Daflon 500 mg/Daflon 1000 mg

Daflon 500 mg: One film-coated tablet contains Micronized purified flavonoid fraction 500 mg, corresponding to Diosmin (90 per cent) 450 mg, Flavonoids expressed as hesperidin (10 per cent) 50 mg, Mean humidity 20 mg.
Daflon 1000 mg: One film-coated tablet contains Micronized purified flavonoid fraction 1000 mg, corresponding to Diosmin (90 per cent) 900 mg, Flavonoids expressed as hesperidin (10 per cent) 100 mg, Mean humidity 40 mg.
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: VASCULOPROTECTIVE/CAPILLARY STABILIZING AGENTS/BIOFLAVONOIDS (C05CA53: cardiovascular system).
Pharmacology: Pharmacodynamics: Daflon exerts an action on the vascular return system: at the venous level, it reduces venous distensibility and reduces venous stasis; at the microcirculatory level, it normalises capillary permeability and reinforces capillary resistance.
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 physiopathology parameters: capacitance, distensibility and emptying time. The best dose/effect ratio is obtained with 2 tablets (for Daflon 500 mg)/1 tablet (for Daflon 1000 mg).
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 studies: 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 14% of the administered quantity; the elimination half-life is of 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: Preclinical data from conventional toxicology studies of repeated dose toxicity, genotoxicity and reproductive function did not reveal any particular risk to humans.

This medication is venotonic (it increases venous tone) and a vasculoprotector (it increases resistance in small blood vessels).
It is recommended for treating venous circulation disorders (swollen legs, pain, restless legs) and for treating symptoms due to acute hemorrhoidal attack.

Oral route.
The tablets should be taken at meal times.
Venous insufficiency: Daflon 500 mg: 2 tablets daily, i.e. one at midday and one in the evening.
Daflon 1000 mg: 1 tablet daily, in the morning.
Acute hemorrhoidal attack: Daflon 500 mg: A 4-day course of 6 tablets daily, followed by 4 tablets daily over the next 3 days.
Daflon 1000 mg: A 4-day course of 3 tablets daily, followed by 2 tablets daily over the next 3 days.
In all cases strictly comply with the doctor's prescription.

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 micronized purified flavonoid fraction or to any of the excipients (see Description).

Acute hemorrhoidal attack: If the hemorrhoid symptoms do not disappear within 15 days, the patient should ask the doctor for advice.
Venous circulation disorders: The most effective way of giving this treatment is in combination with a healthy lifestyle. Avoid exposure to the sun, heat, excessive standing and being overweight. Walking and wearing special support stockings stimulate blood circulation.
If the patient is in any doubt, do not hesitate to ask the doctor or pharmacist for advice.
Effects on ability to drive and use machine: 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 does not modify, or to a negligible extent, the ability to drive or use machines.

Pregnancy: There are no or limited amount of data from the use of Micronized 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.
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 showed no effect on fertility in male and female rats (see Pharmacology: Toxicology: Preclinical safety data under Actions).

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, headache, malaise.
Gastrointestinal disorders: Common: diarrhoea, dyspepsia, nausea, vomiting.
Uncommon: colitis.
Not known: abdominal pain.
Skin and subcutaneous tissue disorders: Rare: rash, pruritus, urticaria.
Not known: isolated face, eyelid and lip oedema. Exceptionally Quincke's oedema.
Reporting of side effects: If the patient experiences any undesirable effect, consult the doctor or pharmacist. This includes any possible side effects not listed in this monograph.
The patient can also declare the undesirable effects directly via the national declaration system by reporting side effects, the patient can help provide more information on the safety of this medicine.

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.

Below 30°C.

Phlebitis & Varicose Preparations / Anorectal Preparations

C05CA53 - diosmin, combinations ; Belongs to the class of bioflavonoids used as capillary stabilizing agents.

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