Venogepanol

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VENOHEPANOL (VENOHEPANOL)

Composition:

Active substances: venorutinol, sodium heparin, dexpanthenol;

1 g of gel contains venorutinol (calculated as 100 % content of the sum of hydroxyethyl-substituted rutin compounds and dry substance) – 20 mg, sodium heparin (calculated as heparin with activity of 120 IU/mg) – 2.499 mg (300 IU), dexpanthenol (calculated as 100 % anhydrous substance) – 30 mg;

Excipients: propylene glycol, edetate disodium, carbomers, sodium hydroxide, purified water.

Pharmaceutical form. Gel.

Main physicochemical characteristics: transparent yellow homogeneous gel.

Pharmacotherapeutic group. Angioprotectors. Agents used in varicose veins. Heparin, combinations. ATC Code C05BA53.

Pharmacological properties.

Pharmacodynamics.

Venogepanol is an antithrombotic, anti-edematous agent with anti-inflammatory effect for topical use. Heparin, included in the composition of the drug, exerts local antithrombotic, anti-edematous and anti-inflammatory actions. Venorutinol exerts venotonic and angioprotective effects, normalizes capillary wall permeability, and increases their tone due to its P-vitamin activity and improvement of microcirculation and tissue trophism. Dexpanthenol stimulates tissue granulation and epithelialization by forming an active metabolite—pantothenic acid—which participates in the synthesis of coenzyme A.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

• Prevention and treatment of varicose vein enlargement, including after surgical interventions;
• thrombosis, thrombophlebitis;
• closed injuries (including sports-related) with hematomas, strains; infiltrates;
• fibrous indurations and external inflammatory processes without skin integrity disruption;
• tenosynovitis.

Contraindications.

Individual hypersensitivity to the active substances or to other components of the drug, hemophilia, hemorrhagic diathesis, idiopathic thrombocytopenic purpura, pronounced thrombocytopenia, ulcerative-necrotic processes in the area of thrombophlebitis, tendency to bleeding, active bleeding, traumatic skin integrity impairment, open and/or infected wounds.

Interaction with other medicinal products and other forms of interaction.

Parenteral administration of nitroglycerin together with the use of Venogepanol, as well as simultaneous use of the gel with thyroxine, tetracycline, antihistamines, ergot alkaloids, nicotine, may weaken the drug's effect.

Enhances the effect of ascorbic acid on the structure and permeability of the vascular wall.

Dextran, phenylbutazone, ketorolac: simultaneous use may increase the risk of bleeding.

Oral anticoagulants (e.g., warfarin, dicoumarol, clopidogrel): simultaneous use with Venogepanol gel may cause prolongation of prothrombin time.

Non-steroidal anti-inflammatory drugs (e.g., diclofenac, ibuprofen, indomethacin), venotonic agents: when used concomitantly, enhance the effect of Venogepanol gel.

Dipyridamole, iloprost: increase the anticoagulant effect of the active ingredient of Venogepanol – heparin.

ACE inhibitors, aliskiren: possible hyperglycemia.

Simultaneous use of Venogepanol with drugs containing sulindac may cause peripheral neuropathy.

Dexpanthenol, included in the composition of Venogepanol, may enhance the effect of depolarizing muscle relaxants (e.g., suxamethonium chloride, decamethonium bromide) and reduce the effect of non-depolarizing muscle relaxants (e.g., tubocurarine chloride) due to its ability to stimulate acetylcholine synthesis.

If the patient is taking any other medicinal products, it is essential to inform the physician.

Special precautions for use.

Apply the gel only to intact skin.

Do not apply to wounded skin areas or infected skin regions (including presence of purulent processes), and ensure the preparation does not enter the eyes or mucous membranes. May be applied under occlusive dressing. To prevent adverse effects, the preparation should be applied to skin cleaned from other medicinal products, cosmetics, and impurities. After application of the gel, avoid exposure of treated skin areas to sunlight. If hypersensitivity reactions occur, discontinue use of the preparation.

Patients with chronic venous insufficiency are recommended to use the preparation both at early and late stages of the disease (reduction in leg heaviness, lower limb edema, and improvement in trophism is observed).

Prolonged use of the preparation is not recommended in patients with severe renal function impairment.

When treating phlebitis, this medicinal product should not be rubbed into the skin.

In case the gel gets into the eyes, rinse thoroughly with water. In case of accidental ingestion of a large amount of gel, induce vomiting and seek immediate medical attention.

If symptoms of illness do not begin to improve or, conversely, health deteriorates, or adverse effects occur, discontinue use of the product and consult a physician for further advice.

