SUNIDERMA 1.27 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Suniderma 1.27 mg/g Cream

Hydrocortisone aceponate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, 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. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

It contains hydrocortisone aceponate as the 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: cutaneous eruption due to allergy or substances that irritate the skin (allergic and irritative contact dermatitis), endogenous eruption related to patient factors (atopic dermatitis), eruption with inflammation and scaling (seborrheic dermatitis), itchy plaques on the skin caused by scratching (neurodermatitis), scaly red condition often covered by silver scales (psoriasis).

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

2. What you need to know before you use Suniderma cream

Do not use Suniderma cream

• If you are allergic to hydrocortisone aceponate or any of the other ingredients of this medicine (listed in section 6).
• on ulcers

Warnings and precautions

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

• Anti-inflammatory drugs (corticosteroids), like the active ingredient of this medicine, have significant effects on the body. Application to large areas of the body or for prolonged periods, especially under occlusive dressings, significantly increases the risk of side effects.
• If hypersensitivity or intolerance to treatment occurs, it should be discontinued and the doctor consulted.
• Due to the possibility of corticosteroid absorption, treatment in extensive areas or under occlusion may lead to effects reported with oral corticosteroid use, such as changes in glands near the kidneys, leading to symptoms like obesity, growth retardation in children, etc. (Cushing's syndrome).
• If you develop an infection during treatment with fungi or bacteria, for example, you should consult your doctor about your treatment, and if the infection spreads, treatment should be discontinued and appropriate therapy initiated.
• Do not apply to the eye or surrounding areas. If treatment is on the face, be careful not to get Suniderma in 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, for example) should not be performed unless the 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 treating psoriasis, strict medical supervision of your disease is recommended 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 medicine, consult your doctor; you may be experiencing an allergic reaction, have an infection, or your condition may require different treatment. If you experience a recurrence of your condition shortly after stopping treatment, within 2 weeks, do not reuse the cream 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 restarting treatment.

Children and adolescents

In children, it is more likely that the corticosteroid will pass into the body through the skin and have side effects in other areas of the body than 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 cream with other medicines

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

This medicine should not be used during pregnancy, unless the benefit to the mother justifies the potential risk to the fetus.

As a general rule, during the first trimester of pregnancy, Suniderma cream should not be applied.

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

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

Driving and using machines

Treatment with Suniderma does not affect the ability to drive or use machines.

Suniderma cream contains stearyl alcohol

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

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

Benzyl alcohol may cause allergic reactions and moderate local irritation.

3. How to use Suniderma cream

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

-Adults: Apply 1 or 2 times a day. A thin layer of cream should be applied directly to the affected area, with a gentle massage until completely absorbed.

Do not exceed application 2 times a day. An increase in the number of applications per day could worsen side effects without improving the therapeutic efficacy of the medicine.

When improvement occurs, the frequency of application can be reduced.

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

Use in children

The recommended dosage is 1 application per day.

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, steroid-free treatment periods should be interspersed.

Occlusive dressings (such as diapers) should be avoided in young children with the use of this medicine.

Topical use.

Gently press the tube and place a small sufficient amount on the hands for the area to be treated. Apply the cream in a thin layer, performing a gentle massage.

Wash your hands well and close the tube firmly after use.

If you use more Suniderma cream than you should

If you apply more Suniderma cream than you should (repeated overdoses), side effects may occur (see section 4).

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

In cases of chronic toxicity, it is advised that corticosteroids be withdrawn gradually. The treatment of overdose is symptomatic. The 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 medicine and the amount ingested.

If you forget to use Suniderma cream

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

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

If you stop using Suniderma cream

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

4. Possible side effects

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

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

Side effects that may occur:

• Thin skin (skin atrophy)
• Stretch marks on the skin
• Skin fragility
• Acne
• Dilation of small blood vessels under the skin (telangiectasias)
• Inflammation of hair follicles (folliculitis)
• Increased hair growth (hypertrichosis)
• Change in skin color
• Hypersensitivity reaction such as allergic contact dermatitis
• Easily bruised skin (easy bruising)
• Redness/irritation
• Secondary infection, including fungal infections
• Appearance of certain red bumps around the mouth (perioral dermatitis) or on the face (rosacea).
• Blurred vision (frequency "not known").

Side effects that affect 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 wound healing (such as leg ulcers), glaucoma, cataracts, etc. may occur.

Steroid withdrawal reaction:

If you use this medicine continuously for prolonged periods, you may experience a withdrawal reaction when stopping treatment, with symptoms such as redness of the skin that can extend beyond the initially treated area, burning sensation, intense itching, skin peeling, open sores that ooze.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 Suniderma cream

Do not store above 25°C.

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Suniderma cream

• The active ingredient is hydrocortisone aceponate. Each gram of cream contains 1.27 mg of hydrocortisone aceponate (0.127%).
• The other ingredients are: emulsifying wax, liquid vaseline, stearyl alcohol, benzyl alcohol, and purified water.

Appearance of the product and pack contents

Suniderma is a white cream.

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

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Laboratoires Bailleul, S.A.

14-16 Avenue Pasteur

L-2310 Luxembourg

LUXEMBOURG

Manufacturer:

Lichtenheldt GmbH Pharmazeutische Fabrik

Lichtenheldt GmbH – Werk I

Industriestrasse 7 – 11

23812 Wahlstedt

(Germany)

Date of last revision of this leaflet: August 2023

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.es