Heparizen 1000

Package Leaflet: Information for the Patient

Heparizen 1000 1000 IU/g Gel

Sodium Heparin

Read the Leaflet Carefully Before Using the Medication, as it Contains

Important Information for the Patient.
This medication should always be used exactly as described in this patient leaflet or as advised by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or if the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

Heparizen 1000 is a gel for topical application; it contains sodium heparin and has a local anticoagulant effect.
Sodium heparin applied externally to the skin in the form of a gel accelerates the absorption of hematomas and infiltrates.
It inhibits superficial inflammatory processes by inactivating enzymes, including hyaluronidase and phosphatase.
It has a long-lasting effect on pathologically changed tissues, relieves pain and tension, improves the metabolism of subcutaneous connective tissue due to its hydrophilic nature, shortening the duration of the disease.
Heparizen 1000 is a supportive medication in the treatment of:

• superficial thrombophlebitis,
• inflammatory conditions of the veins of the lower limbs,
• varicose veins of the lower limbs,
• post-traumatic conditions: hematomas, bruises, swelling.

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 medication (listed in section 6).

Warnings and precautions

Before starting to use Heparizen 1000, the patient should discuss it with their doctor or pharmacist.
Heparizen 1000 should not be applied to open, bleeding, purulent, and discharging wounds, skin lesions of unknown origin, infected skin, mucous membranes, and the eye area. Patients with bleeding disorders should exercise particular caution. The medication should be discontinued if the patient experiences: redness of the skin, rash, itching, burning, erythema.

Children

Heparizen 1000 should not be used in children due to the lack of studies on the safety and efficacy of its use.

Heparizen 1000 and other medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
During topical use of Heparizen 1000, no interactions with other medications used in the form of a gel and applied topically to the skin have been observed. Due to the limited ability of sodium heparin to penetrate the skin, interactions with other medications are insignificant.
Only in patients who are administered oral anticoagulant medications may an enhanced effect of sodium heparin and prolonged blood clotting time occasionally occur.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medication.
Sodium heparin does not cross the placenta. Heparizen 1000 can be used during pregnancy with caution, in cases of absolute necessity.
Sodium heparin does not penetrate into human milk. Heparizen 1000 can be used during breastfeeding with caution, in cases of absolute necessity.

Driving and using machines

Heparizen 1000 does not affect the ability to drive and use machines.

Heparizen 1000 contains propyl parahydroxybenzoate (E 216) and methyl parahydroxybenzoate (E 218)

The medication may cause allergic reactions (possible late-type reactions).

Heparizen 1000 contains ethanol 96%

This medication contains 47.6 mg of ethanol per gram of gel. It may cause a burning sensation on damaged skin. The medication is flammable. It should not be used near an open flame, a lit cigarette, or certain devices (e.g., hair dryers).

3. How to use Heparizen 1000

This medication should always be used exactly as described in this patient leaflet or as advised by a doctor or pharmacist.
In case of doubts, the patient should consult their doctor or pharmacist.
Heparizen 1000 should be applied topically to the skin.
Recommended dose
Apply the gel to the pathologically changed skin surface and the surrounding area 1 to 3 times a day.
Depending on the surface area affected by the disease, apply 5 to 10 cm of gel to the skin and gently massage for a few minutes.

Using more than the recommended dose of Heparizen 1000

There are no reports of overdose symptoms. However, if such a case occurs, the patient should contact their doctor.
The use of protamine sulfate will inactivate sodium heparin due to the formation of stable, pharmacologically inactive complexes.

Missing a dose of Heparizen 1000

A double dose should not be used to make up for a missed dose.

4. Possible side effects

Like all medications, Heparizen 1000 can cause side effects, although not everybody gets them.
Prolonged use of the medication may occasionally cause skin hypersensitivity reactions: erythema, skin inflammation, itching, burning sensation, feeling of cold, dry skin, rash, redness of the skin.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medication.

5. How to store Heparizen 1000

The medication should be stored out of sight and reach of children.
There are no special precautions for storing the medication.
Store in the original, tightly closed packaging.
Shelf life after first opening the tube: 3 years, but no longer than the expiration date stated on the packaging.
Do not use this medication after the expiration date stated on the packaging after: "EXP".
The expiration date refers to the last day of the specified month.
Medications should not be disposed of in wastewater or household waste containers. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Heparizen 1000 contains

• The active substance of the medication 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 what the pack contains

Heparizen 1000 is a semi-solid, colorless, transparent gel.
Packaging: aluminum tube, lacquered, with a membrane and a latex ring, closed with a polyethylene cap with a puncture device, containing 30 g, 50 g, or 100 g of gel, placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

ZIAJA Ltd Pharmaceutical Production Plant sp. z o.o.
ul. Jesienna 9
80-298 Gdańsk
Phone: +48 58 521 34 00

Date of the last update of the leaflet: