Dermocort

Package Leaflet: Information for the User

DERMOCORT, 1.372 mg/g, skin spray, suspension
Hydrocortisone

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

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, consult a doctor.

Table of Contents of the Package Leaflet

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

1. What is Dermocort and what is it used for

Dermocort skin spray, suspension is for local use.
It contains the active substance hydrocortisone, which has anti-inflammatory, anti-itching and vasoconstrictive effects. This medicine belongs to a group of medicines called corticosteroids.
Dermocort is used locally in inflammatory skin conditions of various origins, mainly of allergic origin, of moderate severity, which respond to glucocorticosteroids.

Indications for Use

Dermocort is used locally for the following indications:

• atopic dermatitis;
• allergic contact dermatitis;
• reactions after insect bites or stings (such as itching and irritation).

2. Important Information Before Using Dermocort

When Not to Use Dermocort:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if you have a bacterial, viral or fungal infection, or systemic fungal infection;
• if you have acne vulgaris or rosacea;
• if you have skin atrophy;
• if you have skin cancer or precancerous skin condition;
• if you have perioral dermatitis;
• if you have cutaneous tuberculosis;
• if you have open wounds and damaged skin;
• after vaccinations;
• in children under 12 years of age.

Warnings and Precautions

Before starting to use Dermocort, discuss with your doctor or pharmacist:

• if you have diabetes,
• if you have glaucoma or cataract, as the medicine may worsen the symptoms of the disease. Avoid using the medicine on the eyelids or on the skin around the eyes, due to the risk of glaucoma or cataract.

While using Dermocort, follow these warnings.

• The medicine is for use on the skin only.
• Do not use the medicine on healthy skin.
• Do not inhale the sprayed substance.
• Avoid contact of the medicine with the eyes and mucous membranes.
• Protect your eyes from the sprayed substance. If the suspension gets into your eyes, rinse them thoroughly with warm water.
• If you experience blurred vision or other vision disturbances, consult a doctor.
• If skin irritation occurs at the site of application, stop using the medicine and consult a doctor.
• Do not use large amounts of the medicine, on a large skin surface, wounds, damaged skin, and for a long time, as corticosteroids are absorbed into the blood and may cause side effects (listed in section 4: Possible side effects).
• If a skin infection occurs at the site of application of Dermocort, consult a doctor.
• The medicine may be used on the skin of the armpits and groin only in cases where it is absolutely necessary, as the medicine is absorbed faster in these areas and there is a risk of side effects, even after short-term use. In such cases, consult a doctor.
• After applying Dermocort to the skin, do not cover the area with any dressing (especially foil or plastic), as this increases the absorption of the medicine into the body. Additionally, skin atrophy, stretch marks, and superinfections may occur.

Use with caution in atrophic conditions of the subcutaneous tissue, especially in the elderly.

Children

Do not use in children under 12 years of age.
There is a risk of growth and development disorders in children.

Dermocort and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
No interactions of Dermocort with other medicines are known.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Dermocort may be used during pregnancy only if absolutely necessary, when the benefit to the mother outweighs the potential risk to the fetus.
It is recommended to use the medicine for a short period and on small skin surfaces, and with special caution during the first 3 months of pregnancy.
Breastfeeding
It is not known whether topical corticosteroids pass into breast milk.
During breastfeeding, Dermocort should be used with caution, for a short period, and on a small skin surface.

Driving and Using Machines

Due to the possibility of vision disturbances, the medicine may impair your ability to drive or use machines.

3. How to Use Dermocort

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If you are unsure, consult a doctor or pharmacist.
The medicine is for local use.
The container contains thirty-one 3-second doses of the medicine. The hydrocortisone content in one 3-second dose is approximately 1.7 mg.
Recommended dose
Adults and adolescents from 12 years of age
Apply the spray to the affected skin areas for 1 to 3 seconds, holding the container upright, with the spray head upwards, at a distance of 15 cm to 20 cm.
Usually, the medicine is used 2 times a day at equal intervals.
Highly flammable aerosol. Do not spray near an open flame or other ignition source.
Caution:Protect your eyes from the sprayed substance.
Do not inhale the sprayed substance.
After each application, wash your hands thoroughly with soap and water.

Before Each Use, Shake the Container Energetically Several Times

Duration of treatment
The medicine is intended for short-term use.
If symptoms worsen or do not improve after 7 days of treatment, stop using the medicine and consult a doctor.
Do not use the medicine for more than 7 days without consulting a doctor.
Use in children
Do not use in children under 12 years of age.
There is a risk of growth and development disorders in children.

Accidental Use of a Higher Dose of Dermocort

In case of accidental use of a higher dose of Dermocort, consult a doctor or pharmacist immediately.
Dermocort used for a long time, in large doses, or on large skin surfaces may cause growth and development disorders in children and suppression of the hypothalamic-pituitary-adrenal axis (this is the name of the system of interdependent endocrine glands that produce hormones).
Overdose symptoms may include:

• increased blood sugar levels (hyperglycemia);
• glucosuria (sugar in the urine);
• decreased immunity;
• Cushing's syndrome (characteristic silhouette: moon face, rounded torso, and thin limbs).

Missing a Dose of Dermocort

Continue using the medicine, do not increase the next dose.
Do not use a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects after local use of Dermocort:
Uncommon side effects (may affect up to 1 in 100 people):

• blurred vision, Frequency not known (cannot be estimated from the available data):
• atrophic dermatitis, stretch marks on the skin;
• recurrence of infection;
• post-steroid erythema (skin discoloration and depigmentation);
• superficial vasodilation;
• acne;
• perioral dermatitis;
• periorbital dermatitis;
• folliculitis, hypertrichosis;
• delayed wound healing and ulcers;
• bacterial, fungal, and viral superinfections;
• petechiae (small red or purple spots on the skin);
• skin irritation, such as: burning, redness, excessive dryness, contact allergy;
• glaucoma or cataract;
• suppression of the hypothalamic-pituitary-adrenal axis;
• Cushing's syndrome;
• growth and development disorders in children;
• hyperglycemia, glucosuria;
• edema, hypertension;
• decreased immunity;
• stretch marks.

If you experience any of the above symptoms, stop using the medicine and consult a doctor.

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: (22) 49 21 301, fax: (22) 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Dermocort

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

• Highly flammable aerosol.
• Pressurized container. Heating may cause bursting.
• 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 Dermocort Contains

• The active substance is hydrocortisone (Hydrocortisonum). 1 g of suspension contains 1.372 mg of hydrocortisone.
• The other ingredients are: sorbitan trioleate, lecithin (of animal origin), isopropyl myristate, Drivosol 35A (propane [min. 23%], n-butane [max. 5.0%], isobutane [min. 71.5%])

What Dermocort Looks Like and Contents of the Pack

White or almost white, homogeneous suspension.
Packaging:Aluminum pressurized container internally coated with epoxy-phenolic lacquer, with a spray valve (PET/POM/PA/stainless steel/LDPE) and spray head (PP/acetal resin) and cap with PP, in a cardboard box.
1 container of 110 mL contains 38.25 g of suspension.

Marketing Authorization Holder and Manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number 22 811-18-14

Date of Last Revision of the Package Leaflet: