ISZEMA 1 mg/g CUTANEOUS EMULSION

Introduction

Package Leaflet: Information for the User

Iszema1 mg/g cutaneous emulsion

methylprednisolone 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 symptoms 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 Iszema and what is it used for
2. What you need to know before you start using Iszema
3. How to use Iszema
4. Possible side effects
5. Storage of Iszema
6. Contents of the pack and other information

1. What is Iszema and what is it used for

It is an anti-inflammatory medicine (a corticosteroid) for use on the skin.

Iszema reduces inflammation and allergic reactions of the skin, and reactions associated with excessive cell multiplication (hyperproliferation). Therefore, it reduces redness (erythema), fluid accumulation (edema), and exudate on the inflamed skin. It also relieves itching, burning, or pain.

Iszema is used in the treatment of acute forms of:

• Rash (eczema) mild to moderate related to an external cause, such as:
• • Allergy to a substance that has come into contact with the skin (allergic contact dermatitis).
  • Allergic reaction to substances of habitual use, such as soap (irritant contact dermatitis).
  • Coin-shaped rash (nummular eczema).
  • Itchy rash on hands and feet (dyshidrotic eczema).
  • Unspecified eczema (atopic eczema).

• Eczema related to patient factors (endogenous eczema), such as atopic dermatitis or neurodermatitis.
• Skin rash with inflammation and scaling (seborrheic eczema).

2. What you need to know before you start using Iszema

Do not use Iszema:

• If you are allergic to methylprednisolone aceponate or any of the other ingredients of this medicine (listed in section 6).
• If you have tuberculosis, syphilis, or viral infections (such as chickenpox or herpes).
• If you have rosacea (a condition that causes inflammation of the skin, red/pink), ulcers, acne, or skin diseases with skin thinning (atrophy).
• In areas of the skin that show a vaccination reaction, for example, redness or inflammation after vaccination.
• In inflammation specific to the skin around the upper lip and chin (perioral dermatitis).

• In bacterial or fungal infections, see section "Warnings and precautions".
• It must not be used in the eyes or on open wounds.
• Not to be used in children under 4 months of age due to lack of experience.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Iszema.

Be careful if your doctor diagnoses you with a bacterial or fungal infection, as you should also use the additional treatment prescribed for the infection, because if you do not, the infection may worsen.

Anti-inflammatory drugs (corticosteroids), such as the active ingredient methylprednisolone aceponate, have significant effects on the body. It is not recommended to use Iszema on large areas of the skin or for prolonged periods, as this significantly increases the risk of side effects.

To reduce the risk of side effects:

• Use it at the lowest possible dose, especially in children.
• Use it only for the time strictly necessary to relieve the skin condition.
• Iszema emulsion should not come into contact with the eyes, mouth, open wounds, or mucous membranes (such as the anal or genital area).
• It should not be used in skin folds, groin, or armpits.
• It should not be used under impermeable materials to air and water, including bandages (unless your doctor indicates otherwise), dressings, clothing, or diapers that are not very breathable.

If you use Iszema for diseases other than those for which it has been prescribed, it may mask the symptoms and make the correct diagnosis and treatment difficult.

Contact your doctor if you experience blurred vision or other visual disturbances.

If Iszema is applied to the anal or genital area, some of its ingredients may damage latex products such as condoms or diaphragms. Therefore, they may no longer be effective as contraceptives or as protection against sexually transmitted diseases, such as HIV infection. Consult your doctor or pharmacist if you need more information.

Children

It is essential to consider that diapers can be occlusive. If the doctor assesses the benefits and risks beforehand, Iszema may be prescribed for use in children between 4 months and 3 years.

This medicine is not recommended for use in children under 4 months of age.

Other medicines and Iszema

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

No interactions are known between Iszema emulsion and 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 or pharmacist before using this medicine.

To avoid any risk to the child, do not use Iszema emulsion if you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, unless your doctor advises you to do so.

