Lioton 1000

Package Leaflet: Information for the User

Lioton 1000 8.5 mg (1000 IU)/g

gel
(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 this package leaflet for the patient or as directed by a doctor or pharmacist.

• This package 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 this package 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 Package 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 package and other information

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

Lioton 1000 is a medicinal product in the form of a gel for topical use; it contains heparin, which 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, and swelling.

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 medicinal product (due to the presence of methyl and propyl hydroxybenzoates as excipients, the medicinal product should not be used in patients with paraben allergy).
The medicinal product should not be used on open wounds or oozing skin lesions. It should not be used near the eyes, nose, and mouth.
Lioton 1000 should not be used in case of bleeding.
The medicinal product should not be taken orally.

Warnings and Precautions

Sodium heparin in the form of a gel is usually well-tolerated, but prolonged use of the medicinal product may cause skin hypersensitivity reactions in some individuals. In case of redness, rash, or itching, the use of the medicinal product should be discontinued and appropriate treatment should be applied.
Particular caution should be exercised in patients with a history of bleeding disorders.

Lioton 1000 and Other Medicinal Products

The doctor should be informed about all medicinal products used 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 medicinal products or acetylsalicylic acid, increases the risk of bleeding.

Children

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

Pregnancy and Breastfeeding

There are insufficient data on the use of the medicinal product during pregnancy or breastfeeding. Before using the medicinal product, a doctor should be consulted.

Driving and Using Machines

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

Lioton 1000 Contains Methyl 4-Hydroxybenzoate, Propyl 4-Hydroxybenzoate, Orange Flavor, and Lavender Oil

This medicinal product contains methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate as preservatives. This may cause allergic reactions (possible late-type reactions).
This medicinal product contains flavors, including 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

This medicinal product contains 233 mg of alcohol (ethanol) per gram of gel. Ethanol may cause a burning sensation on damaged skin.

3. How to Use Lioton 1000

Lioton 1000 is intended for topical use. The medicinal product should be used 1 to 3 times a day, applying a 3-10 cm long strip of gel to the skin surface and gently massaging until the gel is absorbed.
In case of swelling after injuries, it is recommended to use the medicinal product 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 medicinal products, Lioton 1000 can cause side effects, although they may not occur in everyone.
In individual cases, symptoms of allergic reactions (redness and itching of the skin) or pseudo-allergic reactions may occur. In such cases, treatment should be discontinued. In some patients who initially have erythema, local administration of heparin in the gel may cause skin changes.
If any of the side effects worsen or if any side effects not listed in the package leaflet occur, a doctor or pharmacist should be informed.

Reporting Side Effects

If any side effects occur, including any side effects not listed in this package leaflet, a doctor or pharmacist, or nurse should be informed.
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: (22) 49-21-301
Fax: (22) 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicinal product.

5. How to Store Lioton 1000

There are no special precautions for storage.

Keep Out of the Reach and Sight of Children.

Lioton 1000 should not be used after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the given month.
Before using the medicinal product, the expiry date stated on the packaging should be checked.
Shelf life after first opening the tube: 24 weeks.
The abbreviation "EXP" on the packaging refers to the expiry date.
The abbreviation "Lot" on the packaging refers to the batch number.
Medicinal products should not be disposed of via wastewater or household waste. A pharmacist should be asked what to do with unused medicinal products. This will help protect the environment.

6. Contents of the Package and Other Information

What Lioton 1000 Contains

The active substance of the medicinal product is sodium heparin (Heparinum natricum). 1 g of gel contains 8.5 mg (1000 IU) of sodium heparin.
Other excipients of the medicinal product are: purified water, ethanol 96%, carbomer, tromethamine, orange flavor (contains linalool, d-limonene, geraniol, citral, citronellol, and farnesol), lavender oil (contains linalool, d-limonene, geraniol, and coumarin), preservatives: methyl 4-hydroxybenzoate (E 218), propyl 4-hydroxybenzoate (E 216).

What Lioton 1000 Looks Like and Contents of the Package

Aluminum tube with a polypropylene cap, containing 20 g, 30 g, 50 g, or 100 g of gel.
Aluminum tube with a polyethylene cap, containing 20 g, 30 g, 50 g, or 100 g of gel.

Marketing Authorization Holder

• A. Menarini Industrie Farmaceutiche Riunite S.r.l. 3 Via Sette Santi 50131 Florence, Italy

Manufacturer

• A. Menarini Manufacturing Logistics and Services S.r.l. 3 Via Sette Santi 50131 Florence, Italy

To obtain more detailed information, the representative of the marketing authorization holder should be contacted:

Berlin-Chemie/Menarini Polska Sp. z o.o.

tel: (22) 566 21 00
fax: (22) 566 21 01
Date of Last Revision of the Package Leaflet: 04/2022