Active ingredients: Beclomethasone (dipropionate), Neomycin (neomycin sulfate)
MENADERM 0.25 mg / g + 5 mg / g cream
MENADERM 0.25 mg / g + 5 mg / g ointment
MENADERM 0.25 mg / g + 5 mg / g cutaneous solution
Why is Menaderm used? What is it for?
MENADERM contains the active ingredients betachlomethasone, belonging to the class of corticosteroids (anti-inflammatory drugs) and neomycin (antibiotic drug).
MENADERM is used in the treatment of skin diseases in which therapy based on local corticosteroid drugs is indicated and complicated by infections with germs sensitive to neomycin such as:
- Allergic and inflammatory dermatitis (allergic or inflammatory skin inflammations), acute and chronic (short or long lasting), exogenous and endogenous (caused by external or internal agents).
- Contact dermatitis of various types, eczema (itchy inflammatory reaction of the skin) of children and eczematous dermatitis, erythematous-exuding skin diseases (with production of exudate, a liquid that forms with inflammation).
- Pustular acne (with limited lesions of the skin, in relief).
- Intertrigo (skin pathology caused by the continuous rubbing of two neighboring body surfaces).
Contraindications When Menaderm should not be used
Do not use MENADERM
- If you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).
- If you have a tuberculous (resulting from tuberculosis), viral (caused by a virus) and luetic (resulting from syphilis, a predominantly sexually transmitted infectious disease) skin lesion.
- As an occlusive dressing (covering the affected area with bandages after application of the medicine) in case of atopic dermatitis (chronic inflammatory skin disease, with intense itching and dryness) (see "Warnings and precautions").
Precautions for use What you need to know before taking Menaderm
Talk to your doctor or pharmacist before using MENADERM.
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena (increased reactivity towards some substances); in this case it is necessary that you stop the treatment and your doctor will eventually institute adequate therapy for the phenomenon of awareness that has occurred.
In the case of occlusive therapy, especially in cases of extensive lesions, it is advisable that you treat one part at a time, as this technique can favor the absorption of the components with the consequent possible appearance of systemic effects (relating to the whole organism). By treating one area at a time, it is possible to avoid any alterations in thermal homeostasis that can occur with an increase in body temperature. If such changes occur, stop the treatment immediately.
The material used for the occlusive dressing can cause individual sensitization phenomena that make it necessary to replace the material used.
In infants, the diaper can act as an occlusive dressing, thus increasing the risk of side effects.
Occlusive therapy is contraindicated in atopic dermatitis (see "Do not use MENADERM"). The product is not for ophthalmic (eye) use.
Children and adolescents
In the first months of life, the application of MENADERM should be carried out only in cases of real necessity and under the direct supervision of the doctor.
Interactions Which drugs or foods can change the effect of Menaderm
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
There are no known drug interactions with MENADERM.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, use MENADERM only in cases of real need and under direct medical supervision, especially in the case of application on large surfaces or with occlusive dressing.
Driving and using machines
There are no known effects on the ability to drive or use machines following the use of MENADERM.
MENADERM contains esters of p-hydroxybenzoic acid which can cause allergic reactions (even delayed).
Dose, Method and Time of Administration How to use Menaderm: Posology
Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Apply a small amount of product (thin layer) to the affected skin area twice a day and massage gently.
The occlusive dressing may be appropriate in particular cases according to the doctor's judgment.
MENADERM cream is preferred in the treatment of delicate or moist skin surfaces.
MENADERM ointment is indicated in the treatment of dry, lichenified (thickened) or scaly lesions and when resorting to occlusive dressing.
MENADERM cutaneous solution is indicated in the treatment of extensive lesions of the skin, skin folds and hairy areas (with the presence of hair).
Overdose What to do if you have taken too much Menaderm
There are no known cases of overdose following the use of MENADERM.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Menaderm
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop the treatment and contact your doctor who will prescribe suitable therapy if you notice any of the side effects listed below:
- Sensation of burning, irritation, dryness of the skin, folliculitis (skin infections), acneiform eruptions (acne-like skin eruptions), hypertrichosis (increased hairiness), hypopigmentation (discolouration of the skin) and, especially using bandaging occlusive, skin atrophy (thinning of the skin). These effects are classic disturbances associated with local corticosteroid therapy (corticosteroid therapy) and occur mostly in a mild and reversible form. They can be favored by occlusive therapy or by the use of doses of the medicine and for prolonged periods of time on large areas of the skin (see "Warnings and precautions").
