Lioton 1000

Patient Information Leaflet: User Information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Lioton 1000 (Lioton 1000 SV/g gels), 8.5 mg (1000 IU)/g, gel

Heparinum natricum
Lioton 1000 and Lioton 1000 SV/g gels are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient information leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should speak to a pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Leaflet:

• 1. What is Lioton 1000 and what is it used for
• 2. Important information before using Lioton 1000
• 3. How to use Lioton 1000
• 4. Possible side effects
• 5. How to store Lioton 1000
• 6. Contents of the packaging and other information

1. What is Lioton 1000 and what is it used for

Lioton 1000 is a medicine in the form of a gel for application to the skin; it contains heparin, has local anticoagulant, anti-edema, and anti-inflammatory effects.

Indications for Use

Supportive treatment:

• for superficial vein diseases such as phlebitis, thrombophlebitis, varicose veins of the lower limbs;
• for subcutaneous hematomas, bruises, edema.

2. Important information before using Lioton 1000

When not to use Lioton 1000

Lioton 1000 should not be used in case of known hypersensitivity to heparin or any of the excipients of the medicine (due to the presence of methyl and propyl hydroxybenzoates as excipients, the medicine should not be used in people with paraben allergy).
The medicine should not be used on open wounds or weeping skin lesions. Do not use in the area of the eyes, nose, and mouth.
Lioton 1000 should not be used in case of bleeding.
The medicine should not be taken orally.

Warnings and Precautions

Sodium heparin in the form of a gel is usually well-tolerated, but long-term use of the medicine may cause skin hypersensitivity reactions in some individuals. In case of redness, rash, or itching, you should immediately stop using the medicine and apply appropriate treatment.
Particular caution should be exercised in patients with a history of bleeding disorders.

Lioton 1000 and other medicines

You should tell your doctor about all the medicines you have taken recently, including those that are available without a prescription.
Using heparin on large skin surfaces or during concurrent anticoagulant therapy, e.g., during the administration of anticoagulant drugs or acetylsalicylic acid, increases the risk of bleeding.

Children

Since there are no studies on the efficacy and safety of use in children under 12 years of age, Lioton 1000 should not be used in this age group.

Pregnancy and Breastfeeding

There are insufficient studies on the use of the medicine during pregnancy or breastfeeding. Before using the medicine, you should consult a doctor.

Driving and Using Machines

Lioton 1000 does not affect the ability to drive and use machines.

Lioton 1000 contains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), neroli aroma, and lavender oil.

This medicine contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) as preservatives. This may cause allergic reactions (possible late-type reactions).
This medicine contains neroli aroma and lavender oil, which include citral, citronellol, coumarin, d-limonene, farnesol, geraniol, and linalool. Citral, citronellol, coumarin, d-limonene, farnesol, geraniol, and linalool may cause allergic reactions.

Lioton 1000 contains ethanol 96%

This medicine contains 243 mg of alcohol (ethanol 96%) per gram of gel. Ethanol 96% may cause a burning sensation on damaged skin.

3. How to use Lioton 1000

Lioton 1000 is intended for application to the skin. The medicine should be used 1 to 3 times a day, applying a strip of gel 3-10 cm long to the skin surface and gently massaging until the gel is absorbed.
In case of edema after injuries, it is recommended to use the medicine for up to 10 days, and in case of treatment of superficial vein diseases for 1 to 2 weeks.

4. Possible side effects

Like all medicines, Lioton 1000 can cause side effects, although not everybody gets them.
In individual cases, symptoms of allergic reactions (skin redness and itching) or pseudo-allergic reactions may occur. In such cases, treatment should be discontinued. In some patients who initially have true erythema, skin changes may appear after local administration of heparin in gel.
If any of the side effects get worse or if you experience any side effects not listed in this leaflet, you should inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. 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.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Lioton 1000

There are no special recommendations for storage.
Store in a place inaccessible and invisible to children.
You should not use Lioton 1000 after the expiry date stated on the packaging.
The expiry date means the last day of the specified month.
Before using the medicine, you should check the expiry date on the packaging.
Shelf life after first opening the tube: 6 months.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Lioton 1000 contains

The active substance of the medicine is sodium heparin (Heparinum natricum). 1 g of gel contains 8.5 mg (1000 IU) of sodium heparin.
Other ingredients of the medicine are: purified water, ethanol 96%, carbomers, tromethamine, neroli aroma (contains linalool, d-limonene, geraniol, citral, citronellol, and farnesol), lavender oil (contains linalool, d-limonene, geraniol, and coumarin), preservatives: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216).

What Lioton 1000 looks like and what the packaging contains

An aluminum tube with a polypropylene cap, containing 50 g or 100 g of gel, in a cardboard box.
An aluminum tube with a polyethylene cap, containing 50 g or 100 g of gel, in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Latvia, the country of export:

• A. Menarini Industrie Farmaceutiche Riunite S.r.l. Via Sette Santi 3, Florence, Italy

Manufacturer:

• A. Menarini Manufacturing Logistics and Services s.r.l. Via Sette Santi 3, Florence, Italy

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Latvia, the country of export:98-0117

Parallel import authorization number: 148/25

Date of approval of the leaflet: 24.04.2025

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