Heparin-hasco

Package Leaflet: Information for the Patient

HEPARIN-HASCO

250 IU/g, gel

Sodium heparin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the package leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If after a few days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

• 1. What is Heparin-Hasco and what is it used for
• 2. Important information before using Heparin-Hasco
• 3. How to use Heparin-Hasco
• 4. Possible side effects
• 5. How to store Heparin-Hasco
• 6. Package contents and other information

1. What is Heparin-Hasco and what is it used for

Heparin-Hasco is intended for topical use on the skin. Topically applied heparin has anticoagulant, anti-inflammatory, and anti-edema effects.
Heparin-Hasco is indicated as an adjunctive treatment for:

• superficial vein diseases: phlebitis, thrombophlebitis, varicose veins of the lower limbs,
• edema, bruises, subcutaneous hematomas.

2. Important information before using Heparin-Hasco

When not to use Heparin-Hasco

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• on open, bleeding, and oozing wounds, mucous membranes, and eye areas, skin lesions of unknown origin, infected skin,
• due to the presence of methyl and propyl parahydroxybenzoate, the medicine should not be used in patients with paraben allergy.

Warnings and precautions

Before starting to use Heparin-Hasco, the patient should discuss it with their doctor, pharmacist, or nurse.
Particular caution should be exercised when using Heparin-Hasco in patients with known bleeding disorders.
Prolonged use of the medicine may cause skin hypersensitivity reactions in some patients.
If skin changes (redness, rash, itching, burning, erythema) occur, the medicine should be discontinued.
The appearance of the skin should be monitored during the use of the medicine.
The medicine should not be used in children due to the lack of clinical studies on its efficacy and safety in this patient group.

Heparin-Hasco and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to use.
Topically applied heparin in the form of a gel is only slightly absorbed into the bloodstream. Due to the low concentration of heparin in plasma, interactions with other medicines are negligible. Only in patients with bleeding disorders, prolonged use of the medicine on large skin areas simultaneously with anticoagulant medicines may enhance the anticoagulant effect. It is recommended to monitor blood coagulation parameters.

Pregnancy, breastfeeding, and fertility

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 medicine.
Pregnancy
Heparin does not cross the placenta; however, during pregnancy, the medicine should be used with caution and only when necessary.
Breastfeeding
Heparin does not pass into breast milk; however, during breastfeeding, the medicine should be used with caution and only when necessary.
Fertility
No data available.

Driving and using machines

There are no data available on the effect of the medicine on the ability to drive and use machines.

Heparin-Hasco contains propylene glycol

The medicine may cause skin irritation.

Heparin-Hasco contains methyl parahydroxybenzoate and propyl parahydroxybenzoate

The medicine may cause allergic reactions (possible late reactions).

3. How to use Heparin-Hasco

This medicine should always be used exactly as described in the package leaflet or as directed by a doctor, pharmacist, or nurse. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.
The medicine is intended for topical use on the skin.
A thin layer of the gel (a strip of 3 cm to 10 cm) should be evenly applied to the affected area, 2 to 3 times a day.
After using the medicine, the patient should wash their hands thoroughly.

4. Possible side effects

Like all medicines, Heparin-Hasco can cause side effects, although not everybody gets them.
During prolonged use of the medicine, skin allergic reactions may occur: redness, itching, rash, burning, erythema, skin inflammation.
Some people may experience other side effects while using Heparin-Hasco.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Heparin-Hasco

Store in a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Heparin-Hasco contains

• The active substance of the medicine is sodium heparin. 1 g of the gel contains 250 IU of sodium heparin.
• The other ingredients (excipients) are: carbomer 5984, sodium hydroxide 30%, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, disodium edetate, rose fragrance AR0287, purified water.

What Heparin-Hasco looks like and what the package contains

Heparin-Hasco is a colorless gel with a rose fragrance.
One package of the medicine contains 35 g of the gel.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine Information
tel. +48 (22) 742 00 22
e-mail: [email protected]

Date of the last update of the leaflet: