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, ointment

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.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any 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 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 therapy, including atopic dermatitis, contact dermatitis, and psoriasis.

2. Important information before using Afloderm

When not to use Afloderm:

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 ointment, inform your doctor. The doctor will decide whether to discontinue the medicine immediately.
Occlusive dressings should not be used, 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 the patient experiences blurred vision or other visual disturbances, they should consult their 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, it should be avoided to use it on large areas of the body, damaged skin, in high doses, for prolonged treatment, and in patients with liver function disorders and in children.
The ointment should only be applied to the armpits and groin area 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 should be exercised 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 mass 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

Inform 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 locally applied medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before using this medicine.
Pregnancy
The use of Afloderm ointment in pregnant women is only allowed when, in the doctor's opinion, the benefit to the pregnant woman outweighs the 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 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 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 an extent that they can 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 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 the product.
Due to the presence of this excipient, the medicine may cause skin irritation.

3. How to use Afloderm

Always use this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Afloderm ointment 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 an occlusive dressing.
Do not use for more than 3 weeks.

Use in children

The use of the medicine in children under 1 year of age is not recommended, due to the lack of safety data.
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, on large areas of the skin, or on damaged skin, with occlusive dressings, and 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 have used more than the recommended dose of the medicine, consult 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 the use of a systemic 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, 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 ointment occur more frequently when using occlusive dressings.
Prolonged use of Afloderm ointment may cause systemic side effects characteristic of corticosteroids, including adrenal suppression (see above - Using more than the recommended dose of Afloderm).
Common (in 1-2% of patients) local side effects 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 include: folliculitis, acne-like changes, skin discoloration, perioral dermatitis, allergic contact dermatitis (burning, swelling, and inflammatory blisters on the skin), secondary infections, atrophic changes, erythema, and striae.
Frequency not known (cannot be estimated from the available data): blurred vision.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, inform your 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
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.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
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 (equivalent to 0.392 mg of alclometasone).
• The other ingredients of the medicine are: hexylene glycol, propylene glycol monostearate, white petrolatum, white wax.

What Afloderm looks like and contents of the pack

The medicine is an ointment.
Afloderm is available in aluminum tubes containing 20 g of ointment, placed 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
81108 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:46/363/01-C
Parallel import authorization number:179/17
Date of leaflet approval: 10.05.2022
[Information about the trademark]