Newven Velpharm (Tablets) Instructions for Use

Marketing Authorization Holder

Elzapharm, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

ATC Code

C05CA53 (Diosmin in combination with other drugs)

Active Substances

Diosmin (Rec.INN)

Hesperidin (Grouping name)

Dosage Form

Newven Velpharm

Film-coated tablets 50 mg+450 mg: 5, 9, 10, 12, 15, 18, 20, 24, 25, 27, 30, 35, 36, 40, 45, 48, 50, 54, 60, 63, 70, 72, 75, 80, 81, 84, 90, 96, 100, 105, 108, 120, 135 or 150 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets of orange-pink color, biconvex, oval, with a score; the appearance of the tablet on the break is from light yellow to grayish-yellow.

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

Shell composition: dry mix for film coating (Opadry^® II 32F230011 orange), containing hypromellose, lactose monohydrate, titanium dioxide, macrogol 4000, yellow iron oxide dye, red iron oxide dye.

5 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
9 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
10 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
12 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
15 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
70 pcs. – jars (1) – cardboard packs.
80 pcs. – jars (1) – cardboard packs.
90 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.

Clinical-Pharmacological Group

Venotonic drug

Pharmacotherapeutic Group

Angioprotectors; capillary stabilizing agents; bioflavonoids

Pharmacological Action

A combined agent with angioprotective and venotonic action, containing bioflavonoids.

It reduces venous distensibility, increases their tone and reduces venous congestion; reduces capillary permeability, fragility and increases their resistance; improves microcirculation and lymph drainage.

With systematic use, it reduces the severity of clinical manifestations of chronic venous insufficiency of the lower extremities of organic and functional nature.

Indications

Symptomatic therapy of venous insufficiency of the lower extremities: feeling of heaviness and pain in the legs.

Symptomatic therapy of acute hemorrhoids.

ICD codes

Dosage Regimen

Take orally.

For venous-lymphatic insufficiency, the daily dose is 900 mg of diosmin + 100 mg of hesperidin.

The frequency of administration is 2 times/day (in the middle of the day and in the evening during meals).

For acute hemorrhoids, during the first 4 days the daily dose is 2.7 g of diosmin + 300 mg of hesperidin (in 2 doses in the morning and evening), during the next 3 days the daily dose is 1.8 g of diosmin + 200 mg of hesperidin (in 2 doses in the morning and evening).

Adverse Reactions

From the digestive system: often – diarrhea, nausea, vomiting, dyspepsia; infrequently – colitis.

From the CNS rarely – dizziness, headache, general malaise.

From the skin: rarely – rash, itching, urticaria; unspecified frequency – isolated edema of the face, lips, eyelids; in exceptional cases – angioedema.

Contraindications

Lactation period (breastfeeding), hypersensitivity to diosmin and hesperidin.

Use in Pregnancy and Lactation

To date, there have been no reports of any side effects when using this combination in pregnant women.

Experimental studies have not observed teratogenic effects of the Diosmin+Hesperidin combination.

Contraindicated for use during lactation (breastfeeding), as it is not known whether Diosmin and Hesperidin are excreted in breast milk.

Special Precautions

In case of hemorrhoid exacerbation, the use of this combination does not replace specific treatment for other anal disorders.

The duration of treatment should not exceed the recommended periods.

If symptoms do not disappear after short-term therapy, a proctological examination should be performed and the ongoing therapy should be reviewed.

In the presence of venous circulation disorders, the maximum effect of treatment is ensured by combining it with a healthy, well-balanced lifestyle, in which it is advisable to avoid prolonged exposure to the sun, prolonged standing, as well as to reduce excess body weight, take walks and in some cases – wear special stockings that 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.