LEXXEMA 1 mg/ml CUTANEOUS SOLUTION

Introduction

Package Leaflet: Information for the User

Lexxema 1mg/ml Cutaneous Solution

Methylprednisolone aceponate

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

• Keep this package 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 package leaflet:

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

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

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

Lexxema solution inhibits inflammatory and allergic reactions of the skin, as well as those associated with an increase in the number of cells (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 pruriginous conditions of the scalp, 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
• irritation due to substances of habitual use (irritant contact dermatitis).
• Unspecified eczema (vulgar eczema)
• Eczema related to patient factors (endogenous eczema), such as atopic dermatitis or neurodermatitis
• Erupción with inflammation and scaling (seborrheic eczema).

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

Do not use Lexxema solution

• If you are allergic (hypersensitive) to the active substance or to any of the other components of this medicine included in section 6.
• If you suffer from tuberculous or syphilitic processes or viral infections (e.g., chickenpox or herpes).
• In ulcers or open wounds or acne.
• In scalp infections caused by bacteria or fungi (unless they are also being treated 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 time strictly necessary to relieve the skin condition.
• If your doctor diagnoses a bacterial or fungal infection; specific additional treatment is required for the infection, 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.
• Applying corticosteroids to large areas of the body or for prolonged periods 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 airtight and waterproof materials, 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 diagnosis and correct treatment more difficult.

Use in children and adolescents

Lexxema solution should not be used in children under 18 years of age because there is no clinical experience available in this age group to date.

Use of Lexxema and other medicines

Tell your doctor, pharmacist, or nurse that you are using, have recently used, or might use any other medicine.

No interactions of Lexxema solution with other medicines are known.

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 solution if you are pregnant or breastfeeding, unless your doctor advises you to do so.

During breastfeeding, do not apply Lexxema solution to the areas that come into contact with the baby's skin.

Driving and using machines

Lexxema solution does not affect the ability to drive and use machines.

3. How to use Lexxema solution

Follow the instructions for applying Lexxema solution exactly 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:

Lexxema 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 of age should not use Lexxema solution, as its safety in this age group has not been established.

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 produce side effects (see section 4).

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

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 medicine and the amount ingested.

If you forget to use Lexxema solution

Do not apply 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 this package leaflet.

If you stop using Lexxema solution

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

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

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4. Possible side effects

Like all medicines, Lexxema solution can cause side effects, although not everybody gets them.

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

Very common: affects more than 1 in 10 patients

Common: affects 1 to 10 in 100 patients

Uncommon: affects 1 to 10 in 1,000 patients

Rare: affects 1 to 10 in 10,000 patients

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

Frequency not known (cannot be estimated from the available data).

Disorders of the skin and subcutaneous tissue

Uncommon: seborrheic dermatitis of the scalp and hair loss

Frequency not known: skin atrophy, acne, telangiectasias, skin striae, perioral dermatitis, skin discoloration, and allergic skin 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 not known: vesicles and erythema at the application site, hirsutism

Eyedisorders:

Frequency not known: blurred vision.

Side effects may occur not only in the treated area but also in completely different areas of the body. This happens if the active substance (a corticosteroid) passes into the body through the skin. This, for example, can increase the pressure in the eye (glaucoma).

Reporting of side effects

If you experience any of the side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System, Website: www.notificaRAM.es.

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

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5. Storage of Lexxema solution

Keep out of the sight and reach of children.

Do not store above 30°C.

Do not use Lexxema solution after the expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

The active substance 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 pack contents

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

ITALFARMACO S.A.

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

Manufacturer:

Berlimed, S.A.

Polígono Industrial Santa Rosa

C/ Francisco Alonso, 7

28806 Alcalá de Henares (Madrid) - Spain

Date of the last revision of this package leaflet: October 2018