Eskulus-zdorovya

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ESCULUS-ZDOROVYE (AESCULUS-ZDOROVYE)

Composition:

Active substances:

100 g of the preparation contains: standardized dry extract of horse chestnut seeds (Hippocastani seminis extractum siccum normatum) (5-7:1) (extractant: ethanol 60% (v/v)) – 4.725 g, thiamine hydrochloride – 0.5 g;

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

Pharmaceutical form. Oral drops, solution.

Main physicochemical properties: clear or slightly opalescent liquid, yellow to reddish-brown in color, with a characteristic odor. Sediment formation may occur during storage.

Pharmacotherapeutic group. Capillary stabilizing agents. ATC code C05CX.

Pharmacological properties.

Pharmacodynamics.

The mechanism of action of escin, contained in horse chestnut seeds, is due to 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 increases venous wall tone, eliminates venous stasis (especially in the lower limbs), 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. It participates in carbohydrate and energy metabolism and serves 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 in the form of 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 other 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.

If unusual symptoms occur in the legs (such as swelling, skin discoloration, sensation of tightness or warmth), as well as pain, medical advice should be sought immediately, as these symptoms may indicate serious medical complications (deep vein thrombosis, i.e. blockage of leg veins by a blood clot).

Non-invasive treatment methods prescribed by a physician must be strictly followed (e.g. application of compresses, wearing supportive elastic stockings, cold water dousing).

This medicinal product contains 116.9 mg of 96% ethanol (alcohol) in 15 drops (1 dose) of the preparation.

Harmful for patients suffering from alcoholism. Caution is advised when administering to patients with liver diseases and to those with epilepsy.

The medicinal product contains lactose. If a patient has been diagnosed with intolerance to certain sugars, medical advice should be sought before taking this medicinal product.

Renal function should be monitored during treatment with this product.

High-dose thiamine administration may interfere with the spectrophotometric determination of theophylline in blood serum and with the detection of urobilinogen using Ehrlich's reagent.

Use during pregnancy or breastfeeding.

This medicinal product is not recommended during pregnancy or breastfeeding due to insufficient data on its safety in these patient groups.

Ability to affect reaction speed when driving or operating machinery.

No effect.

Method of Administration and Dosage.

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 solution should be shaken before use.

Children.

Do not use in children.

Overdose.

Symptoms. Cases of overdose have not been reported. Possible intensification of adverse reactions. Symptoms of poisoning following ingestion of a large amount of extract from horse chestnut seeds: 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 seed extract has been ingested and vomiting has not occurred, gastric lavage is recommended (e.g., with a 0.02% potassium permanganate solution), followed by administration of activated charcoal.

Adverse reactions.

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, hot flushes, angioneurotic edema, shock.

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

Reporting suspected adverse reactions.

Reporting of suspected adverse reactions after medicinal product registration is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Do not freeze.

Keep out of reach and sight of children.

Packaging. 20 ml in a bottle closed with a dropper stopper and sealed with a cap, in a box.

Category of supply. Over-the-counter (without prescription).

Manufacturer. Limited Liability Company "Pharmaceutical Company "Zdorovia".

Manufacturer's address and location of business activity.

22, Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.