DERMIRIT 0.5% CREAM TUBE 20 G

Name
Dermirit 0.5% cream
Hydrocortisone acetate


What is it and what is it for?
Dermirit contains the active ingredient hydrocortisone acetate, a corticosteroid with anti-inflammatory, antiallergic, and antipruritic properties. Dermirit is used to treat insect bites, itching, localized erythema or burns, and eczema (an itchy, inflammatory skin reaction).

Contact your doctor if you do not feel better or if you feel worse after 7 days.


What you need to know before taking the medicine
Do not use Dermirit:
- if you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6);
- if you have a skin infection or disease caused by viruses, bacteria or fungi;
- on skin ulcers, wounds or skin tumors;
- on the skin of the face, the anogenital area or on large lesions;
- to treat infectious diseases (such as syphilis), viral infectious diseases (such as herpes and chickenpox), localized skin rashes around the mouth and nose, acne, rosacea, skin reactions after vaccination, pustular psoriasis;
- on the genital area, especially if you have vaginal discharge;
- if the person who is to use this medicine is a child under 2 years of age;
- if you are pregnant (see section "Pregnancy and breastfeeding").


Warnings and precautions
Talk to your doctor or pharmacist before using Dermirit if you: - are elderly (especially if you suffer from osteoporosis, high blood pressure, low blood potassium levels, diabetes mellitus);
- suffers from subcutaneous atrophy (thinning of the subcutaneous tissues);
- suffers from liver or kidney failure.

The use of topical medications, especially if prolonged, can cause irritation or allergic reactions. If this occurs, discontinue use and consult your doctor .

Avoid contact of the cream with areas near the eyes, as contact with the eye may cause glaucoma (increased pressure within the eye) and cataracts. If this occurs, rinse the affected area thoroughly with water.
Avoid prolonged use as it can cause dilation of blood vessels and thinning of the skin.
Avoid prolonged use of the cream, especially on a large area of ​​skin, or application to damaged skin as the medicine can be absorbed into the blood and cause systemic effects (i.e., effects that can affect different parts of the body).
Do not cover the treated area with occlusive (non-breathable) dressings as this may also facilitate the absorption of the medicine into the blood, causing the appearance of side effects that occur with systemic administration (e.g. by mouth or intravenously) of corticosteroids.
For the same reason, avoid applying the cream to children's diaper areas.

Children
This medicine should not be used in children under 2 years of age.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

While applying the cream you may experience the following side effects:

Frequency not known (the frequency of which cannot be established from the available data)
- acne, bruise-like lesions due to broken capillaries under the surface of the skin;
- reduction in skin thickness, dry skin;
- increased hair growth, skin discoloration;
- striae (stretch marks), dilation of the capillaries that appear on the skin as fine red or bluish streaks;
- dermatitis affecting the areas around the mouth and nose, infection involving the upper part of the hair follicle (folliculitis), itching.

Actions that promote the cream's absorption (e.g., an occlusive dressing) can cause systemic side effects such as swelling (edema), increased blood pressure, and compromised immune system function. Prolonged use, especially on large areas, of creams containing cortisone can cause the development of hypercortisolism (an excessive increase in certain hormones).
Prolonged use of corticosteroids in children can cause growth and developmental disorders.

Application of the cream to the eyelid area has occasionally caused increased pressure within the eye (glaucoma) or cataracts.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.