LYOTROMB 1000-ZDOROVYA

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LIOTROMB 1000-ZDOROVYE (LIOTROMB 1000-ZDOROVYE)

Composition:

Active substance: heparin;

1 g of the preparation contains 1000 IU of sodium heparin;

Excipients: ethanol 96%, 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 medicinal product exerts anti-edematous, anti-exudative, anti-inflammatory, and anticoagulant effects.

Pharmacokinetics.

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

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 subcutaneous veins of the lower limbs. Injuries and contusions, infiltrates and localized edema, subcutaneous hematomas. Injuries and strains of musculotendinous and capsuloligamentous structures.

Contraindications.

Hypersensitivity to heparin or to any other component of the preparation; 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.

Heparin use may potentiate prolongation of prothrombin time in patients receiving oral anticoagulants. The preparation should not be used concomitantly with topical medicinal products, for example those containing tetracycline, hydrocortisone, salicylic acid, as well as with anticoagulants.

Special precautions for use.

In patients presenting hemorrhagic symptoms, careful consideration should be given to the possibility of using the medicinal product. The drug should not be administered in the presence of bleeding, applied to open wounds, infected skin areas with purulent processes, mucous membranes, eyes or areas around the eyes, ulcers, or blisters. In case of coagulation disorders, the gel should not be applied to 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).

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.

Does not affect.

Dosage and Administration.

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

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

Overdose.

Cases of overdose have not been reported to date. Because of negligible systemic absorption, the risk of overdose with topical application is absent. Following accidental oral ingestion of the gel (e.g., by a child), nausea or vomiting may occur. In such cases, gastric lavage should be performed, and symptomatic therapy administered if necessary. The effect of heparin can be neutralized with protamine sulfate.

Side effects

Allergic reactions to heparin when applied to the skin occur very rarely (less than 1 in 10,000 patients receiving treatment). In individual cases (frequency unknown – cannot be estimated from available data), hypersensitivity reactions may occur, especially with prolonged use, such as redness, itching, and swelling of the skin, burning sensation, skin rashes, urticaria, angioneurotic edema, hemorrhages, and sometimes the appearance of small pustules, vesicles, or blisters, which quickly resolve after discontinuation of the product. When applied to large areas of skin, systemic adverse reactions are possible.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after marketing authorization of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions.

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 25 g, 50 g, or 100 g in a carton box.

Supply classification. Over-the-counter (without prescription).

Manufacturer.

LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVTIA".

Manufacturer's address and place of business.

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