Active ingredients: Escin, Diethylamine salicylate
Edeven C.M. 1% + 5% gel
Edeven C.M. 2% + 5% gel
Why is Edeven CM used? What is it for?
Edeven C.M. is a topical drug used to treat joint and muscle pain resulting from trauma (minor traumatology).
Contraindications When Edeven CM should not be used
Do not take Edeven C.M. if you are allergic to aescin and diethylaminasalicylate or any of the other ingredients of this medicine (listed in section 6)
- do not use on open lesions (wounds), mucous membranes and skin areas treated with radiation
Precautions for use What you need to know before taking Edeven CM
Talk to your doctor or pharmacist before taking Edeven C.M ..
There are no risks of addiction and dependence.
Being a preparation for topical applications, its use must be exclusively external.
The use, especially prolonged, of products for topical use can give rise to sensitization phenomena.
Interactions Which drugs or foods can modify the effect of Edeven CM
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No interaction with other medicinal products is known.
The medicine should not be applied together with other products.
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 taking this medicine.
However, it is advisable to avoid prolonged use (maximum 3 weeks) of the product on large skin areas during pregnancy and use on the breast during breastfeeding.
Driving and using machines
Edeven C.M. does not affect the ability to drive or use machines.
Dose, Method and Time of Administration How to use Edeven CM: Posology
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
- Use in adults and adolescents (12-18 years)
The quantity to be applied depends on the extension of the area to be treated.
The recommended dose is a thin layer of Edeven C.M. on the skin of the area to be treated Apply Edeven C.M. 1 to 3 times a day on the affected area. After each application, wash your hands thoroughly. Warning: use only for short periods of treatment and do not exceed the indicated doses.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Overdose What to do if you have taken too much Edeven CM
If you take more Edeven C.M. than it owes
There are no known cases of overdose.
If an excessive dose of Edeven C.M. has been applied, wash the affected area thoroughly.
In case of accidental ingestion / intake of an overdose of Edeven C.M. notify your doctor immediately or go to the nearest hospital.
If you stop taking Edeven C.M.
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 Edeven CM
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In rare cases, hypersensitivity reactions such as redness, peeling and dehydration of the skin may occur.
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. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this medicine.
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 carton after "EXP".
The expiry date refers to the last day of that month. Store at a temperature not exceeding 25 ° C.
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.
It is important to always have the information on the medicine available, so keep both the box and the package leaflet.
What Edeven C.M. contains
(*) C.M .: composition modified by elimination of an active ingredient (sodium heparin)
Edeven C.M. 1% + 5%
The active ingredients are:
- escin and diethylamine salicylate 100 g of gel contain 1g of escin and 5g of diethylamine
The other ingredients are:
- lavender essence, nerolene essence, carboxypolymethylene, meglumine, propylene glycol, ethyl alcohol, sodium edetate, hexyldecanol and hexyldecyl laurate, ethoxydiglycol, butylhydroxytoluene, titanium dioxide, purified water.
Edeven C.M. 2% + 5%
The active ingredients are:
- escin and diethylamine salicylate 100 g of gel contain 2g of escin and 5g of diethylamine
The other ingredients are:
- lavender essence, nerolene essence, carboxypolymethylene, meglumine, propylene glycol, ethyl alcohol, sodium edetate, hexyldecanol and hexyldecyl laurate, ethoxydiglycol, butylhydroxytoluene, titanium dioxide, purified water.
What Edeven C.M. looks like and contents of the pack
Edeven C.M. 1% + 5% comes in the form of a gel for skin use.
The contents of the package are 40 g of gel
Edeven C.M. 2% + 5% comes in the form of a gel for skin use.
The contents of the package are 40 g of gel
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
EDEVEN C.M.
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
(*) C.M .: composition modified by elimination of an active ingredient (sodium heparin)
EDEVEN C.M. 1% + 5% gel
100 g of gel contain:
Active principles:
Escin 1 g
Diethylamine salicylate 5 g
EDEVEN C.M. 2% + 5% gel
100 g of gel contain:
Active principles:
Escin 2 g
Diethylamine salicylate 5 g
For excipients, see 6.1
03.0 PHARMACEUTICAL FORM
Gel for skin use.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Minor traumatology.
