MENADERM SIMPLE 0.25 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Menaderm Simple 0.25 mg/g cream

beclometasone dipropionate

Read this package leaflet carefully before you start using this medicine, as it contains important information for you.Keep this package leaflet, you may need to read it again.

• 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, do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.

• If you experience any side effects, talk to your doctor or pharmacist, even if they are 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 you start using Menaderm Simple
3. How to use Menaderm Simple
4. Possible side effects
5. Storage of Menaderm Simple

Contents of the pack and further information

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

It is an anti-inflammatory medicine, belonging to a group of medicines called corticosteroids, for use on the skin, which reduce 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, 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 (eruption) 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 this cream form is indicated especially in exudative conditions (which secrete fluid).

2. What you need to know before you start using Menaderm Simple

Do not use Menaderm Simple

• If you are allergic to the active ingredient, to other corticosteroids or to any of the other ingredients of this medicine (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 that show a vaccination reaction, i.e. redness or inflammation after vaccination
• In the eyes, or in deep open wounds -In children under 1 year
• In case of bacterial or fungal skin diseases (see the following section).

Warnings and precautionsConsult your doctor or pharmacist before starting to use Menaderm Simple

• This medicine should be used in the lowest possible doses, especially in children, and only for the shortest period 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 otherwise the infection may worsen.
• It should not be used under airtight and waterproof 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, deep open wounds, or mucous membranes (e.g. mouth or genital area, where absorption is much higher).
• If you use the medicine on skin folds (e.g. armpits or groin), you should be very careful because it can increase the absorption of the active ingredient into the body.
• If you are being treated for psoriasis, 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 medicine is not indicated.

In children, it is more likely that the corticosteroid will pass into the body through the skin and have adverse effects in other areas of the body. In children treated with corticosteroids, there may be an alteration of the glands located near the kidneys or an alteration characterized, among other symptoms, by obesity, growth retardation, etc. (Cushing's syndrome) or an increase in intracranial pressure (intracranial hypertension).

Other medicines and Menaderm Simple

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

So far, no interactions of Menaderm Simple 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.

As a general rule, during the first trimester of pregnancy, medicines 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 cream on large areas, for prolonged periods, or with occlusive dressings.

Menaderm Simple cream 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 Simplecontains cetyl alcohol, stearic alcohol, propylene glycol, and benzyl alcohol.

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol and stearic alcohol.

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

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

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

Benzyl alcohol may cause allergic reactions and moderate local irritation.

3. How to use Menaderm Simple

Follow exactly the instructions for administration of this medicine indicated by your doctor. In case of doubt, 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 medicine for a condition on the face, the treatment should be as short as possible.

Use in children:

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

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

Topical use. Administration should be done by gently applying a thin layer to 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. The acute symptoms of excessive use of corticosteroids 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 medicine 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 medicines, this medicine can cause side effects, although not everybody gets 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 the available data):

• Blurred vision
• Thinning of the skin (atrophy)
• Stretch marks
• Dryness of the skin
• Itching or burning
• Redness (erythema)
• Appearance of red spots
• Bruises
• Inflammation of hair follicles (folliculitis)
• Increased hair growth
• Skin condition around the mouth (perioral dermatitis)
• Discoloration of the skin
• 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.aemps.gob.es/ By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Menaderm Simple

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. 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 further information

Composition of Menaderm Simple

-The active ingredient is Beclometasone dipropionate.

1 g of cream contains 0.25 mg of Beclometasone dipropionate (0.025%).

-The other ingredients (excipients) are: cetyl alcohol, stearic alcohol, propylene glycol, extract of Althaea officinalisroot, liquid paraffin, anhydrous lanolin, benzyl alcohol, stearic acid, cetomacrogol 700, sorbitol, and water.

Appearance of the product and contents of the pack

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 cutaneous emulsion and Menaderm Simple 0.25 mg/g ointment.

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 last revision of this package leaflet: December 2020.

Other sources of information

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