Lipohep

Package Leaflet: Information for the Patient

LIPOHEP

2400 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 for the patient or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after a few days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet:

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

1. What is Lipohep and what is it used for

Lipohep is a gel for spraying on the skin. It contains heparin, an active substance with anticoagulant properties, improving tissue perfusion and reducing swelling. It accelerates the absorption of hematomas, prevents the formation of superficial thrombi, and facilitates the dissolution of existing ones.
Lipohep in the form of a gel with liposomes penetrates the skin to a greater extent than other heparin-containing gels.
The medicine is used for local treatment of superficial, limited edema and hematomas resulting from:

• superficial vein thrombosis,
• varicose veins of the lower limbs,
• blunt trauma to soft tissues. Due to the lack of clinical trials in children, Lipohep should not be used in this age group.

2. Important information before using Lipohep

When not to use Lipohep:

• in children under 11 years of age. The medicine should not be used on large areas of skin

Warnings and precautions

Do not use in the eye, nose, and mouth areas due to the presence of ethanol.
Do not use Lipohep on skin with open wounds and on mucous membranes.
The medicine should not be used in patients with skin changes of unknown origin, as well as in areas with purulent infection foci.
In case of skin redness, rash, or itching, discontinue treatment and contact your doctor.

Children and adolescents

Due to the lack of clinical trials in the pediatric population, the medicine should not be used in children under 11 years of age.

Lipohep and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
No interactions between Lipohep and other medicines are known.
However, it is not recommended to use Lipohep simultaneously with other topical medicines for the same skin area.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
Lipohep can be used in pregnant and breastfeeding women, but it should not be used for a long time on a large skin area.
If symptoms persist or if no improvement is observed after treatment, contact your doctor.

Driving and using machines

Lipohep has no effect on the ability to drive and use machines.

3. How to use Lipohep

Use the medicine 1 to 3 times a day, 4 sprays of Lipohep on the affected areas, gently massage.
When applying the medicine to the lower limbs, spread from the bottom up.
In case of acute thrombophlebitis, do not massage the medicine.
When using for the first time, remove the cap, then direct the spray nozzle in a safe direction and press the spray button several times until the first spray is released.

Treatment duration

Depending on the disappearance of disease symptoms, the treatment period is up to 14 days.

Missing a dose of Lipohep

Use the next dose as soon as possible, and then follow the previous dosing schedule.
Use no more than one dose, and then continue the established dosing schedule.
Do not use a double dose to make up for a missed dose.

Using more than the recommended dose of Lipohep

When using the medicine according to the recommendations, no heparin poisoning has been reported so far.
Heparin accidentally taken orally is poorly absorbed from the gastrointestinal tract.
In case of using more than the recommended dose, contact your doctor or pharmacist immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects is as follows:

• very rare: (may occur in no more than 1 in 10,000 people);
• unknown: (frequency cannot be estimated from the available data). When using heparin sodium-containing medicine on the skin, allergic reactions occur very rarely. However, in individual cases, allergic reactions such as skin redness and itching may occur, which usually quickly disappear after discontinuation of the medicine.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, tell your 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Lipohep

Store the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Store at a temperature below 25°C.

6. Contents of the pack and other information

What Lipohep contains

Active substance:1 g of gel contains 2400 IU of sodium heparin (corresponding to 458 IU per spray - approximately 0.19 g of gel)
Excipients:Phospholipon NAT 8539 (soybean lecithin and anhydrous ethanol), ethanol 96%, potassium dihydrogen phosphate, sodium hydroxide, purified water.

What Lipohep looks like and contents of the pack

Orange glass bottles with a spray pump and a polyethylene (PE) cap, in a cardboard box.
Bottles of 25 g or 11.5 g.

Marketing authorization holder and manufacturer

Marketing authorization holder

Cyathus Exquirere Pharmaforschungs GmbH
Rudolfsplatz 2/8
1010 Vienna
Austria

Manufacturer:

Pharbil Waltrop GmbH
Im Wirrigen 25
D-45731 Waltrop
Germany

Date of last revision of the leaflet: