Lipohep

Package leaflet: information for the patient

LIPOHEP
2400 IU/g, gel
Heparinum natricum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist.

• 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 or pharmacist. See section 4.
• If after a few days there is no improvement or if you feel worse, you should contact your doctor.

Table of contents of the leaflet:

1. What Lipohep is and what it is 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 package and other information

1. What Lipohep is and what it is used for

Lipohep is available as a spray gel for topical application to the skin. It contains heparin, an active substance with antithrombotic properties, which improves tissue perfusion and reduces swelling. It accelerates the absorption of hematomas, prevents the formation of superficial thromboses, and facilitates the dissolution of existing clots.
Lipohep in liposomal gel formulation penetrates the skin to a greater extent than other heparin-containing gels.
Lipohep is indicated for the local treatment of superficial, localized swellings and hematomas occurring in:

• superficial thrombophlebitis,
• varicose veins of the lower limbs,
• blunt soft tissue injuries.

Due to lack of clinical data, Lipohep should not be used in children.

2. Important information before using Lipohep

When not to use Lipohep:

• if the patient is allergic to heparin or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a tendency to bleed;
• if the patient has reduced platelet count;
• in children under 11 years of age. The medicine should not be applied to large areas of skin.

Warnings and precautions

Do not use near the eyes, nose, or mouth due to the presence of ethanol.
Do not apply Lipohep to skin with open wounds or to mucous membranes.
Lipohep should not be used in patients with skin lesions of unknown origin or in areas with active purulent infection.
If skin redness, rash, or itching occurs, discontinue treatment and consult a physician.

Children and adolescents
Due to lack of clinical data in the pediatric population, Lipohep should not be used in children under 11 years of age.

Lipohep and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
No interactions between Lipohep and other medicines are known.
However, simultaneous use of Lipohep with other topical medicines on the same skin area is not recommended.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Lipohep may be used during pregnancy and breastfeeding, but should not be applied long-term to large areas of skin.
If symptoms persist or if no improvement is observed after treatment, consult a doctor.

Driving and operating machinery
Lipohep has no influence on the ability to drive or operate machinery.

3. How to use Lipohep

The medicine should be used 1 to 3 times daily, applying 4 sprays of Lipohep to the affected areas,
then gently massaging in. When applying to the lower limbs, spread the medicine from bottom to top.
In cases of acute thrombosis and phlebitis, do not massage the medicine in.
When using for the first time, remove the cap, then direct the spray nozzle in a safe direction
and press the pump several times until the first spray is released.
Duration of treatment
Depending on the persistence of symptoms, the treatment period may last up to 14 days.
Missed dose of Lipohep
Apply the next dose as soon as possible, then continue according to the previous dosing schedule.
Apply no more than one dose at a time, then continue with the established dosing regimen.
Do not use a double dose to make up for a missed dose.
Use of more than the recommended dose of Lipohep
When used as recommended, no cases of heparin poisoning have been reported to date.
Heparin is poorly absorbed from the gastrointestinal tract if accidentally ingested orally.
If more than the recommended dose has been used, seek immediate advice from a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The frequency of adverse effects is defined as follows:

• very rare: (may affect up to 1 in 10,000 people);
• not known: (frequency cannot be estimated from available data).

When applying a medicine containing sodium heparin to the skin, allergic reactions are very rare. However, in isolated cases, allergic reactions such as skin redness and itching may occur, which usually resolve quickly after discontinuation of the medicine.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects 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
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Lipohep

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

6. Contents of the pack and other information

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

What Lipohep looks like and contents of the pack
Amber glass bottles with a spray pump dispenser and a polyethylene (PE) cap, packed in a cardboard box.
Bottles of 25 g or 11.5 g.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Cyathus Exquirere Pharmaforschungs GmbH
Rudolfsplatz 2/8
1010 Vienna
Austria

Manufacturer:
Pharbil Waltrop GmbH
Im Wirrigen 25
D-45731 Waltrop
Germany