ISZEMA 1 mg/g CREAM

2. What you need to know before you use 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, i.e., redness or inflammation after vaccination.
• In inflammation specific to the skin around the upper lip and chin (perioral dermatitis).
• In case of bacterial or fungal infections, see "Warnings and precautions" section.
• It must not be used in the eyes or on open wounds.
• Children under four months, due to lack of experience.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Iszema.

Be particularly 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.

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

Anti-inflammatory drugs (corticosteroids), such as the active ingredient methylprednisolone aceponate, in Iszema have significant effects on the body. It is not recommended to use Iszema on large areas of skin or for extended 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 cream must not come into contact with the eyes, mouth, open wounds, or mucous membranes (such as the anal or genital area).
• It must not be used in skin folds, groin, or armpits.
• It must 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 symptoms and make diagnosis and correct treatment more difficult.

If you apply Iszema 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 weighs the benefits and risks, Iszema cream 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 medicines.

No interactions with other medicines are known at present for Iszema cream.

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 cream if you are pregnant or breastfeeding, unless your doctor tells you to.

If your doctor recommends using Iszema cream 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 cetyl alcohol, benzyl alcohol, and butylhydroxytoluene

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

This medicine contains 10 mg of benzyl alcohol in each gram of cream. Benzyl alcohol may cause allergic reactions and moderate local irritation.

This medicine may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation because it contains butylhydroxytoluene.

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 tells you otherwise, the recommended dose is:

• Apply Iszema cream in a thin layer, once a day, to the affected area, rubbing gently.
• Generally, treatment duration should not exceed 12 weeks. Always make the treatment as short as possible.
• Intermittent treatment is recommended when prolonged treatment is needed.
• If you use Iszema for a skin eruption with inflammation and scaling (seborrheic eczema) on the face, do not treat the affected areas for more than one week.

If during treatment the skin becomes too dry, consult your doctor. Depending on the type of skin affected, it is recommended to change the treatment to another methylprednisolone medicine with a higher fat content (ointment or ointment).

Use in children

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

Treatment duration 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 reappear. Contact your doctor before stopping treatment with Iszema 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.

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

Burning and itching at the application site

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

• Hypersensitivity to the active substance.

• Blisters (bubbles),
• dryness,
• redness (erythema),
• inflammation of the hair follicle (folliculitis), eruptions, and abnormal skin sensation, such as numbness, tingling, or burning (paresthesia).

Rare side effects (may affect up to 1 in 1,000 people):

• Fungal infection
• Cracks in the skin,
• acne,
• infection with pus (pyoderma),
• dilated veins in the skin (telangiectasias)
• skin thinning (atrophy). Cellulitis, inflammation (edema), and irritation at the application site.

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

• Stretch marks on the skin,
• inflammation specific to the skin around the upper lip and chin (perioral dermatitis),
• skin discoloration, and allergic reactions on the skin.

• Increased hair growth (hypertrichosis).
• Blurred vision
• Side effects may occur not only in the treated area but also in completely different areas of the body. This occurs if the active substance (a corticosteroid) passes into the body through the skin. This, for example, can increase pressure in the eye (glaucoma).

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 them directly through the Spanish Medicines Monitoring System for Human Use, Website: www.notificaram.es.

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

5. Storing Iszema

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

Do not store above 25°C.

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

Once the carton is opened, discard the tube with the remaining cream after 2 years.

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 Iszema

• The active substance is methylprednisolone aceponate. Each gram of cream contains 1 mg of methylprednisolone aceponate (0.1%).
• The other ingredients (excipients) are: decyl oleate, glycerol monostearate 40-50, cetyl alcohol, semi-synthetic solid glycerides: mixture of monoglycerides, diglycerides, and triglycerides of C10-C18, semi-synthetic solid glycerides: capric, caprylic, myristic, and stearic triglyceride, macrogol stearate, glycerol 100% (E-422), disodium edetate, benzyl alcohol, butylhydroxytoluene (E-321), and purified water.

Appearance and packaging

Iszema cream is a white opaque cream.

This medicine is presented in aluminum tubes containing 30 and 60 grams of cream.

Not all pack sizes may be marketed.

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/