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Diosmin (Tablets) Instructions for Use

ATC Code

C05CA03 (Diosmin)

Active Substance

Diosmin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Angioprotective drug

Pharmacotherapeutic Group

Angioprotectors; capillary stabilizing agents; bioflavonoids

Pharmacological Action

Angioprotective agent, bioflavonoid. It has a venotonic effect, improves lymphatic drainage, improves microcirculation, reduces the adhesion of leukocytes to the venous wall and their migration into paravenous tissues, improves oxygen diffusion and perfusion in the skin tissue, and has an anti-inflammatory effect.

It blocks the production of free radicals and the synthesis of prostaglandins and thromboxane.

Pharmacokinetics

It is rapidly absorbed from the gastrointestinal tract and is detected in plasma 2 hours after administration. The bioavailability after oral administration is approximately 40-57.9%.

Part of diosmin is metabolized by bacteria in the cecum to form hippuric and benzoic acids.

Cmax in blood plasma is reached 5 hours after administration. It is evenly distributed and accumulates in all layers of the wall of hollow veins and subcutaneous veins of the lower extremities, to a lesser extent in the veins of the kidneys, liver, lungs and other tissues. Vd is 62.1 L.

Selective accumulation of diosmin and/or its metabolites in venous vessels reaches a maximum 9 hours after administration and persists for 96 hours.

It is excreted in urine – 79%, in feces – 11%, in bile – 2.4%.

Indications

Varicose veins of the lower extremities, chronic lymphovenous insufficiency of the lower extremities, hemorrhoids, microcirculation disorders.

ICD codes

ICD-10 code Indication
I83 Varicose veins of lower extremities
I87.2 Venous insufficiency (chronic) (peripheral)
K64 Hemorrhoids and perianal venous thrombosis
ICD-11 code Indication
BD74.1Z Varicose veins of lower extremities, unspecified
BD74.Z Chronic venous insufficiency of lower extremities, 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 to minimize potential gastrointestinal discomfort.

For chronic venous insufficiency and varicose veins of the lower extremities, the typical daily dose is 1000 mg taken as a single administration.

For hemorrhoidal disease during an acute attack, the typical daily dose is 3000 mg, divided into two or three doses.

For the maintenance treatment of hemorrhoidal disease, reduce the daily dose to 1000 mg to 2000 mg as a single or divided dose, based on symptom severity.

Adhere strictly to the dosage and duration prescribed by your physician; the standard treatment course is 2 to 4 months for venous disorders.

Re-evaluate treatment efficacy after 3 months of continuous use.

Do not chew or crush the tablets; swallow them whole with a sufficient amount of water.

Adverse Reactions

From the digestive system common – dyspeptic disorders, incl. nausea, vomiting, diarrhea, heartburn, constipation; uncommon – colitis.

From the CNS rare – headache, malaise, dizziness.

Allergic reactions rare – urticaria; frequency unknown – isolated swelling of the face, lips, eyelids; in exceptional cases – angioedema (Quincke’s edema).

Contraindications

Hypersensitivity to diosmin; children and adolescents under 18 years of age, first trimester of pregnancy, breastfeeding period.

Use in Pregnancy and Lactation

Contraindicated in the first trimester of pregnancy (experience of use is limited). Use in the second and third trimesters is possible only as prescribed by a doctor, in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus.

Use during breastfeeding is not recommended, because there are no data on the excretion of diosmin in breast milk.

In experimental studies, no teratogenic effects on the fetus were identified.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

Treatment of an acute attack of hemorrhoids is carried out in combination with other drugs.

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

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle Rx Icon Diosmin Film-coated tablets, 600 mg: 5, 10, 15, 20, 25, 30, 40, 50, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from light pink to pink, capsule-shaped, biconvex, with a score on one side; on the cross-section – a core from gray-yellow to gray-brown, inclusions of lighter and darker shades are allowed.

1 tab.
Diosmin calculated on the anhydrous substance 600 mg

Excipients: gelatin – 7.8 mg, sodium carboxymethyl starch (type A) – 19.4 mg, magnesium stearate – 9.7 mg, microcrystalline cellulose – up to 970 mg.

Film coating composition Opadry II 85F240012 Pink – 30 mg: polyvinyl alcohol – 12 mg, macrogol-3350 – 7.314 mg, iron oxide red dye – 0.12 mg, iron oxide yellow dye – 0.066 mg, talc – 4.44 mg, titanium dioxide – 6.06 mg.

