Lexxema 1 mg/g cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Lexxema 1 mg/g cream
Methylprednisolone aceponate
Read the entire 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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents
- What Lexxema cream is and what it is used for
- What you need to know before using Lexxema cream
- How to use Lexxema cream
- Possible adverse effects
- How to store Lexxema cream
- Contents of the pack and other information
1. What Lexxema cream is and what it is used for
It is an anti-inflammatory medicine (a corticosteroid) for topical use on the skin.
Lexxema cream reduces inflammation and allergic reactions of the skin, as well as those associated with excessive proliferation 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 cream is used in the treatment of:
- Mild to moderate acute 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 commonly used substances such as soap (irritant contact dermatitis).
- Coin-shaped rash (nummular eczema).
- Itchy rash affecting the hands and feet (dyshidrotic eczema).
- Unspecified eczema (atopic eczema).
- Eczema related to patient-specific factors (endogenous eczema), such as atopic dermatitis or neurodermatitis.
- Skin rash with inflammation and scaling (seborrheic eczema).
This cream formulation is particularly indicated for exudative conditions (those that secrete fluid).
2. What you need to know before using Lexxema cream
Do not use Lexxema cream
- If you are allergic to 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 (e.g., chickenpox or herpes).
- If you have rosacea (a condition causing red/pink skin inflammation), ulcers, acne, or skin diseases associated with thinning of the skin (atrophy).
- On areas of skin showing a vaccine reaction, such as redness or inflammation after vaccination.
- For specific skin inflammation around the upper lip and chin (perioral dermatitis).
- In bacterial or fungal infections; see section “Warnings and precautions”.
- Must not be used in the eyes or on deep open wounds.
- In children under four months of age, due to lack of experience.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Lexxema cream.
If your doctor also diagnoses a bacterial or fungal infection, you must use any additional prescribed treatment for the infection, as otherwise the infection may worsen.
Contact your doctor if you experience blurred vision or other visual disturbances.
Anti-inflammatory drugs (corticosteroids), such as the active substance in Lexxema, have significant effects on the body. The use of Lexxema on 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, especially in children.
- Use only for the minimum time necessary to relieve the skin condition.
- Lexxema cream must not come into contact with the eyes, mouth, open wounds, or mucous membranes (e.g., anal or genital areas).
- Must not be used in skin folds, groin, or armpits.
- Must not be used under air- and water-impermeable materials, including dressings (unless directed by your doctor), bandages, clothing, or non-breathable diapers.
If Lexxema is used for conditions other than those for which it was prescribed, it may mask symptoms and make correct diagnosis and treatment more difficult.
If Lexxema cream 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. Contact your doctor or pharmacist if you need further information.
Children
It is important to note that diapers may be occlusive. If the doctor has previously assessed the benefits and risks, Lexxema cream may be prescribed for use in children between 4 months and 3 years of age.
Other medicines and Lexxema cream
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
No interactions between Lexxema cream and other medicines are currently known.
Pregnancy, breastfeeding, and fertility
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.
To avoid any risk to the child, you must not use Lexxema cream during pregnancy or breastfeeding unless specifically instructed by your doctor.
If your doctor recommends using Lexxema cream during breastfeeding, do not apply the medicine to the breasts and avoid contact of the child with treated areas.
Driving and use of machines
Lexxema cream does not affect your ability to drive or operate machinery.
Lexxema cream contains cetostearyl alcohol and butylhydroxytoluene (E-321)
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetostearyl alcohol and butylhydroxytoluene (E-321).
This medicine may cause irritation of the eyes and mucous membranes 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 instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.
Unless your doctor has instructed otherwise, the recommended dose is:
Cutaneous use.
- Apply a thin layer of Lexxema cream once daily to the affected area, rubbing in gently.
- In general, the duration of treatment should not exceed 12 weeks. Always keep the treatment as short as possible.
- Intermittent treatment is recommended when prolonged treatment is required.
- If you are using Lexxema for a skin rash with inflammation and scaling (seborrheic eczema) on the face, do not treat the affected areas for longer than one week.
If the skin becomes excessively dry during treatment, consult your doctor. Depending on the type of affected skin, it is recommended to switch treatment to another product from the Lexxema range with a higher fat content (Lexxema ointment or Lexxema paste).
Use in children
Lexxema cream must not be used in children under four months of age due to lack of safety data.
The duration of treatment in children should be kept to a minimum and should generally not exceed 4 weeks.
If you use more Lexxema cream than you should
No risk of acute intoxication is expected following a single cutaneous overdose (application over a large area, under conditions favorable for absorption) or following accidental ingestion.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at telephone (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 missed doses. If you have forgotten a dose, continue with your usual schedule according to your doctor's instructions or as described in this leaflet.
If you stop using Lexxema cream
If you stop treatment prematurely, the original symptoms of your skin condition may reappear. Contact your doctor before stopping treatment with Lexxema cream.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The assessment of adverse 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:
Hypersensitivity to the active substance.
Blisters (vesicles), dryness, redness (erythema), inflammation of hair follicles (folliculitis), rashes, and abnormal skin sensations such as numbness, tingling, or burning (paresthesia). -
Rare:
Fungal infection
Skin cracking, acne, pus-forming infection (pyoderma), dilated small blood vessels in the skin (telangiectasia), and thinning of the skin (atrophy).
Cellulitis, swelling (edema), and irritation at the application site. -
Frequency not known:
Stretch marks (striae) on the skin, specific skin inflammation around the upper lip and chin (perioral dermatitis), skin discoloration, and allergic skin reactions.
Excessive hair growth (hypertrichosis).
Blurred vision.
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 into the body through the skin. For example, this could increase eye pressure (glaucoma).
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 Medicines: www.notificaram.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Lexxema cream
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Do not refrigerate or freeze.
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.
Medicines must not be disposed of via wastewater drains or in household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the container and other information
Composition of Lexxema cream
- The active substance is methylprednisolone aceponate (MPA). Each g of cream contains 1 mg of methylprednisolone aceponate (0.1%).
- The other components (excipients) are: decyl oleate, glycerol monostearate 40-50%, cetyl alcohol, hard fat, caprylic-capric-myr listic-ste aric triglycerides, polyoxyl 40 stearate, glycerol 85% (E-422), disodium edetate, benzyl alcohol, butylhydroxytoluene (E-321) and purified water.
Appearance of the product and contents of the pack
Lexxema cream is a white, opaque cream and is available in tubes of 30 g and 60 g.
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 the most recent revision of this leaflet: August 2021.
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/