Phlebodia 600 tablets p / o 600mg, No. 60

• Treatment of symptoms of lymphovenous insufficiency of the lower extremities (feeling of heaviness, fatigue, distention in the legs, pain that intensifies towards the end of the day, swelling);

• Treating the symptoms of acute hemorrhoids;

• Additional treatment for microcirculation disorders.

The drug is intended for oral administration.

Lymphovenous insufficiency of the veins of the lower extremities

In chronic lymphovenous insufficiency, 1 tablet is prescribed per day in the morning, preferably before meals.

Usually, the course of taking the drug is 2 months.

Acute hemorrhoids and exacerbation of chronic hemorrhoids.

In acute hemorrhoids and exacerbation of chronic hemorrhoids, the drug is prescribed for the first four days, 1 tablet 3 times a day with meals; in the next three days, 1 tablet 2 times a day with meals.

In case of recurrence of symptoms, the course of treatment can be repeated on the recommendation of a doctor.

Chronic hemorrhoids

After relief of acute effects, it is recommended to continue taking the drug 1 tablet 1 time per day for 1-2 months.

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

Before using the drug, you should consult your doctor.

Active substance:

Diosmin on a dry matter basis - 600 mg

Excipients:

talc - 10.24 mg

colloidal silicon dioxide - 3.5 mg

stearic acid - 50.05 mg

microcrystalline cellulose up to 910 mg

The composition of the film shell:

SepifilmЃ 002 (hypromellose (E 464) - 9.832 mg, microcrystalline cellulose - 7.866 mg, macrogol 8 stearate type 1 - 1.967 mg). SepispersЃ AP 5523 pink (propylene glycol - traces, hypromellose (E 464) - 0.458 mg, titanium dioxide (E 171) - 4.026 mg, crimson dye [Ponso 4R] (E 124) - 0.401 mg, iron oxide black (E 172) - 0.130 mg, iron oxide red (E 172) - 0.020 mg).
OpaglosЃ 6000 (carnauba wax (E 903) - 0.075 mg, beeswax (E 901) - 0.075 mg, shellac (E 904) - 0.150 mg, ethanol 95 ? - traces).

• Hypersensitivity to the components of the drug,

• children under 18 years of age (experience of use is limited), not recommended during breastfeeding (experience of use is limited).

Tradename:

FLEBODIA 600

INN:

diosmine

Dosage form:

film-coated tablets

Composition for 1 tablet

Active substance:

Diosmin on a dry matter basis - 600 mg

Excipients:

talc - 10.24 mg

colloidal silicon dioxide - 3.5 mg

stearic acid - 50.05 mg

microcrystalline cellulose up to 910 mg

The composition of the film shell:

SepifilmЃ 002 (hypromellose (E 464) - 9.832 mg, microcrystalline cellulose - 7.866 mg, macrogol 8 stearate type 1 - 1.967 mg). SepispersЃ AP 5523 pink (propylene glycol - traces, hypromellose (E 464) - 0.458 mg, titanium dioxide (E 171) - 4.026 mg, crimson dye [Ponso 4R] (E 124) - 0.401 mg, iron oxide black (E 172) - 0.130 mg, iron oxide red (E 172) - 0.020 mg).
OpaglosЃ 6000 (carnauba wax (E 903) - 0.075 mg, beeswax (E 901) - 0.075 mg, shellac (E 904) - 0.150 mg, ethanol 95 ? - traces).

Description

Pink round biconvex film-coated tablets.

Pharmacotherapeutic group

Angioprotective agent.

ATX code:

C05CA03

Pharmacological properties

Pharmacodynamics

Venotonic action: reduces the elasticity of the veins; increases venous tone; reduces venous congestion; enhances the vasoconstrictor effect of adrenaline, norepinephrine.

One tablet contains 600 mg of diosmin, which is the optimal effective daily dose for venotonic action.

Angioprotective action: improves microcirculation; increases capillary resistance; reduces their permeability.

Effect on the lymphatic system: improves lymphatic drainage, increases the tone and frequency of contraction of lymphatic capillaries, increases their functional density, reduces lymphatic pressure.

Has a decongestant effect. Reduces symptoms of inflammation (dose-dependent effect).

Reduces the adhesion of leukocytes to the venous wall and their migration to paravasal tissues; improves oxygen diffusion and tissue perfusion. Blocks the production of free radicals, the synthesis of prostaglandins and thromboxane.

