Instructions for Phlebodia 600 mg film-coated tablets 600 mg No. 30
Composition
active ingredient: diosmine;
1 tablet contains diosmin, which corresponds to 600 mg of diosmin anhydrous pure;
excipients: microcrystalline cellulose, talc, stearic acid, colloidal anhydrous silicon dioxide, coating (hypromellose, microcrystalline cellulose, macrogol stearate 400), Opaglos 6000 (palm wax, yellow wax, gum lac, ethanol 95%), Sepisperse dye (cochineal red A (E 124), propylene glycol, hypromellose, titanium dioxide (E 171), red iron oxide (E 172), black iron oxide (E 172)).
Dosage form
Film-coated tablets.
Main physicochemical properties: film-coated tablets, pink in color.
Pharmacotherapeutic group
Angioprotectors. Capillary stabilizing agents. Bioflavonoids. ATX code C05C A03.
Pharmacological properties
Pharmacodynamics
Phlebodia 600 mg increases the tone of small-caliber veins, thereby improving venous outflow and lymphatic drainage. Venous tone increases due to increased tropism of parietal noradrenaline to vein myocytes (increases synthesis and/or release of noradrenaline; inhibits catechol-o-methyltransferase activity; moderately reduces phosphodiesterase activity). The vasoconstrictor effect of the drug applies only to the venous and lymphatic system. The drug does not affect arterial tone. In animals, Phlebodia 600 mg improves tissue trophism and microcirculation, reduces tissue edema by reducing capillary permeability and increasing their resistance. The drug has a moderate antiplatelet and anti-inflammatory effect. In humans, the anti-inflammatory effect is realized due to anticomplementary activity, inhibition of the peroxide anion release reaction, and reduction of leukotriene production.
Pharmacokinetics
During experimental pharmacokinetic studies using diosmin labeled with C14, it was found that in animals the drug is rapidly absorbed from the gastrointestinal tract, starting from the second hour after administration, the maximum concentration of diosmin in blood plasma is reached by the fifth hour after administration.
Diosmin is evenly distributed in all layers of the venous wall, mainly in the vena cava, saphenous veins of the lower extremities, to a lesser extent in the kidneys, liver and lungs. In other tissues, the drug is found in insignificant quantities. Selective accumulation of diosmin in the walls of venous vessels reaches a maximum at 9 hours after administration and continues for the next 96 hours.
79% is excreted in urine, 11% in feces, and 2.4% in bile, with the presence of an enterohepatic cycle.
Indication
Relief of symptoms of lymphovenous insufficiency: heaviness in the legs, pain, trophic disorders. Comprehensive treatment of functional conditions accompanied by increased capillary permeability. Treatment of functional symptoms of acute hemorrhoids.
Contraindication
Hypersensitivity to the components of the drug, especially in patients prone to allergic reactions to cochineal red A (E 124). The drug is not recommended for use during breastfeeding.
Interaction with other medicinal products and other types of interactions
Diosmin may enhance the vasoconstrictor effect of adrenaline and noradrenaline.
Application features
Chronic lymphovenous insufficiency. This medicine is most effective when combined with a healthy lifestyle. Avoid prolonged exposure to the sun and overheating, prolonged standing or sitting, and lifting heavy weights. Walking and, in some cases, wearing special medical support socks help normalize microcirculation and increase blood flow.
Acute hemorrhoids. The use of the drug does not replace specific therapy for other proctological diseases.
The treatment is carried out in a short course.
If symptoms do not disappear after a short course, a proctological examination should be performed and the therapy being administered should be reviewed.
This medicine contains cochineal red A (E 124), which may cause allergic reactions.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Use during pregnancy or breastfeeding
In experimental studies in animals, no teratogenic effects of diosmin on the fetus were detected. In clinical practice, there have been no reports of any side effects when treating pregnant women with the drug, so the drug is used after consulting a doctor, taking into account the benefit to the mother/risk to the fetus ratio.
Due to the lack of data on the penetration of the drug into breast milk, the use of this drug during breastfeeding is not recommended.
Method of administration and doses
For oral use.
Acute hemorrhoids: 2–3 tablets per day with meals for 7 days. If after treatment the symptoms of hemorrhoids do not disappear, you should consult a doctor for correction of the treatment. The maximum daily dose is 1800 mg (3 tablets).
Children
Not used.
Overdose
No cases of drug overdose have been reported.
Adverse reactions
Allergic reactions are possible, including skin rashes, itching. Rarely, dyspeptic disorders, headache are possible.
Isolated cases of gastrointestinal disorders, which rarely lead to discontinuation of treatment.
Expiration date
5 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Packaging
15 tablets in a blister, 2 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Innothera Chouzy, France.
Location of the manufacturer and its business address
Rue Rene Chantereau, Chouzy-sur-Cisse, Valloire-sur-Cisse, 41150, France.
