Micronized purified flavonoid fraction.
Each one film-coated tablet contains Micronized purified flavonoid fraction 1000 mg Corresponding to: Diosmin: 90 percent 900 mg, Flavonoids expressed as hesperidin: 10 percent 100 mg, Mean moisture 40mg.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Excipients/Inactive Ingredients: 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.
Pharmacotherapeutic Class: Vasculoprotectives/Capillary stabilizing agents/Bioflavonoids. ATC Code: C05CA53.
Pharmacology: Pharmacodynamics: DAFLON exerts a dual action on the venous return system: at vein and venule level, it increases parietal tone and exerts an anti-stasis action; at the microcirculatory level, it reinforces capillary resistance and normalises capillary permeability.
Clinical pharmacology: Controlled, double-blind studies using methods that allow demonstrating and quantifying the activity on venous haemodynamics have confirmed the pharmacological properties of this medicinal product in humans.
Dose/effect relationship: Statistically-significant dose-effect relationships have been demonstrated for the following venous plethysmography parameters: capacitance, distensibility and emptying time. The best dose/effect ratio is obtained when 1000mg tablets daily are taken.
Venotonic activity: It increases venous tone: venous occlusion plethysmography with a mercury strain gauge revealed a reduction in venous emptying time.
Microcirculatory activity: Controlled, double-blind studies have demonstrated a statistically-significant difference between this medicinal product and placebo. In patients with signs of capillary fragility, it increases capillary resistance as measured by angiosterrometry.
Clinical practice: Double-blind placebo-controlled trials have demonstrated the therapeutic effect of the drug in phlebology, in the treatment of chronic venous insufficiency of the lower limbs, both functional and organic.
Pharmacokinetics: In man, following oral administration of the substance containing 14C Diosmin: Excretion is mainly faecal and a mean of 14% of the dose administered is excreted in the urine.
The elimination half-life is 11 hours.
The drug is extensively metabolised as evidenced by the presence of various phenol acids in the urine.
Toxicology: Preclinical safety data: Preclinical data from conventional toxicology studies of repeated dose toxicity, genotoxicity and reproductive function did not reveal any particular risk to humans.
Treatment of symptoms related to venolymphatic insufficiency (heavy legs, pain, restless legs syndrome at bedtime).
Treatment of functional symptoms related to acute hemorrhoidal attack.
Usual dosage: 1 tablet daily in the morning, at meal time.
Haemorrhoidal attack: 3 tablets per day for the first 4 days, then 2 tablets per day for the next 3 days.
No case of overdose with DAFLON has been reported.
Hypersensitivity to the micronised purified flavonoid fraction or to any of the excipients (see Description).
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.
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 (see Pharmacology: Toxicology: Preclinical safety data under Actions).
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
The following undesirable effects have been reported and are ranked using the following frequency: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000), and not known (cannot be estimated from the available data).
Nervous system disorders: Rare: dizziness, headaches, malaise.
Gastrointestinal disorders: Common: diarrhoea, dyspepsia, nausea, vomiting.
Uncommon: colitis.
Frequency not known: abdominal pain.
Skin and subcutaneous tissue disorders: Rare: rash, pruritus, urticaria.
Frequency not known: isolated face, eyelid and lip oedema. Exceptionally, Quincke's oedema.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
No interaction studies have been performed. However, no cases of drug interaction have been reported since the marketing of the product.
Incompatibilities: Not applicable.
Special instructions for disposal and other handling: No special requirements.
Below 30°C.
Shelf life: 4 years.
C05CA53 - diosmin, combinations ; Belongs to the class of bioflavonoids used as capillary stabilizing agents.
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