Full Prescribing Informations:

Contents:
Micronized, purified flavonoid fraction (diosmin, hesperidin).

Description:
Daflon 500: Each film-coated tablet contains 500 mg MPFF (Micronized
purified flavonoid fraction) equivalent to diosmin 450 mg and hesperidin 50
mg.
Daflon 1000: Each tablet contains Micronized purified flavonoid fraction
1000 mg, corresponding to Diosmin (90%) 900 mg, Flavonoids expressed as
hesperidin (10%) 100 mg. The score line is only to facilitate breaking for
ease of swallowing and not to divide into equal doses.

Action:
Pharmacology: Pharmacodynamics: Daflon exerts a dual action on the
venous return system: at vein and venule level, it increases parietal tone
and exerts an anti-stasis action; at the microcirculatory level, it reinforces
capillary resistance and normalizes capillary permeability.
Pharmacokinetics: In humans, following oral administration of the
medicinal product with carbon 14-labelled diosmin: excretion is essentially
fecal and urinary excretion is on average 14% of the administered quantity,
the elimination half-life is 11 hours, the product is highly metabolized as
evidenced by the presence of various phenol acids in the urine.
Toxicology: Preclinical safety data: Non-clinical data reveal no special
hazard for humans based on conventional studies of repeated dose toxicity,
genotoxicity and toxicity to reproduction.

Indications/Uses:
Daflon 500 mg: Recommended for treating venous circulation disorders
(swollen legs, pain, nocturnal cramps) and for treating symptoms due to
acute hemorrhoidal attack.
Daflon 1000: This medicine is a venotonic (it increases venous tone) and a
vasculoprotector (it increases resistance in small blood vessels). This
medicine is recommended for the treatment of venous circulation disorders
(heavy legs, pain, restless legs) and functional symptoms related to acute
hemorrhoidal attack. If the symptoms do not resolve within two weeks, it is
essential to consult the doctor.

Dosage/Direction for Use:
Daflon 500: Oral route. The tablets should be taken at meal times.
Venous insufficiency: 2 tablets daily, one at mid-day and one in the evening.
Acute hemorrhoidal attack: A 4-day course of 6 tablets daily, followed by 4
tablets daily over the next 3 days.
In all cases, strictly comply with the doctor's prescription.
Daflon 1000: Venous insufficiency: 1 tablet daily, at mealtime.
Hemorrhoidal attack: The recommended dose is 3 tablets per day for 4 days
and then 2 tablets per day for the next 3 days, at mealtimes.
Oral route.
Missed dose: Not applicable.

Overdosage:
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 overdose should consist in treatment of
clinical symptoms.
If the patient taken more Daflon than he/she should, contact the doctor or
pharmacist immediately.

Contraindications:
Hypersensitivity to the active substance or to any of the excipients.

Special Precautions:
Hemorrhoidal attack: If the hemorrhoid disorder persists for more than 15
days, it is essential that the patient consults a doctor.
The administration of this product does not preclude treatment for other
anal conditions. The treatment must be short-term.
If symptoms do not subside promptly, a proctological examination should
be performed and the treatment should be reviewed.
Venous circulation disorders: This treatment is at its most effective when
combined with a healthy lifestyle.
Avoid exposure to the sun, heat, standing for too long, excess weight.
Walking, and wearing appropriate stockings when applicable, promote
blood circulation.

Use In Pregnancy & Lactation:
If patient is pregnant or breast-feeding, think may be pregnant or is
planning to have a baby, ask the doctor or pharmacist for advice before
taking this medicine.
Pregnancy: There are no limited amounts of data from the use of
Micronised 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.
Breast-feeding: It is unknown 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 the woman.

Adverse Reactions:
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
The frequency of the possible undesirable effects listed as follows is defined
using the following system: Very common (affects more than 1 user out of
10); Common (affects 1 to 10 users out of 100); Uncommon (affects 1 to 10
users out of 1,000); Rare (affects 1 to 10 users out of 10,000); Very rare
(affects less than 1 user out of 10,000); Frequency not known (cannot be
estimated from the available data).
Nervous system disorders: Rare: dizziness, headaches, discomfort.
Gastrointestinal disorders: Common: diarrhea, dyspepsia (indigestion),
nausea, vomiting. Uncommon: colitis. Frequency not known: abdominal
pain.
Skin and subcutaneous tissue disorders: Rare: rash, pruritus (itching),
urticaria (hives). Frequency not known: isolated face, eyelids, and lips
edema. Exceptionally, Quincke's edema (angioedema).
View ADR Monitoring Form

Drug Interactions:
The patient must always tell the doctor or pharmacist about any other
treatment the patient is receiving.
No interaction studies have been performed. No clinically relevant drug
interaction has been reported to date from post marketing experience on
the product.

Caution For Usage:
Do not throw away any medicines via wastewater of household waste.
Ask a pharmacist how to throw away medicines patients no longer use.
These measures will help protect the environment.

Storage:
Store at temperatures not exceeding 30C.