Vessel Due F

Leaflet attached to the packaging: information for the user

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

Vessel Due F

300 LSU/ml, solution for injection

Sulodexide

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and you should not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Vessel Due F and what is it used for

Vessel Due F contains sulodexide, a substance that acts on certain factors responsible for the blood coagulation process, exerting an antithrombotic effect in arterial and venous vessels. Sulodexide also normalizes increased blood viscosity in people with vascular changes and a risk of thrombosis, and reduces lipid levels. Vessel Due F solution for injection is used to treat venous ulcers of the legs as an adjunct to local and symptomatic therapy, and for the treatment of chronic obstructive arterial disease of the lower limbs of moderate severity (stage II of the Fontaine classification).

2. Important information before using Vessel Due F

When not to use Vessel Due F

• if you are allergic (hypersensitive) to sulodexide or any of the other ingredients of this medicine (listed in section 6), or to heparin or heparin-like medicines;
• if you are using heparin or oral anticoagulants;
• if you have a bleeding disorder and diseases characterized by bleeding.

Warnings and precautions

Before starting to use Vessel Due F, you should discuss it with your doctor or pharmacist.

• if you are also using other anticoagulant medicines, as this may increase the anticoagulant effect and regular monitoring of blood coagulation parameters may be necessary. Sulodexide is an acidic mucopolysaccharide and may react with substances with a basic pH. It should not be mixed in the same syringe or infusion with vitamin K, vitamins B, hydrocortisone, hyaluronidase, calcium gluconate, quaternary ammonium salts, chloramphenicol, tetracyclines, or streptomycin.

Children and adolescents

The safety and efficacy of Vessel Due F in children and adolescents have not been established. There are no available data.

Vessel Due F and other medicines

Sulodexide has a chemical structure similar to heparin, so it may enhance the effect of heparin and oral anticoagulant medicines given at the same time. You should tell your doctor about all the medicines you are taking, or have recently taken, and about any medicines you plan to take, including those available without a prescription.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor for advice before using this medicine. The use of Vessel Due F is not recommended during pregnancy. The use of Vessel Due F is not recommended during breastfeeding.

Driving and using machines

Vessel Due F does not affect the ability to drive or use machines.

Vessel Due F contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per ampoule, which means it is essentially 'sodium-free'.

3. How to use Vessel Due F

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist. Treatment of venous ulcers of the legs as an adjunct to local therapy: 1 ampoule (600 LSU) once a day intramuscularly for 20 days, then 2 capsules (500 LSU) twice a day between meals for 30-70 days. Symptomatic treatment of chronic obstructive arterial disease of the lower limbs of moderate severity (stage II of the Fontaine classification): 1 ampoule (600 LSU) once a day intramuscularly for 20 days, then 2 capsules (500 LSU) twice a day between meals for 6 months. Your doctor will decide on the dose and duration of treatment.

Using more than the recommended dose of Vessel Due F

In case of overdose, bleeding may occur. If you have used more than the recommended dose of Vessel Due F, you should immediately consult a doctor, who will provide appropriate treatment if necessary.

Missing a dose of Vessel Due F

If you miss a dose, you should take it as soon as possible. However, if it is almost time for your next dose, you should skip the missed dose. Do not take a double dose to make up for a missed dose.

Stopping the use of Vessel Due F

If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist. Stopping the use of Vessel Due F does not cause any adverse effects, except for the possibility of worsening symptoms of the disease for which it is being used.

4. Possible side effects

Like all medicines, Vessel Due F can cause side effects, although not everybody gets them. The frequency of side effects is defined as follows: very common (affects 1 or more patients in 10); common (affects 1 to 10 patients in 100); uncommon (affects 1 to 10 patients in 1,000); rare (affects 1 to 10 patients in 10,000); very rare (affects less than 1 patient in 10,000).

• Common: dizziness, abdominal pain, diarrhea, stomach pain, nausea, rash
• Uncommon: feeling of discomfort in the abdominal cavity, dyspepsia, bloating, vomiting, pain at the injection site, hematoma at the injection site (in the case of the injectable product), headache; exanthema, erythema, urticaria
• Very rare: gastrointestinal bleeding, peripheral edema, loss of consciousness, anemia, abdominal pain, gastrointestinal disorders, melena, disorders of blood protein metabolism, genital edema and erythema, menorrhagia, angioedema, purpura. If any of the side effects get worse, or if you notice any side effects not listed in this leaflet, you should tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should 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, 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 this medicine.

5. How to store Vessel Due F

Store in a temperature below 30°C. Store in a place out of sight and reach of children. Do not use Vessel Due F after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Do not use this medicine if you notice that the packaging is damaged. Medicines should not be disposed of via wastewater or household waste. 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 Vessel Due F contains

The active substance of Vessel Due F is sulodexide. 1 ml of the solution contains 300 LSU of sulodexide. 1 ampoule (2 ml solution) contains 600 LSU of sulodexide. The other ingredients are: sodium chloride, water for injections.

What Vessel Due F looks like and contents of the packaging

Ampoules of 2 ml solution for injection. The packaging contains 10 ampoules. For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

Alfasigma S.p.A.
Via Ragazzi del ’99, n. 5
40133, Bologna (BO), Italy

Manufacturer:

Alfasigma S.p.A.
Via Enrico Fermi 1
65020 Alanno (PE), 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 the Czech Republic, the country of export:85/670/92-C

Parallel import authorization number: 115/25

Date of leaflet approval: 27.03.2025

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