04.2 Posology and method of administration
Apply and spread a thin layer of EDEVEN C.M. gel on the skin of the area to be treated 1 to 3 times a day.
04.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients.
EDEVEN C.M. gel should not be used on open lesions (wounds), mucous membranes and skin areas treated with radiation.
Generally contraindicated in pregnancy and during lactation.
04.4 Special warnings and appropriate precautions for use
Being a preparation for topical applications, its use must be exclusively external.
The use, especially prolonged, of products for topical use can give rise to sensitization phenomena.
Keep this medicine out of the reach and sight of children.
04.5 Interactions with other medicinal products and other forms of interaction
No interactions with other medicinal products have been reported.
04.6 Pregnancy and lactation
In case of pregnancy and while breastfeeding it is not recommended to use EDEVEN C.M. gel unless under close medical supervision. However, it is advisable to avoid prolonged use (maximum 3 weeks) of the product on large skin areas during pregnancy and use on the breast during breastfeeding.
04.7 Effects on ability to drive and use machines
EDEVEN C.M. gel does not affect the ability to drive or use machines.
04.8 Undesirable effects
In rare cases, hypersensitivity reactions such as redness, peeling and dehydration of the skin may appear.
04.9 Overdose
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: drugs for topical use, for joint and muscle pain.
ATC code: M02AC.
Escin acts on the vascular walls. In case of increased permeability due to inflammation it reduces exudation, limiting the extravasation of liquids into the tissue and accelerating the absorption of the existing edema. The mechanism of action is based on the modification of the permeability of the affected capillary openings. Furthermore, escin increases the resistance of the capillaries, has an anti-inflammatory effect and improves microcirculation.
Diethylamine salicylate has remarkable analgesic properties. It is easily absorbed by the skin and develops its analgesic action in depth on the treated area. The anti-inflammatory action of diethylamine salicylate reinforces the anti-inflammatory action of escin, eliminating the causes of the disease.
05.2 "Pharmacokinetic properties
It has been shown, in various animal species and in humans, that the absorption of aescin after topical application is very low (
At the point of application, concentrations are clearly measurable in the subcutaneous area and in the underlying musculature. Aescin is not detectable in human blood and urine.
According to the experiments carried out on animals and the literature available on the subject, salicylates are more absorbed. However, the values found in the blood after topical treatment for therapeutic purposes do not fall within the toxicity range.
05.3 Preclinical safety data
Non-clinical data reveal no risk for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, reproductive toxicity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Lavender essence, nerolene essence, carboxypolymethylene, meglumine, propylene glycol, ethyl alcohol, sodium edetate, hexyldecanol and hexyldecyl laurate, ethoxydiglycol, butylhydroxytoluene, titanium dioxide, purified water.
06.2 Incompatibility
In the absence of incompatibility studies, the medicinal product should not be applied with other products.
06.3 Period of validity
2 years.
06.4 Special precautions for storage
Store at a temperature not exceeding 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
EDEVEN C.M. 1% + 5% gel e EDEVEN C.M. 2% + 5% gel:
40 g aluminum tube with internal protective layer and screw cap.
06.6 Instructions for use and handling
No special instructions.
Unused product and waste derived from this medicine must be disposed of in accordance with local legal requirements.
07.0 MARKETING AUTHORIZATION HOLDER
ITALIAN BIOCHEMICAL INSTITUTE GIOVANNI LORENZINI S.p.A.
Via Fossignano, 2 - 04011 - Aprilia (LT)
08.0 MARKETING AUTHORIZATION NUMBER
EDEVEN C.M. 1% + 5% gel AIC N ° 037028014
EDEVEN C.M. 2% + 5% gel AIC N ° 037028026
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
December 2007
10.0 DATE OF REVISION OF THE TEXT
December 2007
