Menaderm Simple 0.25 mg/ml cutaneous emulsion
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
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, 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 must not be given to other people, even if they have the same symptoms as you, as it may 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.
Contents of this leaflet:
- 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 other 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 helps to relieve 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).
- Allergic reaction to commonly used substances such as, for example, soap (irritant contact dermatitis).
- Itchy rash affecting the hands and feet (dyshidrotic eczema).
- Unspecified eczema (eczema vulgaris).
- Eczemas related to patient-specific factors, such as atopic dermatitis or neurodermatitis.
- Skin rash with inflammation and scaling (seborrheic eczema).
- Psoriasis.
Menaderm Simple in this cutaneous emulsion form is particularly indicated for exudative conditions (those that discharge 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 conditions involving skin thinning (atrophy)
- In areas of skin showing a vaccine reaction, i.e. redness or inflammation after vaccination
- In the eyes or in deep open wounds
- In children under 1 year of age
- In case of bacterial or fungal (fungal) skin diseases (see the following section).
Warnings and precautions
- Consult your doctor or pharmacist before starting to use Menaderm Simple. This medicine should be used at the lowest possible dose and only for the minimum time strictly necessary 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 non-breathable dressings, bandages, or diapers.
- Menaderm Simple must not be used on extensive skin areas.
- Menaderm Simple must not come into contact with the eyes, 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 take great care, 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 may occur in glands located near the kidneys or a condition characterized, among other symptoms, by obesity, growth retardation, etc. (Cushing's syndrome), or increased pressure within the skull (intracranial hypertension).
Other medicines and Menaderm Simple
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you might 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 considers it clearly 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 on large skin areas, for prolonged periods, or with occlusive dressings.
Menaderm Simple must not be applied to the breasts during breastfeeding.
Driving and use of machines
The use of Menaderm Simple emulsion 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 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 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.
Shake well before use.
If you use more Menaderm Simple than you should
Excessive use of topical corticosteroids (repeated overdosing) 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 advisable to withdraw corticosteroids gradually.
In case of overdose or accidental ingestion, consult your doctor or pharmacist, go to a medical center, or call the Toxicology Information Service at telephone number 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 missed 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 experiences them.
In general, adverse effects are local and transient, but they may be more frequent when large areas of skin are treated, with prolonged application, use of dressings or occlusive materials, and/or in children.
With the application of corticosteroids to the skin, the following adverse effects have been reported, whose frequency is unknown (cannot be estimated from the available data):
- Blurred vision
- Thinning of the skin (atrophy)
- Skin striae
- Dry skin
- Itching or burning sensation
- Redness (erythema)
- Appearance of red spots
- Bruising
- Inflammation of hair follicles (folliculitis)
- Increased hair growth
- Perioral dermatitis (skin condition around the mouth)
- Skin discoloration
- Acne
- Allergic skin reaction (contact dermatitis)
- Infections
Adverse effects may occur not only in the treated area but also in completely different parts of the body, which may happen if the active substance passes into the body through the skin. 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 the adverse effects are not listed in this leaflet. You may also report them directly via 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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused containers and medicines. 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 ml of emulsion contains 0.25 mg of Beclometasone dipropionate (0.025%).
-
The other components (excipients) are: cetyl alcohol, stearyl alcohol, propylene glycol, root extract of Althaea officinalis, liquid paraffin, soft paraffin, benzyl alcohol, glycerol (E-422), stearic acid, cetomacrogol 700, sorbitol, dimethicone, essence, 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 white liquid. It is supplied 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
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 medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/