Daflon 60 film-coated tablets 500mg

Daflon 60 Film-Coated Tablets 500Mg

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DENOMINATION:
DAFLON 500 MG FILM-COATED TABLETS

PHARMACOTHERAPEUTIC CATEGORY:
Vasoprotectant and venotonic.

ACTIVE INGREDIENTS:
Each film-coated tablet contains 500 mg of micronized purified flavonoi ca fraction consisting of 450 mg diosmin and 50 mg flavonoids expressed as hesperidin.
For a complete list of excipients, see section 6.1.

EXCIPIENTS:
Sodium carboxymethylamido, microcrystalline cellulose, gelatin, glice rin, hypromellose, sodium lauryl sulfate, E172 yellow iron oxide, E 172 red iron o sside, titanium dioxide, macrogol 6000, magnesium stearate, talc.

INDICATIONS:
Symptoms attributable to venous insufficiency; states of capil lare fragility.
Symptomatic treatment of acute hemorrhoidal crisis.

CONTRAINDICATIONS/SECONDARY EFFECTS:
Hypersensitivity to the active ingredient or any of the excipien ts listed in section 6.1.

POSOLOGY:
Posology: venous insufficiency (including of the hemorrhoidal plexus) and capillary frag ility The recommended dose is 2 tablets to be taken in two doses daily.
Do not exceed the maximum daily dose .
Acute hemorrhoidal crisis: the recommended dose is 3 tablets twice a day during the first 4 days of treatment; on the 3 su ccessive days the daily dose is 4 tablets in two administrations .
Do not exceed the maximum daily dose.
Method of administration: take the tablets at the two main meals.
Duration of treatment: treatment should not be prolonged beyond 7 days.
In the absence of a therapeutic response reevaluate the situation.

STORAGE:
This medication does not require any special conditions for co nservation.

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

INTERACTIONS:
No interaction studies have been conducted.
No clinically relevant drug interactions have been se galed so far from the post-marketing e sperience on the product.

ADVERSE EFFECTS:
The following adverse effects or reactions were reported and were categorized according to the following frequency: very common (>=1/10); c ommon (>=1/100, <1/10); uncommon (>=1/1,000, <1/100); rare (>=1/10,0 00, <1/1,000); very rare (<1/10,000), not known (frequency cannot be defined based on available data).
Nervous system disorders.
Rare: dizziness, headache, malaise.
Gastrointes tinal disorders.
Common: diarrhea, dyspepsia, nausea, vomiting; uncommon: colitis ; not known: abdominal pain.
Skin and subcutaneous tissue disorders.
Rare: rash, itching, urticaria; not known: edema of the face, lips, eyelid; Quincke's edema.
Hemol infopoietic system disorders.
Not known: thrombocytopenia.
Reporting of suspected a vverse reactions.
Reporting of suspected adverse reactions that occur after the drug is approved is important, as it allows for continuous monitoring of the risk/benefit ratio of the drug.
Health care professionals are asked to report any suspected adverse reactions through the national reporting system at https://www.aifa.gov.it/conten... ions-adverse-reactions.

PREGNANCY AND LACTATION:
Pregnancy: data on the use of micronized purified flavonoid fraction in pregnant women do not exist or are limited in number.
Animal studies do not indicate reproductive toxicity (ve dere Section 5.3).
As a precaution, it is preferable to avoid the u s e of Daflon during pregnancy.
Lactation: it is not known whether the active pr inciple/metabolites are excreted in breast milk.
Risk to infants/infants cannot be ruled out.
A d ecision must be made whether to discontinue breast milk feeding or discontinue therapy/abstain from Daflon therapy taking into consideration the benefit of breast milk feeding for the infant and the benefit of therapy for the woman.
Fertility: reproductive toxicity studies showed no effect on fertility in either male or female rats (see section 5.3).