Package leaflet: Information for the user

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

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including those 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 ointment 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 ointment 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, rosacea,
in diaper dermatitis,
in fungal or bacterial skin infections, unless appropriate specific treatment has been initiated.

Warnings and precautions
Before starting to use Afloderm, discuss this 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 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 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 possibility of glaucoma and cataract development.
If blurred vision or other visual disturbances occur, consult your doctor.
If skin infection develops, the doctor will initiate appropriate antibacterial or antifungal treatment.
Since corticosteroids can be absorbed through the skin, there is a risk of systemic corticosteroid adverse effects, including suppression of adrenal cortex function, during treatment with Afloderm ointment. Therefore, avoid use over large body surface areas, on damaged skin, in high doses, prolonged treatment, use in patients with hepatic impairment, and use in children.
Apply the ointment 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, the risk of systemic corticosteroid effects (including hypothalamic-pituitary-adrenal axis suppression, Cushing's syndrome, increased intracranial pressure) is greater than in adults, due to a higher body surface area to body weight ratio. Prolonged corticosteroid use may also impair growth and development in children.

Afloderm and other medicines
Inform your doctor or pharmacist about any medicines you are currently using, have recently used, or plan to use.
No studies on interactions with other topically applied medicines have been conducted.

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

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

Breastfeeding
The physician will consider whether to discontinue breastfeeding or the use of Afloderm ointment, 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 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 administered corticosteroids are known to pass into human milk.

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

Important information about some of the ingredients of the medicine
The medicine contains 20 mg of propylene glycol monostearate monopalmitate 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 as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Afloderm ointment is intended for topical use 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 is not recommended in children under 1 year of age due to insufficient 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
When used for prolonged periods, over large skin surface areas, on damaged skin, when occlusive
dressings are used, or in children, increased systemic absorption of the active substance may occur,
leading to 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
retardation in children, increased blood glucose levels (hyperglycemia), and glycosuria.
If a higher than recommended dose has been used, seek immediate medical advice.
The physician will decide whether treatment with the medicine should be discontinued.
If symptoms such as fever, muscle pain, joint pain, and general weakness occur, the physician 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.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Local adverse reactions to Afloderm ointment occur more frequently when occlusive dressings (sealed coverings) are used.
Prolonged use of Afloderm ointment may lead to systemic adverse effects characteristic of corticosteroids, including suppression of adrenal cortex function (see above - Use of doses higher than recommended for Afloderm).
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, sweating and striae, dilation of superficial blood vessels (particularly on the face), hypertrichosis.
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 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 provide more information on the safety of using the medicine.

5. How to store Afloderm

Keep the medicine out of the sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Afloderm contains

The active substance is aclometasone dipropionate. 1 g of ointment contains 0.5 mg of aclometasone dipropionate (equivalent to 0.392 mg of aclometasone).
Other components are: hexylene glycol, propylene glycol monostearate, white soft paraffin, white wax.

What Afloderm looks like and contents of the pack
Afloderm is an ointment.
The medicine is available in aluminium tubes containing 20 g of ointment, packed 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
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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in the Czech Republic, country of export: 46/363/01-C
Parallel import authorisation number: 179/17