AFLODERM 0.5 mg/g Cream

Contents of the leaflet

1. Package Leaflet: Information for the User
2. AFLODERM, 0.5 mg/g, cream
   1. Read all of this leaflet carefully before using this medicine because it contains important information for you.
   2. Contents of the pack
3. What is Afloderm and what is it used for
4. Before you use Afloderm
   1. When not to use Afloderm:
   2. Warnings and precautions
   3. Children
   4. Afloderm and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Important information about some of the ingredients of Afloderm
5. How to use Afloderm
   1. Adults and children over 1 year of age
   2. Use in children
   3. Using more than the recommended dose of Afloderm
   4. Missing a dose of Afloderm
6. Possible side effects
   1. Reporting side effects
7. How to store Afloderm
8. Contents of the pack and other information
   1. What Afloderm contains
   2. What Afloderm looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Package Leaflet: Information for the User

AFLODERM, 0.5 mg/g, cream

Alclometasone dipropionate

Read all of this leaflet carefully before using this medicine because it contains important information for you.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What is Afloderm and what is it used for
• 2. Before you use 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. Before you use Afloderm

When not to use Afloderm:

• if you are 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 is instituted at the same time.

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 using Afloderm, inform your 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 or around the eyes, due to the possibility of glaucoma and cataracts.
If blurred vision or other visual disturbances occur, consult a doctor.
In case of skin infection, the doctor will use appropriate antibacterial or antifungal treatment.
Since corticosteroids are absorbed through the skin, there is a risk of systemic side effects of corticosteroids when using Afloderm, including adrenal suppression. Therefore, avoid using it on large areas of the body, damaged skin, using large amounts, 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 when 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 is required 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 weight than in 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. Long-term use of corticosteroids may also disrupt growth and development in children.

Afloderm and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
No studies on interactions with other topical medicines have been conducted.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Afloderm should be used in pregnant women only if the potential benefit to the mother justifies 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 of 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 possibility of side effects in infants and the benefits of treatment for the mother.
Do not use the medicine on 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. Systemically acting 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 of the 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 the 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 told you. If you are not sure, check with your doctor or pharmacist.
Afloderm is 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

It is not recommended to use the medicine in children under 1 year of age, due to the lack of data on safety.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Using more than the recommended dose of Afloderm

When using the medicine for a long time, using it on large areas of the skin, or on damaged skin, when using occlusive dressings, and when using it in children, due to increased absorption of the active substances into the bloodstream, they may be overdosed and systemic side effects of corticosteroids may occur.
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.
If you use more of the medicine than you should, contact your 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 systemically acting corticosteroid.

Missing a dose of Afloderm

Do not use a double dose to make up for a forgotten dose.
If you have any doubts about using the medicine, consult your 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.
Long-term use of Afloderm cream may cause systemic side effects characteristic of corticosteroids, including adrenal suppression (see above - Using more than the recommended dose).
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, milia, and striae, superficial vasodilation (especially on the face), and excessive hair growth. Allergic reactions may also occur.
Unknown frequency (cannot be estimated from the available data): blurred vision.

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Afloderm

Keep this medicine 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 below 25°C.
Do not use this medicine after the expiry date which is 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 is alclometasone dipropionate. 1 g of cream contains 0.5 mg of alclometasone dipropionate.
• The other ingredients are: propylene glycol, chlorocresol, sodium dihydrogen phosphate dihydrate, phosphoric acid, white petrolatum, macrogol cetostearyl ether, cetostearyl alcohol, glycerol stearate, macrogol stearate 100, sodium hydroxide, purified water

What Afloderm looks like and contents of the pack

The medicine is a cream.
Afloderm is available in aluminum tubes containing 20 g or 40 g of cream, placed in a cardboard box.

Marketing authorization holder

Belupo s.r.o.
Cukrová 14, 81108 Bratislava, Slovakia
Phone: +421 2 5932 4330
Fax: +421 2 5932 4331

Manufacturer

BELUPO Pharmaceuticals & Cosmetics
Danica 5
48000 Koprivnica
Croatia

Date of last revision of the leaflet: