Daflon 500 mg - treatment of venous insufficiency 120 coated tablets

Product Description

A drug useful in cases of venous insufficiency and capillary fragility.

Indications

Daflon 500 Mg is a tablet medication useful for reducing venous stasis, normalizing capillary permeability, and improving capillary resistance.
It is therefore possible to use Daflon 500Mg for bleeding hemorrhoids and in cases of venous insufficiency.
Thanks to the presence of flavonoids, this drug improves blood and lymphatic microcirculation and protects and strengthens the venous walls.

Ingredients

Active ingredients
Each film-coated tablet contains: 500 mg of micronized purified flavonoid fraction consisting of 450 mg of diosmin and 50 mg of flavonoids expressed as Hesperidin.
Excipients
Sodium starch glycolate, microcrystalline cellulose, gelatin, glycerin, hypromellose, sodium lauryl sulfate, yellow iron oxide E172, red iron oxide E172, titanium dioxide, macrogol 6000, magnesium stearate, talc.

Directions for Use and Dosage

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

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed.

Interactions

No interaction studies have been performed.
No interactions have been reported to date. Clinically relevant pharmacological effects from post-marketing experience with the product.

Undesirable effects

The following adverse reactions or effects have been reported and classified 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 (frequency 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: swelling of the face, lips, eyelid; Quincke's edema.
Blood and lymphatic system disorders:
Not known: thrombocytopenia.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions that occur after authorisation 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.

Overdose

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 the Overdose should consist of treating clinical symptoms.

Pregnancy and breastfeeding

Pregnancy
There are no or limited amount of data on the use of micronized purified flavonoid fraction in pregnant women.
Animal studies do not indicate reproductive toxicity.
As a precautionary measure, it is preferable to avoid the use of Daflon during pregnancy.
Breastfeeding
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 breastfeeding or to discontinue/abstain from therapy with Daflon taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility
Toxicity studies Reproductive studies showed no effects on fertility in either male or female rats.

Storage

This medicinal product does not require any special storage conditions.

Format

120 film-coated tablets