placed in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder 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:
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 Authorisation Number in the Czech Republic, country of export: 46/362/01-C
Parallel Import Authorisation Number: 135/23