Leaflet: information for the user

Lexxema 1mg/g cream

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.

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

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 to treat:

• Acute mild to moderate eczema related to an external cause, such as:

• Allergic contact dermatitis.
• Irritant contact dermatitis from substances used habitually, 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.

• Eczema with inflammation and scaling on the skin (seborrheic eczema).

This ointment form is indicated mainly for conditions where the skin is dry (not exuding, but not excessively dry).

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 redness and inflammation in the skin), 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 section “Warnings and precautions”.
• 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, because 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.
• Lexxema ointment must 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 in the armpits.
• Do not use under impermeable materials to air and water, including bandages (unless your doctor tells you to), 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 components may cause deterioration of latex products such as condoms or diaphragms. Therefore, these products may no longer be effective as contraceptives or as protectors against sexually transmitted diseases, such as HIV infection. 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 of Lexxema ointment with other medications have been reported to date.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be 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 tells you to.

If your doctor recommends the use of 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

This medication 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:

Cutaneous Use

• Apply Lexxema cream 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 scaling (seborrheic eczema) on the face, do not treat the affected areas for more than one week.

Use in children

Do not use Lexxema cream in children under four months of age due to lack of safety data.

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

If you use more Lexxema cream than you should

No acute toxicity is expectedafter a single cutaneous application of 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 Toxicology 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 forgot a dose, continue with your regular schedule according to your doctor's instructions or those described in the package insert.

If you interrupt treatment with Lexxema cream

If you interrupt treatment prematurely,the original skin symptoms may reappear. Contact your doctor before interrupting treatment with Lexxema cream.

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

Like all medicines, this medicine may 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:

Thinning of the skin (atrophy), bruising (ecchymosis), superficial bacterial infection (impetigo) and oily skin, blisters (vesicles), dryness, redness (erythema), irritation, eczema, and peripheral edema at the administration site.

• Frequency not known:

Hypersensitivity to the active ingredient

Acne, dilated blood vessels in the skin (telangiectasias), skin striations, specific skin inflammation around the upper lip and chin (perioral dermatitis), skin discoloration, skin allergic reactions.

Folliculitis and 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 ingredient (a corticosteroid) passes into the body through the skin. This, for example, may 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 Medicinal Products for Human Use:www.notificaram.es.

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

Keepthis medicationout of the sight and reach of children.

Do not store at a temperature above25°C

Do not usethis medicationafter the expiration date that appears on the packaging,after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, please ask your pharmacist how to dispose of the packaging and medicines 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 1mg of methylprednisolone aceponate (0.1%).
• The other components (excipients) are: white beeswax, liquid paraffin, Dehymuls E (dicocoil pentaerythritol distearate (and) sorbitan sesquioleate (and) white beeswax (and) aluminum stearate), white solid paraffin, and purified water.

Appearance of the product and contents of the packaging

Lexxema ointment is a yellowish white ointment and is presented in tubes of 30 and60 g.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

ITALFARMACO S.A.

San Rafael 3, 28108-Alcobendas (Madrid)

Responsible for manufacturing:

LEO Pharma Manufacturing Italy S.r.l.

Via E. Schering, 21

20054 Segrate (Milan) - Italy

Last review date of this leaflet:August2021

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