Heparoid Zentiva (Ointment) Instructions for Use

Marketing Authorization Holder

Zentiva, k.s. (Czech Republic)

ATC Code

C05BA01 (Heparinoids organic)

Active Substance

Heparinoids (BP British Pharmacopoeia)

Dosage Form

Heparoid Zentiva

Ointment for external use 200 IU/1 g: tube 30 g

Dosage Form, Packaging, and Composition

Ointment for external use emulsion, “oil in water” type, white or almost white in color.

* with an activity of 100 IU/1 mg

Excipients: hard paraffin – 1.05 g, liquid paraffin – 2.85 g, cetylstearyl alcohol (cetyl alcohol – 60%, stearyl alcohol – 40%) – 0.9 g, stearic acid – 0.6 g, white beeswax – 0.3 g, ethoxylated (C₁₂-C₁₄) fatty alcohols – 0.42 g, distilled monoglycerides – 0.48 g, propylene glycol – 1.5 g, trolamine – 0.045 g, methylparahydroxybenzoate – 0.06 g, propylparahydroxybenzoate – 0.015 g, purified water – 21.66 g.

30 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with antithrombotic action for topical use

Pharmacotherapeutic Group

Direct-acting anticoagulant for topical use

Pharmacological Action

The drug Heparoid Zentiva is an anti-inflammatory, antithrombotic agent for external use.

The drug has anti-inflammatory, anti-exudative action, and anticoagulant activity. It reduces increased blood coagulability in the area of inflammation or damage from injuries, prevents the formation of blood clots; accelerates the resorption of hematomas, reduces the formation of edema and exerts an anti-inflammatory effect, as a result of which the sensation of tension and pain at the site of inflammation or injury is reduced.

Indications

• Phlebitis and thrombophlebitis of superficial veins of various etiologies and localizations (including varicose veins of the lower extremities and chronic venous insufficiency, complicated by phlebitis, thrombophlebitis, periphlebitis, trophic skin disorders); periphlebitis in trophic leg ulcer;
• Hemorrhoids (excluding exacerbation accompanied by bleeding);
• Treatment of local complications after phlebosclerosing therapy, softening of scar tissue in hypertrophic scars;
• Soft tissue bruises, post-traumatic edema, hematomas, tenosynovitis, sprains of tendons and ligaments;

The drug is intended for use in adults and in children, starting from infancy.

ICD codes

Dosage Regimen

Heparoid Zentiva ointment is applied in a layer up to 1 mm thick to the affected area and around it 2-3 times/day at intervals of 4-5 hours and gently rubbed in until completely absorbed.

For extensive hematomas, an impermeable dressing can be applied over the skin surface treated with the ointment, preferably overnight. For venous diseases, a pressure bandage with Heparoid Zentiva ointment can be applied. In the presence of a trophic leg ulcer, the ointment should be rubbed around it.

The duration of the treatment course with Heparoid Zentiva is determined by the doctor individually and is usually 1 to 2 weeks. Without a doctor’s prescription, it is not recommended to use the drug for more than 2 weeks.

Usually, the use of Heparoid Zentiva for venous diseases is part of complex treatment, so it is necessary to carefully follow the doctor’s prescriptions (simultaneous use of other medications, application of a pressure bandage or use of an elastic stocking).

If, in the case of treating soft tissue bruises, no positive dynamics are observed within three days of using Heparoid Zentiva or signs of adverse reactions appear, treatment with the drug should be discontinued and a doctor should be consulted.

Adverse Reactions

Heparoid Zentiva is usually well tolerated.

In rare cases, temporary signs of local skin irritation such as redness, rash, or itching of the skin may occur.

In very rare cases, due to application to large areas and in large doses, hemorrhagic complications are possible due to resorptive action.

If the noted symptoms appear, the use of the drug should be discontinued and a doctor should be consulted to decide on the possibility of further treatment with Heparoid Zentiva. Patients should inform their doctor of all cases of adverse (unusual) effects, including those not listed in this instruction.

Contraindications

• Hemorrhagic diatheses, various forms of purpura, thrombocytopenias, hemophilia, other pathological conditions with a tendency to increased bleeding;
• Hypersensitivity to heparinoid, parabens, propylene glycol, other components of the drug.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, the drug is not recommended for long-term use or on large areas of skin; use of the drug is possible only in justified cases, as prescribed by a doctor.

The drug is not recommended for use in the last trimester of pregnancy due to the possible risk of bleeding during childbirth.

Pediatric Use

The drug is intended for use in children, starting from infancy.

Special Precautions

The drug should not be applied to an open wound surface, damaged skin surface, mucous membranes; avoid getting the ointment into the eyes.

Effect on ability to drive vehicles and mechanisms

The use of the drug does not affect activities requiring increased attention, coordination of movements, high speed of mental and physical reactions, for example: in drivers of vehicles, persons operating machinery, when working at height, etc.

Overdose

Cases of drug overdose have not been described.

If the drug is accidentally ingested by a child, nausea and vomiting may occur; in this situation, it is necessary to cleanse the child’s stomach and consult a doctor.

Drug Interactions

Without consulting a doctor, simultaneous use of Heparoid Zentiva with other medicinal products is not recommended.

Heparoid Zentiva should not be used simultaneously with topical medicinal products containing tetracycline, hydrocortisone, salicylic acid.

Increased caution is necessary with the simultaneous prescription of anticoagulants, due to the possible enhancement of the anticoagulant effect.

Storage Conditions

The drug should be stored in a dry place at a temperature of 10-25°C (50-77°F). The drug should be stored in a place inaccessible to children.

The drug should not be used after the expiration date indicated on the packaging.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.