Product Information for the User

Lexxema 1 mg/g Cream

Methylprednisolone aceponate

Read this entire leaflet carefully before you start using this medicine, as 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before using Lexxema cream

3.How to use Lexxema cream

4.Possible side effects

5.Storage of Lexxema cream

6. Contents of the pack and additional information

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

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

Lexxema cream is used in the treatment of:

• Mild to moderate acute eczema related to an external cause, such as:
• • Allergic contact dermatitis.
  • Irritant contact dermatitis due to substances commonly used, such as soap.
  • Nummular eczema.
  • Dyshidrotic eczema with itchy eruption on hands and feet.
  • Unspecified eczema (eczema vulgaris).
• Eczema related to patient factors (endogenous eczema), such as atopic dermatitis or neurodermatitis.
• Eczema with inflammation and scaling on the skin (seborrheic eczema).

This form, in cream, is mainly indicated for exudative conditions (that secrete fluid).

Do not use Lexxema cream

• If you are allergic to methylprednisolone aceponate (MPA) or any of the other components of this medication (listed in section 6).
• If you have tuberculosis, syphilis, or viral infections (for example, chickenpox or herpes).
• If you have rosacea (a condition that causes skin inflammation, redness), ulcers, acne, or skin diseases with skin thinning (atrophy).
• In areas of the skin that show a vaccine reaction, that is, redness or inflammation after the vaccine.
• In specific skin inflammation around the upper lip and chin (perioral dermatitis).
• In case of bacterial or fungal infections, see the "Warnings and precautions" section.
• Do not use on open deep wounds.
• Children under four months, due to lack of experience.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Lexxema cream

If your doctor diagnoses a bacterial or fungal infection, you must also use the additional treatment prescribed for the infection, because if you do not, the infection may worsen.

Get in touch with your doctor if you experience blurred vision or other visual disturbances.

Corticosteroid medications, such as the active ingredient in Lexxema, have significant effects on the body. It is not recommended to use Lexxema on extensive areas of the skin or for prolonged periods, as this significantly increases the risk of adverse effects.

To reduce the risk of adverse effects:

• Use it at the lowest possible dose, especially in children.
• Use it only for the strictly necessary time to relieve the skin condition.
• Lexcema cream should not come into contact with the eyes, mouth, open wounds, or mucous membranes (for example, the anal or genital area).
• Do not use on skin folds, in the groin or underarms.
• Do not use under impermeable materials to air and water, including bandages (unless your doctor tells you otherwise), dressings, clothing, or diapers that are not breathable.

If Lexxema is used for conditions other than those for which it has been prescribed, it may mask symptoms and make it difficult to diagnose and treat correctly.

If Lexxema cream is applied to the anal or genital area, some of its components may cause deterioration of latex products such as condoms or diaphragms. Therefore, these products may no longer be effective as contraceptives or as protectants against sexually transmitted diseases, such as HIV. Contact your doctor or pharmacist if you need more information.

Children

It is essential to note that diapers can be occlusive. If the doctor evaluates the benefits and risks, Lexxema cream may be prescribed for use in children between 4 months and 3 years.

Other medications and Lexxema cream

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

No interactions of Lexxema cream with other medications are known at this time.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

To avoid any risk to the baby, do not use Lexxema cream if you are pregnant or breastfeeding, unless your doctor tells you to.

If your doctor recommends the use of Lexxema cream during breastfeeding, do not apply the medication to the breasts; do not put the baby in contact with treated areas.

Driving and operating machinery

Lexcema cream does not affect your ability to drive or operate machinery.

Lexcema cream contains cetearyl alcohol and butylhydroxytoluene (E-321)

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetearyl alcohol and butylhydroxytoluene (E-321).

This medication may cause eye irritation and mucous membrane irritation because it contains butylhydroxytoluene (E-321).

Lexcema cream contains benzyl alcohol

This medication contains 10 mg of benzyl alcohol per gram of cream.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol may cause moderate local irritation.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Unless your doctor tells you otherwise,the recommended dose is:

Cutaneous use.

• ApplyLexxemacream in a thin layer, once a day, to the affected area, gently rubbing it in.
• Generally, the 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 Lexxema for a skin eruption with inflammation and peeling (seborrheic eczema) on the face,do not treat the affected areas for more than one week.

If during treatment the skin becomes excessively dry, consult your doctor. Depending on the type of skin affected, it is recommended to change the treatment to another medication from the Lexxema range with a higher fatty content (Lexxema ointment or Lexxema ointment).

Cutaneous use in children

Lexxemacream should not be used in children under four months of age due to a lack of safety data.

The treatment duration in children should be limited to the minimum,generally not exceeding4 weeks.

If you use more Lexxema cream than you should

No acute toxicity risk is expectedaftera single cutaneous applicationof an overdose(application to a large area, under favorable conditions for absorption)or after accidental ingestion.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center, or call the Toxicological Information Service, phone (91) 562 04 20 (indicating the medication and the amount ingested).

If you forgot to use Lexxema cream

Do not use a double dose to compensate for the missed dose. If you have forgotten a dose, continue with your regular schedule according to your doctor's instructions or those described in the prospectus.

If you interrupt treatment with Lexxema cream

If youinterrupt the treatment prematurely,the original symptoms of your skin problem may reappear. Contact your doctor before interrupting treatmentwith Lexxema cream.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The assessment of side effects is based on the following frequencies:

Very common:may affect more than 1 in 10 people

Common:may affect up to 1 in 10 people

Uncommon:may affect up to 1 in 100 people

Rare:may affect up to 1 in 1,000 people

Very rare:may affect up to 1 in 10,000 people.

Frequency not known (cannot be estimated from available data).

• Common:

Burning and itching at the application site

• Uncommon:

Hypersensitivity to the active ingredient.

Blistering, dryness, redness (erythema), inflammation of the hair follicle (folliculitis), rashes, and abnormal skin sensations, such as numbness, tingling, or burning (paresthesia).

• Rare:

Fungal infection

Cracks in the skin, acne, pus-filled infection (pyoderma),enlarged blood vessels in the skin (telangiectasia) and thinning of the skin (atrophy).

Celulitis, inflammation (edema) and irritation at the application site.

• Frequency not known:

Striae in the skin, inflammation specific to the skin around the upper lip and chin (dermatitis perioral), skin discoloration, and allergic reactions in the skin.

Excessive hair growth (hypertrichosis).

Blurred vision.

Side effects can 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. This, for example, can increase eye pressure (glaucoma).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above25°C.

Do not use this medication after the expiration date that appears on the packagingafter CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, please ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lexxema cream

- The active principle is methylprednisolone aceponate (MPA). Each g of cream contains 1 mg of methylprednisolone aceponate (0.1%).

- The other components (excipients) are: decyl oleate, 40-50% monoester of glycerol, cetoestearic alcohol, hard fat, caprylic-capric-myristic-stearic triglycerides, polyoxy 40 stearate, 85% glycerol (E-422), disodium edetate, benzyl alcohol, butylhydroxytoluene (E-321), and purified water.

Appearance of the product and content of the packaging

Lexxema cream is an opaque white cream and is presented in 30 and 60 g tubes.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

ITALFARMACO S.A.

San Rafael 3, 28108-Alcobendas (Madrid) Tel. 916572323

Responsible for manufacturing:

LEO Pharma Manufacturing Italy S.r.l.

Via E. Schering, 21

20054 Segrate (Milan) - Italy

Last review date of this leaflet : August 2021.

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es /