Oblong pink-orange film-coated tablets, one side is scored horizontally.
Each tablet contains: Diosmin (90%): 450 mg; Hesperidin (10%): 50 mg. Excipients/Inactive Ingredients: Microcrystalline cellulose, gelatin, sodium starch glycolate, magnesium stearate, talc, sodium lauryl sulfate, opadry orange.
Action
Pharmacological group: Bioflavonoids that protect the cardiovascular system. ATC code: C05CA53. Pharmacology: Pharmacodynamics:The drug has a dual action on the vascular system returning to the heart.
In veins and venules, the drug reduces the stretchiness of the veins and reduces stagnation in the veins.
In the microcirculation, the drug normalizes capillary permeability and enhances capillary strength. Pharmacokinetics: In humans, after oral dosing with carbone 14-labelled diosmine.
Excretion is mainly in the faeces and excretion in the urine averages about 14% of the dose.
The half-life is 11 hours.
The drug is extensively metabolised, which is recognized by the presence of various phenol acids in the urine.
Indications/Uses
Treatment of symptoms related to venolymphatic insufficiency.
Treatment of functional signs linked to the hemorrhoidal crisis.
Dosage/Direction for Use
Posology: Usual dose: 2 tablets/day, one tablet at noon and one tablet at night.
Hemorrhoidal crisis: 6 tablets/day for the first 4 days, then 4 tablets/day for 3 days.
Children: The safety and effectiveness of the drug for children and adolescents under 18 years of age have not been establish. Method of administration: Oral route, during meals.
Overdosage
Overdose: Data on overdose are limited. The most frequently reported adverse reactions when using overdose are gastrointestinal effects (such as diarrhea, nausea, vomiting, abdominal pain) and skin effects (such as itching, rash). Treatment: Symptomatic treatment.
Contraindications
Contraindicated in patients with hypersensitivity to any ingredient of the drug.
Special Precautions
Hemorrhoidal crisis.
The administration of this product does not exempt from the specific treatment of other anal diseases. The treatment should be a short term one. If the symptoms do not resolve quickly, a proctologic examination should be performed and the treatment should be reviewed. Effects on Ability to Drive and Use Machines: To date, no side effects affecting the ability to drive and use machines have been reported.
Use In Pregnancy & Lactation
Pregnancy: Animal studies have shown no teratogenic potential. On the other hand, in humans, no adverse effects have been reported to date. Lactation: Since there are no data on whether the drug passes into breast milk, mothers are advised not to breastfeed during treatment.
Adverse Reactions
The following terms and frequencies have been used: Very common: R ≥ 1/10.
Common: 1/10 > R ≥1/100.
Uncommon: 1/100 > R ≥1/1000.
Rare: 1/1000 > R ≥1/10000.
Very rare: R <1/10000.
Unknown: cannot be estimated from the available data.
Adverse reactions reported during the marketing of the drug include: Nervous system disorders: Rare: Dizziness, headache, malaise. Gastrointestinal disturbances: Common: Diarrhea, dyspepsia, nausea, vomiting.
Uncommon: Colitis.
Unknown: Abdominal pain. Skin and subcutaneous tissue disorders: Rare: Rash, pruritus, urticaria.
Unknown: Isolated edema of the face, eyelids, lips. Exceptionally, angioedema.
Inform the doctor or pharmacist immediately of any adverse reactions encountered when using the drug.
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