Flebalgin^® Activ (Tablets) Instructions for Use

Marketing Authorization Holder

Pro Product, LLC (Russia)

Manufactured By

PharmVILAR NPO, LLC (Russia)

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)

Dosage Forms

	Flebalgin® Activ	Film-coated tablets, 500 mg: 10, 20, 30, 40, 50, 60 or 120 pcs.
		Film-coated tablets, 1000 mg: 10, 20, 30, 40, 50, 60 or 120 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets oval, orange-pink in color, oval, biconvex, with a score on one side; on the break from grayish-yellow to brownish-gray in color; the presence of lighter and darker inclusions is allowed.

Excipients : microcrystalline cellulose – 52 mg, povidone K30 – 31 mg, sodium carboxymethyl starch – 27 mg, purified water – 20 mg, potato starch – 10 mg, talc – 6 mg, magnesium stearate – 4 mg.

Film coating composition polyvinyl alcohol – 8 mg, titanium dioxide – 4.72 mg, macrogol – 4.04 mg, talc – 2.96 mg, sunset yellow dye – 0.2 mg, yellow iron oxide dye – 0.04 mg, red iron oxide dye – 0.04 mg.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (12) – cardboard packs.
50 pcs. – dark glass jars (1) – cardboard packs.

Film-coated tablets orange-pink in color, oval, biconvex, with a score on one side; on the break from grayish-yellow to brownish-gray in color; the presence of lighter and darker inclusions is allowed.

Excipients : microcrystalline cellulose – 104 mg, povidone K30 – 62 mg, sodium carboxymethyl starch – 54 mg, purified water – 40 mg, potato starch – 20 mg, talc – 12 mg, magnesium stearate – 8 mg.

Film coating composition polyvinyl alcohol – 16 mg, titanium dioxide – 9.44 mg, macrogol – 8.08 mg, talc – 5.92 mg, sunset yellow dye – 0.4 mg, yellow iron oxide dye – 0.08 mg, red iron oxide dye – 0.08 mg.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (12) – cardboard packs.
50 pcs. – dark glass jars (1) – cardboard packs.

Clinical-Pharmacological Group

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

It increases venous tone: a decrease in venous emptying time was demonstrated using venous occlusion plethysmography. In patients with signs of severe microcirculation impairment after therapy with drugs containing this active substance, a (statistically significant, compared to placebo) increase in capillary resistance, assessed by the angiostereometry method, was noted.

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

Pharmacokinetics

After oral administration, it undergoes active metabolism, which is confirmed by the presence of phenolic acids in the urine. It is excreted from the body mainly with feces. On average, about 14% of the administered dose is excreted in the urine. T_1/2 is 11 hours.

Indications

Therapy of symptoms of venous-lymphatic insufficiency: pain; cramps of the lower extremities; sensation of heaviness and fullness in the legs; leg “tiredness”.

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

Symptomatic therapy of acute and chronic hemorrhoids.

ICD codes

Dosage Regimen

Administer orally with a meal. Swallow the tablet whole with a sufficient amount of water.

For the treatment of venous-lymphatic insufficiency of the lower extremities, the recommended daily dose is 1000 mg of the purified micronised flavonoid fraction.

Take one 1000 mg tablet once daily, or one 500 mg tablet twice daily (morning and evening).

For the symptomatic treatment of an acute hemorrhoidal attack, the recommended daily dose is 3000 mg for the first four days, then 2000 mg for the next three days.

Take two 500 mg tablets three times daily for the first four days. Subsequently, take one 500 mg tablet twice daily (morning and evening) for three days.

For the treatment of chronic hemorrhoids, the recommended daily dose is 1000 mg.

Take one 1000 mg tablet once daily, or one 500 mg tablet twice daily (morning and evening).

The duration of treatment for venous-lymphatic insufficiency is typically 1 to 3 months. For chronic hemorrhoids, treatment courses may be repeated as advised by a physician. Clinical improvement for venous symptoms usually appears within 2 weeks.

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 loss is recommended. Walking and, in some cases, wearing special stockings helps 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.