Leaflet: information for the user

Menaderm Simple 0.25 mg/g cream

beclometasone dipropionate

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

Contents of the pack 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 for adults and children over 5 years old, in:

• Acute forms of inflammatory skin conditions (dermatitis) caused by:

• 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).
• Itching eruption on hands and feet (dishidrotic eczema). -Eczema (eruption) without specification (vulgar eczema).
• • Eczemas related to patient factors, such as atopic dermatitis or neurodermatitis.
  • Eruption on the skin with inflammation and peeling (seborrheic eczema).
  • Psoriasis.

Menaderm Simple in this cream form is indicated mainly for exudative conditions (which secrete liquid).

No 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, skin diseases with thinning (atrophy)
• In areas of the skin showing 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 precautionsConsult your doctor or pharmacist before starting to use Menaderm Simple

• This medication should be used in the lowest possible doses, especially in children, and only for the strictly necessary time 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, deep open wounds, or mucous membranes (e.g. the mouth or genital area, where absorption is much higher).
• If you use the medication on 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, a strict medical supervision is recommended in 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, have used recently, or may need to use any other medication.

At present, there are no known interactions between Menaderm Simple and other medications.

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 medication.

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

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 cream on extensive areas, for prolonged periods of time, or with occlusive dressing.

Menaderm Simple cream should not be applied to the breasts during breastfeeding.

Driving and operating machinery

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

Menaderm Simplecontains cetomacrogol, cetearyl alcohol, propylene glycol, and benzyl alcohol.

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetomacrogol and cetearyl alcohol.

This medication contains 40 mg of propylene glycol in each gram of cream.

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

This medication contains 10 mg of benzyl alcohol in each gram of cream.

Benzyl alcohol may cause allergic reactions and moderate local irritation.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

The recommended dose is:

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

Use in children:

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

Topical use. Administration should be done by applying a thin layer smoothly over the affected area, preferably after cleaning.

If you use more Menaderm Simple than you should

Excessive use of topical corticosteroids (repeated overdoses) 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 withdrawn gradually.

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 as instructed by your doctor or as 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 may 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):

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 for 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 point of 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 g of cream 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, stearic acid, cetomacrogol 700, sorbitol, and water.

Appearance of the product and contents of the packaging

Menaderm Simple 0.25 mg/g is a uniform cream with a white color. It is presented in flexible aluminum tubes of 30 and 60 g.

Other presentations: Menaderm Simple 0.25 mg/ml topical emulsion 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/