NUTRASONA 1 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Nutrasona 1mg/g cream

Hydrocortisone buteprate

Read the package leaflet carefully before starting to use the medicine.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, consult your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

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Contents of the Package Leaflet

1. What Nutrasona cream is and what it is used for
2. What you need to know before using Nutrasona cream
3. How to use Nutrasona cream
4. Possible side effects
5. Storage of Nutrasona cream
6. Contents of the pack and further information.

1. What Nutrasona cream is and what it is used for

Nutrasona cream is an anti-inflammatory medicine (a corticosteroid) for use on the skin.

Nutrasona cream reduces inflammation and allergic reactions of the skin, and reactions with excessive cell multiplication (hyperproliferation). Therefore, it reduces redness (erythema), fluid accumulation (edema), and exudate on the inflamed skin. It also relieves itching, burning, or pain.

Nutrasona cream is used to treat acute forms of:

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

• • Allergic reaction to a substance that has come into contact with the skin (allergic contact dermatitis).
  • Irritant reaction to substances of habitual use, such as soap (irritant contact dermatitis).
  • Itchy rash on hands and feet (dyshidrotic eczema).
  • Unspecified eczema (atopic eczema).
• Eczema related to patient factors (endogenous eczema), such as atopic dermatitis or neurodermatitis.
• Skin rash with inflammation and scaling (seborrheic eczema).
• Psoriasis.

2. What you need to know before using Nutrasona cream

Do not use Nutrasona cream

• If you are allergic to hydrocortisone buteprate or any of the other ingredients of this medicine listed in section 6.
• If you have tuberculosis, syphilis, or viral infections (such as chickenpox or herpes).
• In areas of skin affected by red/pink inflammation (rosacea), ulcers, inflammation of the sebaceous glands (acne), or skin diseases with skin thinning (atrophy).
• In areas of skin showing a vaccination reaction, i.e., redness or inflammation after vaccination.
• In specific skin inflammation around the upper lip and chin (perioral dermatitis).
• In bacterial or fungal infections (unless also treated with specific treatment).
• In the eyes, on mucous membranes (e.g., in the mouth), or on open wounds.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Nutrasona cream.

Be careful with Nutrasona cream

If your doctor diagnoses a bacterial or fungal infection, you should also use the additional prescribed treatment for the infection, as the infection may worsen if not treated.

Anti-inflammatory drugs (corticosteroids), such as the active ingredient hydrocortisone buteprate, have significant effects on the body. It is not recommended to use Nutrasona cream on large areas of skin or for prolonged periods, as this significantly increases the risk of side effects.

To reduce the risk of side effects:

• Use the minimum dose possible, especially in children.
• In children under 2 years, this medicine should not be used, and caution is required in children and adolescents, as they are more likely to have the corticosteroid pass through the skin and have side effects in other areas of the body, such as a syndrome characterized by obesity and increased pressure in the head.
• Use it only for the time strictly necessary to relieve the skin condition.
• Nutrasona cream should not come into contact with the eyes, mouth, open wounds, or mucous membranes (e.g., anal or genital area).
• Nutrasona cream should not be used on large areas of skin.
• If you have circulatory problems, do not apply medications with corticosteroids, as the area may become ulcerated.
• Nutrasona cream should not be used under impermeable materials to air and water, including bandages, dressings, clothing, or diapers, which are not very breathable.
• If you are being treated for psoriasis, your doctor should frequently monitor your disease to observe any possible worsening.
• If you use Nutrasona cream for conditions other than those for which it has been prescribed, it may mask symptoms and make diagnosis and correct treatment more difficult.

Other Medicines and Nutrasona Cream

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

No interactions of Nutrasona cream with other medicines are known at present.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

In particular, application to large areas, prolonged use, or use with occlusive dressings should be avoided during pregnancy, if you plan to become pregnant, and during breastfeeding.

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

Driving and Using Machines

Nutrasona cream does not affect your ability to drive or use machines.

Nutrasona Cream Contains Alcohol Stearic, Propylene Glycol, Methyl Parahydroxybenzoate, and Polysorbate 60.

This medicine contains alcohol stearic, which may cause local skin reactions (such as contact dermatitis).

This medicine contains 120 mg of propylene glycol per gram of cream. Propylene glycol may cause skin irritation.

This medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).

This medicine contains polysorbate 60, which may cause allergic reactions.

3. How to Use Nutrasona Cream

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

The recommended dose is:

Adults

Apply Nutrasona cream in a thin layer, one to four times a day, to the affected area, rubbing gently.

Generally, the duration of treatment should not exceed two weeks. If you use Nutrasona cream for a condition on the face, do not treat for more than one week. Always make the treatment as short as possible.

Use in Children

• Children over 2 years:
  • Apply Nutrasona cream in a thin layer, one to two times a day, to the affected area, rubbing gently.
  • In children, the duration of treatment should be as short as possible, in short periods of time, and the minimum amount of product possible.

• Nutrasona cream should not be used in children under 2 years due to lack of experience and lack of established dosage for this age group.

If You Use More Nutrasona Cream Than You Should

No risk is expected after a single overdose of Nutrasona cream. Repeated overdoses may produce side effects (see section 4. Possible Side Effects).

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 medicine and the amount ingested).

If You Forget to Use Nutrasona Cream

Do not use a double dose to make up for forgotten doses; if you have forgotten a dose, continue with your usual schedule as instructed by your doctor or as described in the package leaflet.

If You Stop Using Nutrasona Cream

The original symptoms of your skin problem may reappear. Please contact your doctor before stopping treatment.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects are more likely to occur if anti-inflammatory drugs (corticosteroids) are used on large areas, for prolonged application, with occlusive dressings, or in children.

The use of corticosteroids on the skin can lead to the following side effects:

• Thinning of the skin (atrophy)
• Dry or cracked skin
• Itching
• Redness (erythema)
• Appearance of red spots
• Inflammation of the hair follicle (folliculitis)
• Stretch marks
• Acne
• Bruises
• Infections
• Delayed wound healing
• Specific skin inflammation around the upper lip and chin (perioral dermatitis).
• Allergic skin reaction (contact dermatitis)
• Changes in skin color
• Increased hair growth
• Hair loss
• Side effects can occur not only in the treated area but also in completely different areas of the body. This happens if the active ingredient (a corticosteroid) passes through the skin into the body. This, for example, can increase eye pressure (glaucoma) or can cause increased blood pressure, fluid retention, hyperglycemia, hyperthyroidism, increased cholesterol, osteoporosis.

Frequency not known (cannot be estimated from the available data). Blurred vision

Reporting of Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Nutrasona Cream

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

No special storage conditions are required.

Do not use Nutrasona cream after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of packaging and unused medicines. This will help protect the environment.

6. Contents and Further Information

Composition of Nutrasona 1 mg/g cream:

• The active ingredient is Hydrocortisone buteprate.

Each gram of cream contains 1 mg (0.1%) of hydrocortisone buteprate.

• The other ingredients (excipients) are: alcohol stearic, liquid vaseline, anhydrous lanolin, polysorbate 60 (E 435), sorbitan monoesterate (E-491), monoesterate of glycerin, propylene glycol (E-1520), methyl parahydroxybenzoate (E 218), butylparaben, citric acid (E-330), and purified water.

Appearance of the Product and Packaging Contents

Nutrasona 1 mg/g cream is a homogeneous white cream and is presented in 30 and 60 g tubes.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Isdin, S.A.

Provençals 33

08019 Barcelona

Spain

Manufacturer:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Date of Last Revision of this Package Leaflet:June 2025

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