Daflon 30 Coated Tablets 500mg

Daflon 500 is a flavonoid -based medicine to combat symptoms attributable to venous insufficiency, including hemorrhoids and capillary fragility .

Daflon 500 is a vasoprotector with a micronized purified flavonoid fraction: this formulation, composed of diosmin and other flavonoids expressed in hesperidin, allows to obtain a beneficial effect on venous tone, microcirculation and lymphatic drainage . The micronization process allows to obtain a fast absorption of the product for a rapid effect .

Daflon 500 is useful in case of:

• Swelling in the ankles and legs.

• Localized sensation in the legs of pain, heaviness, tingling, itching, widespread burning.

• Restless legs.

• Evening or night cramps.

• Varicose veins.

• Skin changes such as hardening, discoloration, eczema or ulceration.

• Fragility of the capillary vessels such as broken capillaries in the leg, frequent bruising or spontaneous ecchymosis;

• Pain and discomfort attributable to hemorrhoids.

The Micronized Purified Flavonoid Fraction contained in Daflon® 500 exerts its activity at the venous level in various ways, helping to combat the symptoms at the origin. In particular, Daflon 500 decreases distensibility and reduces stasis. At the microcirculation level, it normalizes permeability and increases capillary resistance .

ACTIVE INGREDIENTS

Active ingredients contained in Daflon 30 Coated Tablets 500mg - What is the active ingredient in Daflon 30 Coated Tablets 500mg?

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. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Daflon 30 Coated Tablets 500mg - What does Daflon 30 Coated Tablets 500mg contain?

Sodium starch glycolate, microcrystalline cellulose, gelatin, glycerin, hypromellose, sodium lauryl sulphate, yellow iron oxide E172, red iron oxide E172, titanium dioxide, macrogol 6000, magnesium stearate, talc.

DIRECTIONS

Therapeutic indications Daflon 30 Coated Tablets 500mg - Why is Daflon 30 Coated Tablets 500mg used? What is it used for?

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

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Daflon 30 Coated Tablets 500mg - When should Daflon 30 Coated Tablets 500mg not be used?

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

DOSAGE

Quantity and method of taking Daflon 30 Coated Tablets 500mg - How to take Daflon 30 Coated Tablets 500mg?

Dosage: venous insufficiency (including haemorrhoidal plexus) and capillary fragility The recommended dose is 2 tablets to be taken in two administrations per day. Do not exceed the maximum daily dose. Acute haemorrhoidal crisis: the 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 administrations. Do not exceed the maximum daily dose. Method of administration: take the tablets with the two main meals. Duration of treatment: treatment should not be continued beyond 7 days. In the absence of a therapeutic response, reassess the situation.

CONSERVATION

Storage Daflon 30 Coated Tablets 500 mg - How to store Daflon 30 Coated Tablets 500mg?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Daflon 30 Coated Tablets 500mg - About Daflon 30 Coated Tablets 500 mg it is important to know that:

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

INTERACTIONS

Interactions Daflon 30 Coated Tablets 500mg - Which medicines or foods can modify the effect of Daflon 30 Coated Tablets 500mg?'

No interaction studies have been performed. No clinically relevant drug interactions have been reported so far from post-marketing experience with the product.

SIDE EFFECTS

Like all medicines, Daflon 30 Coated Tablets 500 mg can cause side effects - What are the side effects of Daflon 30 Coated Tablets 500mg?

The following adverse reactions or effects have been reported and have been 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 (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: oedema of the face, lips, eyelid; Quincke's oedema. Blood and lymphatic system disorders. Not known: thrombocytopenia. Reporting of suspected adverse reactions Reporting of 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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Daflon 30 Coated Tablets 500mg.

Pregnancy: There are no or limited amount of data from the use of micronized purified flavonoid 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. Breastfeeding: It 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 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: Reproductive toxicity studies have shown no effect on fertility in either male or female rats (see section 5.3).