If your doctor recommends the use of Iszema emulsion during breastfeeding, do not apply the medicine to the breasts; do not let the child come into contact with treated areas.

Driving and using machines

This medicine does not affect your ability to drive or use machines.

Iszema contains benzyl alcohol

This medicine contains 12.5 mg of benzyl alcohol in each gram of cutaneous emulsion. Benzyl alcohol may cause allergic reactions and moderate local irritation.

3. How to use Iszema

Follow exactly the administration instructions of this medicine indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

This medicine is for cutaneous use (to be applied to the skin).

Unless your doctor indicates otherwise, the recommended dose is:

• Apply Iszema emulsion, in a thin layer, once a day, to the affected area, rubbing gently.
• Generally, the duration of treatment should not exceed 2 weeks. Always make the treatment as short as possible.
• If you use Iszema emulsion for a skin rash with inflammation (seborrheic eczema) and scaling of the face, do not treat for more than one week.
• If the skin becomes too dry, please consult your doctor. You may need to apply a regulating greasy ointment in addition.

Use in children

Iszema should not be used in children under 4 months of age due to lack of safety data.

The duration of treatment in children should be limited to the minimum, generally not exceeding 4 weeks.

If you use more Iszema than you should

No risk of acute intoxication is expected after a single cutaneous application of an overdose (application to a large area, in circumstances favorable for absorption) or after accidental ingestion. Repeated overdoses may produce side effects (see section 4. Possible side effects).

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 Iszema

Do not use a double dose to make up for forgotten doses; if you have forgotten a dose, continue with your usual schedule as indicated by your doctor or as described in the package leaflet.

If you stop using Iszema

If you stop treatment prematurely, the original symptoms of your skin problem may recur. Contact your doctor before stopping treatment with Iszema emulsion.

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.

Common side effects (may affect up to 1 in 10 people):

• Local skin irritation (such as burning sensation).

Uncommon side effects (may affect up to 1 in 100 people):

• Pain,
• Itching,
• Small blisters and pustules,
• Scaling,
• Superficial wounds (erosion),
• Worsening or recurrence of eczema,
• Cracking of the skin.

Side effects with unknown frequency (cannot be estimated from the available data):

The use of corticosteroids on the skin (such as the active ingredient of Iszema) may cause the following side effects

• Thinning of the skin (atrophy),
• Dry skin,
• Redness (erythema),
• Appearance of red spots,
• Inflammation of the hair follicle (folliculitis),
• Stretch marks,
• Acne,
• Inflammation specific to the skin around the upper lip and chin (perioral dermatitis),
• Allergic skin reaction (contact dermatitis),
• Changes in skin color,
• Increased body hair.
• Side effects may occur not only in the treated area but also in completely different areas of the body. This occurs if the active ingredient (a corticosteroid) passes into the body through the skin (is absorbed). This, for example, can increase pressure in the eye (glaucoma).
• Blurred vision.

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: http://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Iszema emulsion

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

No special storage conditions are required.

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 stated.

Once the packaging is opened, discard the tube with the remaining emulsion after 2 years.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Iszema

• The active ingredient is methylprednisolone aceponate. Each gram of cutaneous emulsion contains 1 mg of methylprednisolone aceponate (0.1%).
• The other ingredients (excipients) are: medium-chain triglycerides, semi-synthetic solid glycerides: capric, caprylic, myristic, and stearic triglyceride, macrogol-2-stearate, macrogol-21-stearate, benzyl alcohol, disodium edetate, glycerol (E-422), and purified water.

Appearance of the product and pack contents

Iszema cutaneous emulsion is a white opaque emulsion.

This medicine is presented in aluminum tubes containing 50 grams of cutaneous emulsion.

Marketing authorization holder and manufacturer

Marketing authorization holder

Isdin S.A.

Provençals 33

08019 Barcelona

Spain

Manufacturer

Bioglan AB

Borrgatan 31, 211 24 Malmö

Sweden

Date of last revision of this leaflet: August 2022

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.gob.es/