Prospecto: information for the user

Nutrasona 1mg/g cream

Hydrocortisone butyrate

Read the entire prospect carefully before starting to use the medication.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribed to you and should not be given to other people, even if they have the same symptoms, as it may harm them.

-If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this prospect, inform your doctor or pharmacist.

1. What isNutrasonacreamand for what it is used

2. Before using Nutrasonacream

3. How to useNutrasona cream

4. Possible adverse effects

5. Storage ofNutrasona cream

6. Additional information.

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

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

Nutrasonacreamis used in the treatment of acute forms of:

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

• • Allergic contact dermatitis due to a substance that has come into contact with the skin.
  • Irritant contact dermatitis due to substances commonly used, such as soap.
  • Itchy eruption on hands and feet (eczema dishidrotic).
  • Unspecified eczema (eczema vulgar).
• Eczema related to patient factors (endogenous eczema), such as atopic dermatitis or neurodermatitis.
• Eczema with inflammation and scaling on the skin (seborrheic eczema).
• Psoriasis.

Do not use Nutrasona cream

• If you are allergic (hypersensitive) to the active ingredient hydrocortisone buteprate or to any of the other components ofNutrasonacream (see also section 6. Additional information).
• If you have tuberculosis, syphilis, or viral infections (for example, chickenpox or herpes).
• In areas of skin affected by redness (rosacea), ulcers, inflammation of the sebaceous glands (acne), or skin diseases with skin thinning (atrophy).
• In areas of skin showing a vaccination reaction, that is, redness or inflammation after the vaccine.
• In specific inflammation of the skin around the upper lip and chin (perioral dermatitis).
• In bacterial or fungal infections (unless treated additionally with a specific treatment).
• In the eyes, in mucous membranes (for example, in the mouth) or in open wounds.

Be especially careful with Nutrasona cream

If your doctor diagnoses in addition a bacterial or fungal infection; then, you must also use the additional treatment prescribed for the infection, because if not, the infection may worsen.

Corticosteroids, such as the active ingredienthydrocortisone buteprate, have significant effects on the body. It is not recommended to use Nutrasona cream in extensive areas of the skin or for prolonged periods, because this significantly increases the risk of adverse effects.

To reduce the risk of adverse effects:

• Use it at the lowest possible dose, especially in children.
• Do not use this medication in children under 2 years and exercise caution in children and adolescents, because they have a higher probability of the corticosteroid passing through the skin and having adverse effects in other parts of the body, such as a syndrome characterized, among other symptoms, by obesity and increased pressure in the head.
• Use it only for the strictly necessary time to alleviate the skin condition.
• Nutrasonacreammust not come into contact with the eyes, mouth, open wounds, or mucous membranes (for example, the anal or genital area).
• Do not useNutrasonacreamin extensive areas of skin.
• Do not applyNutrasonacreamif you have circulatory problems, as it could ulcerate the area.
• Do not useNutrasonacreamunder impermeable materials to air and water, including bandages, dressings, clothing, or diapers, that are poorly breathable.
• If you are being treated for psoriasis, your doctor should frequently monitor your condition to observe any possible worsening.
• If you use Nutrasonacreamfor diseases other than those for which it has been prescribed, it may mask symptoms and make it difficult to diagnose and treat correctly.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

No interactions of Nutrasona cream with other medications are known at this time.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

In particular, avoid applying it to extensive areas, using it for prolonged periods, or with occlusive dressing during pregnancy, in case of planning to become pregnant, and during breastfeeding.

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

Driving and operating machinery

Nutrasona cream does not affect your ability to drive or operate machinery.

Important information about some of the components of Nutrasona cream

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

This medication contains 120 mg of propylene glycol equivalent to2.56 mg/kg. Propylene glycol may cause skin irritation.

This medication may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate.

Follow exactly the administration instructions for Nutrasona cream as indicated by your doctor. Consult your doctor if you have any doubts.

The normal dose is:

Adults

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

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

Use in children

- Children over two years old:

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

- Do not use Nutrasona cream in children under 2 years old, due to lack of experience and because the dosage has not been established for this age group.

If you use moreNutrasona creamthan you should

No adverse effects are expected after a single overdose of Nutrasona cream. Repeated overdoses may cause side effects (see section 4. Possible adverse effects).

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 useNutrasona cream

Do not use a double dose to compensate for the missed dose; if you forgot a dose, continue with your regular schedule as instructed by your doctor or as described in the prospectus.

If you interrupt the treatment withNutrasona cream

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

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

Like all medications, Nutrasona cream may produce adverse effects, although not all people will experience them.

It is more likely that adverse effects will occur if anti-inflammatory medications (corticosteroids) are used in large areas, for prolonged periods, with bandages or occlusive materials, and in children.

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

• Skin thinning (atrophy)
• Dry or cracked skin
• Itching
• Redness (erythema)
• Appearance of red spots
• Folliculitis (inflammation of hair follicles)
• Stretch marks
• Acne
• Bruises
• Infections
• Delayed wound healing
• Specific skin inflammation around the upper lip and chin (perioral dermatitis).
• Contact dermatitis (skin allergic reaction)
• Changes in skin color
• Excessive hair growth
• Hair loss
• 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 (a corticosteroid) passes into the body through the skin. This, for example, may increase eye pressure (glaucoma) or may cause increased blood pressure, fluid retention, hyperglycemia, hyperthyroidism, increased cholesterol, osteoporosis.

Unknown frequency (cannot be estimated from available data). Blurred vision

.

Reporting Adverse Effects

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

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

No special storage conditions are required.

Do not use Nutrasona cream after the expiration date shown on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Nutrasona 1 mg/g cream:

• The active ingredient is Hydrocortisone butyrate.

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

• The other components (excipients) are: stearic acid alcohol, liquid petrolatum, petrolatum, polisorbate 60, sorbitan monostearate, monostearate of glycerin, propylene glycol, methylparaben, butylparaben, citric acid, and deionized water.

Appearance of the product and contents of the package

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Isdin, S.A.

Provençals 33

08019 Barcelona

Spain

Responsible for manufacturing:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Last review date of this prospectus:September 2023

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