Use during pregnancy or breastfeeding.

The preparation should not be used during pregnancy or breastfeeding.

Ability to affect reaction rate while driving or operating machinery.

The use of Venogepanol does not affect reaction speed while driving or operating machinery.

Method of Administration and Dosage

Apply the preparation externally. For adults, apply the gel to intact skin of the affected area 1–3 times daily. In the treatment of venous disorders, the gel should be used in the form of dressings. In the case of varicose ulcers, apply the gel in a ring approximately 4 cm wide around the ulcer. Avoid direct application to the ulcer surface.

The duration of treatment is determined individually by a physician, depending on clinical indications and the course of the disease. In the treatment of injuries (including sports injuries) with hematomas, the treatment duration is 5–7 days.

Children

Do not use.

Overdose

Symptoms: Overdose is unlikely when the recommended dosage regimen is followed. When applied to large skin areas (due to possible systemic absorption), hemorrhagic complications in the form of bleeding of varying severity may occur. In case of accidental ingestion, nausea and vomiting may occur.

Treatment: In case of minor bleeding, reduce the dose or temporarily discontinue the drug. In case of severe bleeding, slowly administer intravenously a 1% solution of protamine sulfate. If the blood heparin concentration is unknown, a single dose of protamine sulfate should not exceed 1 mL.

In case of accidental ingestion, induce vomiting and perform gastric lavage. If indicated, perform peritoneal dialysis. Symptomatic therapy should be provided.

Side effects.

Immune system, skin and subcutaneous tissue: possible local hypersensitivity reactions – hyperemia, skin irritation, burning sensation, skin swelling, itching, rash, including development of small pustules, vesicles or blisters, urticaria, angioneurotic edema, dermatitis (including contact dermatitis), eczema, hemorrhages. Usually these symptoms resolve spontaneously after discontinuation of the drug.

When applied to large areas of skin, systemic adverse reactions are possible.

In case of any negative reactions, consult a physician regarding further use of the drug.

Shelf life. 3 years.

Do not use the drug after the expiry date stated on the packaging.

Storage conditions.

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

Keep out of reach of children.

Packaging.

40 g in a tube and carton.

Prescription status. Over-the-counter.

Manufacturer.

Public joint-stock company "Scientific and Production Center "Borshchagov Chemical and Pharmaceutical Plant".

Manufacturer's address and location of business activity.

17, Miru Street, Kyiv, 03134, Ukraine.

INSTRUCTION

for medical use of medicinal product

VENOHEPANOL

(VENOHEPANOL)

Composition:

Active substances: venorutinol, sodium heparin, dexpanthenol;

1 g of gel contains venorutinol (calculated as 100% content of total hydroxyethyl-substituted rutin compounds and dry substance) – 20 mg, sodium heparin (calculated as heparin with activity of 120 IU/mg) – 2.499 mg (300 IU), dexpanthenol (calculated as 100% anhydrous substance) – 30 mg;

Excipients: propylene glycol, disodium edetate, carbomers, sodium hydroxide, purified water.

Pharmaceutical form. Gel.

Main physicochemical properties: transparent yellow gel of uniform consistency.

Pharmacotherapeutic group. Angioprotectants. Agents used in varicose veins. Heparin combinations. ATC code C05BA53.

Pharmacological properties.

Pharmacodynamics.

Venogepanol is an antithrombotic, anti-edematous agent with anti-inflammatory effect for topical use. Heparin, included in the formulation, exerts local antithrombotic, anti-edematous and anti-inflammatory effects. Venorutinol provides venotonic and angioprotective action, normalizes capillary wall permeability, increases their tone due to P-vitamin activity and improves microcirculation and tissue trophism. Dexpanthenol stimulates tissue granulation and epithelialization by forming an active metabolite – pantothenic acid, which participates in the synthesis of coenzyme A.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

• Prevention and treatment of varicose veins, including after surgical interventions;
• thrombosis, thrombophlebitis;
• closed injuries (including sports-related) with hematomas, strains; infiltrates;
• fibrous indurations and external inflammatory processes without skin integrity disruption;
• tenosynovitis.

Contraindications.

Individual hypersensitivity to active substances or other components of the drug, hemophilia, hemorrhagic diathesis, idiopathic thrombocytopenic purpura, marked thrombocytopenia, ulcerative-necrotic processes in the area of thrombophlebitis, tendency to bleeding, active bleeding, traumatic disruption of skin integrity, open and/or infected wounds.

Interaction with other medicinal products and other types of interactions.

