DERMIRIT

DERMIRIT transfer of marketing authorization to DOC

Package leaflet: information for the patient

Dermirit 0.5% cream

Hydrocortisone acetate
Please read this entire leaflet carefully before using this medicine because it contains important information for you.

• Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not notice improvement or if you notice worsening of symptoms 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 Dermirit is and what it is used for

Dermirit contains the active substance hydrocortisone acetate, a corticosteroid with anti-inflammatory, antiallergic and antipruritic properties. Dermirit is used in the treatment of insect bites, itching, erythema or localized burns, and eczema (inflammatory skin reactions accompanied by 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 to any of the other ingredients of this medicine (listed in section 6);
• if you have a skin infection or skin disease caused by viruses, bacteria, or fungi;
• on cutaneous ulcers, wounds, or skin tumours;
• on facial skin, the anogenital area, or on large skin lesions;
• to treat infectious diseases (such as syphilis), viral infections (such as herpes or chickenpox), skin rashes localized around the mouth and nose, acne, rosacea, skin reactions following 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 potassium levels in the blood, or diabetes mellitus);
• have subcutaneous atrophy (thinning of subcutaneous tissues);
• suffer from liver or kidney insufficiency.

The use, especially if prolonged, of topical medicines may cause irritation or allergic reactions. In such
a case, discontinue treatment and consult your doctor.
Avoid contact of the cream with areas near the eyes, as penetration of the medicine into the eyes may cause glaucoma (increased internal eye pressure) and cataracts. If this occurs, rinse the affected area thoroughly with water.
Avoid prolonged use, as it may cause dilation of blood vessels and thinning of the skin.
Avoid prolonged use of the cream, particularly over a large skin area, or its application on damaged skin, as the medicine may be absorbed into the bloodstream and cause systemic effects (which may thus affect various parts of the body).
Do not cover the treated area with occlusive dressings (non-breathable) as this may also enhance absorption of the medicine into the bloodstream, leading to the occurrence of adverse effects typical of systemic administration (e.g. oral or intravenous) of corticosteroids.
For the same reason, avoid applying the cream to infants in the diaper area.
Caution for athletes: The product contains substances prohibited in doping. Any use differing from the therapeutic indications, dosage regimen, or route of administration specified is forbidden.

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

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Use Dermirit only if strictly necessary and under direct medical supervision.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use Dermirit

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply a thin layer of cream to the affected area twice daily, gently rubbing it in.
Do not exceed the recommended dose.

If you use more Dermirit than you should
If Dermirit is accidentally swallowed or overdosed, contact your doctor immediately or go to the nearest hospital.
There are no known cases of overdose with topical use of hydrocortisone at the concentration contained in Dermirit.
If you accidentally apply too much 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 the missed dose.

If you stop using Dermirit
Do not stop treatment abruptly. Discontinue therapy gradually, for example by using the cream intermittently before stopping completely.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur during application of the cream:
Frequency not known (frequency cannot be determined from the available data).

• acne, bruise-like lesions due to rupture of capillaries beneath the skin surface;
• reduction in skin thickness, dry skin;
• increased hair growth, skin discoloration;
• striae (stretch marks), dilation of capillaries appearing on the skin as fine red or bluish lines;
• dermatitis affecting areas around the mouth and nose, infection involving the upper part of the hair follicle (folliculitis), itching.

Measures that enhance absorption of the cream (e.g. occlusive bandaging) may lead to systemic side effects such as swelling (edema), increased blood pressure, and impairment of the immune system. Prolonged use, especially over large areas, of creams containing corticosteroids may lead to the development of hypercortisolism (excessive increase in certain hormones). Prolonged use of corticosteroids in children may cause disturbances in growth and development. Application of the cream around the eyelid area has occasionally caused increased intraocular pressure (glaucoma) or cataract.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via 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 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dermirit contains

• The active substance is hydrocortisone acetate. 100 g of cream contain 0.5 g of hydrocortisone acetate.
• The other components are: ethylene glycol palmitostearate and polyethylene glycol; polyoxyethylene glycolysated glycerides; vaseline oil, butylhydroxyanisole, benzoic acid, purified water.

Description of the appearance of Dermirit and contents of the pack
Dermirit is a white dermatological cream, available in 20 g aluminium tubes.
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati, 40 - 20121 Milan, Italy
Manufacturer
Beltapharm Spa, via Stelvio, 66 – 20095 Cusano Milanino (MI)
DOPPEL Farmaceutici Srl, Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC)