Leaflet: information for the user

Lexxema 1mg/g topical emulsion

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 Lexxema emulsion is and for what it is used

2. What you need to know before starting to use Lexxema emulsion

3. How to use Lexxema emulsion

4. Possible side effects

5. Storage of Lexxema emulsion

6. Contents of the pack and additional information

Lexxema emulsion contains the active substance, methylprednisolone aceponate.

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

Lexxema 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 emulsion is used in the treatment of acute forms of:

• Mild to moderate eczema related to an external cause, such as:
• • Allergic contact dermatitis.
  • Irritant contact dermatitis.
  • Nummular eczema.
  • Dyshidrotic eczema.
  • Unspecified eczema (eczema vulgaris).

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

Do not use Lexxema emulsion

• If you are allergic to the active ingredient 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.
• In areas of skin affected by inflammation that is red/pink (rosacea), ulcers, inflammation of the sebaceous glands (acne) or skin diseases with thinning of the skin (atrophy of the skin).
• In areas of skin showing a vaccine reaction, for example, redness or inflammation after vaccination.
• In specific inflammation of the skin around the upper lip and chin (perioral dermatitis).
• In bacterial or fungal infections (unless treated additionally with a specific treatment).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Lexxema emulsion

Be especially careful if your doctor diagnoses a skin infection caused by bacteria or fungi; then, you must also use the additional treatment prescribed for the infection, because if not, the infection may worsen.

Corticosteroids, like the active ingredient (MPA) of Lexxema emulsion, have significant effects on the body. It is not recommended to use Lexxema emulsion 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.
• Use it only for the time absolutely necessary to relieve the skin condition.
• Lexcema emulsion should not come into contact with the eyes, mouth, deep open wounds or mucous membranes (for example, the anal or genital area).
• Lexcema emulsion should not be used on extensive areas of skin (more than 40% of the body surface).
• Lexcema emulsion should not be used under impermeable materials to air and water, including bandages, dressings, clothing, or diapers, unless prescribed by your doctor.

If Lexxema emulsion 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.

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

If Lexxema emulsion 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

• Use Lexxema emulsion as little as possible to reduce the risk of adverse effects.
• Lexcema emulsion should not be used under impermeable materials to air and water, such as diapers, unless prescribed by your doctor.
• Lexcema emulsion may be used in children between 4 months and 3 years if prescribed by your doctor. It is not recommended for use in children under 4 months of age.

Use of Lexxema emulsion with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

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

Pregnancy and breastfeeding and fertility

To avoid any risk to the baby, do not use Lexxema emulsion if you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, unless your doctor tells you to.

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

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.

Driving and operating machinery

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

Lexcema emulsion contains benzyl alcohol

This medication contains 1.25 g of benzyl alcohol in each 100 g.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol may cause moderate local irritation.

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

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

• Apply L maxxema emulsion, in a thin layer, once a day, over the affected area, gently rubbing.
• Generally, the duration of treatment with Lexxema emulsion should not exceed two weeks. Always make the treatment as short as possible.
• If you use L maxxema emulsion for a skin eruption with inflammation and peeling of the face (seborrheic eczema), do not treat for more than one week.
• If the skin becomes too dry, consult your doctor. In some cases, you may need to apply a greasy regulating ointment in addition.

Use in children

L maxxema emulsion can be used in children between 4 months and 3 years if your doctor has prescribed it. No dose adjustments are required.

The use of Lexxema emulsion is not recommended in children under four months of age due to a lack of safety data.

If you use more Lexxema emulsion than you should

No adverse effects are expected after a single overdose of Lexxema emulsion (too large a quantity, too large an area of skin, or too frequent use). Repeated overdoses may cause side effects (see section 4. Possible adverse effects).

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 emulsion

Do not use a double dose to compensate for the missed doses; 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 treatment with Lexxema emulsion

If you interrupt the use of Lexxema emulsion prematurely, the original symptoms of your skin problem may reappear. Please contact your doctor before interrupting treatment with Lexxema emulsion.

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

Like all medications,Lexxemaemulsion may cause adverse effects, although not all people will experience them.

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

Very common:may affect more than 1 in 10 patients

Common:may affect up to 1 in 10 patients

Uncommon:may affect up to 1 in 100 patients

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

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

Frequency not known: cannot be estimated from available data.

• Common:
• • Local skin irritation (e.g. burning sensation)

• Uncommon:
• • Pain
  • Itching
  • Small blisters and pustules
  • Exfoliation
  • Superficial wounds (erosion)
  • Worsening or recurrence of eczema
  • Skin cracking

The use of anti-inflammatory medications, called corticosteroids (such as the active ingredient in Lexxema emulsion) on the skin may lead to the following adverse effects (frequency not known).

• Thinning of the skin (atrophy)
• Dry skin
• Redness (erythema)
• Appearance of red spots
• Folliculitis (inflammation of hair follicles)
• Striae
• Acne
• Dermatitis perioral (inflammation of the skin around the upper lip and chin)
• Contact dermatitis (skin allergic reaction)
• Changes in skin color
• Increased hair growth
• 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) is absorbed into the body through the skin. This, for example, may increase eye pressure (glaucoma).
• Blurred vision.

Reporting of 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 leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use, Website:www.notificaram.es.

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

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

Do not store at a temperature above 30°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.

Shelf life after first opening: 3 months.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Lexxema emulsion

• The active principle is Metilprednisolona aceponate (MPA).
• The other components (excipients) are: medium-chain triglycerides, caprylic-capric-myristic-stearic triglyceride, macrogol-2-stearyl ether, macrogol-21-stearyl ether, benzyl alcohol, disodium edetate, glycerol (E-422) (85%) and purified water.

Appearance of the product and contents of the packaging

Lexxema emulsion is a white skin emulsion (similar to a cloudy milk-like cream) and is presented in 20 and 50 g tubes.

The tubes are provided with an extra removable seal.

Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

• Italfarmaco, S.A.

C/ San Rafael, 3

28108 Alcobendas (Madrid) - Spain

Responsible for manufacturing:LEO Pharma Manufacturing Italy S.r.l.

Via E. Schering, 21

20054 Segrate (Milan) - Italy

Date of the last review of this leaflet: August 2019

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