Leaflet: information for the user

Dermosa Hydrocortisone 10 mg/g ointment

Hydrocortisone acetate

Read this leaflet carefully before you start using this medicine, because it containsimportant information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribedonlyfor you,and you must not give it to otherseven if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Dermosa Hydrocortisone ointment and what it is used for

2.What you need to know before you start using Dermosa Hydrocortisone ointment

3.How to use Dermosa Hydrocortisone ointment

4.Possible side effects

5.Storage of Dermosa Hydrocortisone ointment

6.Contents of the pack and additional information

It contains hydrocortisone acetate as its active ingredient, a corticosteroid (anti-inflammatory), which is used on the skin to reduce inflammation of certain skin problems. It reduces redness (erythema), fluid accumulation (edema), and exudate on inflamed skin, and relieves itching, burning, or pain.

Dermosa Hidrocortisona ointmentis indicatedfor:

• Local treatment of inflammatory manifestations and itching of skin diseases that respond to corticosteroids, such as:

• Mild to moderate acute eczema related to an external cause, such as:

• Allergic contact dermatitis.

• Irritant contact dermatitis caused by substances commonly used, such as soap.

• Unspecified eczema (eczema vulgar).

• Eczema related to patient factors (endogenous eczema), such as atopic dermatitis or neurodermatitis.

• Eczema with skin inflammation and scaling (seborrheic eczema).

It helps in the treatment of psoriasis (scaly, red skin condition often covered with silver scales).

Do not use Dermosa Hidrocortisona:

• if you are allergic to hydrocortisone or to any of the other ingredients of this medication (listed in section 6).
• if you have tuberculosis, syphilis, or viral infections (for example, chickenpox or herpes).
• in areas of skin affected by red or pink inflammation in the face (rosacea), in ulcers, acne, or skin diseases with skin thinning (atrophy)
• in skin inflammation around the mouth (perioral dermatitis)
• in areas of skin showing a vaccination reaction, that is, redness or inflammation after the vaccine
• in the eyes or open wounds
• in skin infections caused by bacteria or fungi (see "Warnings and precautions").

Warnings and precautions

Consult your doctor or pharmacist before starting to use Dermosa Hidrocortisona ointment.

• This medication should be used in the smallest possible dose, especially in children, and only for the time strictly necessary to relieve skin symptoms.
• Corticosteroid anti-inflammatory agents have significant effects on the body. They should not be used in large areas of the body or for long periods of time, as this significantly increases the risk of adverse effects.
• If you also develop a bacterial or fungal infection, consult your doctor about your treatment.Corticosteroid medications can hide, activate, or worsen a skin infection.
• You should avoid contact with the eyes, open wounds, or mucous membranes (for example, the mouth). If the medication comes into contact with these areas, wash with plenty of water.
• You should not apply this medication to skin folds, such as the groin or armpits.
• You should not use this medication under occlusive materials such as bandages, unless under the supervision of a doctor. Diapers can act as occlusive bandages.
• If you are being treated for psoriasis, it is recommended to have special medical supervision.
• If you use Dermosa Hidrocortisona ointment for conditions other than those for which it has been prescribed, you may mask symptoms and make it difficult to diagnose and treat correctly.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

In children, the administration of corticosteroids on the skin should be for short periods of time and the minimum effective dose. In children, special caution is required, and in adolescents during growth, it is more likely that the corticosteroid will pass through the skin and have adverse effects in other areas of the body. Note that diapers can be occlusive and increase absorption.

Other medications and Dermosa Hidrocortisona

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

At present, there are no known interactions.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

You should not use Dermosa Hidrocortisona ointment during pregnancy or breastfeeding unless your doctor considers it necessary.

As a general rule, during the first trimester of pregnancy, corticosteroid medications should not be applied to the skin.

If your doctor prescribes Dermosa Hidrocortisona ointment during pregnancy or breastfeeding, do not use it on large areas of your body, or for long periods of time, or use occlusive bandages.

Do not apply the ointment to the breasts during breastfeeding; do not put the baby in contact with treated areas.

Driving and operating machinery

The treatment with Dermosa Hidrocortisona ointment does not affect the ability to drive or operate machinery.

Dermosa Hidrocortisona ointment contains lanolin

This medication may cause local skin reactions (such as contact dermatitis) because it contains lanolin.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

- Adults 12 years and older

Apply a thin layer of the cream to the affected area, two to four times a day, depending on the severity, with a gentle massage. When a favorable response is achieved, the frequency can be reduced to the minimum necessary.

Generally, the treatment duration should not exceed 2 weeks. If you use the medication on the face, the treatment should beasshort as possible.

Use inchildren

Apply a thin layer of the cream to the affected area two to three times a day.

In the case of atopic dermatitis in children, it is recommended to apply the cream twice a day for 7 days.

In children, the treatment should beasshort as possible, in short periods of time, and with the minimum effective amount of the product.

If you use more Dermosa Hydrocortisone than you should

The use of corticosteroid amounts greater than recommended increases the risk of adverse effects.

It is unlikely that an acute overdose will occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center, or call the Toxicological Information Service, phone 91 562 04 20 (indicating the medication and the amount ingested).

If you forgot to use Dermosa Hydrocortisone

Do not apply a double dose to compensate for the missed doses.

If you forget to apply the cream, apply the corresponding dose as soon as possible and continue with your regular schedule.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The appearance of adverse effects, local or in other areas of the body, is greater with excessive application or with occlusive dressings or materials.

The use of corticosteroids on the skin may cause the following adverse effects:

• Thinning of the skin (atrophy)
• Skin dryness
• Maceration
• Itching or burning

• Redness (erythema)
• Appearance of fine blood vessels under the skin surface (telangiectasias)
• Inflammation of hair follicles (folliculitis)
• Striae
• Bruises (ecchymoses)
• Acne
• Infections
• Hair loss
• Excessive hair growth
• Contact dermatitis
• Inflammation of the skin around the upper lip and chin (perioral dermatitis)
• Changes in skin color
• Delayed healing
• Unknown frequency (cannot be estimated from available data): Blurred vision.
• Adverse effects may occur not only in the treated area, but also in completely different areas of the body. This occurs if the active ingredient passes through the skin into the body. For example, this may increase eye pressure (glaucoma) or cause a condition characterized by a rounded face, fat accumulation, weakness, etc. (Cushing's syndrome); high blood pressure, cataracts.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es . By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

No requires special conditions for conservation.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

The shelf life after the first opening of the packaging is: 3 months.

Medications should not be thrown down the drains or in the trash.Deposit the containers and medications that you do not need in the SIGRE collection pointof the pharmacy.In case of doubt, ask your pharmacist how to dispose of the containers and medications that you do not need. In this way, you will help protect the environment.

Composition of Dermosa Hydrocortisone ointment

• The active ingredient is Hydrocortisone acetate. Each gram of ointment contains 10 mg of hydrocortisone acetate (1%).

-The other components are: lanolin and vaseline.

Appearance of the product and content of the packaging

Dermosa Hydrocortisone is presented in the form of a soft, homogeneous yellow-colored ointment.

Each aluminum tube contains 30 g of ointment.

Holder of the marketing authorization and responsible for manufacturing

Teofarma S.r.l.

Via F.lli Cervi, 8

27010 Valle Salimbene Pavia – Italy

Date of the last review ofthis leaflet:June 2016.

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.