Active ingredients: Escin, Phosphatidylcholine
ESSAVEN c.m. 1% + 0,8% gel - c.m .: modified composition (*)
Why is Essaven gel used? What is it for?
WHAT IS IT
ESSAVEN c.m. gel is a vasoprotector.
WHY IT IS USED
ESSAVEN c.m. gel is used to treat symptoms attributable to venous insufficiency and states of capillary fragility.
Contraindications When Essaven gel should not be used
Hypersensitivity to the active substances or to any of the excipients. ESSAVEN c.m. gel should not be spread on open skin wounds, eczema and mucous membranes (anal, etc.).
Precautions for use What you need to know before taking Essaven gel
Avoid contact with eyes. For external use only.
Interactions Which drugs or foods can modify the effect of Essaven gel
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription. No known interactions so far.
Warnings It is important to know that:
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. If this occurs, stop the treatment and establish a suitable therapy. After a short period of treatment without appreciable results, consult your doctor.
What to do during pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. The use of the preparation in case of pregnancy and lactation is not contraindicated.
Effects on ability to drive and use machines
Essaven c.m. gel does not affect the ability to drive or use machines.
Dose, Method and Time of Administration How to use Essaven gel: Posology
How many
Apply the preparation 3 times a day.
Warning: do not exceed the indicated doses without medical advice.
When and for how long
After a short period of treatment, without noticeable results, consult your doctor. Consult your doctor if the disorder occurs repeatedly or if you notice any recent changes in its characteristics.
Like
In correspondence of the painful or swollen regions, distribute the gel evenly until absorbed, even on the surrounding parts, without the need to massage.
Overdose What to do if you have taken too much Essaven gel
No cases of overdose have been reported. In case of accidental ingestion / intake of Essaven c.m. gel immediately notify your doctor or go to the nearest hospital. If you have any questions about the use of Essaven gel c.m., ask your doctor or pharmacist.
Side Effects What are the side effects of Essaven gel
In very rare cases, allergic reactions may occur, such as rash or rash and hives. Itching.
Any skin redness, which is extremely rare, disappears spontaneously by suspending the application of the preparation.
Like all medicines, ESSAVEN C.M. it can cause side effects, although not everybody gets them.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date indicated on the package. The date refers to the product in intact packaging, properly stored.
Keep away from heat sources.
Warning: do not use the medicine after the expiry date indicated on the package. Keep this medicine out of the reach and sight of children.
Medicines should not be disposed of 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 about the medicine available, so keep both the box and the package leaflet.
Other_information "> Other information
Composition
(*) c.m .: composition modified by elimination of an active ingredient (sodium heparin)
100 g of gel contain:
Active principles:
Escin 1 g
Phosphatidylcholine 0.8 g
Excipients: Isopropanol, glycerol, triethanolamine, carbopol 940, cologne, rosemary essence, lavender essence, purified water.
How it looksESSAVEN c.m. comes in the form of a gel. The contents of the package is a 40 g tube.
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 -
ESSAVEN C.M.
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
C, M .: composition modified by elimination of an active principle (sodium heparin).
100 g contain, active principles:
• escin 1 g
• phosphatidylcholine 0.8 g
For the complete list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM -
Gel.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Symptoms attributable to venous insufficiency; states of capillary fragility.
04.2 Posology and method of administration -
Apply the preparation 3 times a day, spreading in correspondence with the painful and swollen regions, distributing the gel evenly until absorbed, even on the surrounding parts, without the need to massage.
Do not exceed the recommended dose.
04.3 Contraindications -
Hypersensitivity to the active substances or to any of the excipients.
Essaven c.m. gel should not be spread on open skin wounds, eczema and mucous membranes (anal, etc.).
04.4 Special warnings and appropriate precautions for use -
Avoid contact with eyes. For external use only.
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. If this occurs, stop the treatment and establish a suitable therapy. After a short period of treatment without appreciable results, consult your doctor.
Keep this medicine out of the reach and sight of children.
04.5 Interactions with other medicinal products and other forms of interaction -
None known so far.
04.6 Pregnancy and breastfeeding -
The use of the preparation in case of pregnancy and lactation is not contraindicated.
04.7 Effects on ability to drive and use machines -
Essaven c.m. gel does not affect the ability to drive or use machines.
04.8 Undesirable effects -
In very rare cases, allergic reactions may occur, such as rash or rash and hives. Itching (frequency not known).
Any skin redness, which is extremely rare, disappears spontaneously by suspending the application of the preparation.
04.9 Overdose -
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: vasoprotectors; ATC code: C05CX
Aescin and polyunsaturated phosphatidylcholine (EPL), with pharmacodynamic and pharmacokinetic synergism, supported by the particular formula of the excipients, have a therapeutic action extended to the venous and arterial branches of the peripheral circulation and to the perivasal tissues.
Escin: increases the tone of the venous wall, reactivates the resting capillaries, activates the circulation of the nutritive capillaries and decreases the hypertonia of the lymphatic capillaries.
EPL: improves arteriolo-capillary circulation and favorably influences cellular metabolism and trophism of endothelium and skin tissues.
05.2 "Pharmacokinetic properties -
Due to its hydrophilic and lipophilic properties, EPL acts as a carrier allowing the rapid penetration of the active ingredients through the double path of the sebaceous and sweat glands. The rapid penetration of the active ingredients has been demonstrated through studies with radioisotopes.
05.3 Preclinical safety data -
The cutaneous application of daily doses approximately 14 times higher than the therapeutic dose for a period of 6 weeks has shown the absence of toxic effects in the rat (LD50 rat, topical application: not determinable and in any case> 1.428 g of gel / kg) .
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Isopropanol, glycerol, triethanolamine, carbopol 940, cologne, rosemary essence, lavender essence, purified water.
06.2 Incompatibility "-
Not relevant.
06.3 Period of validity "-
3 years.
06.4 Special precautions for storage -
Keep away from heat sources.
06.5 Nature of the immediate packaging and contents of the package -
40 g tube.
06.6 Instructions for use and handling -
No special instructions.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
NATTERMANN & CIE GmbH
Cologne (Federal Republic of Germany)
Sales representative in Italy
Sanofi-aventis S.p.A
Viale L- Bodio 37 / B - IT-20158 Milan
08.0 MARKETING AUTHORIZATION NUMBER -
AIC n. 036193011
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
July 12, 2006
10.0 DATE OF REVISION OF THE TEXT -
October 2009