5 pcs. – contour cell packs (1) – cardboard packs.
5 pcs. – contour cell packs (2) – cardboard packs.
5 pcs. – contour cell packs (3) – cardboard packs.
5 pcs. – contour cell packs (4) – cardboard packs.
5 pcs. – contour cell packs (5) – cardboard packs.
5 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
20 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
30 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
40 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
50 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
100 pcs. – polyethylene terephthalate jars (1) – cardboard packs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Bottle OTC Icon Diosmin Film-coated tablets, 600 mg: 10, 15, 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets pink, oval, biconvex; on the cross-section the core is grayish-yellow or light yellow.

1 tab.
Diosmin 600 mg

Excipients: microcrystalline cellulose – 241.5 mg, talc – 18 mg, hypromellose (hydroxypropylcellulose) – 13.5 mg, croscarmellose sodium – 13.5 mg, magnesium stearate – 9 mg, colloidal hydrophobic silicon dioxide – 4.5 mg.

Film coating[hypromellose – 16.2 mg, talc – 5.4 mg, titanium dioxide – 2.79 mg, macrogol 4000 (polyethylene glycol 4000) – 2.43 mg, iron oxide red dye (iron oxide) – 0.18 mg] or [dry mixture for film coating, containing hypromellose (60%), talc (20%), titanium dioxide (10.33%), macrogol 4000 (polyethylene glycol 4000) (9%), iron oxide red dye (iron oxide) (0.67%)] – 27 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
15 pcs. – contour cell packs (1) – cardboard packs.
15 pcs. – contour cell packs (2) – cardboard packs.
15 pcs. – contour cell packs (4) – cardboard packs.
15 pcs. – contour cell packs (6) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (2) – cardboard packs.
30 pcs. – contour cell packs (3) – cardboard packs.
15 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
90 pcs. – jars (1) – cardboard packs.

Marketing Authorization Holder

Izvarino Pharma LLC (Russia)

Dosage Form

Bottle OTC Icon Diosmin Film-coated tablets, 600 mg: 10, 15, 20, 30, 45, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from pink to pink with a grayish tint, oval, biconvex, with a score on one side and an embossed symbol “f” on the other; on the cross-section – a core from grayish-yellow to yellowish-brown, the presence of more or less intensely colored inclusions is allowed.

1 tab.
Diosmin 600 mg

Excipients: microcrystalline cellulose, povidone K 30, colloidal silicon dioxide, magnesium stearate.

Film coating composition Opadry II pink (85F34610) (polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, iron oxide yellow dye, iron oxide red dye, iron oxide black dye).

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
15 pcs. – contour cell packs (1) – cardboard packs.
15 pcs. – contour cell packs (2) – cardboard packs.
15 pcs. – contour cell packs (3) – cardboard packs.
15 pcs. – contour cell packs (4) – cardboard packs.
15 pcs. – contour cell packs (6) – cardboard packs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Bottle OTC Icon Diosmin-Vertex Film-coated tablets, 600 mg

Dosage Form, Packaging, and Composition

Film-coated tablets

1 tab.
Diosmin 600 mg

10 pcs. – contour cell packs – cardboard packs (10 pcs.) – Over-the-Counter
10 pcs. – contour cell packs (3 pcs.) – cardboard packs (30 pcs.) – Over-the-Counter
10 pcs. – contour cell packs (6 pcs.) – cardboard packs (60 pcs.) – Over-the-Counter
15 pcs. – jars – cardboard packs (15 pcs.) – Over-the-Counter
15 pcs. – contour cell packs – cardboard packs (15 pcs.) – Over-the-Counter
15 pcs. – contour cell packs (2 pcs.) – cardboard packs (30 pcs.) – Over-the-Counter
15 pcs. – contour cell packs (4 pcs.) – cardboard packs (60 pcs.) – Over-the-Counter
15 pcs. – contour cell packs (6 pcs.) – cardboard packs (90 pcs.) – Over-the-Counter
30 pcs. – jars – cardboard packs (30 pcs.) – Over-the-Counter
30 pcs. – contour cell packs – cardboard packs (30 pcs.) – Over-the-Counter
30 pcs. – contour cell packs (2 pcs.) – cardboard packs (60 pcs.) – Over-the-Counter
30 pcs. – contour cell packs (3 pcs.) – cardboard packs (90 pcs.) – Over-the-Counter
90 pcs. – jars – cardboard packs (90 pcs.) – Over-the-Counter

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