DERMIRIT 0.5% Cream

Зміст інструкції

1. Dermirit 0,5% cream
   1. What is Dermirit and what is it used for
   2. What you need to know before using Dermirit
   3. How to use Dermirit
   4. Possible side effects
   5. How to store Dermirit
   6. Contents of the pack and other information

Dermirit 0,5% cream

Hydrocortisone acetate

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 7 days.

Contents of this leaflet

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

1. What is Dermirit and what is it used for

Dermirit contains the active ingredient hydrocortisone acetate, a corticosteroid with anti-inflammatory, anti-allergic and anti-pruritic activity. Dermirit is used in the treatment of insect bites, itching, erythema or limited burns and eczema (inflammatory skin reactions with itching).
Consult your doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before using Dermirit

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, in the anogenital area or on large lesions;
• to treat infectious diseases (such as syphilis), viral infectious diseases (such as herpes and varicella), localized skin rashes around the mouth and nose, acne, rosacea, skin reactions after vaccination, pustular psoriasis;
• in the genital area, especially if you have vaginal discharge;
• if the person who needs to use this medicine is a child under 2 years of age;
• if you are pregnant (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before using Dermirit if you:

• are an elderly person (especially if you suffer from osteoporosis, high blood pressure, low potassium levels in the blood, diabetes mellitus);
• suffer from subcutaneous atrophy (thinning of the subcutaneous tissues);
• suffer from liver or kidney failure.

The use, especially if prolonged, of topical medicines can cause irritation or allergic reactions. In such
cases stop the treatment and consult your doctor.
Avoid contact of the cream with the areas adjacent to the eyes as the penetration of the medicine into the
eyes can cause glaucoma (increased intraocular pressure) and cataracts. If this should
happen, rinse the affected area thoroughly with water.

Avoid prolonged usebecause 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 its application on non-intact skin as the medicine can be absorbed into the blood and cause systemic effects (which
can affect different parts of the body).
Do not cover the treated area with occlusive (non-breathable) bandages as this may also
promote absorption of the medicine into the blood, causing the appearance of undesirable effects that
occur with systemic administration (e.g. orally or intravenously) of corticosteroids.
For the same reason, avoid applying the cream in infants in the diaper area.

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

Other medicines and Dermirit
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
No interactions with other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
Use Dermirit only if absolutely necessary and under the direct supervision of your doctor.

Driving and operating machinery
This medicine does not impair the ability to drive and operate machinery.

3. How to use Dermirit

Use this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Apply a thin layer of cream to the area to be treated, twice a day, rubbing gently.
Do not exceed the recommended doses.

If you use more Dermirit than you should
In case of ingestion or accidental intake of an excessive dose of Dermirit, immediately notify your doctor or go to the nearest hospital.
No cases of overdose are known with the topical use of hydrocortisone at the concentration contained in
Dermirit.
If you accidentally use an excessive amount of cream, wash the treated area thoroughly with running water.

If you forget to use Dermirit
Do not use a double dose to make up for a missed dose.

If you stop using Dermirit
Do not abruptly stop therapy. Discontinue treatment gradually, for example
by continuing intermittently before stopping it.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During application of the cream, you may experience the following side effects:

Frequency not known(the frequency of which cannot be estimated on the basis of available data).

• acne, lesions similar to bruises due to the rupture of capillaries under the skin surface;
• reduction in skin thickness, dry skin;
• increased hair growth, skin discoloration;
• striae (stretch marks), dilation of 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 absorption of the cream (e.g. an occlusive dressing) can cause
systemic-type side effects such as swelling (edema), increased blood pressure and
compromised immune system. Prolonged use, especially on large areas, of creams
containing corticosteroids can cause the development of hypercortisolism (excessive increase of certain hormones).
Prolonged use of corticosteroids in children can cause growth and development disorders.
Application of the cream to the eyelid area has occasionally caused increased pressure
inside the eye (glaucoma) or cataracts.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Dermirit

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry date
refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dermirit contains

• The active ingredient is hydrocortisone acetate. 100 g of cream contains 0.5 g of hydrocortisone acetate.
• The other ingredients are: ethylene glycol palmitostearate and polyethylene glycol; polyoxyethylene glycosylated glycerides; petrolatum oil, butylated hydroxyanisole, benzoic acid, purified water.

Description of the appearance of Dermirit and contents of the pack
Dermirit is a dermatological cream of white color, available in aluminum tubes of 20 g.

Marketing Authorisation Holder
S.F. Group S.r.l. – Via Tiburtina, 1143 – 00156 Roma

Manufacturer
Beltapharm Spa, via Stelvio, 66 – 20095 Cusano Milanino (MI)
DOPPEL Farmaceutici Srl, Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC)