Dexapolcort

Package Leaflet: Information for the Patient

DEXAPOLCORT, 0.28 mg/g, skin spray, suspension
Dexamethasone

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or nurse. See section 4.

Table of Contents of the Leaflet:

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

1. What is Dexapolcort and what is it used for

Dexapolcort - skin spray, suspension - contains the active substance dexamethasone, which is a corticosteroid. It has anti-inflammatory, antipruritic, anti-allergic, and vasoconstrictive effects.

Indications for Use

Dexapolcort is indicated for topical use in corticosteroid-responsive skin diseases:

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

2. Important Information Before Using Dexapolcort

When Not to Use Dexapolcort

• If you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6).
• If you have:
• viral, fungal, or tubercular skin infections;
• acne vulgaris or rosacea;
• perioral dermatitis;
• reactions to vaccinations;
• skin cancer or pre-cancerous conditions.

Warnings and Precautions

• Dexapolcort in the form of a spray is intended for topical use on the skin only.
• Do not inhale the sprayed substance.
• Protect your eyes from the sprayed substance. If the suspension gets into your eyes, rinse them thoroughly with warm 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 are absorbed through the skin, prolonged use or application to large areas of the body should be avoided, and the medicine should not be used under occlusive dressings, as this may lead to skin atrophy, striae, and superinfections. Systemic side effects characteristic of corticosteroids may also occur, including adrenal suppression (e.g., Cushing's syndrome, glucosuria, hyperglycemia).
• Dexamethasone may be absorbed through the skin into the blood and have immunosuppressive effects (reduce the body's immune response). Therefore, during treatment with this medicine, you should be careful not to contract an infectious viral disease (e.g., chickenpox, measles).
• Particular caution is required when using the medicine in children, as there is a risk of systemic effects of dexamethasone. In children, due to the larger ratio of body surface area to body mass compared to adults, the risk of systemic effects of corticosteroids, including disorders of the hypothalamic-pituitary-adrenal axis (e.g., Cushing's syndrome), is greater than in adults. Long-term use of corticosteroids may also disrupt growth and development in children.

Dexapolcort and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to use.
During treatment, do not use other topical medicines at the same time, as this may affect the concentrations of the active substances at the site of application and cause interactions or skin irritation.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before using this medicine.
If you are pregnant or think you may be pregnant
Do not use Dexapolcort during pregnancy unless your doctor considers it necessary.
If you are breastfeeding
Your doctor will decide whether to use the Dexapolcort spray while you are breastfeeding.

Driving and Using Machines

There is no data on the effect of the medicine on the ability to drive or operate machinery.

3. How to Use Dexapolcort

Dexapolcort should be used as directed by your doctor.
In case of doubts, consult your doctor again.
The medicine is intended for topical use.
Recommended dose

Adults

Spray the affected areas of the skin with a stream of suspension, holding the can upright, with the spray head up, at a distance of 15-20 cm, for 1-3 seconds. The medicine is usually used 2-4 times a day at equal intervals.
Highly flammable aerosol. Do not spray near an open flame or other ignition source.
Note: Protect your eyes from the sprayed substance.
Do not inhale the sprayed substance.
After each application, wash your hands thoroughly with soap and water.
Shake the can vigorously before use

Duration of Treatment

Your doctor will determine the appropriate duration of treatment.
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 Dexapolcort

After prolonged use on large areas of the skin, in large doses, under occlusive dressings, or on damaged skin, the medicine may be absorbed into the blood and cause systemic effects of corticosteroids (see section 2).
In case of accidental ingestion, contact your doctor or go to the nearest emergency department immediately. Take the medicine in its original packaging so that the medical staff can check which medicine was used.

Missing a Dose of Dexapolcort

If you miss a dose at the usual time, use the medicine as soon as possible, and then continue with regular use.
Do not use a double dose to make up for a missed dose.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dexapolcort may cause local side effects, such as:
burning, itching, irritation at the site of application, excessive drying, atrophic changes, contact dermatitis, perioral dermatitis, maceration, acne-like changes, striae, folliculitis, rash, hirsutism, skin discoloration, secondary skin infections, and folliculitis.
During prolonged use of the spray and/or on large areas of the skin, dexamethasone may be absorbed into the blood and cause systemic side effects characteristic of corticosteroids, including adrenal suppression. In children and infants, growth and development disorders may also occur (see section 2, Warnings and Precautions).

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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]. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Dexapolcort

Keep the medicine out of the sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date (EXP) stated on the packaging .
The expiry date refers to the last day of the month.

• Highly flammable aerosol.
• Pressurized container. Heating may cause a burst.
• Keep away from heat sources, hot surfaces, sparks, open flames, and other ignition sources. No smoking.
• Do not spray near an open flame or other ignition source.
• Pressurized container. Do not pierce or burn, even after use.
• Protect from sunlight. Do not expose to temperatures above 50°C / 122°F. 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 Dexapolcort Contains

The active substance of the medicine is dexamethasone.
1 g of suspension contains 0.28 mg of dexamethasone.
The other ingredients are: sorbitan trioleate, lecithin, isopropyl myristate, a mixture: isobutane 72%, n-butane 4%, propane 24%.

What Dexapolcort Looks Like and Contents of the Pack

Homogeneous suspension, white or almost white in color.
Packaging:a can containing 16.25 g or 32.5 g of suspension, in a cardboard box.

Marketing Authorization Holder and Manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna, ul. A. Fleminga 2, 03-176 Warsaw, Phone: 22 811-18-14. For more detailed information, please contact the representative of the marketing authorization holder.

Date of Last Revision of the Leaflet: