Keep out of reach of children.
Read the directions carefully before use.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients
Diosmin ..................................... 450 mg
Hesperidin ................................... 50 mg
Excipients: Wheat starch, avicel, PVP, magnesium stearate, HPMC, PVA, PEG 6000, talc, titanium dioxide, red iron oxide, yellow iron oxide.
Film coated tablet.
Product description: An oval, light brown, film-coated tablet, plain on both sides and undamaged edges.
No specific studies on the effects of the flavonoid fraction on the ability to drive and use machines have been performed. However, on the basis of the overall safety profile of the flavonoid fraction, the medicinal product has no or negligible effect on the ability to drive and use machines.
Pregnancy
There are no data or limited data from the use of micronized purified flavonoid fraction in pregnant women.
Animal studies have not revealed any evidence of reproductive toxicity.
As a precautionary measure, it is preferable to avoid the use of the medicinal product during pregnancy.
Breast-feeding
It is not known whether the micronized purified flavonoid fraction/metabolites are excreted in breast milk.
A risk for newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility
Reproductive toxicity studies have shown no effect on fertility in male and female rats.
No interaction studies have been performed.
No clinically relevant drug interaction has been reported to date from post-marketing experience on the product.
The following side effects have been reported and are classified according to the following frequency.
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <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: diarrhea, dyspepsia, nausea, vomiting.
Uncommon: colitis.
Not known: abdominal pain.
Skin and subcutaneous tissue disorders
Rare: rash, pruritus, urticaria.
Not known: Isolated oedema of face, lips, eyelids. Exceptionally: Quincke’s oedema.
Please inform your doctor of all undesirable effects upon drug administration.
Symptoms
The experience of overdose is limited. The most common side effects reported with overdose are gastrointestinal disturbances (such as diarrhea, nausea, abdominal pain) and skin reactions (pruritus, rash).
Treatment
Treatment of an overdose should consist of symptomatic treatment.
Hemorrhoidal crisis
The administration of this product as a symptomatic treatment for hemorrhoidal crisis does not preclude the specific treatment of other anal diseases. The treatment should be short-term. If symptoms do not resolve quickly, a proctological examination should be performed and the treatment should be reviewed.
Excipients
Wheat starch contained in this medicine contains only very low levels of gluten and is very unlikely to cause problems if you have coeliac disease. If you have wheat allergy you should not take this medicine.
Treatment of symptoms related to veno-lymphatic insufficiency (heavy, painful legs, restless legs syndrome)
Treatment of functional signs linked to hemorrhoidal crisis
Hypersensitivity to the active ingredient and any excipients of the medicinal product.
METHOD OF ADMINISTRATION
Oral use.
POSOLOGY
Usual dosage: 2 tablets per day, i.e. 1 tablet at midday and 1 tablet in the evening before mealtimes.
Hemorrhoidal crisis: 6 tablets per day for the first 4 days, then 4 tablets per day for 3 days.
Pediatric population
The safety and efficacy of the medicinal product in children and adolescents aged under18 years have not been established.
Or as directed by the physician.
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