Heparin gel

INSTRUCTION for medical use of the medicinal product HEPARIN GEL

Composition:

Active substance: 1 g of the preparation contains 1000 IU of sodium heparin;

Excipients: 96 % ethanol, carbomer, tromethamine, methylparaben (E 218), peppermint oil, purified water.

Pharmaceutical form. Gel.

Main physicochemical characteristics: colorless or slightly yellowish, almost transparent gel of viscous consistency with a specific odor.

Pharmacotherapeutic group. Agents used in varicose veins.

ATC code C05BA03.

Pharmacological properties.

Pharmacodynamics. When applied to the skin, the drug exerts anti-edematous, anti-exudative, anti-inflammatory, and anticoagulant effects.

Pharmacokinetics. Heparin is detectable in blood plasma for 24 hours after administration of the drug, with maximum heparin concentration reached within 8 hours. Elimination occurs primarily via the kidneys. The drug applied to the skin does not affect blood coagulation parameters.

Clinical characteristics.

Indications. Treatment of superficial venous disorders, such as varicose veins and associated complications, phlebothrombosis, thrombophlebitis, superficial periphlebitis. Postoperative varicose phlebitis, complications following surgical removal of the saphenous vein of the leg. Injuries and bruises, infiltrates and localized edema, subcutaneous hematomas. Injuries and sprains of musculotendinous and capsuloligamentous structures.

Contraindications. Hypersensitivity to heparin or to any other component of the drug; bleeding leg ulcers; open and/or infected wounds; hemorrhagic diathesis; purpura; thrombocytopenia; hemophilia. Tendency to bleeding.

Interaction with other medicinal products and other forms of interaction. The use of heparin may contribute to prolongation of prothrombin time in patients receiving oral anticoagulants. The drug should not be used concomitantly with topical medicinal products, such as those containing tetracycline, hydrocortisone, salicylic acid, as well as with anticoagulants.

Special precautions for use.

If a patient has hemorrhagic symptoms, careful consideration should be given before using the drug. The product should not be administered in the presence of bleeding, applied to open wounds, infected skin areas with purulent processes, mucous membranes, eyes or the area around the eyes, ulcers, or blisters. In case of coagulation disorders, the gel is not recommended for application over large skin areas. When treating phlebitis, this medicinal product should not be rubbed into the skin. The presence of methylparaben (E 218) in the formulation may cause allergic reactions (possibly delayed-type).

Use during pregnancy or breastfeeding. Data on the use of the drug during pregnancy or breastfeeding are lacking.

Ability to influence reaction rate while driving or operating machinery. Has no effect.

Method of Administration and Dosage.

Adults should apply the drug 1–3 times daily. Apply a strip of gel 3–10 cm in size to the affected area of skin and gently rub in. The duration of treatment is determined individually by a physician, depending on the severity of the disease.

Children. Due to limited experience with use, the drug should not be prescribed to children.

Overdose. Cases of overdose have not been reported to date. Because of negligible systemic absorption, there is no risk of overdose with topical application. Accidental oral ingestion of the gel (e.g., by a child) may cause nausea or vomiting. In such cases, gastric lavage should be performed, and symptomatic therapy administered if necessary. The effect of heparin can be neutralized with protamine sulfate.

Adverse reactions.

In individual cases, hypersensitivity reactions such as redness, itching and swelling of the skin, burning sensation, skin rashes, urticaria, angioneurotic edema, hemorrhages, and occasionally the appearance of small pustules, vesicles or blisters which rapidly resolve after discontinuation of the drug, may occur. Systemic adverse reactions are possible when applied to large areas of skin.

Shelf life. 3 years from the date of manufacture of the drug in bulk packaging.

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

Keep out of reach of children.

Packaging. Tubes of 25 g or 50 g in a carton.

Availability. Over-the-counter (without prescription).

Manufacturer. Limited Liability Company "Pharmaceutical Company "Vertex".

Manufacturer's name and address of business location.

33, Astronomichna Street, lit. "V-1", Kharkiv, Kharkiv region, 61085, Ukraine.