MENADERM SIMPLE 0.25 mg/ml CUTANEOUS EMULSION

Introduction

Package Leaflet: Information for the User

Menaderm Simple 0.25 mg/ml Cutaneous Emulsion

Beclometasone dipropionate

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

• Keep this 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 only. Do not pass it on to others. 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 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 the 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 (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 this form of cutaneous emulsion 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 substance, 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 diseases with skin thinning (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 - In case of bacterial or fungal skin diseases (see the following section).

Warnings and Precautions

• Talk to your doctor or pharmacist before starting to use Menaderm Simple. This medicine should be used in the lowest possible doses and only for the shortest time 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, because if not, the infection may worsen.
• It should not be used under impermeable materials to air and water, 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 medicine on skin folds (e.g., armpits or groin), you should be very careful because it can increase the absorption of the active substance 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 next to the kidneys or an alteration characterized by, among other symptoms, 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 or have recently used or may need to use any other medicine.

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 will 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 emulsion does not affect the ability to drive or use machines.

Menaderm Simple contains cetostearyl alcohol, stearyl alcohol, propylene glycol, and benzyl alcohol.This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetostearyl alcohol and stearyl alcohol.

This medicine contains 9 mg of propylene glycol in each ml of cutaneous emulsion.

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

This medicine contains 10 mg of benzyl alcohol in each ml of cutaneous emulsion.

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.

For cutaneous use.

Shake before use.

If you use more Menaderm Simple than you should

Excessive use of topical corticosteroids (repeated overdoses) may produce side effects (see section 4). The 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 indicated 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.

In general, side effects are local and transient, but they may be more frequent if extensive 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
• 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 substance passes into the body through the skin. This, for example, can increase the pressure in the eye (glaucoma) or may produce: a condition characterized by a rounded face, fat accumulation, delayed healing, etc. (Cushing's syndrome); increased blood pressure, fluid retention (edema), alterations of the thyroid (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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.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 the sight and reach of children.

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Place 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 substance is Beclometasone dipropionate. 1 ml of emulsion contains 0.25 mg of Beclometasone dipropionate (0.025%).

• The other ingredients (excipients) are: cetostearyl alcohol, stearyl alcohol, propylene glycol, extract of Althaea officinalisroot, liquid paraffin, white soft paraffin, benzyl alcohol, glycerol (E-422), stearic acid, cetomacrogol 700, sorbitol, dimethicone, fragrance, and water.

Appearance of the Product and Contents of the Pack

Menaderm Simple 0.25 mg/ml is a cutaneous 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.

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 Leaflet: December 2020.

Other Sources of Information

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