Edevan C.M.

Edeven C.M. 1% + 5% gel
Edeven C.M. 2% + 5% gel
Aescin and diethylamine salicylate
C.M.: modified composition (*)
Please read this leaflet carefully before using this medicine because
it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your
doctor, pharmacist, or nurse has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
• Contact your doctor if you do not notice any improvement or if you experience worsening of symptoms.

Contents of this leaflet:
1. What Edeven C.M. is and what it is used for
2. What you need to know before using Edeven C.M.
3. How to use Edeven C.M.
4. Possible side effects
5. How to store Edeven C.M.
6. Contents of the pack and other information

1. What Edeven C.M. is and what it is used for
Edeven C.M. is a topical medicinal product used for the treatment of joint and muscle pain due to minor trauma (minor traumatic injuries).

2. What you need to know before using Edeven C.M.

Do not use Edeven C.M. if you are allergic to aescin and diethylamine salicylate or to any
of the other ingredients of this medicine (listed in section 6).

• Do not use on open lesions (wounds), mucous membranes, or skin areas treated with radiation.

Warnings and precautions
Consult your doctor or pharmacist before using Edeven C.M. Do not use for prolonged periods without medical advice.
There is no risk of habituation or dependence.
As this is a topical preparation, it is intended for external use only. Avoid contact with the eyes.
Prolonged or repeated use of topical products may lead to sensitization reactions.

Other medicines and Edeven C.M.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicinal products are known.
This medicine should not be applied simultaneously with other topical products.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
However, prolonged use (maximum 3 weeks) of the product on large skin areas should be avoided during pregnancy.
Breastfeeding
Avoid applying the gel on the breast area during breastfeeding.

Driving and using machines
Edeven C.M. does not affect the ability to drive vehicles or operate machinery.

Edeven C.M. contains butylated hydroxytoluene (BHT)
Edeven C.M. contains butylated hydroxytoluene (BHT), which may cause localized skin reactions (e.g., contact dermatitis) or irritation to the eyes and mucous membranes.

3. How to take Edeven C.M.

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• Use in adults and adolescents (12–18 years)
  The amount to apply depends on the extent of the area to be treated. The recommended dose is a thin layer of Edeven C.M. applied to the skin of the affected area. Apply Edeven C.M. 1 to 3 times daily to the affected part. After each application, wash your hands thoroughly.
  Caution: Use only for short periods and do not exceed the recommended doses. Consult your doctor if symptoms recur or if you have noticed any recent changes in their characteristics.

• Children under 12 years
  The safety and efficacy of Edeven C.M. in children under 12 years of age have not been established.

If you use more Edeven C.M. than you should
There are no known cases of overdose.
If an excessive amount of Edeven C.M. has been applied, wash the affected area thoroughly.
In case of accidental ingestion/overdose of Edeven C.M., contact your doctor immediately or go to the nearest hospital.

If you stop treatment with Edeven C.M.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets
them.
Immune system disorders: in rare cases, hypersensitivity reactions may occur, such
as skin redness, peeling and dehydration of the skin.
Skin and subcutaneous tissue disorders: contact dermatitis.
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your
doctor or pharmacist. You may also report side effects directly through the national
reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-
avversa. By reporting side effects, you can help provide more information on the safety
of this medicine.

5. How to store Edeven C.M.

Keep this medicine 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 refers to the last day of that month.
Store below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.
It is important to always keep medicine information available; therefore,
retain both the packaging and the leaflet.

6. Package contents and other information

What Edeven C.M. contains
(*) C.M.: modified composition due to removal of an active ingredient (sodium heparin)
Edeven C.M. 1% + 5%
The active substances are:

• escin and diethylamine salicylate: 100 g of gel contain 1 g of escin and 5 g of diethylamine.
  The other components are:
• lavender essence, nerolidol essence, carbopolymethylene, meglumine, propylene glycol, ethyl alcohol, sodium edetate, esildecanol and hexyldecyl laurate, ethoxydiglycol, butylhydroxytoluene, titanium dioxide, purified water.

Edeven C.M. 2% + 5%
The active substances are:

• escin and diethylamine salicylate: 100 g of gel contain 2 g of escin and 5 g of diethylamine.
  The other components are:
• lavender essence, nerolidol essence, carbopolymethylene, meglumine, propylene glycol, ethyl alcohol, sodium edetate, esildecanol and hexyldecyl laurate, ethoxydiglycol, butylhydroxytoluene, titanium dioxide, purified water.

Description of the appearance of Edeven C.M. and contents of the pack
Edeven C.M. 1% + 5% is presented as a gel for topical use.
Pack contents: 40 g of gel.
Edeven C.M. 2% + 5% is presented as a gel for topical use.
Pack contents: 40 g of gel.

Marketing Authorization Holder and Manufacturer
ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI S.p.A.
via Fossignano, 2 – 04011 Aprilia (LT)
e-mail: [email protected]