Venitan^® forte (Gel) Instructions for Use

Marketing Authorization Holder

Sandoz, d.d. (Slovenia)

Manufactured By

Salutas Pharma, GmbH (Germany)

ATC Code

C05BA53 (Heparin in combination with other drugs)

Active Substances

Heparin sodium (Rec.INN registered by WHO)

Aescine (DCF adopted for use in France)

Dosage Form

Venitan® forte

Gel for external use 10 mg+100 IU: tube 50 g

Dosage Form, Packaging, and Composition

Gel for external use colorless or slightly opalescent, transparent, homogeneous.

Excipients : dexpanthenol – 5.000 mg, allantoin powder – 3.000 mg, sodium methylparaben – 3.000 mg, sodium hydroxide – 3.700 mg, carboxypolymethylene – carbopol 934 P – 12.500 mg, simethicone emulsion – 2.000 mg, propylene glycol – 50.000 mg, purified water – up to 1000 g.

50 g – aluminum lacquered tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Venotonic + direct anticoagulant for external use

Pharmacotherapeutic Group

Venotonic agent + direct-acting anticoagulant for topical use

Pharmacological Action

A combined agent for external use, containing a venotonic agent and a direct anticoagulant.

Aescine is contained in the seeds of the horse chestnut (Aesculus hippocastanum L., semen), it is a mixture of triterpene saponins. Aescine has an anti-inflammatory effect mainly in the initial phase of the inflammatory reaction, by strengthening the capillary walls and thus reducing their permeability, which is increased during inflammation. Aescine also has a positive effect on capillary wall fragility and increases the tone of venous walls when it is weakened. All this leads to a reduction in venous stasis and fluid accumulation in tissues, preventing the appearance of edema.

Heparin sodium prevents blood clotting, which reduces thrombus formation in vessels, and also has an anti-inflammatory effect.

Indications

Venous insufficiency (pain and heaviness in the legs, night cramps in the calf muscles, skin itching, leg swelling); varicose veins; injuries (bruises, soft tissue swelling, post-traumatic hematomas, sprains); superficial thrombophlebitis.

ICD codes

Dosage Regimen

Apply the gel externally to the affected skin areas one to three times daily.

Use a sufficient amount to cover the entire affected area with a thin layer.

Gently massage until fully absorbed.

For the management of venous insufficiency and varicose veins, apply consistently to areas exhibiting symptoms such as heaviness, pain, or swelling.

For the treatment of superficial thrombophlebitis, apply along the course of the affected vein.

In cases of injuries, such as bruises, sprains, or hematomas, apply promptly to the affected site.

The duration of treatment depends on the severity of symptoms and clinical response.

Do not apply to open wounds, bleeding ulcers, damaged skin, or mucous membranes.

Avoid contact with eyes.

Wash hands thoroughly after application.

Discontinue use immediately if allergic reactions such as skin rash, itching, or urticaria occur.

Adverse Reactions

Allergic reactions in some cases – urticaria, skin rash, skin itching.

Contraindications

Hypersensitivity to the components of the combination.

Use in Pregnancy and Lactation

There are no restrictions on the use of the drug for its indications during pregnancy or breastfeeding. The need to prescribe the drug during pregnancy and lactation (breastfeeding) is determined by the doctor individually.

Pediatric Use

There are no instructions on restrictions for use.

Geriatric Use

There are no instructions on restrictions for use.

Special Precautions

Do not apply to bleeding leg ulcers, to damaged or inflamed skin, to mucous membranes, or in the presence of purulent processes.

If allergic reactions develop, use should be discontinued.

Drug Interactions

Do not apply to affected areas of the skin simultaneously with other medicinal products for external use.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.