Label: information for the usero

Menaderm Simple 0.25 mg/ml topical emulsion

beclometasona dipropionato

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

This medication has been prescribed only to you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Contents of the package and additional information

It is an anti-inflammatory medication, belonging to the group of medications called corticosteroids, for use on the skin, which reduces inflammation and skin allergic reactions. It decreases redness and discomfort such as itching, burning sensation, and pain.

Menaderm Simple is indicated in adults and children over 5 years old, for:

• Acute forms of inflammatory skin conditions (dermatitis) caused by:
• • Allergic contact dermatitis caused by an allergen that has come into contact with the skin.
  • Irritant contact dermatitis caused by substances commonly used such as, for example, soap.
  • Itchy rash on hands and feet (dishidrotic eczema).
  • Unspecified eczema (vulgar eczema).
• Eczemas related to patient factors, such as atopic dermatitis or neurodermatitis.
• Rash on the skin with inflammation and peeling (seborrheic eczema).
• Psoriasis.
• Menaderm Simple in this form of cutaneous emulsion is indicated mainly in exudative conditions (which secrete liquid).

Do not use Menaderm Simple

• If you are allergic to the active ingredient, other corticosteroids, or any of the other components of this medication (listed in section 6)
• If you have tuberculosis, syphilis, or viral infections (e.g. herpes or chickenpox)
• If you have chronic inflammation with redness around the nose and cheeks (rosacea), inflammation around the mouth (perioral dermatitis), ulcers, acne, or diseases with skin thinning (atrophy)
• In areas of the skin that show a vaccine reaction, i.e. redness or inflammation after the vaccine
• In the eyes, or in deep open wounds
• In children under 1 year - In case of bacterial or fungal skin diseases (see the next section).

Warnings and precautions

• Consult your doctor or pharmacist before starting to use Menaderm Simple.This medication should be used in the lowest possible doses and only for the time strictly necessary to treat the skin condition.
• If bacterial or fungal infections develop, consult your doctor, who will establish the appropriate antibacterial or antifungal treatment, because otherwise the infection may worsen.
• Do not use under impermeable materials to air and water, such as bandages, dressings, or diapers, that are poorly breathable.
• Menaderm Simple should not be used on extensive areas of skin.
• Menaderm Simple should not come into contact with the eyes, open wounds, or mucous membranes (e.g. the mouth or genital area, where absorption is much higher).
• If you use the medication in skin areas with folds (e.g. armpits or groin), you must be very careful because it may increase the absorption of the active ingredient into the body.
• If you are being treated for psoriasis, it is recommended to have strict medical supervision of the evolution of symptoms.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children

Do not use in children under 1 year. In children under 5 years, the use of this medication is not indicated.

In children, it is more likely that the corticosteroid will pass through the skin and have adverse effects in other parts of the body. In children treated with corticosteroids, an alteration of the glands located near the kidneys or a characteristic alteration, among other symptoms, such as obesity, growth delay, etc. (Cushing's syndrome) or an increase in intracranial pressure (intracranial hypertension) may occur.

Other medications and Menaderm Simple

Inform your doctor or pharmacist if you are using or have recently usedor may need to use any other medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant,consult your doctor or pharmacist before using this medication.

As a general rule, during the first trimester of pregnancy, corticosteroid medications should not be applied.

Menaderm Simple will not be used during pregnancy or breastfeeding unless your doctor considers it clearly necessary, weighing the benefits against the risks. Pregnant women or those planning to become pregnant, or during breastfeeding, should not use Menaderm Simple on extensive areas, for prolonged periods of time, or with occlusive dressing.

Do not apply Menaderm Simple to the breasts during breastfeeding.

Driving and operating machinery

The use of Menaderm Simple emulsion does not affect the ability to drive or operate machinery.

Menaderm Simplecontains cetomacrogol, stearic alcohol, propylene glycol, and benzyl alcohol.This medication may cause local skin reactions (such as contact dermatitis) because it contains cetomacrogol and stearic alcohol.

This medication contains 9 mg of propylene glycol in each ml of topical emulsion..

This medication may cause skin irritation because it contains propylene glycol.

This medication contains 10 mg of benzyl alcohol in each ml of topical emulsion.

Benzyl alcohol may cause allergic reactions and moderate local irritation.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.

The recommended dose is:

Adults: One or two applications on the skin per day. In general, treatment should not exceed two weeks. If you use the medication for any facial condition, treatment should be as short as possible.

Use in children:

• Children over 5 years old: One or two applications on the skin per day.
• Menaderm Simple is contraindicated in children under 1 year and is not indicated in children under 5 years old.

Treatment in children should be as short as possible, in short periods of time, and with the minimum amount of the product possible.

Topical use.

Shake before use.

If you use more Menaderm Simple than you should

Excessive use of topical corticosteroids (repeated overdose) may cause adverse effects (see section 4). Treatment of overdose is symptomatic. Acute symptoms of excessive corticosteroid use are generally reversible. In cases of chronic toxicity, it is recommended that corticosteroids be gradually withdrawn.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or go to a medical center, or call the Toxicological Information Service, phone 91 562 04 20 (indicating the medication and the amount ingested).

If you forgot to use Menaderm Simple

Do not use a double dose to compensate for the missed dose; 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 have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Generally, adverse effects are local and transient, but they may be more frequent if large areas are treated or with prolonged application, with dressings or occlusive materials and/or in children.

With the application of corticosteroids on the skin, the following effects have been reported, whose frequency is unknown (the frequency cannot be estimated from the available data):

• Blurred vision
• Skin thinning (atrophy)
• Striae
• Skin dryness
• Itching or burning
• Redness (erythema)
• Appearance of red patches
• Bruising
• Folliculitis (inflammation of hair follicles)
• Excessive hair growth
• Dermatitis around the mouth (perioral dermatitis)
• Skin discoloration
• Acne
• Contact dermatitis (allergic skin reaction)
• Infections
• Adverse effects may occur not only in the treated area, but also in completely different areas of the body, which occurs if the active ingredient passes through the skin into the body. This, for example, may increase eye pressure (glaucoma) or may cause: a condition characterized by a rounded face, accumulation of fat, delayed healing, etc. (Cushing's syndrome); increased blood pressure, fluid retention (edema), thyroid dysfunction (hyperthyroidism), increased blood sugar levels and urine (hyperglycemia and glucosuria).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for human use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Menaderm Simple:

• The active ingredient is Beclometasona dipropionate. 1 ml of emulsion contains 0.25 mg of Beclometasona dipropionate (0.025 %).

• The other components (excipients) are: cetyl alcohol, stearyl alcohol, propylene glycol, extract of root ofAlthaea officinalis, liquid paraffin, paraffin wax, benzyl alcohol, glycerol (E-422), stearic acid, cetomacrogol 700, sorbitol, dimethicone, fragrance and water.

Appearance of the product and contents of the packaging

Menaderm Simple 0.25 mg/ml is a topical emulsion. It is a uniform liquid with a white color. It is presented in 60 ml bottles.

Other presentations: Menaderm Simple 0.25 mg/g cream and Menaderm Simple 0.25 mg/g ointment.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS MENARINI, S.A.

Alfons XII, 587 – E 08918 Badalona (Barcelona) Spain

Telephone: +34 934 628 800 – Email:[email protected]

Last review date of this leaflet: December 2020.

Other sources of information

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/