Menaderm Simple 0.25 mg/g ointment
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Menaderm Simple 0,25 mg/g ointment
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, consult 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, 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
- Storage of Menaderm Simple
- Contents of the pack and other information
1. What Menaderm Simple is and what it is used for
It 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).
- 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 (nummular eczema).
• Eczemas related to patient-specific factors, such as atopic dermatitis or neurodermatitis.
• Skin rash with inflammation and scaling (seborrheic eczema).
• Psoriasis.
Menaderm Simple in the form of ointment is particularly indicated for dry conditions.
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 causing thinning of the skin (atrophy)
- On areas of skin showing a vaccine reaction, such as 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 infections (see next section).
Warnings and precautions
Talk to your doctor or pharmacist before using Menaderm Simple
- This medicine should be used at the lowest possible dose, especially in children, 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 should 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 cautious, as this may increase the 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 be absorbed through the skin 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 and growth delay, etc. (Cushing's syndrome), or increased pressure inside the skull (intracranial hypertension).
Other medicines and Menaderm Simple
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
No interactions between Menaderm Simple ointment and other medicines are currently known.
Pregnancy, breast-feeding 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, corticosteroid-containing medicines 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 extensive skin areas, for prolonged periods, or with occlusive dressings.
Menaderm Simple 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 methyl parahydroxybenzoate, lanolin, and ethanol. It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218).
This medicine may cause local skin reactions (such as contact dermatitis) because it contains lanolin.
This medicine contains 0.0042 mg of alcohol (ethanol) in each gram of ointment. Alcohol (ethanol) may cause a burning sensation on damaged skin.
3. How to use Menaderm Simple
Follow exactly the instructions given by your doctor for administering this medicine. 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, administered in short periods and using the smallest possible amount of the product.
Cutaneous use.
Administration should be performed by applying a thin layer to the affected area and rubbing gently, preferably after cleansing.
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 from excessive use of corticosteroids 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 or 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 forgotten 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, the frequency of which is unknown (cannot be estimated from the available data):
- Blurred vision
- Thinning of the skin (atrophy)
- Skin striae
- Dry skin
- Itching or burning
- Redness (erythema)
- Appearance of red spots
- Bruising
- Inflammation of hair follicles (folliculitis)
- Increased 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 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 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 container, after EXP. The expiry date is the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused 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.
Each gram of ointment contains 0.25 mg of beclometasone dipropionate (0.025%).
- The other components (excipients) are: methyl parahydroxybenzoate (E-218), lanolin, liquid paraffin, soft paraffin, extract of root of Althaea officinalis, and ethyl alcohol.
Appearance of the product and contents of the pack
Menaderm Simple 0.25 mg/g ointment is a uniform, yellow, oily paste. It is supplied in flexible aluminum tubes of 30 g and 60 g.
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
Telephone: +34 934 628 800 – E-mail: [email protected]
Date of the most recent revision of this leaflet: December 2020.
Other sources of information
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/