Active ingredients: Escin, Diethylamine (Diethylamine salicylate)
REPARIL C.M. 1% + 5% gel
REPARIL C.M. 2% + 5% 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 -
REPARIL C.M. GEL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
(*) C.M .: composition modified by elimination of an active principle (sodium heparin).
REPARIL C.M. 1% + 5% gel
100 g of gel contain:
Active principles:
Escin 1 g
Diethylamine salicylate 5 g
REPARIL C.M. 2% + 5% gel
100 g of gel contain:
Active principles:
Escin 2 g
Diethylamine salicylate 5 g
For the full list of excipients see section 6.1
03.0 PHARMACEUTICAL FORM -
Gel.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Minor traumatology
04.2 Posology and method of administration -
Adults and adolescents (12-18 years):
Apply and spread a thin layer of REPARIL C.M. gel on the skin of the area to be treated 1 to 3 times a day.
Apply the gel directly on the affected part. After each application, wash your hands thoroughly.
Children under 12 years old:
The safety and efficacy of REPARIL C.M. in children below 12 years of age have not been established. There are no data available.
04.3 Contraindications -
Hypersensitivity to the active substances or to any of the excipients.
REPARIL C.M. gel should not be used on open lesions (wounds), mucous membranes and skin areas treated with radiation.
04.4 Special warnings and appropriate precautions for use -
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.
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 breastfeeding -
In the event of pregnancy and breastfeeding, it is not recommended to use REPARIL CM gel unless under strict medical supervision. However, prolonged use (maximum 3 weeks) of the product on large skin areas during pregnancy and use on the breast should be avoided. while breastfeeding.
04.7 Effects on ability to drive and use machines -
REPARIL 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 aescin, 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, bitter orange flower essence, carbomers, macrogol 6 glycerol caprilocaprate, disodium edetate, trometamol, isopropyl alcohol, purified water.
06.2 Incompatibility "-
Not relevant
06.3 Period of validity "-
5 years.
06.4 Special precautions for storage -
This medicine does not require any special storage conditions
06.5 Nature of the immediate packaging and contents of the package -
REPARIL C.M. 1% + 5% gel and 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 HOLDER OF THE "MARKETING AUTHORIZATION" -
Madaus GmbH
51101 Cologne (Germany)
08.0 MARKETING AUTHORIZATION NUMBER -
REPARIL C.M. 1% + 5% gel - tube 40 g AIC n. 036397014
REPARIL C.M. 2% + 5% gel - tube 40 g AIC n. 036397026
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
13 July 2006/13 July 2011
