LEXXEMA 1 mg/g OINTMENT

Introduction

Package Leaflet: Information for the User

Lexxema1mg/gointment

Methylprednisolone aceponate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Lexxema ointment and what is it used for
2. What you need to know before you use Lexxema ointment
3. How to use Lexxema ointment
4. Possible side effects
5. Storage of Lexxema ointment

1. Contents of the pack and other information

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

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

Lexxema ointment reduces inflammation and allergic reactions of the skin, and reactions associated with excessive cell proliferation (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:

• Acute eczema of mild to moderate severity related to an external cause, such as:
• • Allergic reaction to a substance that has come into contact with the skin (allergic contact dermatitis).
  • Allergic reaction to substances of habitual use, such as soap (irritant contact dermatitis).
  • Coin-shaped eruption (nummular eczema).
  • Itchy eruption on hands and feet (dyshidrotic eczema).
  • Unspecified eczema (atopic eczema).
• Eczema related to patient factors (endogenous eczema), such as atopic dermatitis or neurodermatitis.
• Skin eruption with inflammation and scaling (seborrheic eczema).

This form, in ointment, is particularly suitable for very dry conditions.

2. What you need to know before you use Lexxema ointment

Do not use Lexxema ointment

• If you are allergic to methylprednisolone aceponate (MPA) 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.
• Not to be used in children under four months of age due to lack of safety data.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Lexxema ointment.

If your doctor diagnoses a bacterial or fungal infection, 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 (MPA) ofLexxema , have significant effects on the body. It is not recommended to useLexxema on large areas of the skin or for prolonged periods, as this significantly increases the risk ofadverse effects.

To reduce the risk ofadverse effects:

• Use it at the lowest possible dose, especially in children.
• Use it only for the time strictly necessary to relieve the skin condition.
• Lexxema ointment must not come into contact with the eyes, mouth, open wounds, or mucous membranes (e.g., anal or genital area).
• It must not be used in skin folds, groin, or armpits.
• It must not be used under airtight and waterproof materials, including bandages (unless your doctor indicates otherwise), dressings, clothing, or diapers, which are not very breathable.

If you use Lexxema for diseases other than those for which it has been prescribed, it may mask the symptoms and make it difficult to diagnose and treat correctly.

If you apply Lexxema ointment 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 infection. Contact your doctor or pharmacist if you need more information.

Children

It is essential to consider that diapers can be occlusive. If the doctor assesses the benefits and risks beforehand, Lexxema ointment may be prescribed for use in children between 4 months and 3 years of age.

Other medicines and Lexxema ointment

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

No interactions of Lexxema ointment with other medicines are known to date.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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

If your doctor recommends the use of Lexxema ointment during breastfeeding, do not apply the medicine to the breasts; do not let the baby come into contact with treated areas.

Driving and using machines

Lexxema ointment does not affect your ability to drive or use machines.

3. How to use Lexxema ointment

Follow exactly the instructions of administration of this medicine indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again.

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

Topical use

• Apply Lexxema ointment in a thin layer, once a day, to the affected area, rubbing gently.
• Generally, the duration of treatment 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

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

The duration of treatment in children should be limited to the minimum, generally not exceeding 4 weeks.

If you use more Lexxema ointment than you should

No risk of acute intoxication is expected after single topical 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 medicine and the amount ingested).

If you forget to use Lexxema ointment

Do not use a double dose to make up for forgotten doses. If you have forgotten a dose, continue with your usual schedule as instructed by your doctor or as described in the leaflet.

If you stop using Lexxema ointment

If you stop treatment prematurely, the original symptoms of your skin problem may recur. Please contact your doctor before stopping treatment with Lexxema ointment.

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.

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 the available data).

• Common:

Burning at the application site and inflammation of hair follicles (folliculitis).

• Uncommon:

Dilated veins in the skin (telangiectasia), skin cracks, itching, pain, blisters (vesicles), and pimples (pustules) at the application site.

• Frequency not known:

Hypersensitivity to the active ingredient.

Acne, skin thinning (atrophy), skin stretch marks, 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 parts of the body. This happens if the active ingredient (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 they are possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es.

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

5. Storage of Lexxema ointment

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

Do not store above 30°C.

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

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 Lexxema ointment

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

• The other ingredients (excipients) are: white petrolatum (semisolid), liquid petrolatum, microcrystalline wax, hydrogenated castor oil.

Appearance and pack size of the product

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

ITALFARMACO S.A.

San Rafael 3, 28108-Alcobendas (Madrid)

Tel. 916572323

Manufacturer:

LEO Pharma Manufacturing Italy S.r.l.

Via E. Schering, 21

20054 Segrate (Milan) - Italy

Date of last revision of this leaflet:August 2021

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