Package Insert: Information for the User

Suniderma 1.27 mg/g Cream

Hydrocortisone aceponate

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

It contains hydrocortisone aceponate as its active ingredient, which is a corticosteroid (anti-inflammatory), that when applied to the skin reduces redness, inflammation, and itching caused by certain skin problems.

Suniderma cream is indicated for skin conditions (dermatoses) that respond to treatment with corticosteroids, such as various types of eczema: skin rash due to allergy or substances that irritate the skin (allergic and irritant contact dermatitis), skin rash related to patient factors (atopic dermatitis), skin rash with inflammation and scaling (seborrheic dermatitis), itchy skin plaques caused by scratching (neurodermatitis), scaly, reddish skin condition often covered with silver scales (psoriasis).

Suniderma, in this pharmaceutical form, in cream, will be used particularly in acute and exudative forms (that secrete liquid).

Do not use Suniderma cream

• If you are allergic to hydrocortisone acetate or any of the other components of this medication (listed in section 6).
• If you have any viral infection (e.g., herpes or chickenpox), bacterial, or fungal infection (see "Warnings and precautions")
• If you have symptoms of tuberculosis or syphilis on the skin
• If you have had a reaction after applying any vaccine to the application area
• In ulcers
• If you have acne, rosacea (red or pink facial skin condition)or perioral dermatitis (certain red bumps around the mouth).

Warnings and precautions

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

• Anti-inflammatory drugs (corticosteroids), like the active ingredient in this medication, have significant effects on the body. Applying it to large areas of the body or for prolonged periods, especially under occlusive materials, significantly increases the risk of adverse effects.
• If hypersensitivity or intolerance to treatment occurs, discontinue and consult a doctor.
• Due to the possibility of corticosteroid absorption, treatment in extensive areas or under occlusion may lead to effects that have been reported with oral corticosteroid use, such as adrenal gland alteration, resulting in symptoms like obesity, growth retardation in children, etc. (Cushing's syndrome).
• If you develop an infection during treatment, such as fungal or bacterial, consult your doctor about treatment and discontinue treatment if the infection spreads.
• Do not apply to the eyes or areas close to the eyes. If treatment is on the face, be cautious to prevent Suniderma from coming into contact with the eyes, and treatment should be as short as possible.
• Do not apply to open wounds.
• Do not apply to mucous membranes (e.g., the nose or mouth).
• Treatment under occlusion (with bandages, etc.) should not be done unless a doctor indicates it and under their control. Note that diapers and skin folds, such as the groin or armpits, can produce occlusive conditions.
• If treating psoriasis, a strict medical supervision of your condition is recommended to observe any possible worsening.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• Note a worsening of your condition during use of this medication, consult your doctor; you may be experiencing an allergic reaction, have an infection, or your condition may require a different treatment. If you experience a recurrence of your condition shortly after discontinuing treatment, within 2 weeks, do not use the cream again without consulting your doctor, unless your doctor has previously indicated it. If your condition has resolved and, in case of recurrence, the redness extends beyond the initial treatment area and you experience a burning sensation, consult a doctor before reinitiating treatment.

Children and adolescents

In children, it is morelikely that the corticosteroid will pass through the skin and have adverse effects in other areas of the bodythan in adult patients.

It is preferable to avoid the use of corticosteroids in children and pay special attention to occlusions such as those produced by diapers.

Use of Suniderma cream with other medications

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

Pregnancy, breastfeeding, and fertility

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

This medicationshould not be used during pregnancy,except if the benefit to the mother justifies the potential risk to the fetus.

As a general rule, duringthe first trimester of pregnancydo not applySuniderma cream.

Pregnant women or those planning to become pregnant should not apply it to large areas of the skin, or for prolonged periods, or use occlusive dressings.

If you are breastfeeding, inform your doctor before using Suniderma cream. If you use it during breastfeeding, do not apply the cream to the breast area.

Driving and operating machinery

Treatment with Suniderma does not affect the ability to drive or operate machinery.

