Liogel 1000

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LIOGEL 1000 (LIOGEL 1000)

Composition:

Active substance: 1 g of gel contains 1000 IU of sodium heparin, calculated as 100 % substance;

Excipients: ethanol 96 %, methylparaben (methyl p-hydroxybenzoate) (E 218), carbomers, tromethamine, lavender oil, neroli oil, purified water.

Pharmaceutical form. Topical gel.

Main physicochemical properties: clear or almost clear, colorless or slightly yellowish gel with a characteristic odor. It should be homogeneous in appearance.

Pharmacotherapeutic group. Agents used in varicose veins.

ATC code C05BA03.

Pharmacological properties.

Pharmacodynamics.

LioGel 1000 exerts anti-edematous, anti-exudative, anti-inflammatory, and anticoagulant effects when applied to the skin.

Pharmacokinetics.

Heparin is detectable in blood plasma for up to 24 hours after application of the drug, with peak heparin concentration reached within 8 hours. Elimination occurs primarily via the kidneys. When applied to the skin, the drug 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 the saphenous vein of the leg. Injuries and contusions, infiltrates and localized edema, subcutaneous hematomas. Injuries and sprains of musculotendinous and capsuloligamentous structures.

Contraindications.

Hypersensitivity to heparin or to other components 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.

The use of heparin may potentiate the 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, or anticoagulants.

Special precautions for use.

The medicinal product contains methyl parahydroxybenzoate as an excipient; therefore, it should not be used in patients with allergy to parabens. Careful consideration should be given to the possibility of using Liogel 1000 in patients presenting with hemorrhagic symptoms. The product must not be administered in cases of bleeding, nor applied to open wounds, infected skin areas with purulent processes, mucous membranes, eyes and periorbital areas, ulcers or blisters. In case of coagulation disorders, the gel should not be applied over large skin areas. When treating phlebitis, this medicinal product should not be rubbed into the skin.

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

Ability to affect reaction speed when driving or operating machinery. The drug does not affect the ability to drive or operate machinery.

Method of Administration and Dosage.

For adults: apply the gel 1–3 times a day. Apply 3–10 cm of gel 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 course.

Children. Due to limited experience of use, the drug should not be administered to children.

Overdose.

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

Side effects.

In individual cases, hypersensitivity reactions such as redness, itching and swelling of the skin, burning sensation, skin rash, urticaria, angioneurotic edema, hemorrhages, and sometimes the appearance of small pustules, vesicles or blisters may occur. These symptoms quickly resolve after discontinuation of the drug. When applied to large areas of skin, systemic adverse reactions are possible.

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. 30 g, 50 g, or 100 g in a tube; 1 tube per carton.

Availability. Over-the-counter.

Manufacturer. JSC "FITOPHARM".

Manufacturer's address.

2 Sybirtseva St., Bakhmut, Donetsk region, 84500, Ukraine.

Marketing Authorization Holder. JSC "FITOPHARM".

Address of the Marketing Authorization Holder and/or its representative.

12 Almatynska St., Kyiv, 02092, Ukraine.