Daflon 500 30 tablets minsan 023356025

DAFLON * 30CPR RIV 500MG

Therapeutic indications

Symptoms attributable to venous insufficiency; states of capillary fragility. Symptomatic treatment of acute hemorrhoidal crisis.

Dosage and method of use

DosageVenous insufficiency (also of the haemorrhoidal plexus) and capillary fragilityThe recommended dose is 2 tablets to be taken in two doses per day. Do not exceed the maximum daily dose.Acute hemorrhoidal crisisThe recommended dose is 3 tablets twice a day during the first 4 days of treatment; in the following 3 days the daily dose is 4 tablets in two doses. Do not exceed the maximum daily dose. Method of administration Take the tablets with the two main meals. Duration of treatment The treatment must not be continued beyond 7 days. In the absence of a therapeutic response, reassess the situation.

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 ranked under the following frequency: very common (≥1 / 10); common (≥1 / 100, Nervous system disorders Rare: dizziness, headache, malaiseGastrointestinal disordersCommon: diarrhea, dyspepsia, nausea, vomiting Uncommon: colitis Not known: abdominal painSkin and subcutaneous tissue disordersRare: rash, pruritus, urticaria Not known: edema of the face, lips, eyelid; Quincke's edemaDisorders of the blood and lymphatic systemNot known: thrombocytopeniaReporting of suspected adverse reactionsReporting 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.

Special warnings

Important information about some of the ingredients Daflon contains less than 1 mmol (23 mg) sodium per tablet, i.e. essentially 'sodium-free'.

Pregnancy and breastfeeding

PregnancyData 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 timeIt is not known 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.FertilityReproductive toxicity studies showed no effects on fertility in either male or female rats (see section 5.3).

Expiration 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.

Overdose

SymptomsThere 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).ManagementManagement of overdose should consist of treatment of clinical symptoms.

Active principles

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.

Excipients

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.