Micronized purified flavonoid fraction.
Each film-coated tablet contains: Micronized purified flavonoid fraction corresponding to: Diosmin: 450 mg, Flavonoids expressed as hesperidin: 50 mg.
Pharmacotherapeutic group: Vasoprotectives; capillary stabilizing agents; bioflavonoids. ATC code: C05CA53.
Pharmacology: In pharmacology: Hemolax 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 normalises capillary permeability.
Pharmacodynamics: Dose/effect relationship: Statistically significant dose-effect relationships have been demonstrated for the following venous plethysmography parameters: capacitance, distensibility and emptying time. The best dose-effect ratio is obtained with 2 tablets.
Venotonic activity: It increases venous tone: venous occlusion plethysmography with a mercury strain gauge revealed a reduction in venous emptying time.
Microcirculatory activity: In patients with signs of capillary fragility, it increases capillary resistance as measured by angiosterrometry.
Efficacy and clinical safety: The medicinal product has therapeutic activity in phlebology, in the treatment of chronic venous insufficiency (functional and organic) of the lower limbs.
Pharmacokinetics: In humans, following oral administration of the medicinal product with carbon 14-labelled diosmin: Excretion is essentially faecal and urinary excretion is on average of 14% of the administered quantity.
The elimination half-life is 11 hours.
The product is highly metabolised, this metabolism is revealed by the presence of different phenol acids in the urine.
Toxicology: No special hazard for humans based on conventional studies of repeated dose toxicity, genotoxicity and toxicity to reproduction.
Treatment of symptoms related to venolymphatic insufficiency (heavy legs, pain, early morning restless legs).
Treatment of functional symptoms related to acute hemorrhoidal attack.
Usual Dose: 2 tablets daily in 2 divided doses, mid-day and evening at meal times.
Acute hemorrhoidal attack: 6 tablets daily (in 3 divided doses) for the first 4 days, then 4 tablets daily (in 2 divided doses) for the next 3 days.
Paediatric population: The safety and efficacy of Hemolax in children and adolescents under 18 years of age have not been established.
Symptoms: The most frequently reported adverse events in overdose cases were gastrointestinal events (such as diarrhoea, nausea, abdominal pain) and skin events (such as pruritus, rash).
Management: Management of overdose should consist in treatment of clinical symptoms.
Known hypersensitivity to any ingredient in the formula.
Hemorrhoidal attack: 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.
Effects on ability to drive and use machines: None known.
Pregnancy: There are no or limited amount 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 Hemolax during pregnancy.
Lactation: 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 Hemolax therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
The adverse reactions reported consist mainly in gastrointestinal events (diarrhoea, dyspepsia, nausea, vomiting).
Adverse reactions listed as follows are classified according to frequency and system organ class.
Nervous system disorders: Rare: dizziness, headaches, malaise.
Gastrointestinal disorders: Common: diarrhoea, dyspepsia, nausea, vomiting; Uncommon: colitis; Not known: abdominal pain.
Skin and subcutaneous tissue disorders: Rare: rash, pruritus, urticarial; Not known: isolated face, eyelid and lip oedema. Exceptionally, Quincke's oedema.
No interaction studies have been performed. No clinically relevant drug interaction has been reported to date from post-marketing experience on the product.
C05CA53 - diosmin, combinations ; Belongs to the class of bioflavonoids used as capillary stabilizing agents.
Hemolax FC tab 500 mg
6 × 10's
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