Dermocort

Package leaflet: Information for the user

DERMOCORT, 1.372 mg/g, cutaneous aerosol, suspension
Hydrocortisone
Please read this leaflet carefully before using this medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

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

Table of contents

1. What Dermocort is and what it is 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 Dermocort is and what it is used for
Dermocort is a cutaneous aerosol suspension intended for topical use.
It contains the active substance hydrocortisone, which has anti-inflammatory, antipruritic (anti-itch), and vasoconstrictive effects. This medicine belongs to a group of medicines called corticosteroids.
Dermocort is used topically in inflammatory skin conditions of various origins, particularly those of allergic origin, of moderate severity, which respond to glucocorticosteroids.

Indications for use
Dermocort is indicated for topical use in the following conditions:

• Atopic dermatitis;
• Allergic contact dermatitis;
• Reactions following 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 bacterial, viral, or fungal infections, or systemic fungal infections;
• If you have acne vulgaris or rosacea;
• If you have skin atrophy;
• If you have skin cancer or pre-cancerous skin conditions;
• If you have perioral dermatitis;
• If you have cutaneous tuberculosis;
• If you have open wounds or damaged skin;
• After vaccination;
• In children under 12 years of age.

Warnings and precautions
Before using Dermocort, discuss with your doctor or pharmacist:

• If you have diabetes;
• If you have glaucoma or cataracts, as the medicine may worsen symptoms. Avoid applying the medicine to eyelids or the skin around the eyes due to the risk of glaucoma or cataracts.

While using Dermocort, observe the following warnings:

• This medicine is for external use on the skin only.
• Do not apply the medicine to healthy skin.
• Do not inhale the sprayed substance.
• Avoid contact with eyes and mucous membranes.
• Protect the eyes from the sprayed suspension. If the suspension gets into the eyes, rinse thoroughly with lukewarm water.
• If you experience blurred vision or other visual disturbances, consult your doctor.
• If skin irritation occurs at the site of application, discontinue use and consult your doctor.
• Do not use large doses, over large skin areas, on wounds, damaged skin, or for prolonged periods, as corticosteroids may be absorbed into the bloodstream and cause side effects (listed in section 4: Possible side effects).
• If a skin infection develops at the site of application, consult your doctor.
• This medicine may be used on the axillary or groin areas only when absolutely necessary, as absorption is faster in these areas and there is a risk of developing or worsening side effects, even with short-term use. In such cases, consult your doctor.
• After applying Dermocort, do not cover the treated area with any dressing (especially plastic film or adhesive bandages), as this increases systemic absorption of the medicine. Additionally, epidermal atrophy, striae (stretch marks), and secondary infections may occur.

Use with caution in conditions involving atrophy of subcutaneous tissue, especially in elderly patients.

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

Dermocort and other medicines
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
No interactions between Dermocort and other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy
Dermocort may be used during pregnancy only if clearly necessary, when the benefit to the mother outweighs the potential risk to the fetus.
Short-term use on small skin areas is recommended, with particular caution during the first trimester of pregnancy.

Breastfeeding
It is not known whether topically applied corticosteroids pass into breast milk.
During breastfeeding, Dermocort should be used cautiously, for short periods and on small skin areas only.

Driving and operating machinery
Due to the possibility of visual disturbances, this medicine may impair psycho-physical performance and the ability to drive or operate machinery.

3. How to use Dermocort

This medicine should always be used exactly as described in this patient information leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is intended for topical use only.
The container contains thirty-one 3-second doses of the medicine. The amount of hydrocortisone in one 3-second dose is approximately 1.7 mg.

Recommended dose
Adults and adolescents aged 12 years and older
Affected areas of skin should be sprayed with a stream of the suspension for 1 to 3 seconds, holding the container upright with the spray head pointing upwards, at a distance of 15 to 20 cm.
The medicine is usually applied twice daily at regular intervals.

Extremely 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, hands should be thoroughly washed with soap and water.
Before each use, shake the container vigorously several times.

Duration of treatment
This medicine is intended for short-term use only.
If symptoms worsen or there is no improvement after 7 days of treatment, discontinue use and consult your doctor.
Do not use this medicine for longer than 7 days without consulting your doctor.

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

Taking more than the recommended dose of Dermocort
If more than the recommended dose of Dermocort has been taken, consult your doctor or pharmacist immediately.
Prolonged use of Dermocort, especially in high doses or over large areas of skin, may cause impaired growth and development in children and suppression of the hypothalamic–pituitary–adrenal axis (a system of interrelated endocrine glands producing hormones).
Symptoms of overdose may include:

• increased blood glucose (hyperglycaemia);
• glucose in urine (glucosuria);
• reduced immunity;
• Cushing's syndrome (characteristic appearance: moon-shaped face, rounded trunk, and thin limbs).

Missed dose of Dermocort
Continue using the medicine as prescribed without increasing the next dose.
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions possible after topical use of Dermocort:

Adverse reactions occurring not very commonly (may affect up to 1 in 100 patients):

• blurred vision.

Adverse reactions occurring with unknown frequency (frequency cannot be estimated from the available data):

• cutaneous atrophy, striae;
• recurrence of infection;
• post-steroidal pigmentation (skin discoloration and hypopigmentation);
• superficial capillary dilation;
• acne;
• perioral dermatitis;
• periorbital dermatitis;
• folliculitis, hypertrichosis;
• delayed wound and ulcer healing;
• bacterial, fungal, and viral superinfections;
• petechiae (small red or purple spots on the skin);
• skin irritation, such as burning, erythema, excessive dryness, contact allergy;
• glaucoma or cataract;
• suppression of the hypothalamic-pituitary-adrenal axis;
• Cushing's syndrome;
• growth and development retardation in children;
• hyperglycemia, glycosuria;
• edema, hypertension;
• decreased immunity;
• striae.

If any of the above symptoms occur, discontinue use of the medicine and contact your doctor.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Dermocort

Keep this medicine out of sight and reach of children.
Store 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 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. 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
A white or almost white, homogeneous suspension.
Packaging: A pressurized aluminium container internally coated with epoxy-phenolic lacquer,
closed with an atomizing valve (PET/POM/PA/stainless steel/LDPE) and spray head
(PP/acetal resin), together with a PP cap, placed in a cardboard box.
1 container with a capacity of 110 mL contains 38.25 g of suspension.
Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2 Street
03-176 Warsaw
Telephone number: 22 811-18-14
For further information, please contact the representative of the Marketing Authorisation Holder.