Dexapolcort 0,28 mg/g. spray 55 ml.

1. What Dexapolcort is and what it is used for
Dexamethasone - the active ingredient of the medicinal product Dexapolcort is a corticosteroid with anti-inflammatory, antipruritic, antiallergic and vasoconstrictive effects. Dexapolcort is used for the local treatment of the following skin diseases that respond to 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 Dexapolcort
Do not use Dexapolcort:
If you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6);
If you have been 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
Dexapolcort is intended for topical application to the skin only.
Do not inhale the spray.
Keep the spray out of your eyes. In case of contact with the mucous membrane of the eye, the eye should be rinsed thoroughly with lukewarm water.
Avoid contact of the medicinal product with mucous membranes.
If skin inflammation occurs at the application site, discontinue use of the medicinal product and inform your doctor.
Since corticosteroids are absorbed through the skin, avoid using the medicinal product for a prolonged period of time or on large areas of the body and do not use under an occlusive (waterproof) dressing, as this may lead to epidermal atrophy, stretch marks or superinfections. Systemic side effects typical of corticosteroids may also occur, such as adrenal suppression (including symptoms of Cushing's syndrome, sugar in the urine, increased blood sugar).
Dexamethasone can penetrate the skin into the bloodstream and have an immunosuppressive effect (reduction of the body's defenses). For this reason, during the course of therapy, you should be careful not to get infected with an acute viral infection (e.g. chickenpox, measles).
Special care should be taken when using the medicinal product in children due to the risk of systemic effects of dexamethasone.
Since the ratio of body surface area to body mass in children is greater than in adults, the risk of systemic effects of corticosteroids, including suppression of the hypothalamic-pituitary-adrenal axis (e.g. Cushing's syndrome) is higher than in adults. Prolonged use of corticosteroids may also cause impaired growth and development in children.
Using other medicines
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not use other topical medicines at the same time, as this could affect the concentrations of the active substances at the application site and may cause interactions and skin irritation.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor before using this medicine.

If you are pregnant or think you may be pregnant
Avoid using Dexapolcort during pregnancy unless your doctor considers it necessary.

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

Driving and using machines
There is no evidence of an effect of the medicinal product on the ability to drive and use machines.

3. How to use Dexapolcort
Always use Dexapolcort exactly as your doctor has told you. If you are not sure, 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, holding the bottle vertically, 15 to 20 cm from the treatment area. The medicinal product is usually applied 2 to 4 times a day at regular intervals.
Extremely flammable aerosol. Do not spray on an open flame or other source of ignition.

Caution:
Keep the eyes away from the spray.
Do not breathe in the spray.
Wash your hands with soap and water after each use of the medicinal product.
Before each use, the bottle should be shaken vigorously several times.

Duration of treatment
The doctor will determine the exact time of use of this medicine.
If you have the impression that the effect of the medicinal product is too strong or too weak, consult your doctor.

If you have used more Dexapolcort than you should
With prolonged use of the medicinal product on large skin surfaces, in high doses, under occlusive (waterproof) dressings or on damaged skin, it is possible that
to enter the bloodstream and cause systemic effects typical of corticosteroids (see section 2).
If you accidentally swallow the medicine, contact your doctor immediately or go to the emergency department of the nearest hospital. You should take the medicine in the original packaging with you so that the staff can check what you have swallowed.

If you forget to use Dexapolcort
If you miss a dose of the medicine at the scheduled time, you should take it as soon as possible and then continue the treatment as directed.
Do not take a double dose of the medicine to make up for a forgotten dose.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dexapolcort may cause local adverse reactions such as: burning, itching, irritation at the site of application, severe dryness, atrophic skin changes, contact dermatitis, inflammation around the mouth, skin maceration, acne-like rash, stretch marks, sweating disorders, rash, severe hair growth, skin discoloration, secondary skin infections and folliculitis.
When the medicinal product is applied for a prolonged period of time and/or on large skin surfaces, it is possible for dexamethasone to penetrate the bloodstream and cause systemic manifestations typical of corticosteroids, including suppression of adrenal function. In children and infants, growth and development disorders may also occur.
5. How to store Dexapolcort
Keep out of the reach and sight of children.
Store below 25°C.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Extremely flammable aerosol.
Pressurised container. May explode if heated.
Keep away from heat, hot surfaces, sparks, open flames and other sources of ignition. No smoking.
Do not spray on an open flame or other source of ignition.
Pressurised container: do not pierce or burn, even after use.
Keep away from direct sunlight. Do not expose to temperatures exceeding 50°C/122°F.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information
What Dexapolcort contains
The active substance is: dexamethasone.
1 g of the suspension contains 0.28 mg of dexamethasone.
The other ingredients are: sorbitan trioleate, lecithin, isopropyl myristate, a mixture of isobutane, butane and propane.

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

 

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