- Development of non-sensitive microorganisms (which do not respond to treatment with MENADERM), including fungi (fungi), which can result from prolonged use of the antibiotic (neomycin).
Systemic side effects caused by corticosteroids are very unlikely to occur.
However, if your renal function is compromised, it is possible that you may exceptionally experience ototoxicity phenomena (toxicity at the level of ears) and nephrotoxicity (kidney toxicity) caused by systemic reabsorption (passage into the blood) of neomycin.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Italian Medicines Agency, Website: http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicinal.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month and to the product in intact packaging, correctly stored. MENADERM cream and MENADERM ointment.
Store below 30 ° C.
MENADERM cutaneous solution.
No special storage precautions are required.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Deadline "> Other information
What MENADERM contains
MENADERM cream
1 g of cream contains:
Active ingredients: beclomethasone dipropionate 0.25 mg, neomycin sulphate 5 mg.
Other components: glyceryl monostearate, cetomacrogol, liquid paraffin, white petroleum jelly, isopropyl myristate, myristyl alcohol, esters of p-hydroxybenzoic acid, purified water.
MENADERM ointment
1 g of ointment contains:
Active ingredients: beclomethasone dipropionate 0.25 mg, neomycin sulphate 5 mg.
Other components: decyl oleate, liquid paraffin, esters of p-hydroxybenzoic acid, white vaseline.
MENADERM cutaneous solution
1 g of cutaneous solution contains:
Active ingredients: beclomethasone dipropionate 0.25 mg, neomycin sulphate 5 mg.
Other components: glyceryl monostearate, cetomacrogol, liquid paraffin, white petroleum jelly, isopropyl myristate, myristyl alcohol, esters of p-hydroxybenzoic acid, purified water.
Description of what MENADERM looks like and contents of the pack
MENADERM cream
Cream. 30 g tube containing a cream with a soft, white, homogeneous consistency, practically odorless.
MENADERM ointment
Ointment. 30 g tube containing an ointment of soft consistency, white-gray, homogeneous, greasy to the touch, practically odorless.
MENADERM cutaneous solution
Skin solution. 30 g bottle with dropper containing a semi-liquid, white, homogeneous, practically odorless lotion.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
MENADERM CREAM - SKIN SOLUTION.
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
MENADERM CREAM
1 g contains:
beclomethasone dipropionate 0.25 mg, neomycin sulfate 5 mg.
Excipients with known effects: esters of p-hydroxybenzoic acid
MENADERM SKIN SOLUTION
1 g contains:
beclomethasone dipropionate 0.25 mg, neomycin sulfate 5 mg.
Excipients with known effects: p-hydroxybenzoic acid esters
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM -
Skin cream and solution.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Menaderm is indicated in the treatment of skin diseases in which local corticotherapy is indicated, and complicated by infections with germs sensitive to neomycin: allergic and inflammatory dermatitis, acute and chronic, exogenous and endogenous; contact dermatitis of various types, infantile eczema and eczematous dermatitis, erythematous-exuding skin diseases. Pustular acne, intertrigo.
04.2 Posology and method of administration -
In general, two daily applications of Menaderm on the affected skin area are sufficient, using a small amount of product each time and gently massaging.
The occlusive dressing may be appropriate in particular cases in the judgment of the doctor.
Menaderm cream is to be preferred, due to its water-miscible vehicle, in the treatment of delicate or moist skin surfaces.
The Menaderm cutaneous solution is indicated in the treatment of extensive skin lesions, skin folds and hair areas.
04.3 Contraindications -
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. The use of Menaderm is contraindicated in tuberculous, viral and luetic skin lesions. The use in occlusive therapy is contraindicated in atopic dermatitis.
04.4 Special warnings and appropriate precautions for use -
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and possibly institute a suitable therapy. need and under the direct supervision of the doctor. The product is not for ophthalmic use.
If the occlusive bandage technique is adopted, since it can favor the absorption of the components with the consequent possible appearance of systemic effects, it is advisable in cases of extensive lesions, to treat one part at a time; in this way any alterations in homeostasis can also be avoided. which occur with an increase in body temperature requiring, if it occurs, the interruption of treatment. The material used for the occlusive dressing can cause individual sensitization phenomena that make it necessary to replace the material used. Occlusive therapy is contraindicated in atopic dermatitis. It should be borne in mind that in infants the diaper can act as an occlusive dressing, thus increasing the risk of side effects.
