Package leaflet: Information for the user

HEPARIN-HASCO
250 IU/g, gel
Sodium heparin
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor, pharmacist, or nurse.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after a few days, or if you feel worse, you should contact your doctor.

Contents of the leaflet:

What Heparin-Hasco is and what it is used for
Important information before using Heparin-Hasco
How to use Heparin-Hasco
Possible side effects
How to store Heparin-Hasco
Contents of the pack and other information

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

Heparin-Hasco is intended for topical application to the skin. Topically applied heparin has antithrombotic, anti-inflammatory, and anti-edematous effects.
Heparin-Hasco is indicated for supportive treatment in:

diseases of superficial veins: phlebitis, thrombophlebitis, varicose veins of the lower limbs,
oedema, contusions, subcutaneous haematomas.

2. Important information before using Heparin-Hasco

When not to use Heparin-Hasco

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

Warnings and precautions
Before starting to use Heparin-Hasco, consult your doctor, pharmacist, or nurse.
Exercise particular caution when using Heparin-Hasco in patients with diagnosed bleeding disorders.
Prolonged use of the medicine may cause skin hypersensitivity reactions in some patients.
If skin changes occur (redness, rash, itching, burning, erythema), discontinue use of the medicine.
Monitor skin condition regularly during treatment.
Heparin-Hasco should not be used in children due to lack of clinical data on efficacy and safety in this patient group.

Heparin-Hasco and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Heparin, when applied topically as a gel, is only minimally absorbed into the bloodstream. Due to low plasma concentrations, interactions with other medicines are negligible. However, in patients with bleeding disorders, prolonged application over large skin areas simultaneously with anticoagulant medicines may enhance anticoagulant effects. Monitoring of blood coagulation parameters is recommended.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your 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 clearly necessary.

Breastfeeding
Heparin does not pass into breast milk; however, during breastfeeding, the medicine should be used with caution and only when clearly necessary.

Fertility
No data available.

Driving and operating machinery
There are no data on the influence of the medicine on the ability to drive or operate machinery.

Heparin-Hasco contains propylene glycol
This medicine may cause skin irritation.

Heparin-Hasco contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
These may cause allergic reactions (including delayed-type reactions).

3. How to use Heparin-Hasco

This medicine should always be used exactly as described in the patient information leaflet or as
advised by a doctor, pharmacist, or nurse. If in doubt, consult a doctor,
pharmacist, or nurse.
This medicine is intended for topical application to the skin.
It is recommended to apply an even, thin layer of gel (a strip 3 cm to 10 cm long) to the affected area,
2 to 3 times daily.
After applying the medicine, hands should be washed thoroughly.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
During prolonged use of the medicine, allergic skin reactions may occur: redness,
itching, rash, burning, erythema, inflammatory skin conditions.
In some individuals, other adverse reactions may occur during treatment with Heparin-Hasco.
Reporting of adverse reactions
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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]
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 Heparin-Hasco

Store below 25°C.
Keep the medicine in a place inaccessible and out of sight 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Heparin-Hasco contains

The active substance is sodium heparin. 1 g of 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 aroma AR0287, purified water.

What Heparin-Hasco looks like and contents of the pack
Heparin-Hasco is a colourless gel with a rose scent.
One package contains 35 g of gel.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information on the Medicine
tel. + 48 (22) 742 00 22
e-mail: [email protected]
Date of the latest revision of the leaflet: