HEPARIZEN 1000

Package leaflet: Information for the patient

Heparizen 1000 1000 IU/g gel
Sodium heparin
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days of treatment, or if you feel worse, consult your doctor.

Table of contents

1. What Heparizen 1000 is and what it is used for
2. Important information before using Heparizen 1000
3. How to use Heparizen 1000
4. Possible side effects
5. How to store Heparizen 1000
6. Contents of the pack and other information

1. What Heparizen 1000 is and what it is used for

Heparizen 1000 is a topical gel containing sodium heparin, which exerts a local antithrombotic effect.
When applied externally to the skin in the form of a gel, sodium heparin accelerates the absorption of hematomas and infiltrates. It inhibits superficial inflammatory processes by neutralizing enzymes such as hyaluronidase and phosphatase.
It acts persistently on pathologically altered tissues, relieving pain and the sensation of tension, and improves metabolism in the subcutaneous connective tissue due to its hydrophilic nature, thereby shortening the duration of illness.
Heparizen 1000 is an adjunctive treatment for:

• Thrombophlebitis of superficial veins,
• Inflammatory conditions of the veins in the lower limbs,
• Varicose veins of the lower limbs,
• Post-traumatic conditions: hematomas, contusions, edema.

It is also used in the prevention and treatment of hypertrophic scars and keloids.

2. Important information before using Heparizen 1000

When not to use Heparizen 1000:

• if the patient is allergic to sodium heparin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Heparizen 1000, discuss it with your doctor or pharmacist.
Do not use Heparizen 1000 on open, bleeding, purulent, or oozing wounds, skin lesions of unknown origin, infected skin, mucous membranes, or around the eyes. Patients with bleeding disorders should exercise particular caution. The medicine should be discontinued if patients develop: skin redness, rash, itching, burning sensation, or skin erythema.
Children
Heparizen 1000 should not be used in children due to lack of data on safety and efficacy.
Heparizen 1000 and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
No interactions with other medicines applied topically to the skin in gel form have been observed during local use of Heparizen 1000. Due to limited absorption of sodium heparin through the skin, interactions with other medicines are unlikely to be significant.
However, in patients receiving oral anticoagulant therapy, an enhanced effect of sodium heparin and prolonged blood clotting time may occasionally occur.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Sodium heparin does not cross the placenta. Heparizen 1000 may be used during pregnancy cautiously, only when clearly necessary.
Sodium heparin does not pass into human milk. Heparizen 1000 may be used during breastfeeding cautiously, only when clearly necessary.
Driving and operating machinery
Heparizen 1000 has no influence on the ability to drive or operate machinery.
Heparizen 1000 contains propyl parahydroxybenzoate (E 216) and methyl parahydroxybenzoate (E 218)
This medicine may cause allergic reactions (including delayed-type reactions).
Heparizen 1000 contains 96% ethanol
This medicine contains 47.6 mg of ethanol in each gram of gel. It may cause a burning sensation on damaged skin. The medicine is flammable. Do not use near open flames, lit cigarettes, or certain devices (e.g. hair dryers).

3. How to use Heparizen 1000

This medicine should always be used exactly as described in this patient information leaflet or as directed by a physician. If in doubt, consult a doctor or pharmacist.
Heparizen 1000 should be applied topically to the skin.
Recommended dose
Apply the gel to the affected skin area and surrounding region 1 to 3 times daily.
Depending on the surface area affected, apply 5 to 10 cm of gel to the skin and gently massage for several minutes.
Use of a higher than recommended dose of Heparizen 1000
There are no reports of overdose symptoms. However, if such a case occurs, contact a doctor.
Protamine sulfate administration will inactivate sodium heparin by forming stable, pharmacologically inactive complexes.
Missed dose of Heparizen 1000
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Prolonged use of the medicine may occasionally lead to skin hypersensitivity reactions: erythema,
skin inflammation, itching, burning sensation, sensation of cold, dry skin, rash, skin redness.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Heparizen 1000

Keep the medicine out of sight and reach of children.
No special storage conditions are required for this medicine.
Store in the original, tightly closed packaging.
Shelf life after first opening of the tube: 3 years, but not beyond the expiry date stated on the
packaging after "EXP".
Do not use this medicine after the expiry date indicated on the packaging following "EXP".
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Heparizen 1000 contains

• The active substance is sodium heparin. One gram of gel contains 1000 IU of sodium heparin.
• The other ingredients are: carbomer, ethanol 96%, propyl parahydroxybenzoate (E 216), methyl parahydroxybenzoate (E 218), sodium hydroxide, purified water.

What Heparizen 1000 looks like and contents of the pack
Heparizen 1000 is a semi-solid, colorless, transparent gel.
Pack: aluminum tube, lacquered, with a membrane and latex ring, closed with a polyethylene cap with a piercing device, containing 30 g, 50 g or 100 g of gel, placed in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
ZIAJA Ltd Zakład Produkcji Leków sp. z o.o.
Jesienna 9 Street
80-298 Gdańsk
Tel.: +48 58 521 34 00