MENADERM SIMPLE 0.25 mg/g OINTMENT

Introduction

Package Leaflet: Information for the User

Menaderm Simple 0.25 mg/g Ointment

Beclometasone dipropionate

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Menaderm Simple and what is it used for
2. What you need to know before using Menaderm Simple
3. How to use Menaderm Simple
4. Possible side effects

5 Conservation of Menaderm Simple

1. Contents of the packaging and additional information

1. What is Menaderm Simple and what is it used for

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

Menaderm Simple is indicated in adults and children over 5 years of age, 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 substances of habitual use, such as soap (irritant contact dermatitis).
• Itchy eruption on hands and feet (dyshidrotic eczema).
• Eczema (rash) unspecified (atopic eczema).

Eczemas related to patient factors, such as atopic dermatitis or neurodermatitis.

Skin eruption with inflammation and scaling (seborrheic eczema).

Psoriasis.

Menaderm Simple in the form of ointment is particularly indicated in dry conditions.

2. What you need to know before starting to use Menaderm Simple

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 of the skin around the nose and cheeks (rosacea), inflammation around the mouth (perioral dermatitis), ulcers, acne, or skin thinning diseases (atrophy)
• In areas of the skin showing a vaccination reaction, i.e., redness or inflammation after vaccination
• In the eyes or on open wounds
• In children under 1 year of age
• In case of bacterial or fungal skin infections (see the following 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 time strictly necessary to treat the skin condition.
• In case of bacterial or fungal infections, consult your doctor, who will establish the appropriate antibacterial or antifungal treatment, as the infection may worsen if not treated.
• It should not be used under impermeable materials, such as bandages, dressings, or diapers, which are not very breathable.
• Menaderm Simple should not be used on large areas of skin.
• Menaderm Simple should not come into contact with the eyes, open wounds, or mucous membranes (e.g., mouth or genital area, where absorption is much higher).
• If you use the medication on skin folds (e.g., armpits or groin), you should be very cautious, as it may increase the absorption of the active ingredient into the body.
• If you are being treated for psoriasis, strict medical supervision is recommended to monitor 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 of age. In children under 5 years of age, the use of this medication is not indicated.

In children, it is more likely that the corticosteroid will pass into the body through the skin and have adverse effects on other areas of the body. In children treated with corticosteroids, it may cause alterations in the glands located near the kidneys or a condition characterized by, among other symptoms, obesity, growth retardation, 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 recently used, or may need to use any other medication.

To date, no interactions have been reported between Menaderm Simple ointment 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, during the first trimester of pregnancy, medications containing corticosteroids should not be applied.

Menaderm Simple should not be used during pregnancy or breastfeeding unless your doctor considers it clearly necessary, weighing the benefits against the risks.

Pregnant or breastfeeding women, or those planning a pregnancy, should not use Menaderm Simple on large areas, for prolonged periods, or with occlusive dressings.

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

Driving and Using Machines

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

Menaderm Simple contains methylparaben, lanolin, and ethanol.It may cause allergic reactions (possibly delayed) because it contains methylparaben (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. Alcohol (ethanol) may cause a burning sensation on damaged skin.

3. How to Use Menaderm Simple

Follow your doctor's instructions for using this medication exactly. If you are unsure, consult your doctor again.

The recommended dose is:

Adults:

One or two applications to the skin per day.

In general, treatment should not exceed two weeks. If you use the medication for a facial condition, treatment should be as short as possible.

Use in Children:

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

In children, treatment should be as short as possible, for short periods, and with the minimum amount of product necessary.

Topical use.

Administration should be performed by applying a thin layer to the affected area and gently rubbing, preferably after cleaning.

If you use more Menaderm Simple than you should

Excessive use of topical corticosteroids (repeated overdoses) may cause side 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 Toxicology Information Service, phone 91 562 04 20 (indicating the medication and the amount ingested).

If you forget to use Menaderm Simple

Do not use 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 the package leaflet.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Generally, side 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 to the skin, the following effects have been reported, whose frequency is not known (cannot be estimated from available data):

• Blurred vision
• Skin thinning (atrophy)
• Stretch marks
• Dry skin
• Itching or burning
• Redness (erythema)
• Appearance of red spots
• Bruises
• Inflammation of hair follicles (folliculitis)
• Increased hair growth
• Condition around the mouth (perioral dermatitis)
• Skin discoloration
• Acne
• Allergic skin reaction (contact dermatitis)
• Infections
• Side 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 into the body through the skin. This, for example, can increase eye pressure (glaucoma) or may cause: a condition characterized by a rounded face, fat accumulation, delayed healing, etc. (Cushing's syndrome); increased blood pressure, fluid retention (edema), thyroid disorders (hyperthyroidism), increased blood and urine sugar levels (hyperglycemia and glucosuria).

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Menaderm Simple

Keep out of sight and reach of children.

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

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the Packaging and Additional Information

Composition of Menaderm Simple:

• The active ingredient is Beclometasone dipropionate.

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

• The other components (excipients) are: methylparaben (E-218), lanolin, liquid paraffin, white soft paraffin, extract of Althaea officinalisroot, and ethanol.

Appearance of the Product and Packaging Contents

Menaderm Simple 0.25 mg/g ointment is a uniform, oily paste with a yellow color. It is available in 30 and 60 g aluminum tubes.

Other presentations: Menaderm Simple 0.25 mg/ml cutaneous emulsion and Menaderm Simple 0.25 mg/g cream.

Marketing Authorization Holder and Manufacturer

LABORATORIOS MENARINI, S.A.

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

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

Date of the Last Revision of this Package Leaflet: December 2020.

Other Sources of Information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/