Clinical studies have confirmed: a decrease in the average venous pressure in the superficial and deep vein system of the lower extremities, demonstrated in a double-blind, placebo-controlled study conducted under Doppler ultrasound control; and an increase in systolic and diastolic blood pressure in patients with postoperative orthostatic hypotension.

Pharmacokinetics

After oral administration, the drug is rapidly absorbed from the gastrointestinal tract and is determined in blood plasma after 2 hours. The maximum concentration in blood plasma is reached 15 hours after ingestion. It is evenly distributed and accumulates in all layers of the wall of the vena cava and saphenous veins of the lower extremities, to a lesser extent in the kidneys, liver, lungs and other organs. Selective accumulation of diosmin and / or its metabolites in venous vessels reaches a maximum by 9 hours after administration and lasts for 96 hours. It is excreted mainly by the kidneys (79%), also by the intestines (11%) and with bile (2.4%).

Indications for use

• Treatment of symptoms of lymphovenous insufficiency of the lower extremities (feeling of heaviness, fatigue, distention in the legs, pain that intensifies towards the end of the day, swelling);

• Treating the symptoms of acute hemorrhoids;

• Additional treatment for microcirculation disorders.

Contraindications

• Hypersensitivity to the components of the drug,

• children under 18 years of age (experience of use is limited), not recommended during breastfeeding (experience of use is limited).

Pregnancy and the period of breastfeeding

Pregnancy

Application during pregnancy is possible only as directed by a doctor in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

In experimental studies, there was no teratogenic effect on the fetus. Until now, 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.

Breastfeeding period

Due to the lack of data on the penetration of the drug into breast milk, it is not recommended for lactating women to take the drug.

Method of administration and dosage

The drug is intended for oral administration.

Lymphovenous insufficiency of the veins of the lower extremities

In chronic lymphovenous insufficiency, 1 tablet is prescribed per day in the morning, preferably before meals.

Usually, the course of taking the drug is 2 months.

Acute hemorrhoids and exacerbation of chronic hemorrhoids.

In acute hemorrhoids and exacerbation of chronic hemorrhoids, the drug is prescribed for the first four days, 1 tablet 3 times a day with meals; in the next three days, 1 tablet 2 times a day with meals.

In case of recurrence of symptoms, the course of treatment can be repeated on the recommendation of a doctor.

Chronic hemorrhoids

After relief of acute effects, it is recommended to continue taking the drug 1 tablet 1 time per day for 1-2 months.

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

Before using the drug, you should consult your doctor.

Side effect

The incidence of adverse reactions is presented as follows: very often (more than 1/10 cases), often (more than 1/100 and less than 1/10 cases), infrequently (more than 1/1000 and less than 1/100 cases), rarely (more than 1 / 10000 and less than 1/1000 cases) and very rarely (less than 1/10000 cases). Adverse reactions, the frequency of development of which is not possible to estimate from the available data, have the designation 'frequency is unknown.'

While taking the drug Flebodia 600, the following adverse reactions were reported:

• from the gastrointestinal tract: rarely - dyspeptic disorders (heartburn, nausea, abdominal pain);

• from the central nervous system: rarely - headache.

If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects that are not indicated in the instructions, inform your doctor.

Overdose

Overdose symptoms are not described.

Interaction with other medicinal products

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

You should inform your doctor about all medications you are taking.

special instructions

Acute hemorrhoids can be treated in combination with other treatments. In the event that the symptoms do not disappear after the recommended course of treatment, you should consult with a specialist who will select further therapy.

Impact on the ability to drive vehicles

There is no data on the negative effect of the drug on the ability to drive vehicles and other mechanisms.

Release form

Film-coated tablets.

15 or 18 tablets in PVC / aluminum blister.

1, 2, 4 or 6 blisters of 15 tablets with instructions for use in a cardboard box.

1 blister of 18 tablets with instructions for use in a cardboard box.

Shelf life

3 years. Do not use after the expiration date.

Storage conditions

Store at a temperature not exceeding 30 ? C.
Keep out of the reach of children.

Conditions of dispensing from pharmacies

Without recipe.

Name of the holder (owner) of RU:

Innoter Laboratories
22, Avenue Aristide Briand, 94110 Arkay, France

Manufacturer

All stages of production:

Innotera Chusi
Rue Rene Chantero, Chusy-sur-Sice, Valloire-sur-Sis, 41150, France

Consumer claims should be sent to:

INNOTEK LLC
115035, Moscow, Sadovnicheskaya embankment, 71