Active ingredients: Beclometasone (Beclometasone dipropionate)
MENADERM SIMPLEX
Why is Menaderm simplex used? What is it for?
Pharmacotherapeutic group
Topical corticosteroids.
THERAPEUTIC INDICATIONS
Acute and chronic allergic dermatitis, exogenous and endogenous; contact dermatitis of various types. Infantile eczema and eczematous dermatitis. Dyshidrosis. Anogenital itching. Burns. Solar erythema, reactions to chemical agents, to vegetable substances. Adjuvant in the treatment of psoriasis.
Contraindications When Menaderm simplex should not be used
Individual hypersensitivity to one or more constituents of the product. The use of MENADERM SIMPLEX is contraindicated in tuberculous, viral and luetic skin lesions.
Occlusive therapy is contraindicated in atopic dermatitis.
In pregnant and breastfeeding women, the use of MENADERM SIMPLEX should be carried out in cases of real need and under the direct supervision of the doctor, especially in the case of applications on large surfaces or with occlusive dressing.
Precautions for use What you need to know before taking Menaderm simplex
If the occlusive bandage technique is adopted, since it can favor percutaneous absorption 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 thermal 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.
This medicinal product contains esters of p-hydroxybenzoic acid therefore may be mildly irritating to the skin, eyes and mucous membranes.
Interactions Which drugs or foods can modify the effect of Menaderm simplex
Not known.
Warnings It is important to know that:
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.
In very early childhood, the application of MENADERM SIMPLEX should be carried out in cases of real need and under the direct supervision of the doctor. In case of use in the presence of skin infections, institute adequate therapy and if this fails, interrupt the corticosteroid treatment. The product is not for ophthalmic use.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
In pregnant and breastfeeding women, the use of Menaderm Simplex should be carried out in cases of real need and under the direct supervision of the doctor, especially in the case of applications on large surfaces or with occlusive dressing.
Effects on ability to drive and use machines
Not relevant.
Dose, Method and Time of Administration How to use Menaderm simplex: Posology
Two applications a day, on the affected skin area. If necessary, the dressing can be protected with an occlusive bandage.
Duration of treatment
According to the doctor's judgment.
Overdose What to do if you have taken an overdose of Menaderm simplex
There are no known cases of overdose. In case of accidental ingestion / intake of an overdose of Menaderm Simplex, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Menaderm simplex
Systemic corticosteroid side effects are unlikely, however their occurrence may 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.
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.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
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. Side effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Do not use this medicine after the expiry date which is stated on the carton.
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.
KEEP THE MEDICINAL PRODUCT OUT OF THE SIGHT AND REACH OF CHILDREN
Deadline "> Other information
Composition
MENADERM SIMPLEX 0.025% CREAM
100 g contain:
- Active ingredient: beclomethasone dipropionate 0.025 g.
- Excipients: glyceryl monostearate, cetomacrogol, liquid paraffin, white petroleum jelly, isopropyl myristate, myristyl alcohol, esters of p-hydroxybenzoic acid, purified water.
MENADERM SIMPLEX 0.025% OIL
100 g contain:
- Active ingredient: beclomethasone-dipropionate 0.025 g.
- Excipients: oleate decyl, liquid paraffin, esters of p-hydroxybenzoic acid, white petroleum jelly.
MENADERM SIMPLEX 0.025% SKIN SOLUTION
100 g contain:
- Active ingredient: beclomethasone dipropionate 0.025 g.
- Excipients: glyceryl monostearate, cetomacrogol, liquid paraffin, white petroleum jelly, isopropyl myristate, myristyl alcohol, esters of p-hydroxybenzoic acid, purified water.
Pharmaceutical form and content
Beclomethasone dipropionate 0.025% cream and ointment for topical use. 30 g tube.
0.025% solution of beclomethasone dipropionate for topical use. Bottle of 30 g.
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 SIMPLEX CREAM - SKIN SOLUTION.
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
MENADERM SIMPLEX 0.025% CREAM
100 g contain:
active ingredient: beclomethasone dipropionate 0.025 g.
excipients with known effects: esters of p-hydroxybenzoic acid
MENADERM SIMPLEX 0.025% SKIN SOLUTION
100 g contain:
active ingredient: beclomethasone dipropionate 0.025 g.
excipients with known effects: esters of p-hydroxybenzoic acid
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 -
Acute and chronic allergic dermatitis, exogenous and endogenous, contact dermatitis of various types. Infantile eczema and eczematous dermatitis. Dyshidrosis. Anogenital itching. Burns. Sunburn; reactions to chemical agents, to vegetable substances. Adjuvant in the treatment of psoriasis.
04.2 Posology and method of administration -
In general, two daily applications of Menaderm Simplex 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 Simplex cream is to be preferred, due to its water-miscible vehicle, in the treatment of delicate or moist skin surfaces.
Menaderm Simplex 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 Simplex is contraindicated in tuberculous, viral and luetic skin lesions. 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. In very early childhood the application of Menaderm Simplex should be carried out in cases of actual need and under the direct supervision of the doctor. In case of use in the presence of skin infections, institute adequate therapy and if this fails, discontinue corticosteroid treatment. The product is not for ophthalmic use.
If the occlusive bandage technique is adopted, since it can favor percutaneous absorption 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 thermal 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.
This medicinal product contains esters of p-hydroxybenzoic acid therefore may be mildly irritating to the skin, eyes and mucous membranes.
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 Simplex should be carried out in cases of real need and under the direct supervision of the doctor, especially in the case of applications on large surfaces or with occlusive bandages.
04.7 Effects on ability to drive and use machines -
Not relevant.
04.8 Undesirable effects -
Systemic corticosteroid side effects are unlikely, however their occurrence may 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. 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.
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 Simplex is a dermatological preparation presented in three pharmaceutical forms (cream and solution) intended for the treatment of numerous skin diseases of an inflammatory and allergic nature. The active ingredient of the product is beclomethasone-17,21-dipropionate, a halogenated synthetic glucocorticoid, with an intense antireaction and antiallergic action, especially topically. In the skin vasoconstriction test according to McKenzie, beclomethasone-17,21-dipropionate is 5000 times more potent than hydrocortisone.
05.2 "Pharmacokinetic properties -
Following cutaneous application, beclomethasone-17,21-dipropionate is normally not absorbed in significant quantities, and only exerts its action locally. However, in the case of treatments of large skin areas with high doses and especially if an occlusive dressing is used, it is possible that percutaneous absorption will no longer be negligible. The fraction eventually absorbed is converted in the liver into inactive metabolites, and this further accounts for the high tolerability of this steroid.
05.3 Preclinical safety data -
Menaderm Simplex 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 SIMPLEX 0.025% CREAM
Glyceryl monostearate, cetomacrogol, liquid paraffin, white petroleum jelly, isopropyl myristate, myristyl alcohol, esters of p-hydroxybenzoic acid, purified water.
MENADERM SIMPLEX 0.025% 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 "-
4 years.
06.4 Special precautions for storage -
This medicinal product does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package -
MENADERM SIMPLEX 0.025% CREAM
30g soft aluminum tube.
MENADERM SIMPLEX 0.025% SKIN SOLUTION
30 g bottle with 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 SIMPLEX 0.025% CREAM - A.I.C. n. 041406012.
MENADERM SIMPLEX 0.025% SKIN SOLUTION - A.I.C. n. 041406036
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
Date of first authorization: 21 April 1986
Date of last renewal: 1 June 2010
10.0 DATE OF REVISION OF THE TEXT -
September 2016
