HEPARIN-DARNITSA

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT HEPARIN-DARNITSA (HEPARIN-DARNITSA)

Composition:

Active substance: heparin;

1 g of gel contains sodium heparin 600 IU;

Excipients: carbomer, tromethamine, propylene glycol, benzyl alcohol, purified water.

Pharmaceutical form. Gel.

Main physical and chemical properties: homogeneous, transparent, colorless gel with a weak specific odor.

Pharmacotherapeutic group. Agents for use in varicose veins. Heparins or heparinoids for topical use. Heparin. ATC code C05BA03.

Pharmacological properties.

Pharmacodynamics.

Sodium heparin is a direct-acting anticoagulant; it inhibits thrombin biosynthesis, suppresses fibrin formation from fibrinogen, reduces platelet aggregation, and inhibits hyaluronidase activity. When applied locally, Heparin-Darnytsia gel exerts antithrombotic, anti-inflammatory, and anti-edematous effects. The medicinal product does not exhibit local irritant effects.

Pharmacokinetics.

When applied to the skin, only a small amount of sodium heparin enters the systemic circulation, and it is mainly excreted by the kidneys.

Clinical characteristics.

Indications.

Treatment of superficial venous diseases such as varicose veins and associated complications, phlebothrombosis, thrombophlebitis, superficial periphlebitis.

Postoperative varicose phlebitis, complications following surgical removal of the leg's saphenous vein. Injuries and contusions, infiltrates and localized edema, subcutaneous hematomas. Injuries and strains of musculotendinous and capsuloligamentous structures.

Contraindications.

Individual hypersensitivity to heparin or any of the components of the medicinal product, bleeding leg ulcers and/or infected wounds, hemorrhagic diathesis, purpura, thrombocytopenia, hemophilia, tendency to bleeding.

Interaction with other medicinal products and other forms of interaction.

Oral anticoagulants – concomitant use with Heparin-Darnytsia gel may lead to prolonged prothrombin time.

Nonsteroidal anti-inflammatory drugs, venotonic agents – the effect of Heparin-Darnytsia gel is enhanced when used concomitantly.

Topical medicinal products (e.g., nonsteroidal anti-inflammatory agents) – concomitant use with Heparin-Darnytsia gel significantly enhances absorption of other medicinal products through the skin.

Heparin-Darnytsia should not be used concomitantly with topical medicinal products, for example those containing tetracycline, hydrocortisone, salicylic acid, or anticoagulants.

Special precautions for use.

Heparin-Darnytsia gel should not be applied to open wounds and should not be used in the presence of purulent processes.

Do not apply to large areas of skin, areas of skin with increased sensitivity, or mucous membranes. Avoid contact of the gel with the eyes.

Monitoring of blood coagulation parameters under medical supervision is recommended.

In case of blood coagulation disorders, the gel is not recommended for application to large areas of skin. The medicinal product should not be administered in cases of bleeding.

The medicinal product should be used with caution in hemorrhagic conditions.

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

Important information about excipients.

This medicinal product contains propylene glycol, which may cause skin irritation.

Use during pregnancy or breastfeeding.

Do not use this medicinal product during pregnancy or breastfeeding.

Ability to affect reaction rate while driving or operating machinery.

Has no effect.

Dosage and Administration.

The medicinal product Heparin-Darnytsia is intended for topical use. Apply a strip of gel 3–10 cm in length, using gentle rubbing motions, to the skin of the affected area 1–3 times daily. The dosage of the medicinal product depends on the size of the affected area.

The duration of treatment is determined individually by a physician, taking into account the severity of the disease course.

Children.

Due to limited experience of use, the medicinal product should not be prescribed to children.

Overdose.

With topical application – unlikely. Due to the lack of information regarding accidental overdose or ingestion of the medicinal product, there are no specific recommendations for these conditions.

Treatment: general supportive measures may be used.

Accidental oral ingestion of the gel in a child may cause nausea or vomiting. In such a case, gastric lavage should be performed, and symptomatic therapy may be administered if necessary. The effect of heparin can be neutralized with protamine sulfate.

Side effects.

Skin and subcutaneous tissue disorders: skin swelling, rash, itching, redness, swelling, burning sensation, hemorrhages; sometimes development of small pustules, vesicles or blisters, which quickly disappear after discontinuation of the medicinal product.

Immune system disorders: hypersensitivity reactions, including urticaria, angioneurotic edema.

When applied to large areas of skin, systemic adverse reactions may occur.

Reporting of suspected adverse reactions.

Reporting of suspected adverse reactions after authorization of the medicinal product is an important procedure. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions through the national reporting system.

Shelf life. 3 years.

Storage conditions.

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

Keep out of reach and sight of children.

Packaging.

30 g in a tube; 1 tube in a carton.

Supply classification. Over-the-counter.

Manufacturer: JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's address and location of business activity.

13 Boryspylska Street, Kyiv, 02093, Ukraine.