Parenteral administration of nitroglycerin together with Venogepanol, as well as simultaneous use of the gel with thyroxine, tetracycline, antihistamines, ergot alkaloids, nicotine, may reduce the drug's efficacy.

Enhances the effect of ascorbic acid on vascular wall structure and permeability.

Dextran, phenylbutazone, ketorolac: simultaneous use may increase the risk of bleeding.

Oral anticoagulants (e.g., warfarin, dicoumarol, clopidogrel): concurrent use with Venogepanol gel may prolong prothrombin time.

Non-steroidal anti-inflammatory drugs (e.g., diclofenac, ibuprofen, indomethacin), venotonic agents: when used simultaneously, enhance the effect of Venogepanol gel.

Dipyridamole, iloprost: increase the anticoagulant effect of the active ingredient of Venogepanol – heparin.

ACE inhibitors, aliskiren: hyperglycemia is possible.

Simultaneous use of Venogepanol with drugs containing sulindac may cause peripheral neuropathy.

Dexpanthenol, included in Venogepanol, may enhance the effect of depolarizing muscle relaxants (e.g., suxamethonium chloride, decamethonium bromide) and reduce the effect of non-depolarizing muscle relaxants (e.g., tubocurarine chloride) due to its ability to stimulate acetylcholine synthesis.

If the patient is taking any other medicinal products, this must be reported to the physician.

Special precautions.

Apply the gel only on intact skin.

Do not apply on wound surfaces or infected skin areas (including purulent processes), and ensure the product does not enter eyes or mucous membranes. May be applied under occlusive dressing. To prevent unwanted effects, apply the product on skin cleaned of other medicinal products, cosmetics and dirt. After gel application, avoid sun exposure on treated skin areas. Discontinue use if hypersensitivity reactions occur.

Patients with chronic venous insufficiency are recommended to use the drug at both early and late stages of the disease (reduction in leg heaviness, lower limb edema, improved tissue trophism).

Prolonged use of the drug is not recommended in patients with severe renal impairment.

When treating phlebitis, this medicinal product should not be rubbed into the skin.

In case of gel getting into the eyes, rinse thoroughly with water. In case of accidental ingestion of a large amount of gel, induce vomiting and consult a physician.

If symptoms do not improve or, conversely, health condition worsens, or adverse effects occur, discontinue use of the drug and consult a physician regarding further treatment.

Use during pregnancy or breastfeeding.

Do not use the drug during pregnancy or breastfeeding.

Ability to influence reaction rate when operating vehicles or machinery.

Use of Venogepanol does not affect reaction speed when operating vehicles or machinery.

Method of administration and dosage.

Apply externally. Adults should apply the gel to intact skin of the affected area 1–3 times daily. For treatment of venous disorders, the drug should be used as a dressing with gel. For varicose ulcers, apply the gel in a ring approximately 4 cm wide around the ulcer. Avoid direct application on the ulcer surface.

Duration of treatment is determined individually by a physician depending on clinical indications and disease course. For trauma treatment (including sports-related) with hematomas, treatment duration is 5–7 days.

Children.

Do not use.

Overdose.

Symptoms. Overdose is unlikely when following the recommended dosage regimen. When applied to large skin areas (due to possible systemic absorption), hemorrhagic complications such as bleeding of varying severity may occur. Accidental ingestion may cause nausea and vomiting.

Treatment. In case of minor bleeding, reduce the dose or temporarily discontinue the drug. In case of severe bleeding, slowly administer 1% protamine sulfate solution intravenously. If the heparin concentration in blood is unknown, a single dose of protamine sulfate should not exceed 1 ml.

In case of accidental ingestion, induce vomiting and perform gastric lavage. Perform peritoneal dialysis if indicated. Symptomatic therapy.

Side effects.

Immune system, skin and subcutaneous tissue: possible local hypersensitivity reactions – hyperemia, skin irritation, burning sensation, skin swelling, itching, rash, including development of small pustules, vesicles or blisters, urticaria, angioedema, dermatitis (including contact dermatitis), eczema, hemorrhages. Systemic adverse reactions are possible when applied to large skin areas. Usually these symptoms resolve spontaneously after discontinuation of the drug.

In case of any negative reactions, consult a physician regarding further use of the drug.

Shelf life. 3 years.

Do not use the drug after the expiry date stated on the packaging.

Storage conditions.

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

Keep out of reach of children.

Packaging.

40 g in a tube and carton.

Prescription status. Over-the-counter.

Manufacturer.

Public joint-stock company "Scientific and Production Center "Borshchagov Chemical and Pharmaceutical Plant".

Manufacturer's address and location of business activity.

17, Miru Street, Kyiv, 03134, Ukraine.