MEGALIS

INSTRUCTIONS for medical use of the medicinal product LIOGEL 1000

Composition

The active substance: 1 g of gel contains sodium heparin in terms of 100% substance 1000 IU; excipients: ethanol 96%, methylparaben (methylhydroxybenzoate) (E 218), carbomers, tromethamine, lavender oil, neroli oil, purified water.

Pharmaceutical form

Gel for external use.

Main physical and chemical properties

Transparent or almost transparent, colorless or with a slightly yellowish tint gel with a specific odor. It should be homogeneous in appearance.

Pharmacotherapeutic group

Agents used for varicose vein enlargement.

ATC code C05V A03.

Pharmacological properties

Pharmacodynamics

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

Pharmacokinetics

Heparin is detected in plasma within 24 hours after application of the preparation, with the peak concentration of heparin reached after 8 hours. Excretion occurs mainly through the kidneys. The preparation applied to the skin does not affect blood coagulation parameters.

Clinical characteristics

Indications

Treatment of superficial vein diseases, such as varicose vein enlargement and related complications, phlebothrombosis, thrombophlebitis, superficial periphlebitis. Postoperative varicose phlebitis, complications after surgical removal of the subcutaneous vein of the leg. Injuries and hematomas, infiltrates, and localized edema, subcutaneous hematomas. Injuries and stretching of muscle-tendon and capsular-ligamentous structures.

Contraindications

Increased sensitivity to heparin or other components of the preparation, trophic ulcers of the legs that bleed, open and/or infected wounds, hemorrhagic diathesis, purpura, thrombocytopenia, hemophilia. Tendency to bleeding.

Interaction with other medicinal products and other types of interactions

The use of heparin can contribute to the prolongation of prothrombin time in patients taking oral anticoagulants. The preparation should not be used together with topical preparations, such as those containing tetracycline, hydrocortisone, salicylic acid, or anticoagulants.

Special instructions

As an excipient, the medicinal product contains methylhydroxybenzoate, so it should not be used in patients with an allergy to parabens. If the patient has hemorrhagic symptoms, the possibility of using the LioGel 1000 preparation should be carefully weighed. The preparation should not be prescribed for bleeding, applied to open wounds, infected skin areas with purulent processes, mucous membranes, eyes, and areas around the eyes, or to ulcers and blisters. In case of blood coagulation disorders, the gel is not recommended to be applied to large areas of skin. In the treatment of phlebitis, this medicinal product should not be rubbed into the skin.

Use during pregnancy or breastfeeding

Data on the use of the preparation during pregnancy or breastfeeding are not available.

Ability to affect the speed of reaction when driving vehicles or operating machinery

The preparation does not affect the ability to drive vehicles or operate machinery.

Method of administration and dosage

Adults should use the preparation 1-3 times a day. Apply 3-10 cm of gel to the affected skin area and gently rub in. The duration of treatment is determined by the doctor individually, taking into account the severity of the disease.

Children

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

Overdose

Overdose symptoms have not been described to date. Due to the low systemic absorption, the risk of overdose of the preparation for local use is absent. In the event of accidental oral administration of the gel (e.g., by a child), nausea or vomiting may occur. In this case, the stomach should be rinsed, and if necessary, symptomatic therapy should be prescribed. The action of heparin can be neutralized with protamine sulfate.

Adverse reactions

In individual cases, hypersensitivity reactions may occur, such as redness, itching, and swelling of the skin, burning sensation, skin rash, urticaria, angioedema, hemorrhages, and sometimes the formation of small pustules, blisters, or bubbles that quickly resolve after discontinuation of the preparation. When applied to large areas of skin, systemic side effects are possible.

Shelf life

3 years.

Do not use the preparation after the expiration date stated on the packaging.

Storage conditions

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

Store in a place inaccessible to children.

Packaging

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

Release category

Over-the-counter.

Manufacturer

PRJSC "FITOFARM".

Location of the manufacturer and its address

Ukraine, 84500, Donetsk region, Bakhmut, Sibirceva street, 2.

Applicant

PRJSC "FITOFARM".

Location of the applicant and/or representative of the applicant

Ukraine, 02092, Kyiv, Almatinskaya street, 12.