Suniderma 1.27 mg/g ointment

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Suniderma 1.27 mg/g ointment

Hydrocortisone aceponate

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Leaflet contents

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

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

The active substance is hydrocortisone aceponate, a corticosteroid (anti-inflammatory) which, when applied to the skin, reduces redness, inflammation, and itching caused by certain skin conditions.

Suniderma ointment is indicated for skin disorders (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), endogenous rash related to patient factors (atopic dermatitis), rash with inflammation and scaling (seborrheic dermatitis), itchy skin plaques caused by scratching (neurodermatitis), scaly reddish lesions often covered with silvery scales (psoriasis).

Suniderma, in this pharmaceutical form as an ointment, is particularly suitable for thick and dry skin conditions.

2. What you need to know before using Suniderma ointment

Do not use Suniderma ointment

• If you are allergic to hydrocortisone aceponate or to any of the other ingredients of this medicine (listed in section 6).
• if you have a viral (e.g., herpes or chickenpox), bacterial, or fungal infection (see section "Warnings and precautions")
• if you have symptoms of tuberculosis or syphilis affecting the skin
• if you have developed a reaction at the application site after receiving any vaccine
• in ulcers
• if you have acne, rosacea (a red/rosy skin condition of 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.

• Anti-inflammatory drugs (corticosteroids), such as the active ingredient in this medicine, have significant effects on the body. Application over 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, treatment must be discontinued and you should consult your doctor.
• Due to the potential for absorption of the corticosteroid, treatment over extensive areas or under occlusion may lead to effects reported with oral corticosteroid use, for example, disturbances of glands located near the kidneys leading to symptoms such as obesity, growth retardation in children, etc. (Cushing's syndrome).
• If you develop a fungal or bacterial infection during treatment, consult your doctor about your treatment; if the infection spreads, treatment should be discontinued and appropriate therapy initiated.
• Do not apply in ocular therapy or in areas near the eyes. If treatment is on the face, take care to avoid contact of Suniderma with the eyes, and treatment should be as short as possible.
• Do not apply on open wounds.
• Do not apply on mucous membranes (e.g., nose or mouth).
• Occlusive treatment (e.g., with bandages) should not be performed unless directed and supervised by your doctor. Note that diapers as well as skin folds such as in the groin or armpits may create occlusive conditions.
• If you are being treated for psoriasis, strict medical supervision of your condition is recommended to monitor for possible worsening.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• If you notice worsening of your condition during 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 your condition recurs shortly after stopping treatment, within the following 2 weeks, do not reapply the ointment without consulting your doctor, unless your doctor has previously instructed you otherwise. If your condition has resolved and, in case of recurrence, redness spreads beyond the initial treatment area and you experience a burning sensation, consult a doctor before resuming treatment.

Children and adolescents

In children, corticosteroids are more likely to pass through the skin into the body and cause adverse effects in other parts of the body compared to adult patients.

The use of corticosteroids in children should preferably be avoided, and special attention should be paid to occlusive conditions such as those caused by diapers.

Use of Suniderma ointment with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to 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 unless the benefit to the mother justifies the potential risk to the fetus.

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

Pregnant women or those planning to become pregnant should not apply it over large areas of skin, 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 on the breast area.

Driving and using machines

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

3. How to use Suniderma ointment

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

• Adults: Apply once or twice daily. A thin layer of ointment should be applied directly to the affected area, with gentle massage until completely absorbed.

Do not exceed application more than twice daily. Increasing the number of daily applications may worsen adverse effects without improving the therapeutic efficacy of the medicine.

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

If your doctor considers it necessary for chronic conditions to continue treatment for longer than 2 weeks, treatment should be intermittent (e.g., once daily, twice weekly), under medical supervision.

Use in children

The recommended dosage is one application daily.

Prolonged continuous use in children should not exceed 1 week, and the smallest effective amount of product should be applied.

If the doctor considers prolonged use necessary, treatment-free intervals without steroid therapy should be included.

Occlusive dressings (such as diapers) must be avoided in young children when using this medicine.

For cutaneous use.

Gently squeeze the tube and place a small sufficient amount onto hands. Apply the ointment in a thin layer with gentle massage.

Wash hands thoroughly and tightly close the tube after use.

If you use more Suniderma ointment than you should

If more Suniderma ointment is applied (repeated overdose), adverse effects may occur (see section 4).

If the ointment is used more frequently than recommended or over large areas of skin, it may be absorbed into the body and cause various disorders.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to use Suniderma ointment

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

If you forget to apply the ointment, apply the missed dose as soon as you remember, then continue treatment as usual.

If you stop treatment with Suniderma ointment

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The use of corticosteroids over prolonged periods and/or over extensive areas or under occlusive dressings or materials may cause adverse effects not only at the site of application but also in other parts of the body.

Possible adverse effects:

• Cutaneous atrophy (thinning of the skin)
• Skin striae (stretch marks)
• Skin fragility
• Acne
• Dilation of small superficial blood vessels beneath the skin (telangiectasias)
• Inflammation of hair follicles (folliculitis)
• Increased hair growth (hypertrichosis)
• Change in skin color
• Hypersensitivity reactions such as allergic contact dermatitis
• Easy bruising (bruises)
• Redness/irritation
• Secondary infections, including fungal infections
• Development of certain red bumps around the mouth (perioral dermatitis) or elsewhere on the face (rosacea)
• Blurred vision (frequency "not known")

Adverse effects affecting other parts of the body may include:

Development of a condition characterized by a rounded face, obesity, fat accumulation in the neck area (Cushing's syndrome), delayed wound healing (such as sores and leg ulcers), glaucoma, cataracts, etc.

Steroid withdrawal reaction:

If you use this medicine continuously for prolonged periods, a steroid withdrawal reaction may occur when stopping treatment, with some of the following symptoms: skin redness that may spread beyond the originally treated area, burning or stinging sensation, intense itching, skin peeling, open sores that ooze.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and other information

Composition of Suniderma ointment

• The active substance is hydrocortisone acetonide. Each gram of ointment contains 1.27 mg of hydrocortisone acetonide (0.127%).

• The other components are: aluminium distearate, Protegin WX*, Dub BW**, magnesium sulfate heptahydrate, filamentous vaseline, liquid vaseline and purified water.

• Composition of Protegin WX: vaseline, ozokerite, hydrogenated castor oil, glyceryl isostearate and polyglyceryl oleate

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

Appearance of the medicinal product and contents of the pack

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 latest revision of this leaflet: August 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es