Phlebodia 600,600 mg 60 pcs

ATC code:
С05СА03

PHARMACOLOGICAL PROPERTIES
Pharmacodynamics

Venotoninizing and angioprotective agent with vasoconstrictor effect, increasing capillary resistance and reducing their permeability.

It has anti-edematous, fibrinolytic and anti-inflammatory effects.

Venotonic and angioprotective effects have been demonstrated in clinical trials.

Venotonizing effects

Increased vasoconstrictor effects of adrenaline, noradrenaline and serotonin on superficial arm veins or isolated saphenous vein.
Increase in venous tone as assessed by venous capacity measurement with plethysmography; reduction of blood stasis in the veins.
Venotonic effect is dose-dependent.
Decrease in mean venous pressure (in both superficial system and deep veins) demonstrated by dopplerography in a double-blind placebo-controlled clinical trial.
Increase in systolic and diastolic blood pressure in orthostatic hypotension in the postoperative period.
Activity after safenectomy.
Angioprotective effect

Dose-dependent increase in capillary resistance.
Pharmacokinetics

Absorption

After oral administration of Phlebodia 600, diosmin is metabolized by intestinal bacteria to diosmetin. Diosmethine is absorbed and found in the bloodstream as conjugates (glucuronides and sulfates). The main metabolite of diosmin is diosmetin-3-O-glucuronide.

Peak plasma concentrations are reached between 12 and 15 hours after administration of Phlebodia 600.

Distribution

An animal pharmacokinetic study of carbon-14-labeled diosmin showed preferential distribution of radioactivity in the vena cava and saphenous veins.

Excretion

In animals, 79% is excreted with urine, 11% with feces, and 2.4% with bile, confirming intestinal-hepatic recirculation.

In humans, diosmetin-3-O-glucuronide is found in urine.

Indications

Treatment of symptoms of lymphovenous insufficiency of the lower extremities (feeling of heaviness, fatigue, bloating in the legs, pain that increases towards the end of the day, swelling);
Treatment of symptoms of acute hemorrhoids;
Additional treatment for microcirculation disorders.

Pharmacological effect

ATH CODE:
C05CA03

PHARMACOLOGICAL PROPERTIES
Pharmacodynamics

A venotonic and angioprotective agent that has a vasoconstrictor effect, increases capillary resistance and reduces their permeability.

Has anti-edematous, fibrinolytic, anti-inflammatory effects.

Venotonic and angioprotective effects have been demonstrated in clinical studies.

Venotonic effect

Increasing the vasoconstrictor effect of adrenaline, norepinephrine and serotonin on the superficial veins of the arms or the isolated saphenous vein.
Increased venous tone, assessed by measuring venous capacity using plethysmography; reducing blood stagnation in the veins.
The venotonic effect is dose-dependent.
Reduction in mean venous pressure (both superficial and deep venous) demonstrated by Doppler ultrasound in a double-blind, placebo-controlled clinical trial.
Increased systolic and diastolic blood pressure with orthostatic hypotension in the postoperative period.
Activity after safenectomy.
Angioprotective effect

Dose-dependent increase in capillary resistance.
Pharmacokinetics

Absorption

After oral administration of Phlebodia 600, diosmin is metabolized by intestinal bacteria into diosmetin. Diosmetin is absorbed and found in the bloodstream in the form of conjugates (glucuronides and sulfates). The main metabolite of diosmin is diosmetin-3-O-glucuronide.

Peak plasma concentrations are reached between 12 and 15 hours after taking Phlebodia 600.

Distribution

A pharmacokinetic study of carbon-14 labeled diosmin in animals showed a predominant distribution of radioactivity in the vena cava and saphenous veins.

Removal

In animals, 79% is excreted in urine, 11% in feces and 2.4% in bile, confirming enterohepatic recirculation.

In humans, diosmetin-3-O-glucuronide is found in urine.

Special instructions

The medicine contains crimson dye (Ponceau 4R), which can potentially cause an allergic reaction.

Hemorrhoids in the acute stage:

Taking this drug does not replace specific treatment for other anal diseases.

If symptoms do not show signs of rapid improvement, a proctological examination should be performed and treatment should be reconsidered if necessary.

INFLUENCE ON THE ABILITY TO DRIVE VEHICLES
No special studies have been conducted on the effect of the drug on the ability to drive a car or use machinery. However, according to the safety profile, the drug does not affect the ability to drive a car or use machinery.

Active ingredient

Diosmin

Composition

Active ingredient:

Diosmin in terms of dry matter……….600 mg

Excipients:

talc……………………………………………………10.24 mg

colloidal silicon dioxide…………………3.5 mg

stearic acid…………………………..50.05 mg

microcrystalline cellulose…………up to 910 mg

Film shell composition:

Sepifilm® 002 (hypromellose (E 464) – 9.832 mg, microcrystalline cellulose – 7.866 mg, macrogol 8 stearate type 1 – 1.967 mg). Sepispers® AP 5523 pink (propylene glycol – traces, hypromellose (E 464) – 0.458 mg, titanium dioxide (E 171) – 4.026 mg, crimson dye [Ponceau 4R] (E 124) – 0.401 mg, iron oxide black (E 172) – 0.130 mg, iron red oxide (E 172) – 0.020 mg).

Opaglos® 6000 (carnauba wax (E 903) – 0.075 mg, beeswax (E 901) – 0.075 mg, shellac (E 904) – 0.150 mg, ethanol 95° – traces).

Pregnancy

Pregnancy

Data on the use of diosmin (the active ingredient of Phlebodia 600) in pregnant women are limited.

Animal studies do not indicate direct or indirect harmful effects in terms of reproductive toxicity. Experimental studies have not revealed any teratogenic effects on the fetus. To date, in clinical practice there have been no reports of cases of malformation or fetotoxic effects on the fetus when using the drug in pregnant women.

As a precaution, it is preferable not to use the drug during pregnancy. Use as prescribed by a doctor is possible in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding period

Due to the lack of data on the penetration of the drug into breast milk, nursing women are not recommended to take the drug.

A decision must be made to stop breastfeeding or to discontinue/abstain from therapy with Phlebodia 600, taking into account the benefits of breastfeeding for the child and the benefits of therapy for the woman.

Contraindications

Hypersensitivity to diosmin or to any of the excipients, children under 18 years of age (limited experience), not recommended during breastfeeding (limited experience).

Side Effects

Adverse reactions are listed according to the name of systemic organ classes and frequency of occurrence. The incidence of adverse reactions is presented as follows: very often (≥ 1/10 cases), often (≥ 1/100 and < 1/10 cases), infrequently (≥ 1/1000 and < 1/100 cases), rarely (≥ 1/10,000 and < 1/1000 cases) and very rarely (< 1/10,000 cases). Adverse reactions, the frequency of which cannot be estimated from the available data, are designated “frequency unknown.”The following adverse reactions have been reported while taking Phlebodia 600:gastrointestinal disorders*: often – gastralgia, infrequently – bloating, diarrhea, dyspepsia, nausea, rarely – vomiting;
disorders of the skin and subcutaneous tissue: uncommon – allergic reactions (rash, itching, urticaria, angioedema).
If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

*Gastrointestinal disorders rarely lead to discontinuation of treatment.

Interaction

Clinically significant effects of interaction with other drugs have not been described.

The patient should inform the attending physician about all medications taken.

Overdose

No cases of overdose or overdose-related adverse reactions have been reported.

Storage conditions

Store at a temperature not exceeding 30 °C.

Keep out of the reach of children.

Shelf life

5 years. Do not use after expiration date.

Manufacturer

Innotera Chouzy, France