Suniderma cream contains alcohol estearílico

This medicationmay cause local skin reactions (such as contact dermatitis) because it containsalcohol estearílico.

Suniderma cream contains 22 mg of benzyl alcohol per gram of cream.

Benzyl alcohol may cause allergic reactions and moderate local irritation.

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

-Adults: Apply 1 or 2 times a day. Apply a thin layer of cream directly to the affected area, massaging it in until fully absorbed.

Do not exceed 2 applications per day. Increasing the number of daily applications may worsen side effects without improving the therapeutic efficacy of the medication.

When improvement occurs, the application frequency may be reduced.

If the doctor considers it necessary, in chronic conditions, treatment may be prolonged for 2 weeks. Treatment should be intermittent (e.g., once a day, twice a week), with medical follow-up.

Use in children

The recommended dosage is 1 daily application.

Continuous use in children should not exceed 1 week, and the minimum effective amount of the product should be applied.

If the doctor considers it necessary to use for a prolonged period, treatment-free periods should be interposed.

Adhesive dressings (such as diapers) should be avoided in young children when using this medication.

Skin use.

Gently press the tube and apply a small amount to the hands sufficient for the area to be treated.Apply the cream in a thin layer, massaging it in.

Wash hands thoroughly and tightly close the tube after use.

If you use more Suniderma cream than you should

If you apply more than the recommended amount ofSunidermacream (repeated overdoses), you may experience side effects (see section4).

If you use the cream more frequently than you should or on large areas of the skin, it may be absorbed into the body and cause various disorders.

In cases of chronic toxicity, corticosteroids should be withdrawn gradually. The treatment of overdose is symptomatic. Acute symptoms of excessive corticosteroid use are generally reversible.

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 forgot to use Suniderma cream

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

If you forgot to apply the cream, apply the corresponding dose when you remember, and continue treatment as usual.

If you interrupt treatment with Suniderma cream

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

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

The use of corticosteroids for prolonged periods and/or in extensive areas or with dressings or occlusive materials can produce adverse effects not only in the application area but also in other areas of the body.

Adverse effects that can occur:

- Skin atrophy (thinning of the skin thickness)

- Striae in the skin

- Skin fragility

- Acne

- Dilations of small superficial blood vessels under the skin (telangiectasias)

- Inflammation of hair follicles (folliculitis)

- Increased hair growth (hypertrichosis)

- Change in skin color

- Hypersensitivity reaction such as contact allergic dermatitis

- Easy bruising (ecchymoses)

- Redness/irritation

- Secondary infection, including fungal infections

- Appearance of certain red grains around the mouth (perioral dermatitis) or on the rest of the face (rosacea).

- Blurred vision (frequency "unknown").

Adverse effects that affect other parts of the body are:

Itmay cause a condition characterized by a rounded face, obesity, accumulation of fat in the cervical area (Cushing's syndrome), delayed healing (such as leg wounds and ulcers), glaucoma, cataracts, etc.

Withdrawal reaction to steroids:

If you use this medication continuously for prolonged periods, you may experience a withdrawal reaction when stopping treatment with some of the following symptoms: redness of the skin that may extend beyond the initially treated area, burning or stinging sensation, intense itching, skin peeling, open sores that suppurate.

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 on the safety of this medication.

Do not store at a temperature above25ºC.

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.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Suniderma cream

- The active ingredient is hydrocortisone aceponate. Each g of cream contains 1.27 mg of hydrocortisone aceponate (0.127%).

- The other components are: emulsifying wax, petrolatum, stearic alcohol, benzyl alcohol, and purified water.

Appearance of the product and contents of the packaging

Suniderma is a white cream.

It is presented in tubes containing 30 g and 60 g.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratoires Bailleul, S.A.

14-16 Avenue Pasteur

L-2310 Luxembourg

LUXEMBOURG

Responsible for manufacturing:

Lichtenheldt GmbH Pharmaceutical Factory

Lichtenheldt GmbH – Werk I

Industriestrasse 7 – 11

23812 Wahlstedt

(Germany)

Last review date of this leaflet: August 2023

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