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

Cramps of the calf muscles, hemorrhoids, trophic ulcers, heaviness and pain in the legs, pain, anal fissures, varicose veins, vascular eye diseases Treatment of symptoms of lymphovenous insufficiency of the lower extremities (feeling of heaviness, fatigue, distension in the legs, pain that increases at the end of the day, edema);
Treatment of symptoms of acute hemorrhoids;
Additional treatment of microcirculatory disorders.

Active ingredient

Diosmin

Composition

Active substance:

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

Excipients:

talc……………………………………………10,24 mg

colloidal silicon dioxide…………………3,5 mg

stearic acid…………………………..50.05 mg

microcrystalline cellulose………… to 910 mg

Contents of the film coating:

Sepiphilm® 002 (hypromellose (E 464) – 9.832 mg, microcrystalline cellulose – 7.866 mg, macrogoal 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, black iron oxide (E 172) – 0.130 mg, red iron 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).

How to take, the dosage

Lymphovenous insufficiency of the veins of the lower limbs

In chronic lymphovenous insufficiency prescribe 1 tablet a day, with meals.

Usually the course of the preparation preparation is 2 months.

Acute hemorrhoids

In acute hemorrhoids the preparation is prescribed during the first four days 1 tablet 3 times a day with meals; during the next three days 1 tablet 2 times a day with meals.

In case of recurrent symptoms the course of treatment can be repeated upon the recommendation of the doctor.

Chronic hemorrhoids

After the acute symptoms are relieved it is recommended to continue taking the preparation once a day for 1 tablet 1-2 months.

If one or more doses of the drug are missed, it is necessary to continue using the drug as usual and in the usual dose.

Before using the drug you should consult your doctor.

Interaction

No clinically significant effects of interaction with other drugs were described.

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

Special Instructions

The medication contains the crimson dye (Ponceau 4R), which could potentially cause an allergic reaction.

Acute hemorrhoids:

Taking this medication does not replace specific treatment of other anal conditions.

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

Effects on the ability to drive vehicles
No special studies of the effect of the drug on the ability to drive or operate machinery have been conducted. Nevertheless, according to the safety profile data, the drug has no effect on the ability to drive and operate machinery.

Contraindications

Hypersensitivity to diosmin or to any of the excipients, children under 18 years of age (experience of use is limited), not recommended during breast-feeding (experience of use is limited).

Side effects

Adverse reactions are listed according to the name of the systemic organ classes and frequency of occurrence. The incidence of adverse reactions is presented as follows: very common (≥ 1/10 cases), common (≥ 1/100 and < 1/10 cases), infrequent (≥ 1/1000 and < 1/100 cases), rare (≥ 1/10000 and < 1/1000 cases) and very rare (< 1/10000 cases). Unwanted reactions, the incidence of which cannot be estimated from the available data, have the designation “frequency unknown”.

The following adverse reactions have been reported while taking Flebodia 600:

gastrointestinal disorders*: frequently – gastralgia, infrequently – bloating, diarrhea, dyspepsia, nausea, rarely – vomiting;
Skin and subcutaneous tissue disorders: infrequently – allergic reactions (rash, itching, urticaria, angioedema).
If any of the side effects mentioned in the instructions are aggravated, or if you notice any other side effects not specified in the instructions, inform the doctor.

*Gastrointestinal disorders rarely lead to discontinuation of treatment.

Overdose

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

Pregnancy use

Pregnancy

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

Studies on animals indicate no direct or indirect harmful effects with respect to reproductive toxicity. No teratogenic effects on the fetus have been identified in experimental studies. So far in clinical practice there have been no reports of cases of malformational or fetotoxic effects on the fetus when using the drug in pregnant women.

As a precautionary measure, it is preferable not to use the drug during pregnancy. Administration by prescription is possible in cases when the expected benefits to the mother exceed the potential risk to the fetus.

Breast-feeding

Because of the lack of data on penetration of the drug into the breast milk it is not recommended to breast-feeding women.

A decision should be made to stop breastfeeding or to stop / abstain from therapy with Flebodia 600 taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Similarities

Venolek, Flebofa, Diosmin