LEXXEMA 1mg/g CREAM

Introduction

Package Leaflet: Information for the User

Lexxema 1 mg/g Cream

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

1. What is Lexxema cream and what is it used for
2. What you need to know before you use Lexxema cream
3. How to use Lexxema cream
4. Possible side effects
5. Storing Lexxema cream
6. Contents of the pack and other information

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

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

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

Lexxema cream is used in the treatment of:

• Acute mild to moderate eczema related to an external cause, such as:
• • Allergy 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 (vulgar 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 cream, is indicated mainly in exudative conditions (those that secrete fluid).

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

Do not use Lexxema cream

• If you are allergic to methylprednisolone aceponate (MPA) or any of the other components 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 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 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 of Lexxema, have significant effects on the body. It is not recommended to use Lexxema on large areas of skin or for extended periods, as this significantly increases the risk of side effects.

To reduce the risk of side 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 cream must not come into contact with the eyes, mouth, open wounds, or mucous membranes (such as the anal or genital area).
• It must not be used in skin folds, groin, or armpits.
• It must not be used under impermeable materials to air and water, including bandages (unless your doctor indicates otherwise), dressings, clothing, or diapers that 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 Lexxema cream is applied to the anal or genital area, some of its components could 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 consider that diapers can be occlusive. If the doctor weighs the benefits and risks, Lexxema cream may be prescribed for use in children between 4 months and 3 years.

Other medicines and Lexxema cream

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

No interactions with other medicines are known for Lexxema cream.

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 medicine.

To avoid any risk to the child, 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 medicine to the breasts; do not let the child come into contact with treated areas.

Driving and using machines

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

Lexxema cream contains cetyl alcohol and butylhydroxytoluene (E-321)

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

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

Lexxema cream contains benzyl alcohol

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

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol may cause moderate local irritation.

3. How to use Lexxema cream

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

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

Topical use.

• Apply Lexxema cream 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.

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

Use in children

Lexxema cream 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 a minimum, generally not exceeding 4 weeks.

If you use more Lexxema cream 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 cream

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

If you stop using Lexxema cream

If you stop treatment prematurely, the original symptoms of your skin problem may reappear. Contact your doctor before stopping treatment with Lexxema cream.

If you have any other questions about 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 and itching at the application site.

• Uncommon:

Hypersensitivity to the active ingredient.

Blisters (bubbles), dryness, redness (erythema), inflammation of the hair follicle (folliculitis), eruptions, and abnormal skin sensation, such as numbness, tingling, or burning (paresthesia).

• Rare:

Fungal infection.

Cracks in the skin, acne, infection with pus (pyoderma), dilated veins in the skin (telangiectasia), and skin thinning (atrophy).

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

• Frequency not known:

Stretch marks on the skin, 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 it is possible side effects not listed in this leaflet. You can also report them 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. Storing Lexxema cream

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

Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the carton 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 cream

• The active ingredient is methylprednisolone aceponate (MPA). Each gram of cream contains 1 mg of methylprednisolone aceponate (0.1%).
• The other ingredients (excipients) are: decyl oleate, glycerol monostearate 40-50%, cetyl alcohol, hard fat, capric/caprylic/myristic/stearic triglycerides, polyoxyl 40 stearate, glycerol 85% (E-422), disodium edetate, benzyl alcohol, butylhydroxytoluene (E-321), and purified water.

Appearance of the product and pack contents

Lexxema cream is a white opaque cream and is available in tubes of 30 and 60 g.

Marketing authorisation holder and manufacturer

Marketing authorisation 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/