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Venarus® (Tablets) Instructions for Use

ATC Code

C05CA53 (Diosmin in combination with other drugs)

Active Substance

Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin)

Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin) (Grouping name)

Clinical-Pharmacological Group

Venotonic and venoprotective drug

Pharmacotherapeutic Group

Venotonic and venoprotective agent

Pharmacological Action

A venotonic agent that also has angioprotective properties. It reduces venous distensibility and venous congestion, decreases capillary permeability, and increases their resistance.

Results of clinical studies confirm the pharmacological activity of drugs containing this active substance in relation to venous hemodynamic parameters.

It increases venous tone: venous occlusion plethysmography has shown a decrease in venous emptying time.

In patients with signs of severe microcirculation impairment, therapy with drugs containing this active substance leads to a (statistically significant, compared to placebo) increase in capillary resistance, as assessed by angiostereometry.

Therapeutic efficacy has been proven in the treatment of chronic venous diseases of the lower extremities, as well as in the treatment of hemorrhoids.

Pharmacokinetics

After oral administration, it undergoes active metabolism, as confirmed by the presence of phenolic acids in the urine. It is eliminated from the body mainly with feces. On average, about 14% of the administered dose is excreted in the urine. T1/2 is 11 hours.

Indications

Therapy of symptoms of veno-lymphatic insufficiency: pain; cramps in the lower limbs; sensation of heaviness and distension in the legs; “tired” legs.

Therapy of manifestations of veno-lymphatic insufficiency: swelling of the lower limbs; trophic changes of the skin and subcutaneous tissue; venous trophic ulcers.

Symptomatic therapy of acute and chronic hemorrhoids.

ICD codes

ICD-10 code Indication
I83.2 Varicose veins of lower extremities with ulcer and inflammation
I87.2 Venous insufficiency (chronic) (peripheral)
I89.0 Lymphedema, not elsewhere classified
K64 Hemorrhoids and perianal venous thrombosis
ICD-11 code Indication
BD74.Z Chronic venous insufficiency of lower extremities, unspecified
BD93.Z Lymphedema, unspecified
DB6Z Hemorrhoids or perianal venous diseases, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer orally with a meal.

For chronic venous insufficiency of the lower extremities: take two tablets per day, one in the morning and one in the evening.

For acute hemorrhoids: take six tablets per day for the first four days, then reduce to four tablets per day for the next three days.

For chronic hemorrhoids: take four tablets per day for the first three days, then reduce to two tablets per day for the next four days.

Subsequent maintenance therapy for chronic conditions is two tablets per day.

The standard treatment duration is one to three months for venous insufficiency.

For hemorrhoidal symptoms, the typical course is up to one week for acute episodes and can be repeated several times per year.

Follow the prescribed duration of therapy as directed by a physician.

Do not exceed the recommended daily dose.

Adverse Reactions

From the nervous system rarely – dizziness, headache.

From the digestive system often – diarrhea, dyspepsia, nausea, vomiting; infrequently – colitis; frequency not specified – abdominal pain.

From the skin: rarely – rash, itching, urticaria; frequency not specified – isolated edema of the face, lips, eyelids; in exceptional cases – angioedema.

General reactions rarely – general malaise.

Contraindications

Hypersensitivity to the active substance.

Use in Pregnancy and Lactation

To date, there have been no reports of adverse effects when used in pregnant women.

Use during breastfeeding is not recommended.

Special Precautions

In case of exacerbation of hemorrhoids, the use of this medicinal product does not replace specific treatment for other anal disorders.

If symptoms do not disappear after the recommended course of therapy, an examination by a proctologist should be performed.

In the presence of venous circulation disorders, the maximum treatment effect is achieved by combining therapy with a healthy (balanced) lifestyle: it is advisable to avoid prolonged exposure to the sun, prolonged standing, and weight reduction is recommended in case of excess body weight. Walking and, in some cases, wearing special stockings help improve blood circulation.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

PFC Alium, LLC (Russia)

Manufactured By

FP Obolenskoe, JSC (Russia)

Dosage Form

Bottle OTC Icon Venarus® 1000 Film-coated tablets, 1000 mg: 15, 18, 20, 27, 30, 36, 40, 45, 50, 54, 60, 63, 70, 72, 75, 80, 81, 90, 105, 120, or 135 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets orange-pink in color, biconvex, oblong in shape, with rounded ends, with a score; on the cross-section, the core is from grayish-yellow to brownish-gray in color.

1 tab.
Purified micronised flavonoid fraction (incl. diosmin 90%, flavonoids expressed as hesperidin 10%) 1000 mg

Excipients: microcrystalline cellulose type 101, sodium carboxymethyl starch (sodium starch glycolate), gelatin, talc, magnesium stearate.

Film coating composition: hypromellose (hydroxypropyl methylcellulose), macrogol 6000 (polyethylene glycol 6000), sodium lauryl sulfate, magnesium stearate, titanium dioxide, iron oxide red dye, iron oxide yellow dye.

9 pcs. – blister packs – cardboard packs.
9 pcs. – blister packs (2) – cardboard packs.
9 pcs. – blister packs (3) – cardboard packs.
9 pcs. – blister packs (4) – cardboard packs.
9 pcs. – blister packs (5) – cardboard packs.
9 pcs. – blister packs (6) – cardboard packs.
9 pcs. – blister packs (7) – cardboard packs.
9 pcs. – blister packs (8) – cardboard packs.
9 pcs. – blister packs (9) – cardboard packs.
10 pcs. – blister packs – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (7) – cardboard packs.
10 pcs. – blister packs (8) – cardboard packs.
10 pcs. – blister packs (9) – cardboard packs.
15 pcs. – blister packs – cardboard packs.
15 pcs. – blister packs (2) – cardboard packs.
15 pcs. – blister packs (3) – cardboard packs.
15 pcs. – blister packs (4) – cardboard packs.
15 pcs. – blister packs (5) – cardboard packs.
15 pcs. – blister packs (6) – cardboard packs.
15 pcs. – blister packs (7) – cardboard packs.
15 pcs. – blister packs (8) – cardboard packs.
15 pcs. – blister packs (9) – cardboard packs.

Marketing Authorization Holder

PFC Alium, LLC (Russia)

Manufactured By

Aliym, JSC (Russia)

Dosage Form

Bottle OTC Icon Venarus® 500 Film-coated tablets, 500 mg: 20, 30, 40, 45, 60, 70, 80, 90, 105, 120, or 135 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets orange-pink in color, biconvex, oblong in shape, with rounded ends, with a score; on the cross-section, the core is from grayish-yellow to brownish-gray in color.

1 tab.
Purified micronised flavonoid fraction 500 mg,
   Incl. diosmin 90%
   flavonoids expressed as hesperidin 10%

Excipients: microcrystalline cellulose type 101, sodium carboxymethyl starch, gelatin, talc, magnesium stearate.

Film coating composition: hydroxypropyl methylcellulose, macrogol 6000, sodium lauryl sulfate, magnesium stearate, titanium dioxide, iron oxide red dye, iron oxide yellow dye.

10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (7) – cardboard packs.
10 pcs. – blister packs (8) – cardboard packs.
10 pcs. – blister packs (9) – cardboard packs.
15 pcs. – blister packs (2) – cardboard packs.
15 pcs. – blister packs (3) – cardboard packs.
15 pcs. – blister packs (4) – cardboard packs.
15 pcs. – blister packs (6) – cardboard packs.
15 pcs. – blister packs (7) – cardboard packs.
15 pcs. – blister packs (8) – cardboard packs.
15 pcs. – blister packs (9) – cardboard packs.

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