Dexapolcort

Package leaflet: Information for the patient

DEXAPOLCORT, 0.28 mg/g, cutaneous aerosol, suspension
Dexamethasonum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet:

1. What is Dexapolcort and for what purpose is it used
2. Important information before using Dexapolcort
3. How to use Dexapolcort
4. Possible adverse effects
5. How to store Dexapolcort
6. Contents of the package and other information

1. What is Dexapolcort and for what purpose is it used

Dexapolcort - cutaneous aerosol, suspension - contains dexamethasone as the active substance, which is a corticosteroid. It exerts anti-inflammatory, antipruritic, antiallergic, and vasoconstrictive effects.
Indications
Dexapolcort is indicated for topical use in corticosteroid-responsive skin disorders, including:

• allergic skin diseases;
• acute allergic contact dermatitis;
• insect bite reactions;
• urticaria, lichen urticatus;
• first-degree burns.

2. Important information before using Dexapolcort

When not to use Dexapolcort

• If the patient is allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6).
• If the patient has:
  • viral, fungal or tuberculous skin infections;
  • acne vulgaris or rosacea;
  • perioral dermatitis;
  • reactions following vaccinations;
  • skin cancer or a precancerous condition.

Warnings and precautions

• Dexapolcort in aerosol form is intended for topical use on the skin only.
• Do not inhale the sprayed substance.
• Protect the eyes from the sprayed substance. If the suspension gets into the eyes, rinse thoroughly with lukewarm water.
• Avoid contact of the medicine with mucous membranes.
• If skin irritation occurs at the site of application, discontinue use and consult a doctor.
• Since corticosteroids can be absorbed through the skin, prolonged use, application over large areas of the body, or use under occlusive dressings (sealed coverings) should be avoided, as this may lead to skin atrophy, striae, and skin damage. Systemic adverse effects characteristic of corticosteroids may also occur, including suppression of adrenal function (e.g. Cushing's syndrome, glycosuria, hyperglycemia).
• Dexamethasone may be absorbed through the skin into the bloodstream and exert immunosuppressive effects (reducing the body's immunity). Therefore, during treatment, the patient should take care to avoid contracting infectious viral diseases (e.g. chickenpox, measles).
• Particular caution is required when using this medicine in children, as there is a risk of systemic effects of dexamethasone. In children, due to a higher body surface area to body weight ratio compared to adults, the risk of systemic corticosteroid effects—including disturbances in the hypothalamic-pituitary-adrenal axis (e.g. Cushing's syndrome)—is greater than in adults. Long-term use of corticosteroids may also impair growth and development in children.

Dexapolcort and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to use.
Do not apply other topical medicines simultaneously during treatment, as this may affect the concentration of active substances at the site of application and may lead to interactions or skin irritation.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
If the patient is pregnant or suspects she may be pregnant
Use of Dexapolcort should be avoided during pregnancy unless the doctor considers treatment necessary.
If the patient is breastfeeding
The decision on the use of Dexapolcort aerosol in breastfeeding women should be made by a doctor.

Driving and operating machinery
There are no data available regarding the effect of this medicine on the ability to drive vehicles or operate machinery.

3. How to use Dexapolcort

Dexapolcort should be used as directed by the physician.
If in doubt, consult your doctor again.
This medicine is intended for topical use only.
Recommended dose
Adults
Spray the affected skin areas with the suspension stream, holding the container vertically, with the spray head upwards, at a distance of 15 to 20 cm, for 1 to 3 seconds. The medicine is usually applied 2 to 4 times daily at regular intervals.
Extremely flammable aerosol. Do not spray near open flame or other sources of ignition.
Warning: Protect eyes from the sprayed substance.
Do not inhale the sprayed substance.
After each application, hands should be thoroughly washed with soap and water.
Shake the container vigorously before use
Duration of treatment
Your doctor will determine the appropriate duration of treatment.
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 Dexapolcort
When used over long periods, over large skin surface areas, in high doses, under occlusive (sealed) dressings, or on damaged skin, the medicine may be absorbed into the bloodstream and cause systemic corticosteroid effects (see section 2).
In case of accidental ingestion, seek immediate medical advice from a doctor or go to the nearest hospital emergency department. Bring the medicine in its original packaging so that the medical staff can identify exactly which medicine has been taken.
Missed dose of Dexapolcort
If you miss a dose at your usual scheduled time, apply the medicine as soon as possible, then continue with your regular dosing schedule.
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everyone will experience them.
Dexapolcort may cause local adverse reactions such as:
burning, itching, irritation at the site of application, excessive drying, skin atrophy, contact dermatitis, perioral dermatitis, skin maceration, acneiform eruptions, striae, hypertrichosis, skin depigmentation, secondary skin infections, and folliculitis.
During prolonged use of the aerosol and/or over large areas of skin, dexamethasone may be absorbed into the bloodstream and cause systemic adverse reactions typical of corticosteroids, including suppression of adrenal function. In children and infants, growth and developmental disorders may also occur (see section 2 When not to use Dexapolcort – Warnings and precautions).
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products 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
e-mail: [email protected]
Reporting adverse reactions enables continuous monitoring of the medicine's safety and helps gather further information on its safe use.

5. How to store Dexapolcort

Keep this medicine out of sight and reach of children.
Store below 25ºC.
Do not use this medicine after the expiry date (EXP) stated on the container.
The expiry date refers to the last day of the stated month.

• Extremely flammable aerosol.
• Pressurised container: may burst if heated.
• Store away from heat sources, hot surfaces, sparks, open flame, and other sources of ignition. Smoking is prohibited.
• Do not spray on an open flame or other sources of ignition.
• Pressurised container: do not pierce or burn, even after use.
• Protect from sunlight. Do not expose to temperatures above 50°C / 122°F.
  Do not dispose of medicines via sewage or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Dexapolcort contains
The active substance is dexamethasone.
Each 1 g of the suspension contains 0.28 mg of dexamethasone.
The other ingredients are: sorbitan trioleate, lecithin, isopropyl myristate, mixture: isobutane 72%, n-butane 4%, propane 24%.
What Dexapolcort looks like and contents of the pack
A homogeneous white or almost white suspension.
Packaging: container containing 16.25 g or 32.5 g of suspension, in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2 Street
03-176 Warsaw
Phone number: 22 811-18-14
For further information, please contact the representative of the Marketing Authorisation Holder.