Dexapolcort N

Package Leaflet: Information for the Patient

DEXAPOLCORT N, (1.38 mg + 0.28 mg)/g, spray for the skin, suspension
Neomycin sulfate+ 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.
• In case of any doubts, consult a doctor or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects 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 N and what is it used for
• 2. Important information before using Dexapolcort N
• 3. How to use Dexapolcort N
• 4. Possible side effects
• 5. How to store Dexapolcort N
• 6. Contents of the pack and other information

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

Dexapolcort N - spray for the skin, suspension - contains two active substances - neomycin sulfate and dexamethasone.
Neomycin- is an aminoglycoside antibiotic with a broad spectrum of antibacterial activity, effective against many Gram-positive and Gram-negative bacteria.
Dexamethasone- is a corticosteroid with anti-inflammatory, antipruritic, anti-allergic, and vasoconstrictive properties.
Dexapolcort N acts on neomycin-sensitive bacteria in skin inflammation foci and limits local inflammatory processes, reducing redness and itching.

Indications for use

Dexapolcort N is indicated for the local treatment of skin infections caused by bacteria sensitive to neomycin, in cases where anti-inflammatory and/or antipruritic treatment is also necessary.

2. Important information before using Dexapolcort N

When not to use Dexapolcort N

• If the patient is allergic to neomycin, 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 or rosacea;
• perioral dermatitis;
• reactions to vaccinations;
• skin cancer or pre-cancerous conditions.

Warnings and precautions

• Dexapolcort N in the form of a spray is intended only for local use on the skin.
• Do not inhale the sprayed substance.
• Protect the eyes from the sprayed substance. If the suspension gets into the 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.
• Due to the fact that 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, the patient should be careful not to contract an infectious 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 higher than in adults. Long-term use of corticosteroids may also disrupt growth and development in children.
• Due to the ototoxic (harmful to hearing) and nephrotoxic (harmful to kidneys) effects of neomycin, the medicine should not be used for prolonged periods, on large areas of skin, or on damaged skin.
• Prolonged use of the medicine may lead to the proliferation of neomycin-resistant bacterial strains and allergy to neomycin. In the case of infections caused by bacteria insensitive to neomycin or fungi, the doctor will prescribe appropriate antibacterial or antifungal treatment.

Dexapolcort N and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
During treatment, do not use other medicines locally, 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, consult your doctor before using this medicine.
If you are pregnant or think you may be pregnant
Do not use Dexapolcort N during pregnancy, unless your doctor considers it necessary.
If you are breastfeeding
Your doctor will decide whether to use the Dexapolcort N spray while breastfeeding.

Driving and using machines

There is no data on the effect of the medicine on the ability to drive and use machines.

3. How to use Dexapolcort N

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

Adults

Spray the affected areas of the skin with a stream of suspension, holding the container vertically, with the spray head upwards, 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 container vigorously before use

Treatment duration

Your doctor will determine the appropriate treatment duration.
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 N

After prolonged use on large areas of skin, in large doses, under occlusive dressings, or on damaged skin, the medicine may be absorbed into the blood and cause systemic corticosteroid effects (see section 2).
In case of accidental ingestion, consult your doctor or go to the nearest hospital 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 N

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

4. Possible side effects

Like all medicines, Dexapolcort N can cause side effects, although not everybody gets them.
Dexamethasone may cause local side effects, such as:
burning, itching, irritation at the site of application, excessive dryness, atrophic changes of the skin, contact dermatitis, perioral dermatitis, maceration of the skin, acne-like changes, striae, folliculitis, rash, hypertrichosis, skin discoloration, secondary skin infections, and folliculitis.
During prolonged use of the spray and/or on large areas of 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).
Neomycin, a component of the medicine, may cause local skin irritation, allergic reactions, hearing loss, and kidney damage.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 side effects will help gather more information on the safety of the medicine.

5. How to store Dexapolcort N

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. Smoking is prohibited.
• 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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Dexapolcort N contains

The active substances are neomycin sulfate and dexamethasone.
1 g of suspension contains 1.38 mg of neomycin sulfate and 0.28 mg of dexamethasone.
Other ingredients are: sorbitan trioleate, lecithin, isopropyl myristate, a mixture: isobutane 72%, n-butane 4%, propane 24%

What Dexapolcort N looks like and contents of the pack

Homogeneous suspension, white or almost white in color.
Packaging:container containing 16.25 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: