Leaflet: information for the user

Lexxema 1mg/ml topical solution

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, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do 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 is Lexxema solution and what it is used for

2.What you need to know before using Lexxema solution

3.How to use Lexxema solution

4.Possible side effects

5.Storage of Lexxema solution

6. Contents of the pack and additional information

Lexxema solution is an anti-inflammatory medication (a corticosteroid) for exclusive use on the scalp.on the scalp.

Lexxema solution inhibits skin inflammatory and allergic reactions, as well as those associated with an increase in cell number (hyperproliferation), leading to a reduction in redness and fluid accumulation (edema), and relieving itching, burning, or pain.

Lexxema solution is indicated for the treatment of inflammatory and pruritic scalp conditions, such as:

-Acute eczema related to an external cause, such as:

-Allergy to a substance that has come into contact with the scalp (allergic contact dermatitis), or by

-Irritation due to habitual substances (irritant contact dermatitis).

-Unspecified eczema (eczema vulgar)

-Eczema related to patient factors (endogenous eczema), such as atopic dermatitis or neurodermatitis

- Inflammatory and flaking eruption (seborrheic eczema).

No use Lexxema solution

• If you are allergic (hypersensitive) to the active ingredient or to any of the other components of this medication included in section 6.
• If you have tuberculosis or syphilitic processes or viral infections (e.g. varicella or herpes).
• In ulcers or open wounds or acne.
• In scalp infections caused by bacteria or fungi (unless treated additionally with a specific treatment).

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Lexxema 1 mg/ml solution.

• Corticosteroids should be used with caution, in the lowest possible dose and only for the strictly necessary time to relieve the skin condition.
• If your doctor diagnoses an additional bacterial or fungal infection; an additional specific treatment prescribed for the infection is required because, if not, the infection may worsen.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• Lexxema solution is flammable, so it should not be applied near an open flame.
• When applying Lexxema solution, avoid contact with the eyes and open wounds and mucous membranes.
• The application of corticosteroids to large areas of the body or for prolonged periods significantly increases the risk of local or systemic side effects (in areas of the body other than the application site).
• Lexxema solution should not be used under impermeable materials to air and water, such as bandages or non-breathable clothing.
• If you use Lexxema solution for conditions other than those for which it has been prescribed, it may mask symptoms and make it difficult to diagnose and treat correctly.

Use in children and adolescents

Lexxema Solution should not be used in children under 18 years of age because there is currently no clinical experience with them.

Use of Lexxema and other medications

Inform your doctor, pharmacist or nurse that you are using, have recently taken or may need to use any other medication.

No interactions of Lexxema solution with other medications are known.

Pregnancy, breastfeeding and fertility

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.

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

During breastfeeding, do not apply Lexxema solution to the treated areas.

Driving and operating machinery

Lexxema solution does not affect the ability to drive and operate machinery.

Follow exactly the application instructions for Lexxema solution as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

EXCLUSIVE CUTANEOUS USE ON THE SCALP.

The normal dose is:

Adults and adolescents over 18 years old:

Lexcema solution is applied once a day to the affected areas of the scalp.

The solution should be applied in the form of drops with a gentle massage.

Your doctor will indicate the duration of treatment with Lexxema solution, but it should not exceed 4 weeks.

Use in children

Children under 18 years old should not use Lexxema solution as its safety has not been established in them.

If you use more Lexxema Solution than you should

Studies have not indicated that any risk can be expected after the application of a single overdose. Repeated overdoses may cause adverse effects (see section 4).

After accidental oral ingestion of the solution, effects due to the isopropyl alcohol excipient may be expected. These effects may manifest as central nervous system depression after ingestion of only a few milliliters, or gastrointestinal disturbances.

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, Telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Lexxema solution

Do not apply 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 prospectus.

If you interrupt the treatment withLexcema solution

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

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

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Like all medications, Lexxema solution may cause side effects, although not everyone will experience them.

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

Very common:affects more than 1 in 10 patients

Common:affects 1 to10 in every 100 patients

Uncommon:affects 1 to10 in every 1,000 patients

Rare:affects 1 to10 in every 10,000 patients

Very rare:affects less than 1 in every 10,000 patients.

Frequency cannot be estimated from available data.

Dermatological and subcutaneous tissue disorders

Uncommon: seborrheic dermatitis and hair loss

Frequency cannot be estimated: skin atrophy, acne, telangiectasias, skin striations, perioral dermatitis, skin discoloration, and skin allergic reactions

General disorders and administration site conditions

Common: burning sensation at the application site

Uncommon: pruritus, pain, dryness, folliculitis, irritation, and eczema at the application site and localized sensation of heat.

Frequency cannot be estimated: vesicles and erythema at the application site, hirsutism

Eye disorders:

Frequency cannot be estimated: blurred vision.

Side 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) passes through the skin into the body. This, for example, can increase eye pressure (glaucoma).

Reporting of side effects

If you experience any type ofsideeffects, consult your doctor or pharmacist, even if it is a side 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 side effects, you can contribute to providing more information on the safety of this medication.

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Keep out of sight and reach of children.

Do not store at a temperature above 86°F (30°C).

Do not use Lexxema solution after the date that appears on the container after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Dispose of containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. By doing so, you will help protect the environment.

The active principle is Methylprednisolone aceponate. Each ml of solution contains 1 mg of methylprednisolone aceponate.

The other components (excipients) are: isopropyl myristate and isopropyl alcohol.

Appearance of the product and contents of the packaging

Lexxema 1 mg/ml cutaneous solution is a clear, transparent liquid, presented in a multidose container with a dropper cap, in 50 ml and 20 ml.

Only some sizes of packaging may be marketed.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization:

ITALFARMACO S.A.

C/ San Rafael, 3 – 28108 Alcobendas (Madrid)

Manufacturer responsible:

Berlimed, S.A.

Polígono Industrial Santa Rosa

C/ Francisco Alonso, 7

28806 Alcalá de Henares (Madrid)- Spain

Last review date of this leaflet:October 2018