04.5 Interactions with other medicinal products and other forms of interaction -
Not known
04.6 Pregnancy and breastfeeding -
In pregnant and breastfeeding women, the use of Menaderm should be carried out in cases of real need and under the direct supervision of the doctor, especially if it is applied to large surfaces or with an occlusive bandage.
04.7 Effects on ability to drive and use machines -
There are no known effects on the ability to drive or use machines following the use of MENADERM.
04.8 Undesirable effects -
Systemic corticosteroid side effects are unlikely. However, their appearance can be favored by occlusive therapy and when large skin areas are treated with high doses and for prolonged periods of time. In these cases, these are the classic disorders of corticotherapy, mostly in a mild and reversible form. In subjects with impaired renal function, ototoxicity and nephrotoxicity phenomena due to systemic reabsorption of neomycin are exceptionally possible in case of application of high doses on large surfaces and for prolonged periods of time, especially under occlusive dressing. Local corticotherapy can sometimes lead to burning sensations, irritation, dry skin, folliculitis, acneiform eruptions, hypertrichosis, hypopigmentation and, especially using the occlusive bandage, skin atrophy. The possible occurrence of the reactions mentioned above requires the interruption of the treatment and, where necessary, the institution of suitable therapy. The same is true in the case of the development of non-sensitive microorganisms, including fungi, which can result from prolonged use of the antibiotic.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose -
There are no known cases of overdose.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Menaderm is a dermatological preparation presented in two pharmaceutical forms (cream and solution) intended for the treatment of numerous skin diseases of an inflammatory and allergic nature, complicated by bacterial infection. Active ingredients of the product are beclometasone-17,21-dipropionate and neomycin. Beclometasone-17,21-dipropionate is a halogenated synthetic glucocorticoid, endowed, especially topically, with an intense antireaction and antiallergic action. In the skin vasoconstriction test according to McKenzie, beclomethasone-17,21-dipropionate is 5000 times more potent than hydrocortisone. Neomycin sulfate is an aminoglycoside antibiotic with a broad spectrum of antibacterial action.
05.2 "Pharmacokinetic properties -
Absorption
Following skin application, usually both beclomethasone-17,21-dipropionate and neomycin are not absorbed in significant quantities, and they exert their action only locally.
However, in the case of treatments of large skin areas with high doses and especially if an occlusive bandage is used, it is possible that the percutaneous absorption takes on a no longer negligible character.
Biotransformation
The portion of the steroid eventually absorbed is converted in the liver into inactive metabolites, and this further accounts for the high tolerability of beclomethasone-17,21-dipropionate.
05.3 Preclinical safety data -
Menaderm applied to the skin of rats at a dose of 3 g / kg / day for 28 days was well tolerated both locally and systemically (in particular, there was no suppression of adrenocortical activity).
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
MENADERM CREAM
Glyceryl monostearate, cetomacrogol, liquid paraffin, white petroleum jelly, isopropyl myristate, myristyl alcohol, esters of p-hydroxybenzoic acid, purified water.
MENADERM SKIN SOLUTION
Glyceryl monostearate, cetomacrogol, liquid paraffin, white petroleum jelly, isopropyl myristate, myristyl alcohol, esters of p-hydroxybenzoic acid, purified water.
06.2 Incompatibility "-
No specific incompatibilities are known.
06.3 Period of validity "-
48 months.
06.4 Special precautions for storage -
Store below 30 ° C.
06.5 Nature of the immediate packaging and contents of the package -
MENADERM CREAM
30g soft aluminum tube.
MENADERM SKIN SOLUTION
30 g bottle and polythene dropper and polypropylene screw cap.
06.6 Instructions for use and handling -
No special instructions
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
A. Menarini Industrie Farmaceutiche Riunite s.r.l. - Via Sette Santi 3, Florence.
08.0 MARKETING AUTHORIZATION NUMBER -
MENADERM CREAM - A.I.C. n. 020883094.
MENADERM SKIN SOLUTION - A.I.C. n. 020883118.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
Date of first authorization: 21 April 1986
Date of most recent renewal: May 31, 2010
10.0 DATE OF REVISION OF THE TEXT -
September 2016
