AFLODERM 0.5 mg/g Ointment

Contents of the leaflet

1. Package Leaflet: Information for the User
2. AFLODERM, 0.5 mg/g, ointment
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Afloderm and what is it used for
4. Important information before using 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 ingredients of the medicine
5. How to use Afloderm
   1. Adults and children over 1 year of age
   2. Use in children
   3. Using a higher dose of Afloderm than recommended
   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, ointment

Alclometasone dipropionate

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

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your 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 ointment 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 ointment is indicated for the local treatment of inflammatory and pruritic skin diseases that respond to corticosteroid treatment, including atopic dermatitis, contact dermatitis, and psoriasis.

2. Important information before using 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 tuberculosis of the skin,
• in viral skin infections, especially in common herpes, cowpox, and chickenpox,
• 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 your doctor, pharmacist, or nurse.
If a skin allergic reaction (itching, burning, or redness of the skin) occurs after applying Afloderm ointment, inform your doctor. The doctor will decide whether to discontinue the medicine.
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 skin of 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 you experience blurred vision or other vision disturbances, contact your doctor.
In the 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 ointment, including adrenal suppression. 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 ointment 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 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 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. Long-term use of corticosteroids can also disrupt growth and development in children.

Afloderm and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
No studies have been conducted on interactions with other locally applied medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
The use of Afloderm ointment 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 topical corticosteroid use 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 ointment, taking into account the possibility of side effects in children and the benefits of treatment for the mother.
Do not use the medicine on the breast skin before breastfeeding.
It is not known whether topically applied corticosteroids, including alclometasone dipropionate, are absorbed through the skin to an extent that may pass into breast milk. Generally, systemically acting corticosteroids pass into breast milk.

Driving and using machines

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

Important information about some ingredients of the medicine

The medicine contains 20 mg of propylene glycol monopalmitynostearate in each gram of product. Due to the presence of this excipient, the medicine may cause skin irritation.

3. How to use Afloderm

Use this medicine always as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
Afloderm ointment 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 an occlusive dressing.
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, ask your 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 in the case of using occlusive dressings, as well as in children, due to increased absorption of the active substances into the bloodstream, there may be an overdose 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 inhibition in children, increased blood sugar levels (hyperglycemia), and glycosuria.
If you use a higher dose of the medicine than recommended, 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 missed dose.
If you have any doubts about using the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Afloderm ointment can cause side effects, although not everybody gets them.
Local side effects of Afloderm ointment occur more frequently when using occlusive dressings.
Long-term use of Afloderm ointment 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, milia, and striae, superficial vasodilation (especially on the face), and hypertrichosis.
Unknown frequency (cannot be estimated from available data): blurred vision.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Tel.: +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 the 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 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 the medicine is alclometasone dipropionate. 1 g of ointment contains 0.5 mg of alclometasone dipropionate.
• The other ingredients of the medicine are: propylene glycol monopalmitynostearate, white petrolatum, white wax

What Afloderm looks like and contents of the pack

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

Marketing authorization holder

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

Manufacturer

BELUPO Pharmaceuticals & Cosmetics
Danica Street 5
48 000 Koprivnica
Croatia

Date of last revision of the leaflet: