Escuven®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ESCUVEN®

Composition:

Active substance: aescin;

1 g of gel contains 10 mg of amorphous β-aescin;

Excipients: carbomer, propylene glycol, triethanolamine, methylparaben (E 218), ethanol 96%, purified water.

Pharmaceutical form. 1% gel.

Main physicochemical properties: colorless or slightly yellowish, slightly opalescent, transparent, homogeneous gel.

Pharmacotherapeutic group. Angioprotectors. Capillary-stabilizing agents.

ATC code C05CX03.

Pharmacological properties.

Pharmacodynamics.

Aescin is a natural mixture of triterpene saponins extracted from horse chestnut seeds (Aesculus hippocastanum L.), which possess anti-edematous, venotonic properties and anti-inflammatory activity. In addition, aescin acts at the initial stage of the inflammatory process associated with increased membrane and capillary permeability and exudate production into surrounding tissues.

Aescin exhibits anti-serotonin and antihistamine effects.

Aescin inhibits prostaglandin synthetase activity. This enzyme is required for the formation of prostaglandins, which play an important role in the inflammatory mechanism.

Aescin prevents the decrease in ATP content in endothelial cells and increases the activity of phospholipase A2, the enzyme responsible for the release of inflammatory mediators' precursors.

Aescin reduces the activity of lysosomal enzymes that degrade proteoglycans present in capillary walls. This increases capillary resistance, reduces their permeability, thereby decreasing exudate volume and edema formation.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Varicose veins, leg swelling and pain associated with venous insufficiency, post-traumatic bruises and bruises after injections and infusions.

Contraindications.

Hypersensitivity to the components of the drug, skin damage (e.g., burns, eczema, open wounds).

Interaction with other medicinal products and other types of interactions.

Unknown. It is not recommended to apply the gel to the same area of skin together with other topical products.

Special precautions for use.

Do not apply the gel to inflamed skin, open wounds, or mucous membranes. Do not rub in when applying. If skin inflammation, thrombophlebitis, severe pain, sudden swelling of one or both legs, or cardiac or renal insufficiency occurs, consult a physician immediately. In case of sudden onset of pronounced symptoms of venous insufficiency (swelling, skin discoloration, sensation of tension and pain), especially in one limb, venous thrombosis of the lower limbs should be ruled out.

Use of the gel in varicose vein disease does not replace other preventive or therapeutic measures (e.g., wearing supportive elastic stockings, cold water dousing).

Avoid contact of the gel with eyes and mucous membranes. Wash hands thoroughly after each application.

The gel contains methylparaben (E 218), which may cause allergic reactions (including delayed-type), and in rare cases bronchospasm, as well as propylene glycol (E 1520), which may cause skin irritation.

Use during pregnancy or breastfeeding.
Due to lack of adequate data, Esquven® gel should not be used during pregnancy or breastfeeding.

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

Method of Administration and Dosage

Apply the gel in a thin layer to the affected area of skin and surrounding regions 2–3 times daily. Do not rub in.

In cases of varicose vein enlargement, simultaneous use of an elastic bandage or compression stockings is recommended.

The duration of treatment depends on the extent of therapeutic effect. If no improvement is observed after 14 days of therapy, consult a physician.

Children

There is insufficient experience with the use of the drug in children; therefore, its use is not recommended in this age group.

Overdose

There are no reports of overdose.

Side effects.

Hypersensitivity reactions are possible, including dermatitis (including allergic dermatitis), skin rashes, itching, erythema, skin burning sensation, bronchospasm. If such reactions occur, discontinue use of the product and consult a physician.

Shelf life. 3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

Tubes of 30 g or 50 g.

Availability. Over-the-counter.

Manufacturer/Applicant.

TOV "Ternopharm".

Manufacturer's address and place of business.

TOV "Ternopharm".

4 Fabrychna Street, Ternopil, 46010, Ukraine.

Tel./Fax: (0352) 521-444, http://www.ternopharm.com.ua