Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Vessel Due F
300 LSU/ml, solution for injection
Sulodexide
Please read the following information carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual and must not be passed on to others, as it may harm them, even if their symptoms are the same.
If any adverse effects occur in the patient, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What Vessel Due F is and what it is used for
Important information before using Vessel Due F
How to use Vessel Due F
Possible side effects
How to store Vessel Due F
Contents of the pack and other information

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

Vessel Due F contains sulodexide – an active substance which acts as an antithrombotic agent in both arterial and venous vessels by affecting certain factors involved in the blood coagulation process. Sulodexide also normalizes increased blood viscosity in patients with vascular changes and risk of thrombosis, and reduces lipid concentrations.
Vessel Due F solution for injection is indicated in the treatment of venous leg ulcers as an adjunct to local and symptomatic therapy, and in the treatment of moderate-stage chronic obstructive arterial disease of the lower limbs (Fontaine stage II).

2. Important information before using Vessel Due F

When not to use Vessel Due F

if the patient is allergic (hypersensitive) to sulodexide or any of the other components of this medicine (listed in section 6), or to heparin or heparin-like drugs;
if the patient is using heparin or oral anticoagulants;
if the patient has a bleeding tendency or diseases associated with bleeding.

Warnings and precautions
Before starting treatment with Vessel Due F, discuss this with your doctor or pharmacist.

if other anticoagulant medicines are used concomitantly, as this may enhance the anticoagulant effect and regular monitoring of blood coagulation parameters is required. Sulodexide is an acidic mucopolysaccharide and may react with alkaline substances. It should not be mixed in the same syringe or infusion with vitamin K, B-complex vitamins, 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 yet been established. No data are available.

Vessel Due F and other medicines
Sulodexide has a chemical structure similar to heparin and may therefore enhance the effect of heparin and oral anticoagulant drugs when administered simultaneously.
Inform your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
The use of this medicine is not recommended in pregnant women.
The use of this medicine is not recommended during breastfeeding.

Driving and operating machinery
Vessel Due F has no influence on the ability to drive vehicles or operate machinery.

Vessel Due F contains sodium.
The medicine contains less than 1 mmol (23 mg) of sodium per ampoule, meaning the medicine is considered "sodium-free".

3. How to use Vessel Due F

This medicine should always be used exactly as directed by the physician or pharmacist. If in doubt,
consult your doctor or pharmacist.

Treatment of venous leg ulcers as an adjunct to local therapy
1 ampoule (600 LSU) once daily by intramuscular injection for 20 days, followed by 2 capsules (500 LSU) twice daily between meals for 30–70 days.

Symptomatic treatment of moderate-stage chronic arterial occlusive disease of the lower limbs (Fontaine classification stage II)
1 ampoule (600 LSU) once daily by intramuscular injection for 20 days, followed by 2 capsules (500 LSU) twice daily between meals for 6 months.

The physician will determine the dosage and duration of treatment.

Use of a higher than recommended dose of Vessel Due F
In case of overdose, bleeding may occur.
If a higher than recommended dose of Vessel Due F has been used, consult a doctor immediately. The doctor will initiate appropriate treatment if necessary.

Missed dose of Vessel Due F
If a dose is missed, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose. Do not use a double dose to make up for a missed one.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The frequency of adverse reactions is defined as follows: very common (affects 1 or more out of 10 people); common (affects 1 to 10 out of 100 people); uncommon (affects 1 to 10 out of 1,000 people); rare (affects 1 to 10 out of 10,000 people); very rare (affects fewer than 1 out of 10,000 people).

Common: dizziness, abdominal pain, diarrhoea, stomach pain, nausea, rash
Uncommon: discomfort in the abdominal cavity, dyspepsia, bloating, vomiting, pain at the injection site, bruising at the injection site (in case of injectable formulation), headache; skin rash, erythema, urticaria
Very rare: gastrointestinal bleeding, peripheral oedema, loss of consciousness, anaemia, abdominal pain, gastrointestinal disorders, melaena, disturbances in blood plasma protein metabolism, swelling and redness of the genital area, excessive menstruation, angioedema, petechiae. If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vessel Due F

Store below 30°C.
Keep 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 stated month.
Do not use this medicine if the packaging is damaged.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

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

What Vessel Due F looks like and contents of the pack
Ampoules with 2 ml of solution for injection.
Pack contains 10 ampoules.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in the Czech Republic, 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, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation Number in the Czech Republic, country of export: 85/670/92-C
Parallel Import Authorisation Number: 115/25