Escuzan drops

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ESKUZAN® DROPS

Composition:

Active substances: 100 g of solution contains 4.725 g of dry extract from horse chestnut seeds (Hippocastani extractum siccum normatum) (5−7:1) [extracting agent ethanol 60% (v/v)], 0.5 g thiamine hydrochloride;

Excipients: ethanol 96%, purified water, lactose monohydrate, colloidal silicon dioxide.

Pharmaceutical form. Oral drops.

Main physicochemical characteristics: clear or slightly cloudy liquid, yellow to reddish-brown in color, with a characteristic odor. During storage, sediment formation may occur.

Pharmacotherapeutic group.

Capillary stabilizing agents. ATC code C05C X.

Pharmacological properties.

Pharmacodynamics.

The mechanism of action of escin, found in horse chestnut seeds, is based on the stabilization of lysosomal membranes and inhibition of the release of autolytic cellular enzymes, resulting in reduced degradation of mucopolysaccharides and improved trophic processes in the walls of venous vessels and adjacent connective tissue. The drug reduces pathologically increased vascular-tissue permeability, preventing transcapillary filtration of low-molecular-weight proteins, electrolytes, and water into the interstitial space. It enhances venous wall tone, eliminates venous stasis (particularly in the lower extremities), reduces peripheral edema, and alleviates sensations of leg heaviness, fatigue, tension, itching, and pain.

Thiamine hydrochloride is converted in the body into active thiamine diphosphate and participates in carbohydrate and energy metabolism, serving as a coenzyme in numerous enzymatic reactions.

Pharmacokinetics.

After oral administration, escin is rapidly absorbed, primarily from the duodenum. It undergoes pronounced first-pass liver metabolism. In tissue fluid and blood plasma, escin binds to proteins (approximately 84%) and cholesterol. It is metabolized in the liver. Escin is excreted from the body via urine and bile as metabolites.

Clinical characteristics.

Indications.

Chronic venous insufficiency:

• edema;
• calf muscle cramps;
• itching, as well as pain and sensation of heaviness in the legs;
• varicose veins.

Post-thrombotic syndrome.

Trophic changes in the veins of the lower limbs, e.g. leg ulcers.

Hemorrhoids.

Prevention and treatment of post-traumatic and postoperative edema and hematomas.

Contraindications.

Hypersensitivity to the components of the drug. Renal insufficiency, allergic diseases.

Interaction with medicinal products and other types of interactions. The drug may enhance the effect of antithrombotic agents. Cephalosporin antibiotics increase the concentration of free escin in blood and the risk of adverse effects. Concomitant use of the drug with aminoglycoside antibiotics should be avoided due to enhanced nephrotoxic effect of aminoglycosides.

Thiosemicarbazone and 5-fluorouracil, as well as simultaneous infusion of solutions containing sulfites, inhibit thiamine activity.

Special precautions for use.

If unusual symptoms occur in the legs (swelling, skin color changes, sensation of tightness or warmth), as well as pain, you should immediately consult a doctor, as these symptoms may indicate serious medical complications (venous thrombosis in the legs, i.e. blockage of leg veins by a blood clot).

You must strictly follow the non-invasive treatment methods prescribed by your doctor (application of compresses, wearing supportive elastic stockings, cold water dousing).

The medicinal product contains a small amount of ethanol (less than 100 mg per dose).

The medicinal product contains lactose. If you have been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicinal product.

Renal function should be monitored during treatment with this drug.

Administration of thiamine in high doses may interfere with spectrophotometric determination of theophylline in blood serum and with the Ehrlich reagent test for urobilinogen.

Use during pregnancy or breastfeeding. The drug is not recommended during pregnancy or breastfeeding due to insufficient safety data in these patient groups.

Ability to influence reaction speed when driving or operating machinery. No effect.

Dosage and Administration.

It is recommended to take 12–15 drops 3 times daily before meals, with a small amount of liquid. The treatment course lasts from 2 weeks to 2–3 months.

Due to the possible presence of plant-derived sediment, the medication should be shaken before use.

Children.

Do not use in children.

Overdose.

Symptoms. Cases of overdose have not been reported. Overdose may enhance adverse effects. Symptoms of poisoning following ingestion of a large amount of horse chestnut fruit extract include: feeling of anxiety, severe diarrhea, vomiting, mydriasis, drowsiness, delirium, and potentially fatal outcome due to respiratory paralysis within 24–48 hours.

Treatment. Symptomatic. If a large amount of horse chestnut fruit extract has been ingested and vomiting has not occurred, gastric lavage is recommended (e.g., with 0.02% potassium permanganate solution), along with administration of activated charcoal.

Side effects.

Cardiovascular system: tachycardia, increased heart rate, arterial hypotension.

Nervous system: headache, dizziness.

Gastrointestinal tract: dyspeptic symptoms, epigastric pain, nausea, diarrhea, vomiting.

Immune system: hypersensitivity reactions, including urticaria, rash, pruritus, feeling of warmth, angioneurotic edema, shock.

When high doses of the medicinal product are used, nephrotoxic reactions and thrombosis are possible.

Shelf life. 3 years.

Storage conditions.

Store in a place inaccessible to children, at a temperature of 8−25 °C. Do not freeze.

Packaging.

20 ml in a bottle with dropper, 1 bottle in a cardboard box.

Category of release. Over-the-counter.

Manufacturer.

Pharma Verwaltungs-GmbH, Germany.

Manufacturer's location and address of business operation.

Dornburgsweg 35, 38855 Wernigerode, Germany.

Marketing Authorization Holder.

Esparma GmbH.

Address of the Marketing Authorization Holder.

Bielefelder Strasse 1, 39171 Sulzetal, Germany.