Source: Marketing Authorisation Holder Revision Year: 2019 Publisher: Les Laboratoires Servier France.
Pharmacotherapeutic group: VASCULOPROTECTIVE / CAPILLARY STABILIZING AGENTS / BIOFLAVONOIDS
ATC Code: C05CA53: cardiovascular system
It is active upon the return vascular system in the following way:
Double blind controlled studies using methods by which the effects of the product on venous haemodynamics could be demonstrated and quantified have confirmed the above pharmacological properties in man.
A statistically significant dose-effect relationship was established with respect to venous plethysmographic parameters: capacitance, distensibility and rate of emptying. The optimum dose-effect ratio was obtained with 2 tablets.
DAFLON 500 mg increases venous tone: venous occlusion plethysmography with a mercury stress gauge demonstrated a decrease in the rate of emptying.
Double-blind controlled studies showed a statistically significant difference between placebo and the drug. In patients presenting with signs of capillary fragility, DAFLON 500 mg increases capillary resistance, as measured by angiosterrometry.
Double-blind placebo-controlled trials have demonstrated the activity of the drug in phlebology, in the treatment of chronic venous insufficiency of the lower limbs (both functional and organic).
In man, following oral administration of the substance containing 14C Diosmin:
Non-clinical data from conventional studies of repeated toxicity administration, genotoxicity and reproductive function toxicity studies do not show any specific risk for humans.
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