DAFLON 500 30 TABLETS
Symptoms attributable to venous insufficiency; states of capillary fragility.
Dosage and method of use
2 film-coated tablets per day (1 at noon and 1 in the evening) at mealtimes, even in venous insufficiency of the haemorrhoidal plexus.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
The following adverse effects or reactions have been reported and ranked under the following frequency: very common (≥1 / 10); common (≥1 / 100, Nervous system disorders Rare: dizziness, headache, malaise Gastrointestinal disorders Common: diarrhea, dyspepsia, nausea, vomiting Uncommon: colitis Not known: abdominal pain Skin and subcutaneous tissue disorders Rare: rash, pruritus, urticaria Not known: edema of the face, lips, eyelid; Quincke's edema Disorders of the blood and lymphatic system Not known: thrombocytopenia Reporting of suspected adverse reactions Reporting of suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Pregnancy and breastfeeding
Pregnancy Data on the use of purified micronized flavonoic fraction in pregnant women do not exist or are limited in number. Animal studies do not indicate reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Daflon during pregnancy. Feeding time 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 women. Fertility Reproductive toxicity studies showed no effects on fertility in either male or female rats (see section 5.3).
Expiry and retention
This medicinal product does not require any special storage conditions.
Interactions with other drugs
No interaction studies have been performed. To date, no clinically relevant drug interactions have been reported from post marketing experience on the product.
Symptoms There is limited experience with Daflon overdose. The most frequently reported adverse events in overdose cases were gastrointestinal events (such as diarrhea, nausea, abdominal pain) and skin events (such as pruritus, rash). Management Management of overdose should consist of treatment of clinical symptoms.
Each film-coated tablet contains 500 mg of purified micronized flavonoic fraction consisting of 450 mg of diosmin and 50 mg of flavonoids expressed in hesperidin. For the full list of excipients, see section 6.1.
Sodium carboxymethyl starch, microcrystalline cellulose, gelatin, glycerin, hypromellose, sodium lauryl sulfate, yellow iron oxide E172, red iron oxide E 172, titanium dioxide, macrogol 6000, magnesium stearate, talc.