Micronized, purified flavonoid fraction (diosmin, hesperidin).
Each film-coated tablet contains 500 mg MPFF (Micronized purified flavonoid fraction) equivalent to 450 mg diosmin and 50 mg hesperidin.
Daflon 500 mg is recommended for treating venous circulation disorders (swollen legs, pain, nocturnal cramps) and for treating symptoms due to acute hemorrhoidal attack.
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.
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.
Hypersensitivity to the active substance or to any of the excipients.
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.
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.
Reporting of adverse drug reaction:
For suspected adverse drug reaction, report to the FDA at www.fda.gov.ph.
Seek medical attention immediately at the first sign of any adverse drug reaction.
Possible side effects: Like all medicines, Diosmin + Hesperidin (Daflon 500 mg) can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if the patient notices any side effects not listed in this leaflet, please tell the doctor or pharmacist.
Diosmin + Hesperidin (Daflon 500 mg) is usually well tolerated.
The following side effects can appear: Common (less than one out of 10, but more than one out of 100 users): diarrhea, dyspepsia, nausea, vomiting.
Uncommon (less than one out of 100, but more than one out of 1,000 users): colitis (inflammation of colon).
Rare (less than one out of 1,000, but more than one out of 10,000 users): dizziness, headache, malaise, rash, pruritus, urticaria.
Frequency not known: abdominal pain, isolated face, lip, eyelid edema (swelling). Exceptionally, Quincke's edema (rapid swelling of tissues such as the face, lips, mouth, tongue or throat that may result in breathing difficulty).
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.
Store at temperatures not exceeding 30°C.
C05CA53 - diosmin, combinations ; Belongs to the class of bioflavonoids used as capillary stabilizing agents.