SUNIDERMA 1.27 mg/g OINTMENT

Introduction

Package Leaflet: Information for the User

Suniderma 1.27 mg/g Ointment

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 pack

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

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

It contains the active ingredient hydrocortisone aceponate, 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: cutaneous eruption due to allergy or substances that irritate the skin (allergic and irritant 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 with silver scales (psoriasis).

Suniderma, in this pharmaceutical form, in ointment, will be used particularly in thick and dry forms.

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

Do not use Suniderma ointment

• 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 ointment.

• 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 materials, 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 located 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 ointment 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 ointment 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 plan to become pregnant, consult your doctor before using this medicine.

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

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

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

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

Driving and using machines

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

3. How to use Suniderma ointment

Follow exactly the administration instructions of this medicine indicated 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 ointment should be applied directly to the affected area, performing 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 small children with the use of this medicine.

Topical use.

Press the tube gently and place a small amount sufficient for the area to be treated on your hands. Apply the ointment in a thin layer, performing a gentle massage.

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

If you use more Suniderma ointment than you should

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

If you use the ointment more frequently than you should or on large areas of the skin, it can be absorbed and pass into the body, causing 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 ointment

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

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

If you stop using Suniderma ointment

If you have any other questions about 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 large areas or with occlusive dressings or materials may produce side effects not only in the area of application but also in other areas 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
• Easy bruising (bruises)
• Redness/irritation
• Secondary infection, including fungal infections
• Appearance of certain red bumps around the mouth (perioral dermatitis) or on the rest of 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 or itching, intense itching, skin peeling, open sores that ooze.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is 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. Storing Suniderma ointment

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 other information

Composition of Suniderma ointment

• The active ingredient is hydrocortisone aceponate. Each gram of ointment contains 1.27 mg of hydrocortisone aceponate (0.127%).
• The other ingredients are: aluminum distearate, Protegin WX*, Dub BW**, magnesium sulfate heptahydrate, petrolatum, liquid petrolatum, and purified water.

• Composition of Protegin WX: petrolatum, ozokerite, hydrogenated ricinoleic acid, glycerol isooleate, and polyglyceryl oleate

* Composition of Dub BW: glycerol stearate, cetyl palmitate, and wax

Appearance and packaging

Suniderma is a white ointment.

It is available in tubes containing 30 g and 50 g.

Marketing authorization holder and manufacturer

Marketing authorization 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