Package leaflet: Information for the patient

DEXAPOLCORT N, (1.38 mg + 0.28 mg)/g, cutaneous aerosol, suspension
Neomycin sulfate + Dexamethasone
Please read this 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, consult your doctor or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Table of contents of the leaflet:

What is Dexapolcort N and what is it used for
Important information before using Dexapolcort N
How to use Dexapolcort N
Possible side effects
How to store Dexapolcort N
Contents of the pack and other information

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

Dexapolcort N cutaneous aerosol, suspension, contains two active substances: neomycin sulfate and dexamethasone.
Neomycin – is an aminoglycoside antibiotic with broad-spectrum antibacterial activity, effective against many Gram-positive and Gram-negative bacteria.
Dexamethasone – is a corticosteroid with anti-inflammatory, antipruritic, antiallergic effects and causes constriction of blood vessels.
Dexapolcort N acts against neomycin-sensitive bacteria present in skin inflammatory lesions and reduces local inflammatory processes, diminishing redness and itching.
Indications
Dexapolcort N is indicated for local treatment of bacterial skin infections caused by bacteria sensitive to neomycin, when anti-inflammatory and/or antipruritic therapy is also required.

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 tuberculosis skin infections;
- acne vulgaris or rosacea;
- perioral dermatitis;
- reactions following vaccinations;
- skin cancer or a pre-cancerous condition.

Warnings and precautions

Dexapolcort N in aerosol form is intended for topical use on the skin only.
Do not inhale the sprayed substance.
Protect the eyes from the sprayed suspension. 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 may be absorbed through the skin, prolonged use, application over large areas of the body, or use under occlusive dressings (sealed) should be avoided, as this may lead to epidermal atrophy, striae, and skin atrophy. Systemic adverse effects typical 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 act immunosuppressively (reducing the body's immunity). Therefore, during treatment, the patient should take care not to contract a contagious viral disease (e.g. chickenpox, measles).
Particular caution is required when using this medicine in children, due to the risk of systemic effects of dexamethasone. In children, because of the 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 children's growth and development.
Due to the ototoxic (hearing-damaging) and nephrotoxic (kidney-damaging) effects of neomycin, the medicine should not be used long-term, over large skin areas, or on damaged skin.
Prolonged use of the medicine may lead to the proliferation of bacterial strains resistant to neomycin and to neomycin allergy. In case of infections caused by bacteria insensitive to neomycin or by fungi, the doctor should initiate appropriate antibacterial or antifungal treatment.

Dexapolcort N 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 use 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
Avoid using Dexapolcort N during pregnancy unless the doctor considers its use necessary.
If the patient is breastfeeding
The decision to use Dexapolcort N aerosol in breastfeeding women should be made by a doctor.

Driving and operating machinery
There is no data available on the influence of the medicine on the ability to drive or operate machinery.

3. How to use Dexapolcort N
Use Dexapolcort N exactly as directed by your doctor.
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, 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.
Highly 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, wash hands thoroughly 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 N
Prolonged use over large skin areas, in high doses, under occlusive dressings (sealed), or on damaged skin may lead to systemic absorption of the corticosteroid and cause systemic corticosteroid effects (see section 2).
In case of accidental ingestion, contact a doctor immediately or go to the nearest emergency department. Bring the medicine in its original packaging so that medical staff can identify the product used.

Missed dose of Dexapolcort N
If a dose is missed at the usual scheduled time, apply the medicine as soon as possible, then continue with the regular dosing schedule.
Do not use a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Dexamethasone may cause local adverse reactions such as:
burning, itching, irritation at the site of product application, excessive skin dryness, skin atrophy, contact dermatitis, perioral dermatitis, skin maceration, acneiform changes, striae, miliaria, rash, hypertrichosis, skin depigmentation, secondary skin infections, and folliculitis.
During prolonged use of the aerosol and (or) over large skin areas, dexamethasone may be absorbed into the bloodstream and cause systemic adverse effects typical of corticosteroids, including suppression of adrenal function. In children and infants, impaired growth and development may also occur (see section 2 When Dexapolcort N must not be used – Warnings and precautions).
Neomycin, an ingredient of the medicine, may cause local skin irritation, allergic reactions, ototoxicity, and nephrotoxicity.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 4921 301; fax: +48 22 4921 309
e-mail: [email protected]
Reporting adverse effects helps to provide 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 below 25ºC.
Do not use this medicine after the expiry date (EXP) stated on the packaging.
The expiry date refers to the last day of the stated month.

Extremely flammable aerosol.
Pressurised container: may burst if heated.
Keep away from heat sources, 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.
Protect from sunlight. Do not expose to temperatures exceeding 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. Such measures will help protect
the environment.

6. Contents of the pack and other information

What Dexapolcort N contains
The active substances of the medicinal product are neomycin sulfate and dexamethasone.
1 g of the suspension contains 1.38 mg of neomycin sulfate and 0.28 mg of dexamethasone.
Other components: sorbitan trioleate, lecithin, isopropyl myristate, mixture: isobutane
72%, n-butane 4%, propane 24%
What Dexapolcort N looks like and contents of the pack
A homogeneous white or almost white suspension.
Pack: container containing 16.25 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.