Leaflet: information for the user

Menaderm Simple 0.25 mg/g ointment

beclometasone dipropionate

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 Menaderm Simple is and what it is used for

2.What you need to know before using Menaderm Simple

3.How to use Menaderm Simple

4.Possible side effects

5Storage of Menaderm Simple

6.Contents of the pack and additional information

It is ananti-inflammatory medication, which belongs 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:

• Allergy to a substance that has come into contact with the skin (allergic contact dermatitis).
• Allergic reaction to common substances used such as, for example, soap (irritant contact dermatitis).
• Itchy rash on hands and feet (eczema dishidrotic).
• Eczema (rash) without specification (eczema vulgar).

?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 the form of ointment, is indicated mainly for dry conditions.

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, 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, 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, as otherwise the infection may worsen.
• This medication should not be used under impermeable materials to air and water, such as bandages, dressings, or diapers, which 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 in areas of the skin with folds (e.g. armpits or groin), you must be very careful as 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.
• Consult 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, there may be an alteration of the adrenal glands located near the kidneys or a characteristic alteration, among other symptoms, by obesity, growth delay, etc. (Cushing's syndrome) or an increase in intracranial pressure (intracranial hypertension).

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 ointment and other medications.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be 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.

Menaderm Simple 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 Simple contains parahydroxybenzoic acid methyl ester, lanolin, and ethanol.It may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoic acid methyl ester (E-218).

This medication may cause local skin reactions (such as contact dermatitis) because it contains lanolin.

This medication contains 0.0042 mg of alcohol (ethanol) per gram of ointment. Ethanol may cause a burning sensation on damaged skin.

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.

Generally, 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 Simpleis contraindicated in children under 1 year and is not indicated in children under 5 years.

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 on the affected area and gently rubbing it in, 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 for 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 callthe Toxicological Information Service, phone 91 562 04 20 (indicating the medication and the amount ingested).

If you forgot to useMenaderm 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 medicationcan produce adverse effects, although not all people experience them.

In generaladverse effects are local and transient, but they maybe more frequent if large areas are treated or withprolonged application,with dressings or occlusive materialsand/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 cutaneous

-Skin dryness

- Itching or burning

- Redness (erythema)

- Appearance of red patches

- Hematomas

- Inflammation of hair follicles (folliculitis)

- Increased hair growth

- Affection around the mouth (perioral dermatitis)

- Skin discoloration

-Acne

-Skin allergic reaction (contact dermatitis)

-Infections

- Adverse effects can 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, can 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 usethis medicationafter 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.Deposit the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Menaderm Simple:

• The active principle is Beclometasona dipropionate.

Each gram of ointment contains 0.25 mg of beclometasona dipropionate (0.025%).

• The other components (excipients) are:parahidroxibenzoate of methyl (E-218), lanolina,liquid paraffin, paraffin wax, extract of root ofAlthaea officinalisand ethanol.

Appearance of the product and contents of the packaging

Menaderm Simple0.25 mg/gointment, is a uniform and yellowish oily paste. It is presented in flexible aluminum tubes of 30 and 60 g.

Other presentations: Menaderm Simple0.25 mg/ml skin emulsion andMenaderm Simple0.25 mg/g cream.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS MENARINI, S.A.

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

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

Date of the last review of this leaflet: December 2020.

Other sources of information

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