Daflon 60 Coated Tablets 500mg

Symptoms attributable to venous insufficiency; states of capillary fragility

Therapeutic indications

Symptoms attributable to venous insufficiency; states of capillary fragility.

Dosage and method of use

2 film-coated tablets per day (1 at midday and 1 in the evening) at mealtimes, even in venous insufficiency of the haemorrhoidal plexus.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Side effects

The following adverse effects or reactions have been reported and have been ranked according to the following frequency: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000), 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: abdominal edema face, lips, eyelid; Quincke's edema Blood and lymphatic system disorders Not known: thrombocytopenia Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization 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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

None.

Pregnancy and breastfeeding

Pregnancy There are no or limited data on the use of micronized purified flavonoic fraction in pregnant women. 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. Breast -feeding It is not known whether the active substance/metabolites are excreted in human milk. A risk to 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 effect on fertility in either male or female rats (see section 5.3).

Expiration and conservation

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 with the product.

Overdose

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 cutaneous events (such as pruritus, rash). Management Management of overdose should consist of treatment of clinical symptoms.

Active principles

Each film-coated tablet contains 500 mg of purified micronized flavonoid fraction consisting of 450 mg of diosmin and 50 mg of flavonoids expressed as hesperidin. For the full list of excipients, see section 6.1.

Excipients

Sodium carboxymethyl starch, microcrystalline cellulose, gelatin, glycerin, hypromellose, sodium lauryl sulfate, E172 yellow iron oxide, E 172 red iron oxide, titanium dioxide, macrogol 6000, magnesium stearate, talc.