Leaflet: information for the user

Lexxema1mg/gointment

Methylprednisolone aceponate

Read this 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, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must 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.

6. Contents of the pack and additional information

An anti-inflammatory medication (a corticosteroid) for use on the skin.

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

Lexxema ointment 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 eruptions on hands and feet.
  • Unspecified eczema (eczema vulgaris).
• Eczema related to patient factors (endogenous eczema), such as atopic dermatitis or neurodermatitis.
• Seborrheic eczema with inflammation and scaling.

This form, in ointment, is indicated mainly in very dry conditions.

Do not use Lexxema ointment

• 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 the eyes or 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 ointment.

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.

Corticosteroids, like the active ingredient (MPA) of 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 alleviate the skin condition.
• Lexxema ointment 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 advises otherwise), dressings, clothing, or diapers, which are slightly 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 ointment is applied to the anal or genital area, some of its ingredients may damage latex products such as condoms or diaphragms. Therefore, these products may no longer be effective as contraceptives or as protection 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 considers the benefits and risks, Lexxema ointment may be prescribed for use in children between 4 months and 3 years.

Other medications and Lexxema ointment

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

No interactions with other medications have been reported for Lexxema ointment.

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 medication.

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

If your doctor recommends using Lexxema ointment 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 ointment does not affect your ability to drive or operate machinery.

Follow exactly the administration instructions for 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:

Skin use

• ApplyL maxxemaointment 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 useL maxxemafor a skin eruption with inflammation and peeling (seborrheic eczema) on the face, do not treat the affected areas for more than one week.

Skin use in children

L maxxemaointment 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 should not exceed 4 weeks.

If you use more Lexxema ointment than you should

No acute toxicity risk is expectedafter a single topical application of an overdose (application to a large area, in favorable conditions for absorption) orafter 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 ointment

Do not use a double dose to make up 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 leaflet.

If you interrupt the treatment with Lexxema ointment

If you interrupt the treatment prematurely,the original symptoms of your skin problem may reappear. Please contact your doctor before interrupting the treatmentwith Lexxemaointment.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

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

Very frequent:may affect more than 1 in 10 people

Frequent:may affect up to 1 in 10 people

Infrequent: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.

Unknown frequency (cannot be estimated from available data).

• Frequent:

Burning sensation at the application site and hair follicle inflammation (folliculitis).

• Infrequent:

Visible blood vessels in the skin (telangiectasia), skin cracks, itching, pain, vesicles (blisters), pustules (acne-like lesions) and papules (papules) at the application site.

• Unknown frequency:

Hypersensitivity to the active ingredient

Acne, skin thinning (atrophy), skin discoloration, specific skin inflammation around the upper lip and chin (perioral dermatitis), skin discoloration and skin allergic reactions.

Excessive hair growth (hypertrichosis)

Blurred vision.

Adverse 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 through the skin into the body. This, for example, may increase eye pressure (glaucoma).

Reporting Adverse Effects

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

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

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

Do not store at a temperature above30°C

Do not use this medication after the expiration date that appears on the packaging after 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 ointment

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

• The other components (excipients) are: white paraffin (semi-solid), liquid paraffin, microcrystalline wax, hydrogenated ricin oil.

Appearance of the product and contents of the packaging

Lexxema ointment is a translucent whitish to slightly yellowish ointment and is presented in tubes of 30 and 60 g.

Not all packaging sizes may be marketed.

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

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