Diosmin + Hesperidin Vertex (Tablets) Instructions for Use

Marketing Authorization Holder

Vertex, JSC (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 Form

Diosmin + Hesperidin Vertex

Film-coated tablets, 500 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets pink in color, biconvex, oblong, with a score on one side; the core on a cross-section is grayish-yellow or light yellow in color.

Excipients: microcrystalline cellulose 101 – 82 mg, hypromellose – 31 mg, sodium carboxymethyl starch (sodium starch glycolate, type A) – 27 mg, talc – 6 mg, magnesium stearate – 4 mg.

Film coating [hypromellose – 12 mg, talc – 4 mg, titanium dioxide – 2.066 mg, macrogol 4000 (polyethylene glycol 4000) – 1.8 mg, iron oxide red dye (iron oxide, E172) – 0.134 mg] or [dry film coating mixture containing hypromellose (60%), talc (20%), titanium dioxide (10.33%), macrogol 4000 (polyethylene glycol 4000) (9%), iron oxide red dye (iron oxide) (0.67%)] – 20 mg.

10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.

Clinical-Pharmacological Group

Venotonic drug

Pharmacotherapeutic Group

Angioprotectors; capillary stabilizing agents; bioflavonoids

Pharmacological Action

Venotonic agent, also possesses angioprotective properties. 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.

Increases venous tone: venous occlusion plethysmography demonstrated a decrease in venous emptying time. In patients with signs of pronounced microcirculation impairment, therapy with drugs containing this active substance showed (statistically significant, compared to placebo) an increase in capillary resistance, 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. T_1/2 is 11 h.

Indications

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

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

Symptomatic treatment of acute and chronic hemorrhoids.

ICD codes

Dosage Regimen

Administer orally with a meal.

For chronic venous and lymphatic insufficiency of the lower limbs, the standard dosage is 1000 mg per day, taken as two 500 mg tablets once daily, one in the morning and one in the evening.

For acute hemorrhoidal attack, the initial dosage is 3000 mg per day, taken as three 500 mg tablets twice daily for the first four days of therapy.

Following the initial four-day period for acute hemorrhoids, reduce the dosage to 2000 mg per day, taken as two 500 mg tablets twice daily for the next three days.

For chronic hemorrhoidal disease management, the standard maintenance dosage is 1000 mg per day, taken as two 500 mg tablets once daily.

The total daily dose may be taken as a single administration or divided into two doses, depending on physician recommendation and patient tolerance.

The duration of treatment is determined by the treating physician based on the severity of symptoms and clinical response.

Swallow the tablets whole with a sufficient amount of water; do not chew or crush.

Adverse Reactions

Nervous system disorders rarely – dizziness, headache.

Digestive system disorders often – diarrhea, dyspepsia, nausea, vomiting; infrequently – colitis; frequency not specified – abdominal pain.

Skin and subcutaneous tissue disorders: rarely – rash, itching, urticaria; frequency not specified – isolated edema of the face, lips, eyelids; in exceptional cases – angioedema.

General disorders 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 hemorrhoid exacerbation, 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, a proctologist examination 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 sun exposure, 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.