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Micronised purified flavonoid fraction.
500-mg: Each film-coated tablet contains micronised purified flavonoid fraction 500 mg, corresponding to Diosmin 450 mg and Flavonoids expressed as hesperidin: 10 percent equivalent to 50 mg.
1,000-mg: Micronized purified flavonoid fraction 1000 mg corresponding to: Diosmin: 90 percent 900 mg, Flavonoids expressed as hesperidin: 10 percent 100 mg, Mean moisture 40 mg for one film-coated tablet.
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 group: VASOPROTECTIVES/CAPILLARY STABILIZING AGENTS/BIOFLAVONOIDS. C05CA53: Cardiovascular system.
Pharmacology: Pharmacodynamics: In pharmacology: 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.
In 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.
500-mg: The best dose-effect ratio is obtained with 2 tablets.
1,000-mg: The best dose/effect ratio is obtained with 1 tablet.
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.
Efficacy and clinical safety: In clinical practice: Controlled, double-blind clinical studies versus placebo demonstrated the therapeutic activity of the medicinal product in phlebology, in the treatment of chronic venous insufficiency (functional and organic) of the lower limbs.
Pharmacokinetics: In humans, following oral administration of the medicinal product with carbon 14-labelled diosmin: Excretion is essentially faecal and urinary excretion is on average of 14% of the administered quantity.
The elimination half-life is 11 hours.
The product is highly metabolised, this metabolism is revealed by the presence of different phenol acids in the urine.
Toxicology: Preclinical safety data: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, genotoxicity and toxicity to reproduction.
Treatment of symptoms related to venolymphatic insufficiency (heavy legs, pain, early morning restless legs).
Treatment of functional symptoms related to acute hemorrhoidal attack.
500-mg: Posology: Usual Dose: 2 tablets daily in 2 divided doses, mid-day and evening at meal times.
Acute Hemorrhoidal Attack: 6 tablets daily for the first 4 days, then 4 tablets daily for 3 days.
Paediatric population: The safety and efficacy of DAFLON 500 mg in children and adolescents under 18 years of age have not been established.
1,000-mg: Posology: Venolymphatic insufficiency: 1 tablet daily, in the morning at breakfast.
Acute hemorrhoidal attack: 3 tablets daily (in 3 divided doses) for the first 4 days, then 2 tablets per day (in 2 divided doses) for the next 3 days.
Paediatric population: The safety and efficacy of Daflon 1000 mg in children and adolescents under 18 years of age have not been established.
Method of administration: Oral route.
Symptoms: There is limited experience with DAFLON overdose. The most frequently reported adverse events in overdose cases were gastrointestinal events (such as diarrhoea, nausea, abdominal pain) and skin events (such as pruritus, rash).
Management: Management of overdose should consist in treatment of clinical symptoms.
Hypersensitivity to the active substance or to any of the excipients listed in Description.
Hemorrhoidal attack: The administration of this product does not preclude treatment for other anal conditions. The treatment must be short-term. If symptoms do not subside promptly, a proctological examination should be performed and the treatment should be reviewed.
Effects on the ability to drive and use machines: No specific 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 have 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.
Animal studies do not indicate reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
As a precautionary measure, it is preferable to avoid the use of DAFLON during pregnancy.
Breast-feeding: 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 showed no effect on fertility in male and female rats (see Pharmacology: Toxicology: Preclinical safety data under Actions).
500-mg: Summary of safety profile:
Side effects reported with DAFLON in clinical trials are of mild intensity. They consist mainly in gastro intestinal events (diarrhoea, dyspepsia, nausea, vomiting).
Tabulated list of adverse reactions: 500-mg:
The following adverse reactions have been reported and are ranked using the following frequency: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). (See table.)
Click on icon to see table/diagram/image
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.
Common: diarrhoea, dyspepsia, nausea, vomiting.
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. No clinically relevant drug interaction has been reported to date from post-marketing experience on the product.
Incompatibilities: Not applicable.
Special instructions for disposal and other handling: 1,000-mg: No special requirements.
Store below 30°C.
Shelf life: 500-mg: 3 years.
1,000-mg: 4 years.
C05CA53 - diosmin, combinations ; Belongs to the class of bioflavonoids used as capillary stabilizing agents.
FC tab 500 mg x 30's. 1,000 mg (salmon coloured, oblong shaped, scored on both faces) x 30's.