Daflon 500 mg

Daflon 500 mg

diosmin + hesperidin

Manufacturer:

Servier

Distributor:

Maxxcare
Full Prescribing Info
Contents
Micronized, purified flavonoid fraction.
Description
Each tablet contains micronized purified flavonoid fraction 500 mg (450 mg diosmin + 50 mg flavonoids expressed as hesperidin).
The innovation with Daflon 500 mg consists of the micronization of its active constituent from particles of 15-40 microns to particles of <2 microns. Micronization of Daflon 500 mg increases gastrointestinal absorption compared to nonmicronized diosmin (urinary 57.9% vs 32.7%). This new and optimized form allows a better absorption of Daflon 500 mg, thus better bioavailability and consequently to a more rapid onset of efficacy, right from the 1st hour and longer.
Excipients/Inactive Ingredients: Daflon 500 mg also contains the following excipients: Sodium starch glycolate, microcrystalline cellulose, gelatine, magnesium stearate, talc.
Film-coating: titanium dioxide (E 171), glycerol, sodium lauryl sulphate, macrogol 6000, hypromellose, yellow iron oxide (E 172), red iron oxide (E 172), magnesium stearate.
Action
Daflon 500 mg is a phlebotonic drug and a vascular protecting agent.
The efficacy of Daflon 500 mg is accounted for by its specific action on the principal elements of venous disease.
Daflon 500 mg is phlebotonic: It reinforces venous tone by prolonging the activity of parietal noradrenaline with a more rapid onset and longer duration compared to placebo. Thus, Daflon 500 mg decreases venous capacitance, venous distensibility and venous emptying time.
Daflon 500 mg protects the microcirculation by fighting the microcirculation-damaging process; it combats venous inflammation by decreasing leukocyte activation, and as a consequence, by inhibiting the release of inflammatory mediators, principally free radicals and prostaglandins. Thus, Daflon 500 mg normalizes capillary permeability and strengthens capillary resistance.
Daflon 500 mg acts on the lymphatic system: It improves lymphatic drainage by increasing lymph flow and lymph oncotic pressure. This action on the lymphatic system associated with a phlebotonic and vasculoprotective effect, explains the activity of Daflon 500 mg on CVI-associated edema.
Double-blind, placebo-controlled studies have demonstrated Daflon 500 mg's efficacy on chronic venous insufficiency. Daflon 500 mg significantly improves disabling symptoms of venous insufficiency which affect everyday active life: Heavy legs, pain, heat sensation, edema, functional impairment and nocturnal cramps.
In addition to conventional compression therapy, Daflon 500 mg has also demonstrated to cure 3 times as many venous leg ulcers as placebo, and to accelerate their complete healing.
Daflon 500 mg is highly effective in the treatment of chronic hemorrhoidal disease. It significantly improves subjective symptoms and objective signs eg, anal discomfort, pain, redness, anal discharge, proctitis, tenesmus, pruritus, erythema and bleeding. Daflon 500 mg also significantly reduces the frequency, severity and duration of acute hemorrhoidal attacks and bleeding by chronic treatment.
Indications/Uses
Treatment of symptoms related to venolymphatic insufficiency (heavy legs, pain, restless legs syndrome at bedtime).
Treatment of functional symptoms related to acute haemorrhoidal attack.
Dosage/Direction for Use
Usual dosage: 2 tablets daily, i.e. 1 tablet at midday and 1 tablet in the evening, at meal times.
Haemorrhoidal attack: 6 tablets per day for the first 4 days, then 4 tablets per day for 3 days.
Contraindications
Hypersensitivity to the micronised purified flavonoid fraction or to any of the excipients.
Special Precautions
The administration of this product for the symptomatic treatment of acute haemorrhoids does not preclude treatment for other anal conditions. The treatment must be of short duration. If symptoms do not subside promptly, a proctological examination should be performed and the treatment should be reviewed.
Effects on ability to drive and use machines: No studies on the effects of flavonoid fraction on the ability to drive and use machines have been performed. However, on the basis of the overall safety profile of flavonoid fraction, DAFLON has no or negligible influence on the ability to drive and use machines
Use In Pregnancy & Lactation
Pregnancy: There are no or limited amount of data from the use of micronised purified flavonoid fraction in pregnant women.
Experimental studies performed in animals have not revealed a teratogenic effect.
As a precautionary measure, it is preferable to avoid the use of DAFLON during pregnancy.
Breastfeeding: It is unknown whether the active substance/metabolites are excreted in human milk.
A risk to the newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from DAFLON therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: Reproductive toxicity studies have shown no effects on female and male rats.
Adverse Reactions
Some cases of minor gastrointestinal and neurovegetative disorders have been reported, which never required cessation of treatment.
Drug Interactions
None.
Caution For Usage
Incompatibilities: None.
Storage
Store at room temperature below 30°C.
MIMS Class
Anorectal Preparations / Phlebitis & Varicose Preparations
ATC Classification
C05CA53 - diosmin, combinations ; Belongs to the class of bioflavonoids used as capillary stabilizing agents.
Presentation/Packing
Tab 30's.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in