Heparinum Gsk

Package Leaflet: Information for the Patient

HEPARINUM GSK, 300 IU/g, cream
Heparinum natricum

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 for the patient or as directed 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 the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

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

1. What is Heparinum GSK and what is it used for

Heparinum GSK is a cream for topical use, exclusively on the skin. The medicine contains heparin, which has anticoagulant and anti-inflammatory effects. It accelerates the absorption of subcutaneous hematomas and edema. It plays an important role in eliminating local inflammatory conditions. It relieves pain and contributes to the faster resolution of inflammatory edema.

Indications for use:

Supportive treatment in superficial vein diseases, such as:

• phlebitis, thrombophlebitis, varicose veins of the lower limbs,
• edema, bruising, subcutaneous hematomas.

2. Important information before using Heparinum GSK

When not to use Heparinum GSK

The medicine should not be used:

• if the patient is allergic to the active substance (heparin), heparinoids, or any of the other ingredients of this medicine (listed in section 6),
• on open wounds, mucous membranes, or in the eye area, as the medicine contains alcohol,
• if the patient has skin changes of unknown origin,
• on infected wounds,
• orally.

Warnings and precautions

Before starting to use Heparinum GSK, the patient should discuss it with their doctor or pharmacist:

• if the patient has a bleeding disorder (tendency to bleed) or bleeding wounds,
• if the patient has polycythemia vera (an increase in the number of red and white blood cells and platelets, causing clots and thrombi),
• In some patients, long-term use of the medicine may cause skin hypersensitivity reactions (see section 4: Possible side effects).

Children

The medicine should not be used in children under 12 years of age.

Heparinum GSK and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient should not use the following medicines at the same time as Heparinum GSK due to the risk of bleeding:

• anticoagulant medicines (medicines used to reduce blood clotting, e.g., warfarin),
• acetylsalicylic acid (used to relieve pain and reduce fever, e.g., aspirin).

Heparinum GSK used on large areas of skin may increase the risk of bleeding.

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 medicine. The patient should avoid using Heparinum GSK during pregnancy, unless the benefit to the mother outweighs the potential risk to the fetus. The patient should avoid using Heparinum GSK during breastfeeding, unless the benefit to the mother outweighs the potential risk to the child. Pregnant and breastfeeding women may use Heparinum GSK only on the advice of a doctor.

Driving and using machines

The medicine has no or negligible influence on the ability to drive and use machines.

Heparinum GSK contains benzyl alcohol and cetyl stearyl alcohol

Heparinum GSK contains 1 mg of benzyl alcohol in 100 mg of cream. Benzyl alcohol may cause allergic reactions and mild local irritation. Due to the presence of benzyl alcohol, the medicine should not be used in premature infants or newborns. The medicine may cause poisoning and allergic reactions in infants and children up to 3 years of age. Heparinum GSK contains 5 mg of cetyl stearyl alcohol in 100 mg of cream. Cetyl stearyl alcohol may cause local skin reactions (e.g., contact dermatitis).

3. How to use Heparinum GSK

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. Heparinum GSK is intended for use on the skin only.

Recommended dosage

A thin layer of cream (a strip 3 to 10 cm long) should be applied evenly to the affected areas. The medicine should be used 1 to 3 times a day.

Duration of treatment

In the treatment of phlebitis, thrombophlebitis, varicose veins of the lower limbs, edema, bruising, and subcutaneous hematomas - the medicine should be used for 1 to 2 weeks. In the treatment of acute edema after blunt injuries - the medicine should be used for up to 10 days. If there is no improvement or the patient feels worse, they should consult their doctor.

Use in children

The medicine should not be used in children under 12 years of age.

Using more than the recommended dose of Heparinum GSK

In case of taking a dose of the medicine larger than recommended, the patient should immediately consult their doctor or pharmacist. There are no data on the overdose of heparin used topically. If the patient accidentally used the medicine orally, they should immediately contact their doctor.

Missing a dose of Heparinum GSK

The patient should apply the cream as soon as possible and use the next dose at the usual time. In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Heparinum GSK can cause side effects, although not everybody gets them. If any of the following side effects occur, the patient should stop the treatment and consult their doctor immediately.

Rare side effects

May occur in up to 1 in 1,000 patients:

• hypersensitivity reactions (allergic reactions) manifested by: rash, redness, swelling, erythema, itching, dryness of the skin, or burning. These symptoms occur rarely, especially after long-term use of the medicine.

Other side effects

Other side effects have occurred in a small number of patients, but their frequency is not known.

• nodular-papular skin changes with blood presence, skin rash associated with vasculitis caused by the breakdown of white blood cells (called leukocytoclastic vasculitis). These symptoms occur in some patients with polycythemia vera (an increase in the number of red and white blood cells and platelets, causing clots and thrombi),

raised and itchy rash (hives), redness, itching.

Reporting side effects

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 or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Heparinum GSK

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

6. Contents of the pack and other information

What Heparinum GSK contains

• The active substance of the medicine is sodium heparin (Heparinum natricum). 1 g of cream contains 300 IU of sodium heparin.
• The other excipients are: glycerol monostearate, polysorbate 60, sorbitan stearate, cetyl stearyl alcohol, benzyl alcohol, liquid paraffin, anhydrous citric acid, purified water.

What Heparinum GSK looks like and contents of the pack

The medicine is a white cream, odorless or with a slightly noticeable almond smell. The packaging of the medicine: an aluminum tube (internally coated with a membrane and a polypropylene or polyethylene cap), containing 20 g of cream, placed in a cardboard box.

Marketing authorization holder

GSK PSC Poland sp. z o.o.
ul. Grunwaldzka 189,
60-322 Poznań

Manufacturer

Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder.
Date of last revision of the leaflet:June 2022