Dermosa Hydrocortisone 10 mg/g ointment

2. What you need to know before starting to use Dermosa Hydrocortisone Ointment

Do not use Dermosa Hydrocortisone:

• 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 (such as chickenpox or herpes).
• on areas of skin affected by red/pink inflammation on the face (rosacea), on ulcers, acne, or diseases with skin thinning (atrophy)
• on skin inflammation around the mouth (perioral dermatitis)
• on areas of skin showing a vaccination reaction, i.e., redness or inflammation after vaccination
• in the eyes or on open wounds
• on skin infections caused by bacteria or fungi (see "Warnings and Precautions").

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Dermosa Hydrocortisone Ointment.

• This medication should be used in the lowest possible dose, especially in children, and only for the shortest necessary time to relieve the skin condition.
• Corticosteroids have significant effects on the body. They should not be used on large areas of the body or for long periods, as this significantly increases the risk of side effects.
• If you also develop a bacterial or fungal infection, you should consult your doctor about treatment. Corticosteroid medications can hide, trigger, or worsen a skin infection.
• You should avoid contact with the eyes, open wounds, or mucous membranes (such as the mouth). If the medication comes into contact with these areas, wash with plenty of water.
• This medication should not be applied to skin folds, such as the groin or armpits.
• This medication should not be used under occlusive materials, such as bandages, unless under medical supervision. Diapers can act as occlusive dressings.
• If you are being treated for psoriasis, medical supervision is recommended.
• If you use Dermosa Hydrocortisone Ointment for conditions other than those for which it was prescribed, you may mask symptoms and make diagnosis and correct treatment more difficult.
• 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 and the minimum effective amount. In children, special caution is required, and in adolescents during the growth period, as it is more likely that the corticosteroid will pass into the body through the skin and have side effects in other areas of the body. Note that diapers can be occlusive and may increase absorption.

Other Medications and Dermosa Hydrocortisone

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medication.

No interactions are known at present.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medication.

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

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

If your doctor prescribes Dermosa Hydrocortisone Ointment during pregnancy or breastfeeding, you should not use it on large areas of your body, or for long periods, or use occlusive dressings.

Do not apply the ointment to the breasts during breastfeeding; do not let the child come into contact with treated areas.

Driving and Using Machines

Treatment with Dermosa Hydrocortisone Ointment does not affect the ability to drive or use machines.

Dermosa Hydrocortisone Ointment contains Lanolin

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

3. How to use Dermosa Hydrocortisone Ointment

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is:

• Adults from 12 years

Apply a thin layer of the ointment to the affected area, 2 to 4 times a day, depending on the severity, with gentle massage. When a favorable response is achieved, the frequency can be reduced to the minimum necessary.

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

Use inChildren

Apply a thin layer of the ointment to the affected area, 2 to 3 times a day.

In case of atopic dermatitis in children, application twice a day for 7 days is recommended.

In children, treatment should be as short as possible, for short periods, and with the minimum effective amount of the product.

If you use more Dermosa Hydrocortisone than you should

Using higher amounts of corticosteroids than recommended increases the risk of side effects.

Acute overdose is unlikely.

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

If you forget to use Dermosa Hydrocortisone

Do not apply a double dose to make up for forgotten doses.

If you forget to apply the ointment, apply the corresponding dose as soon as possible and continue with the usual schedule.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The appearance of side 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 can cause the following side effects:

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

• Redness (erythema)
• Appearance of fine blood vessels under the skin surface (telangiectasias)
• Inflammation of the hair follicles (folliculitis)
• Stretch marks
• Bruises (bruises)
• Acne
• Infections
• Hair loss
• Increased hair growth
• Allergic skin reaction (contact dermatitis)
• Inflammation of the skin around the upper lip and chin (perioral dermatitis)
• Changes in skin color
• Delayed wound healing
• Frequent unknown (cannot be estimated from available data): Blurred vision.
• Side effects can occur not only in the treated area but also in completely different areas of the body. This occurs if the active ingredient passes into the body through the skin. For example, it can increase pressure in the eye (glaucoma) or produce a condition characterized by a rounded face, fat accumulation, weakness, etc. (Cushing's syndrome); increased blood pressure (hypertension), cataracts.

Reporting Side Effects

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

5. Storage of Dermosa Hydrocortisone Ointment

No special storage conditions are required.

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

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

The validity period after the first opening of the package is: 3 months.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dermosa Hydrocortisone Ointment

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

• The other ingredients are: lanolin and petroleum jelly.

Appearance of the Product and Package Contents

Dermosa Hydrocortisone is presented as an ointment, which is soft, homogeneous, and yellow in color.

Each aluminum tube contains 30 g of ointment.

Marketing Authorization Holder and Manufacturer

Teofarma S.r.l.

Via F.lli Cervi, 8

27010 Valle Salimbene Pavia – Italy

Date of the Last Revision ofthis Package Leaflet:June 2016.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.