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Stimulven® (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)

Clinical-Pharmacological Group

Venotonic drug

Pharmacotherapeutic Group

Venotonic and venoprotective agent

Pharmacological Action

A venotonic agent that also possesses 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, 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. The T1/2 is 11 hours.

Indications

Treatment of symptoms of venous-lymphatic insufficiency: pain; leg cramps; sensation of heaviness and distension in the legs; “tired” legs.

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

Symptomatic treatment 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 and lymphatic insufficiency of the lower extremities: take two tablets daily, one in the morning and one in the evening.

For acute hemorrhoids: take six tablets daily (three tablets in the morning and three in the evening) for the first four days.

Subsequently, reduce the dosage to four tablets daily (two tablets in the morning and two in the evening) for the next three days.

For long-term management of chronic hemorrhoidal disease, the standard maintenance dose is two tablets daily.

The total daily dose may be taken as a single administration or divided into two doses.

Adhere strictly to the prescribed treatment duration. Clinical improvement for venous symptoms typically occurs within two weeks.

For hemorrhoidal episodes, the standard treatment course is one week. If symptoms persist, extend treatment for a second week.

Consult a physician if no symptomatic improvement is observed after the recommended treatment period.

Adverse Reactions

Nervous system disorders rarely – dizziness, headache.

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

Skin and subcutaneous tissue disorders: rarely – rash, pruritus, 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 is not recommended during breastfeeding.

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 loss is recommended. Walking and, in some cases, wearing special stockings help improve blood circulation.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°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

Nizhpharm JSC (Russia)

Manufactured By

OHFK, JSC (Russia)

Dosage Form

Bottle OTC Icon Stimulven® Film-coated tablets, 1000 mg: 10, 20, 30, 40, 50, 60 or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets orange-pink in color, oval in shape, biconvex; the core on the cross-section is from pale yellow to grayish-yellow in color with a heterogeneous structure.

1 tab.
Purified micronised flavonoid fraction 1000 mg
    diosmin – 900 mg (90%)
    flavonoids expressed as hesperidin – 100 mg (10%)

Excipients: microcrystalline cellulose type 102, hypromellose, sodium starch glycolate, talc, magnesium stearate.

Film coating composition VIVACOAT® PC-3O-569 [hypromellose, macrogol 6000, iron oxide red, iron oxide yellow, titanium dioxide, glycerol, magnesium stearate], sodium lauryl sulfate.

10 pcs. – blister packs (1) – cardboard boxes.
10 pcs. – blister packs (2) – cardboard boxes.
10 pcs. – blister packs (3) – cardboard boxes.
10 pcs. – blister packs (4) – cardboard boxes.
10 pcs. – blister packs (5) – cardboard boxes.
10 pcs. – blister packs (6) – cardboard boxes.
10 pcs. – blister packs (10) – cardboard boxes.

Marketing Authorization Holder

Salyutfarma, LLC (Russia)

Manufactured By

OHFK, JSC (Russia)

Dosage Form

Bottle OTC Icon Stimulven® Film-coated tablets, 500 mg: 10, 14, 15, 20, 28, 30, 40, 42, 45, 50, 56, 60, 70, 75, 84, 90, 100, 140 or 150 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets orange-pink in color, oval in shape; the core on the cross-section is from pale yellow to grayish-yellow in color with a heterogeneous structure.

1 tab.
Purified micronised flavonoid fraction 500 mg
    diosmin
    flavonoids expressed as hesperidin
450 mg (90%)
50 mg (10%)

Excipients: sodium starch glycolate – 27 mg, talc – 6 mg, magnesium stearate – 4 mg.

Film coating composition hypromellose – 6.886 mg, macrogol 6000 – 0.71 mg, iron oxide red – 0.054 mg, iron oxide yellow – 0.161 mg, titanium dioxide – 1.326 mg, glycerol – 0.415 mg, magnesium stearate – 0.415 mg, sodium lauryl sulfate – 0.033 mg.

10 pcs. – blister packs (1) – cardboard boxes.
10 pcs. – blister packs (2) – cardboard boxes.
10 pcs. – blister packs (3) – cardboard boxes.
10 pcs. – blister packs (4) – cardboard boxes.
10 pcs. – blister packs (5) – cardboard boxes.
10 pcs. – blister packs (6) – cardboard boxes.
10 pcs. – blister packs (10) – cardboard boxes.
14 pcs. – blister packs (1) – cardboard boxes.
14 pcs. – blister packs (2) – cardboard boxes.
14 pcs. – blister packs (3) – cardboard boxes.
14 pcs. – blister packs (4) – cardboard boxes.
14 pcs. – blister packs (5) – cardboard boxes.
14 pcs. – blister packs (6) – cardboard boxes.
14 pcs. – blister packs (10) – cardboard boxes.
15 pcs. – blister packs (1) – cardboard boxes.
15 pcs. – blister packs (2) – cardboard boxes.
15 pcs. – blister packs (3) – cardboard boxes.
15 pcs. – blister packs (4) – cardboard boxes.
15 pcs. – blister packs (5) – cardboard boxes.
15 pcs. – blister packs (6) – cardboard boxes.
15 pcs. – blister packs (10) – cardboard boxes.

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