Label: information for the user

Suniderma 1.27 mg/g ointment

Hydrocortisone aceponate

Read this label carefully before starting to use the medication, as it contains important information for you.

• Keep this label, 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 label. 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 ointment 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 ointment, will be used particularly in thick and dry forms.

Do not use Suniderma ointment

• 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 (for example, 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 to any vaccine after applying it
• On ulcers
• If you have acne, rosacea (red or pink skin condition on the face)or perioral dermatitis (certain red bumps around the mouth).

Warnings and precautions

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

• 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 you experience hypersensitivity or intolerance to the treatment, discontinue it and consult your doctor.
• Due to the possibility of corticosteroid absorption, treatment on extensive areas or under occlusion may lead to effects that have been reported with oral corticosteroid use, such as adrenal suppression, obesity, growth retardation in children, etc. (Cushing's syndrome).
• If you develop an infection during treatment, such as a fungal or bacterial infection, consult your doctor about your treatment and discontinue the treatment if the infection spreads.
• Do not apply to the eyes or areas close to the eyes. If treatment is on the face, be careful 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 your doctor indicates it and under their control. Note that diapers as well as skin folds, such as the groin or armpits, can produce occlusive conditions.
• If you are being treated for psoriasis, it is recommended to have strict medical supervision of your condition to observe any possible worsening.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• If you notice a worsening of your condition during the 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 stopping treatment, within 2 weeks, do not use the ointment 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.

Using Suniderma ointment 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 plan to become pregnant, consult your doctor before using this medication.

This medication should 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 pregnancySuniderma ointmentshould not be applied.

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 ointment. If you use it during breastfeeding, do not apply the ointment to the breast area.

Driving and operating machinery

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

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 ointment directly to the affected area, performing a gentle massage until complete absorption.

Do not exceed the application of 2 times a day. An increase in the number of daily applications may worsen the adverse 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 more than 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 place a small amount sufficient for the area to be treated on the hands.Apply the ointment in a thin layer, performing a gentle massage.

Wash hands well and tightly close the tube after use.

If you use more Suniderma ointment than you should

If you apply more than the recommended amount ofSunidermaointment (repeated overdoses), adverse effects may occur (see section4).

If you use the ointment 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, it is recommended that corticosteroids 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Suniderma ointment

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

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

If you interrupt treatment with Suniderma ointment

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

Like all medications, this medication may 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 may produce adverse effects not only in the application area but also in other parts of the body.

Adverse effects that may occur:

- Skin atrophy (thinning of skin thickness)

- Striae in the skin

- Skin fragility

- Acne

-Dilatations 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

- Ease of bruising (bruises)

- Redness/irritation

- Secondary infection, including fungal infections

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

- Blurred vision (frequency "unknown").

Adverse effects affecting other parts of the body are:

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. may occur.

Withdrawal reaction to steroids:

If you use this medication continuously for prolonged periods, a withdrawal reaction may occur when treatment is stopped, with 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 disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Suniderma ointment

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

- The other components are: aluminium distearate, Protegin WX*, Dub BW**, magnesium heptahydrate sulphate, petrolatum, liquid petrolatum and purified water.

*composition ofProtegin WX: petrolatum, ozokerite, hydrogenated ricin oil, isoestearate of glycerol and poliglycerol oleate

**composition ofDub BW: glycerol stearate, cetyl palmitate and wax

Appearance of the product and contents of the packaging

Suniderma is a white ointment.

It is presented in tubes containing 30 g and 50 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 for Medicines and Medical Devices (AEMPS) http://www.aemps.es