Menaderm Simple 0.25 mg/g cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Menaderm Simple 0,25 mg/g cream
beclometasone dipropionate
Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Menaderm Simple is and what it is used for
- What you need to know before using Menaderm Simple
- How to use Menaderm Simple
- Possible side effects
- How to store Menaderm Simple
Pack contents and additional information
1. What Menaderm Simple is and what it is used for
Menaderm Simple is an anti-inflammatory medicine that belongs to a group of medicines called corticosteroids, for topical use on the skin, which reduce inflammation and allergic skin reactions. 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 for:
-
Acute forms of inflammatory skin conditions (dermatitis) caused by:
- Allergic reaction to a substance that has come into contact with the skin (allergic contact dermatitis).
- Irritant allergic reaction to commonly used substances such as, for example, soap (irritant contact dermatitis).
- Itchy rash on the hands and feet (dyshidrotic eczema).
- Unspecified eczema (eczema).
- Eczema related to patient-specific factors, such as atopic dermatitis or neurodermatitis.
- Skin rash with inflammation and scaling (seborrheic eczema).
- Psoriasis.
Menaderm Simple in this cream form is particularly indicated for exudative conditions (those that secrete fluid).
2. What you need to know before 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 varicella)
- If you have chronic skin inflammation with redness around the nose and cheeks (rosacea), inflammation around the mouth (perioral dermatitis), ulcers, acne, or skin-thinning diseases (atrophy)
- On areas of skin showing a vaccine reaction, i.e., redness or inflammation after vaccination
- In the eyes, or on deep open wounds
- In children under 1 year of age
- In case of bacterial or fungal (fungal) skin diseases (see next section).
Warnings and precautions
Consult your doctor or pharmacist before starting to use Menaderm Simple
- This medicine should be used at the lowest possible doses, especially in children, and only for the strictly necessary duration to treat the skin condition.
- If bacterial or fungal infections develop, consult your doctor, who will establish appropriate antibacterial or antifungal treatment, as otherwise the infection may worsen.
- Do not use under air- and water-impermeable materials, such as bandages, dressings, or non-breathable diapers.
- Menaderm Simple must not be used on extensive areas of skin.
- Menaderm Simple must not come into contact with the eyes, deep open wounds, or mucous membranes (e.g., mouth or genital area), where absorption is significantly higher.
- If you use the medicine on skin folds (e.g., armpits or groin), you must be very careful, as this may increase absorption of the active substance into the body.
- If you are being treated for psoriasis, strict medical monitoring of symptom progression is recommended.
- Contact your doctor if you experience blurred vision or other visual disturbances.
Children
Do not use in children under 1 year of age. This medicine is not indicated for use in children under 5 years of age.
In children, corticosteroids are more likely to pass through the skin into the body and cause adverse effects in other parts of the body. In children treated with corticosteroids, disturbances of glands located near the kidneys may occur, or a condition characterized, among other symptoms, by obesity, growth retardation, etc. (Cushing's syndrome), or increased pressure inside the skull (intracranial hypertension).
Other medicines and Menaderm Simple
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
No interactions between Menaderm Simple and other medicines are currently known.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
As a general rule, medicines containing corticosteroids should not be used during the first trimester of pregnancy.
Menaderm Simple should not be used during pregnancy or breastfeeding unless your doctor clearly considers it necessary, weighing the benefits against the risks. Pregnant women or those planning pregnancy, as well as women who are breastfeeding, should not use Menaderm Simple cream on extensive skin areas, for prolonged periods, or under occlusive dressings.
Menaderm Simple cream must 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 operate machinery.
Menaderm Simple contains cetyl alcohol, stearyl alcohol, propylene glycol, and benzyl alcohol.
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol and stearyl alcohol.
This medicine contains 40 mg of propylene glycol per gram of cream.
This medicine may cause skin irritation because it contains propylene glycol.
This medicine contains 10 mg of benzyl alcohol per gram of cream.
Benzyl alcohol may cause allergic reactions and moderate local irritation.
3. How to use Menaderm Simple
Follow exactly the instructions for use of this medicine as given by your doctor. If in 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 are using the medicine for a facial condition, 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 of age and is not indicated in children under 5 years.
In children, treatment should be as short as possible, for short periods of time, and using the smallest possible amount of the product.
Cutaneous use. Administration should be performed by gently applying a thin layer to the affected area, preferably after cleansing.
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 gradually withdrawn.
In case of overdose or accidental ingestion, consult your doctor or pharmacist or go to a medical center, or call the Toxicology Information Service, telephone 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 missed a dose, continue with your usual schedule according to your doctor's instructions or those described in this leaflet.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
In general, adverse effects are local and transient, but they may occur more frequently when large areas are treated, with prolonged application, use of dressings or occlusive materials, and/or in children.
With topical application of corticosteroids to the skin, the following adverse effects have been reported, with frequency unknown (frequency cannot be estimated from available data):
- Blurred vision
- Thinning of the skin (atrophy)
- Skin striae (stretch marks)
- Dry skin
- Itching or burning sensation
- Redness (erythema)
- Appearance of red spots
- Bruising
- Inflammation of hair follicles (folliculitis)
- Excessive hair growth
- Skin condition around the mouth (perioral dermatitis)
- Skin discoloration
- Acne
- Allergic skin reaction (contact dermatitis)
- Infections
Adverse effects may occur not only in the treated area but also in completely different areas of the body, which may happen if the active ingredient passes through the skin into the body. This, for example, could increase eye pressure (glaucoma) or lead to a condition characterized by a rounded face, fat accumulation, delayed wound healing, etc. (Cushing's syndrome); increased blood pressure, fluid retention (edema), thyroid disorders (hyperthyroidism), increased blood and urine sugar levels (hyperglycemia and glycosuria).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse 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 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 unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Menaderm Simple
-The active substance is Beclometasone dipropionate.
1 g of cream contains 0,25 mg of Beclometasone dipropionate (0,025 %).
-The other components (excipients) are: cetyl alcohol, stearic alcohol, propylene glycol, root extract of Althaea officinalis, liquid paraffin, soft paraffin, benzyl alcohol, stearic acid, cetomacrogol 700, sorbitol and water.
Appearance of the product and contents of the container
Menaderm Simple 0,25 mg/g is a uniform white cream. It is supplied 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
Telephone: +34 934 628 800 – E-mail: [email protected]
Date of the most recent review of this leaflet: December 2020.
Other sources of information
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/