Lexxema 1 mg/g cutaneous emulsion
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Lexxema 1mg/g cutaneous emulsion
Methylprednisolone aceponate
Read all of 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of this leaflet
- What Lexxema emulsion is and what it is used for
- What you need to know before using Lexxema emulsion
- How to use Lexxema emulsion
- Possible side effects
- How to store Lexxema emulsion
- Contents of the pack and other information
1. What Lexxema emulsion is and what it is used for
Lexxema emulsion contains the active substance methylprednisolone aceponate.
Lexxema emulsion is an anti-inflammatory medicine (a corticosteroid) for use on the skin.
Lexxema reduces skin inflammation and allergic reactions, as well as 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 to treat acute forms of:
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Mild to moderate rash (eczema) related to external causes, such as:
- Allergy to a substance that has come into contact with the skin (allergic contact dermatitis).
- Allergic reaction to commonly used substances, such as soap (irritant contact dermatitis).
- Coin-shaped rash (nummular eczema).
- Itchy rash on the hands and feet (dyshidrotic eczema).
- Unspecified eczema (vulgar eczema).
-
Eczema related to patient-specific factors (endogenous eczema), such as atopic dermatitis or neurodermatitis.
-
Skin rash with inflammation and scaling (seborrheic eczema).
2. What you need to know before using Lexxema emulsion
Do not use Lexxema emulsion
- If you are allergic to the active substance methylprednisolone aceponate (MPA) or to 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.
- On areas of skin affected by red/pink inflammation (rosacea), ulcers, sebaceous gland inflammation (acne), or skin diseases causing thinning of the skin (atrophic skin diseases).
- On areas of skin showing a vaccination reaction, for example, redness or swelling after vaccination.
- On specific skin inflammation around the upper lip and chin (perioral dermatitis).
- In bacterial or fungal infections (unless treated concomitantly with specific therapy).
Warnings and precautions
Consult your doctor or pharmacist before starting to use Lexxema emulsion.
Take special care if your doctor has also diagnosed a bacterial or fungal skin infection; in such cases, you must also use the additional treatment prescribed for the infection, as otherwise the infection may worsen.
Anti-inflammatory drugs (corticosteroids), such as the active ingredient (MPA) in Lexxema emulsion, have significant effects on the body. The use of Lexxema emulsion over large areas of skin or for prolonged periods is not recommended, as this significantly increases the risk of adverse effects.
To reduce the risk of adverse effects:
- Use the lowest possible dose.
- Use it only for the minimum time necessary to relieve the skin condition.
- Lexxema emulsion must not come into contact with the eyes, mouth, deep open wounds, or mucous membranes (e.g., anal or genital areas).
- Lexxema emulsion must not be used on extensive areas of skin (more than 40% of body surface area).
- Lexxema emulsion must not be used under occlusive dressings or impermeable materials, including bandages, dressings, non-breathable clothing, or diapers, unless specifically prescribed by your doctor.
If Lexxema emulsion is used for conditions other than those for which it was prescribed, it may mask symptoms and interfere with correct diagnosis and treatment.
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 damage latex products such as condoms or diaphragms. Therefore, these products may no longer be effective as contraceptives or as protection against sexually transmitted infections, such as HIV infection. Contact your doctor or pharmacist if you need further information.
Children
- Use Lexxema emulsion as little as possible to minimize the risk of adverse effects.
- Lexxema emulsion must not be used under occlusive materials such as diapers unless specifically prescribed by your doctor.
- Lexxema emulsion may be used in children aged between 4 months and 3 years if prescribed by your doctor. It is not recommended for use in children under 4 months of age.
Using Lexxema emulsion with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.
No interactions between Lexxema emulsion and other medicines are currently known.
Pregnancy, breastfeeding, and fertility
To avoid any risk to the child, do not use Lexxema emulsion if you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, unless your doctor specifically instructs you to do so.
If your doctor recommends using Lexxema emulsion during breastfeeding, do not apply the medicine to the breasts and avoid contact between the treated areas and the infant.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Lexxema emulsion does not affect your ability to drive or operate machinery.
Lexxema emulsion contains benzyl alcohol
This medicine contains 1.25 g of benzyl alcohol in each 100 g.
Benzyl alcohol may cause allergic reactions.
Benzyl alcohol may cause moderate local irritation.
3. How to use Lexxema emulsion
Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Unless otherwise directed by your doctor, the recommended dose is:
- Apply Lexxema emulsion as a thin layer once daily to the affected area, gently rubbing it in.
- In general, the duration of treatment with Lexxema emulsion should not exceed two weeks. Always keep the treatment as short as possible.
- If you are using Lexxema emulsion for a skin rash with inflammation and scaling on the face (seborrheic eczema), do not treat for longer than one week.
- If your skin becomes excessively dry, consult your doctor. A moisturizing ointment may eventually need to be applied as well.
Use in children
Lexxema emulsion may be used in children between 4 months and 3 years of age if prescribed by your doctor. Dose adjustments are not required.
The use of Lexxema emulsion is not recommended in children under four months of age due to lack of safety data.
If you use more Lexxema emulsion than you should
No risk is expected after a single overdose of Lexxema emulsion (too large an amount, too large an area of skin, or too frequent use). Repeated overdoses may cause adverse effects (see section 4. Possible side effects).
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at 91 562 04 20 (indicating the medicine and the amount ingested).
If you forget to use Lexxema emulsion
Do not use a double dose to make up for missed doses. If you have missed a dose, continue with your regular schedule as instructed by your doctor or as described in this leaflet.
If you stop using Lexxema emulsion
If you stop using Lexxema emulsion prematurely, the original symptoms of your skin condition may reappear. Please contact your doctor before stopping treatment with Lexxema emulsion.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Lexxema emulsion may cause adverse effects, although not everyone experiences 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 the available data.
-
Common:
- Local skin irritations (e.g. burning sensation)
-
Uncommon:
- Pain
- Itching
- Small blisters and pustules
- Desquamation (skin peeling)
- Superficial skin lesions (erosion)
- Worsening or recurrence of eczema
- Skin cracking
The use of anti-inflammatory drugs called corticosteroids (such as the active substance 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
- Inflammation of the hair follicle (folliculitis)
- Stretch marks (striae)
- Acne
- Specific skin inflammation around the upper lip and chin (perioral dermatitis)
- Skin allergic reaction (contact dermatitis)
- 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 may happen if the active substance (a corticosteroid) passes through the skin into the body (is absorbed). For example, this could increase eye pressure (glaucoma).
- Blurred vision.
Reporting of adverse effects
If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products, Website: www.notificaram.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Lexxema emulsion
Keep this medicine out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Validity period after first opening: 3 months.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, consult your pharmacist on how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Package contents and other information
Composition of Lexxema emulsion
- The active substance is Methylprednisolone aceponate (MPA).
- The other components (excipients) are: medium-chain triglycerides, caprylic-capric-miristic-stearic triglyceride, macrogol-2-stearyl ether, macrogol-21-stearyl ether, benzyl alcohol, disodium edetate, glycerol (E-422) (85%), and purified water.
Appearance of the medicinal product and contents of the container
Lexxema emulsion is a white cutaneous emulsion (similar to an opaque milky cream) and is available in tubes of 20 g and 50 g.
The tubes are provided with a removable seal.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
- Italfarmaco, S.A.
C/ San Rafael, 3
28108 Alcobendas (Madrid) - Spain
Manufacturer: LEO Pharma Manufacturing Italy S.r.l.
Via E. Schering, 21
20054 Segrate (Milan) - Italy
Date of the most recent revision of this leaflet: August 2019
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/