DAFLON 120CPR RIV 500MG

DAFLON 500 MG FILM

active ingredients

Each film-coated tablet contains 500 mg of micronized purified flavonoic fraction consisting of 450 mg of diosmine and 50 mg of flavonoids expressed in esperidine. For the full list of excipients, see paragraph 6.1.

Excellent

Sodium carboxylamicide, microcrystalline cellulose, gelatin, glycerin, ipromellose, laurilsulfate sodium, yellow iron oxide E172, red iron oxide E 172, titanium dioxide, 6000 macrogol, magnesium stearate, talc.

Therapeutic indications

Symptoms attributable to venous failure; states of capillary fragility. Syntomatic treatment of acute hemorrhoidary crisis.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Population Venous insufficiency (also of hemorrhoidary plexus) and capillary fragility The recommended dose is 2 tablets to be taken in two administrations a day. Do not exceed the maximum daily dose. Acute Hemorrhoidaria Crisis The recommended dose is 3 tablets twice daily during the first 4 days of treatment; in the next 3 days the daily dose is 4 tablets in two administrations. Do not exceed the maximum daily dose. How to administration Take the tablets to the two main meals. Duration Treatment The treatment should not be protracted over 7 days. In the absence of a therapeutic response, reevaluate the situation.

Conservation

This medicine does not require any special condition for conservation.

Warnings

Important information about some Daflon excipients contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially 'without sodium'.

Interactions

No interaction studies have been carried out. So far no clinically relevant pharmacological interaction has been reported by post marketing experience on the product.

Effects

The following adverse effects or reactions were reported and were classified according to the following frequency: very common (≥1/10); common (≥1/100, Rare nervous system pathologies: dizziness, headache, malaise Gastrointestinal diseases Municipality: diarrhea, dyspepsia, nausea, vomiting Not common: colitis Not known: abdominal pain Pathologies of skin and subcutaneous tissue Rare: rash, itching, hives Not known: edema to the face, lips, eyelid; edema of Quincke Emolinfopoietic system pathologies Notable: trombocytopenia Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the risk/benefit ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Synonyms There is a limited experience with the overdose of Daflon. The most frequently reported adverse events in cases of overdose were gastrointestinal events (such as diarrhea, nausea, abdominal pain) and skin events (such as itching, rash). Management Overdose management must consist of treating clinical symptoms.

Pregnancy

Data relating to the use of micronized flavonoic fraction in pregnant women do not exist or are in limited number. Animal studies do not indicate reproductive toxicity (see paragraph 5.3). For precautionary purposes, it is preferable to avoid the use of Daflon during pregnancy.

Food

It is not known whether the active ingredient/metabolites are excreted in breast milk. The risk for infants/ infants cannot be excluded. The decision must be taken if you stop breast milking or stop the therapy/care with Daflon taking into consideration the benefit of breast milk for the child and the benefit of the therapy for the woman.

Fertility

Reproductive toxicity studies have shown no effect on fertility in rats or males or females (see paragraph 5.3).

Source: Farmadati