DEXAPOLCORT 0,28 mg/g cutaneous spray, suspension Dexamethasone – 16,25 g

What Dexapolcourt is and what it is used for
Dexamethasone – the active ingredient in the medicine Dexapolcort is a corticosteroid with anti-inflammatory, anti-pruritic, anti-allergic and vasoconstrictive effects. Dexapolcort is used for the topical treatment of the following skin conditions in the setting of corticosteroid therapy:

allergic skin disorders;
acute contact dermatitis;
reactions to insect bites;
urticaria, strophulus;
first-degree burns.
2. What you need to know before you use Dexapolcourt
Do not use Dexapolcourt:

If you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6);
If you are diagnosed with:
viral, fungal or tuberculous skin infections;
usually acne or acne rosacea;
inflammation of the skin around the mouth (perioral dermatitis);
reactions after prophylactic vaccination;
skin cancer and precancerous conditions.
Warnings and precautions
Dexapolcourt is intended for topical application to the skin only.

Do not inhale the sprayed substance.
Protect your eyes from the spray. In case of contact with the mucous membranes of the eyes, the eye should be rinsed gently with lukewarm water.
Avoid contact of the medicinal product with mucous membranes.
If inflammation of the skin occurs at the application site, stop taking the medicine and tell your doctor.
As corticosteroids are absorbed through the skin, avoid using the medicine for a long time or on large areas of the body and do not use under an occlusive (waterproof) dressing, as this may lead to atrophy of the epidermis, stretch marks or superinfections. Systemic side effects typical of corticosteroids, such as adrenal suppression (including symptoms of Cushing’s syndrome, urinary sugar, high blood sugar), may also occur.
Dexamethasone can penetrate the skin into the bloodstream and have an immunosuppressive effect (reduction of the body’s defenses). Therefore, during the course of therapy you should be careful not to get an acute viral infection (eg chickenpox, measles).
Special care should be taken when using the drug in children due to the risk of systemic effects of dexamethasone.
Because the ratio of body surface area to body weight is higher in children than in adults, the risk of systemic effects of corticosteroids, incl. suppression of the hypothalamic-pituitary-adrenal axis (eg Cushing’s syndrome) is higher than in adults. Prolonged use of corticosteroids can also cause impaired growth and development in children.
Use of other drugs
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not use other topical medicinal products at the same time, as this may affect the concentrations of the active substances at the site of application and may cause skin interactions and irritation.

Pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

If you are pregnant or think you may be pregnant
Avoid using Dexapolcort during pregnancy unless your doctor tells you to.

If you are breast-feeding
Your doctor will decide whether to use Dexapolcort while breast-feeding.

3. How to use Dexapolcourt
Always use Dexapolcort exactly as your doctor has told you. If you are not sure about anything, ask your doctor again.
This medicine is for topical use.

Recommended dose
Adults
The affected areas should be sprayed with the suspension for 1 to 3 seconds, keeping the vial upright, 15 to 20 cm from the treated area. The medicine is usually given 2 to 4 times a day at regular intervals.
Extremely flammable aerosol. Do not spray on a naked flame or any incandescent material.

Attention:
Keep eyes away from the spray.
Do not inhale the sprayed substance.
Wash your hands with soap and water after each administration.
Before each use, the vial should be shaken vigorously several times.

Duration of treatment
Your doctor will determine the exact time of use of this medicine.
If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor.

What Dexapolcort looks like and contents of the pack
Homogeneous, white to off-white suspension.
Aluminum vials containing 16.25 g or 32.5 g of the suspension, placed in a cardboard box.

Marketing Authorization Holder and Manufacturer:
Tarchomin Pharmaceutical Works “Polfa” S.A., Poland.