Venoplant^® (Tablets) Instructions for Use

Marketing Authorization Holder

Dr. Willmar Schwabe GmbH & Co. KG (Germany)

ATC Code

C05CX (Drugs reducing capillary permeability, other)

Active Substance

Horse chestnut (USP United States Pharmacopeia)

Dosage Form

Venoplant®

Prolonged-release film-coated tablets, 263.2 mg: 20, 25, 40, 50, 80, or 100 pcs.

Dosage Form, Packaging, and Composition

Prolonged-release film-coated tablets light brown in color, round, biconvex; on the fracture, a light brown coating and a brown to light brown core are visible.

* dry extract obtained from the seeds of Aesculus hippocastanum L., fam. Hippocastanaceae;
** extractant: ethanol 50%.

Excipients : anhydrous calcium hydrogen phosphate – 36.8 mg, colloidal silicon dioxide – 15.4 mg, Eudragit RL 30D/dry substance (aqueous suspension: poly(ethyl acrylate:methyl acrylate:trimethylammonioethyl methacrylate chloride) copolymer 1:2:0.2 – 30 g; sorbic acid – 0.25 g; purified water – up to 100 ml) – 14 mg, Eudragit RS 30D/dry substance (aqueous suspension: poly(ethyl acrylate:methyl acrylate:trimethylammonioethyl methacrylate chloride) copolymer 1:2:0.1 – 30 g; sorbic acid – 0.25 g; purified water – up to 100 ml) – 10 mg, triethyl citrate – 3.564 mg, polysorbate 80 – 0.036 mg, povidone K25 – 20 mg, crospovidone – 10 mg, magnesium stearate – 2 mg.

Coating composition hypromellose (5 mPa.s) – 11.33 mg, macrogol 4000 – 5.67 mg, iron oxide red (E172) – 0.22 mg, iron oxide yellow (E172) – 1.09 mg, titanium dioxide (E171) – 0.68 mg, antifoaming emulsion/dry substance (dimethicone – 18.5%; anhydrous colloidal silicon dioxide – 1.5%, α-octadecyl-ω-hydroxypoly(oxyethylene)-5 – 3%, sorbic acid – 0.1%, purified water – 76.9%) – 0.01 mg, talc – 1 mg, sodium saccharin – 0.025 mg, vanillin – 0.405 mg.

20 pcs. – blisters (1) – cardboard packs.
20 pcs. – blisters (2) – cardboard packs.
20 pcs. – blisters (4) – cardboard packs.
25 pcs. – blisters (1) – cardboard packs.
25 pcs. – blisters (2) – cardboard packs.
25 pcs. – blisters (4) – cardboard packs.

Clinical-Pharmacological Group

Venotonic herbal drug

Pharmacotherapeutic Group

Venotonic agent of plant origin

Pharmacological Action

Venotonic agent of plant origin. Reduces capillary permeability, has a venotonic, anti-edematous, anti-inflammatory, and angioprotective effect.

It prevents the activation of lysosomal enzymes that break down proteoglycan, increases the tone of the venous wall, eliminates venous stasis, and reduces capillary permeability and fragility. It reduces exudation, decreases fluid extravasation into tissues, and accelerates the resorption of existing edema. It inhibits inflammatory processes, improves microcirculation, and promotes the repair of organs and tissues.

Indications

Chronic venous insufficiency of CEAP class I-III: varicose veins, edema, cramps in the calf muscles, feeling of heaviness in the legs.

ICD codes

Dosage Regimen

Take orally. Swallow the prolonged-release tablet whole with a sufficient amount of liquid, such as a glass of water. Do not chew, crush, or break the tablet, as this can damage the prolonged-release properties.

Administer the standard adult dose of one 263.2 mg tablet twice daily. Take one tablet in the morning and one tablet in the evening to maintain consistent therapeutic levels.

Take the tablets with meals to improve tolerability and minimize potential gastrointestinal discomfort. Adhere strictly to the twice-daily dosing schedule for optimal therapeutic effect.

The duration of treatment is determined by the severity of symptoms and clinical response. Continue treatment for several weeks, as the full venotonic and anti-edematous effects may develop gradually over time.

Use the drug only for the approved indications of chronic venous insufficiency symptoms, including feeling of heaviness in the legs, edema, and calf cramps. Discontinue use and consult a physician if symptoms worsen or do not improve after a reasonable treatment period.

Do not exceed the recommended daily dose of two tablets. This product is contraindicated in individuals with known hypersensitivity to horse chestnut or any of the excipients. It is not for use in children or adolescents under 18 years of age.

Adverse Reactions

Allergic reactions feeling of heat, urticaria, skin rash, skin itching, anaphylactic shock.

From the digestive system dyspepsia (including nausea).

From the nervous system dizziness, headache.

Contraindications

Children and adolescents under 18 years of age; hypersensitivity to horse chestnut.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is not recommended.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

Use in elderly patients is permitted.

Special Precautions

Effect on the ability to drive vehicles and machinery

During the use of the drug, caution should be exercised when engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Drug Interactions

Concomitant use with indirect anticoagulants is not recommended, as this agent enhances their effect.

Storage Conditions

Store at 15°C (59°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.