Dermosa hydrocortisone 10 mg/g ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dermosa Hydrocortisone 10 mg/g ointment

Hydrocortisone acetate

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

It contains hydrocortisone acetate as the active substance, a corticosteroid (anti-inflammatory), which is applied to the skin to reduce inflammation in certain skin conditions. It reduces redness (erythema), fluid accumulation (edema), and exudate in inflamed skin, and relieves itching, burning, or pain.

Dermosa Hydrocortisone Ointment is indicated for: Local treatment of inflammatory and itchy manifestations of skin diseases that respond to corticosteroids, such as:

• Acute forms of mild to moderate eczema related to an external cause, such as:

• Allergy to a substance that has come into contact with the skin (allergic contact dermatitis).

• Allergic reaction to substances commonly used, for example, soap (irritant contact dermatitis).

• Unspecified eczema (venous eczema).

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

• Skin rash with inflammation and scaling (seborrheic eczema).

Assistance in the treatment of psoriasis (reddish scaly condition frequently covered by silvery scales).

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

Do not use Dermosa Hydrocortisone:

• if you are allergic to hydrocortisone or to any of the other ingredients of this medicine (listed in section 6).
• if you have tuberculosis, syphilis, or viral infections (e.g., chickenpox or herpes).
• on areas of skin affected by facial redness/rosacea, ulcers, acne, or skin conditions involving skin thinning (atrophy).
• on areas of skin affected by perioral dermatitis (inflammation around the mouth).
• on areas of skin showing a vaccine reaction, such as redness or swelling after vaccination.
• in the eyes or on open wounds.
• for skin infections caused by bacteria or fungi (see "Warnings and precautions").

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Dermosa Hydrocortisone ointment.

• This medicine should be used at the lowest possible dose, especially in children, and only for the minimum time necessary to relieve the skin condition.
• Corticosteroid anti-inflammatory medicines have significant effects on the body. They should not be used over large areas of the body or for prolonged periods, as this greatly increases the risk of adverse effects.
• If you develop a bacterial or fungal skin infection, consult your doctor regarding treatment. Corticosteroid medicines may mask, trigger, or worsen skin infections.
• Avoid contact with the eyes, open wounds, or mucous membranes (e.g., mouth). If the medicine comes into contact with these areas, rinse thoroughly with plenty of water.
• Do not apply this medicine to skin folds, such as the groin or armpits.
• Do not use this medicine under occlusive materials such as bandages, unless under medical supervision. Diapers may act as occlusive dressings.
• If you are being treated for psoriasis, close medical supervision is recommended.
• If you use Dermosa Hydrocortisone ointment for conditions other than those for which it was prescribed, it may mask symptoms and interfere with correct diagnosis and treatment.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

In children, the use of corticosteroids on the skin should be limited to short periods and the smallest effective amount. Special caution is required in children and adolescents during growth periods, as corticosteroids are more likely to be absorbed through the skin and may cause adverse effects elsewhere in the body. Note that diapers may be occlusive and may increase absorption.

Other medicines and Dermosa Hydrocortisone

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

No interactions are currently known.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Do not use Dermosa Hydrocortisone ointment during pregnancy or breastfeeding unless your doctor considers it necessary.

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

If your doctor prescribes Dermosa Hydrocortisone ointment during pregnancy or breastfeeding, do not use it over large areas of the body, for prolonged periods, or with occlusive dressings.

Do not apply the ointment to the breasts during breastfeeding; avoid contact between the treated areas and the infant.

Driving and using machines

Treatment with Dermosa Hydrocortisone ointment does not affect the ability to drive or operate machinery.

Dermosa Hydrocortisone ointment contains lanolin

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

3. How to use Dermosa Hydrocortisone ointment

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

• Adults from 12 years of age

Apply a thin layer of the ointment to the affected area two to four times a day, depending on severity, with gentle massage. Once a favorable response has been achieved, the frequency may be reduced to the minimum necessary.

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

Use in children

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

In cases of atopic dermatitis in children, application twice daily for 7 days is recommended.

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

If you use more Dermosa Hydrocortisone than you should

Using larger amounts of corticosteroids than recommended increases the risk of adverse effects.

Acute overdose is unlikely.

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

If you forget to use Dermosa Hydrocortisone

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

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The occurrence of adverse effects, either at the application site or in other parts of the body, is higher with excessive application or when occlusive dressings or materials are used.

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

• Thinning of the skin (atrophy)

• Dry skin

• Maceration

• Itching or burning sensation

• Redness (erythema)

• Appearance of fine blood vessels under the skin surface (telangiectasias)

• Inflammation of hair follicles (folliculitis)

• Skin stretch marks (striae)

• Bruising (contusions)

• Acne

• Infections

• Hair loss

• Increased hair growth

• Allergic skin reaction (contact dermatitis)

• Specific skin inflammation around the upper lip and chin (perioral dermatitis)

• Changes in skin color

• Delayed wound healing

• Frequency not known (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 may happen if the active substance passes through the skin into the body. For example, this could increase eye pressure (glaucoma) or cause a condition characterized by a rounded face, fat accumulation, weakness, etc. (Cushing's syndrome); increased blood pressure (hypertension), cataracts.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dermosa Hydrocortisone Ointment

No special storage conditions are required.

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dermosa Hydrocortisone ointment

• The active substance 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 contents of the container

Dermosa Hydrocortisone is presented as a soft, homogeneous yellow ointment.

Each aluminium tube contains 30 g of ointment.

Marketing Authorisation Holder and Manufacturer

Teofarma S.r.l.

Via F.lli Cervi, 8

27010 Valle Salimbene Pavia – Italy

Date of the most recent revision of this leaflet: June 2016.

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