Patient Information Leaflet

Warning! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
Vessel Due F
300 LSU/ml, solution for injection
Sulodexidum
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual and should not be passed on to others. It may harm them, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 on certain factors involved in blood coagulation, thereby exerting antithrombotic effects in both arterial and venous vessels. Sulodexide also normalizes increased blood viscosity in patients with vascular changes and at risk of thrombosis, and reduces lipid concentrations.
Vessel Due F solution for injection is used in the treatment of venous leg ulcers as an adjunct to local therapy, and in the symptomatic treatment of moderate chronic obstructive arterial disease of the lower limbs (Stage II according to Fontaine's classification).

2. Important information before using Vessel Due F

When not to use Vessel Due F

if the patient is allergic to the active substance (sulodexide) or to any of the other ingredients of this medicine (listed in section 6), or to heparin or heparinoids (medicines that reduce blood clotting);
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.
Sulodexide is an acidic mucopolysaccharide and may react with alkaline substances. It must not be mixed in the same syringe or infusion with vitamin K, B-group vitamins, hydrocortisone, hyaluronidase (a substance used in medicine to improve drug dispersion in the body), calcium gluconate (used in cases of calcium deficiency in the blood), disinfectants (quaternary ammonium salts), or certain types of antibiotics (chloramphenicol, tetracyclines, streptomycin).

Children and adolescents
The safety and efficacy of Vessel Due F in children and adolescents under 18 years of age have not been established. No data are available.

Vessel Due F 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. Vessel Due F may enhance the effect of concomitantly administered heparin and oral anticoagulant drugs.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.

Pregnancy
For safety reasons, sulodexide is not recommended for use in pregnant women.

Breastfeeding
Vessel Due F should not be used during breastfeeding.

Fertility
Animal studies have not shown any direct or indirect harmful effects on fertility in men and women.

Driving and operating machinery
This medicine has no or negligible influence on the ability to drive and 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 as directed by a physician or pharmacist. If in doubt,
consult a physician 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 chronic arterial occlusive disease of the lower limbs (Stage II according to Fontaine's classification)
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
If more than the recommended dose of Vessel Due F has been used, consult a physician immediately. If bleeding occurs, go to the nearest hospital.
Missed dose of Vessel Due F
Do not take a double dose to make up for a missed dose.
Stopping Vessel Due F
If you have any further doubts regarding the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Common adverse reactions (affects 1 to 10 patients in 100):

dizziness,
diarrhoea,
stomach pain,
rash.

Uncommon adverse reactions (affects 1 to 10 patients in 1,000):

loss of consciousness,
headache,
bleeding in the stomach,
itchy rash,
itchy, red and dry skin,
swelling, particularly of ankles and feet,
bruising at the injection site.

Frequency not known (frequency cannot be estimated from the available data):

anaemia,
disturbances in metabolism of proteins present in the liquid part of blood called plasma (plasma protein metabolism disorders),
disturbance in perception of the surrounding world,
seizure,
tremor,
visual disturbances,
palpitations,
sudden redness of the face,
coughing up blood-stained sputum (haemoptysis),
black stools due to gastrointestinal bleeding,
vomiting,
bloating,
indigestion,
nausea,
discomfort in the abdominal cavity,
rapidly increasing subcutaneous swelling,
skin redness,
purple spots resembling bruises (purpura),
blood spots under the skin (petechiae),
itching,
difficulties in emptying the bladder,
painful urination,
excessive menstrual bleeding,
swelling of genital organs,
redness of the skin around the genital organs,
chest pain,
pain,
pain at the injection site.

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform a doctor or pharmacist.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can also 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, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl

By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Vessel Due F

Store below 30°C.
Keep 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 stated month.
Do not use this medicine if the packaging is damaged.
Medicines must 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.
One vial of injection solution contains 600 LSU sulodexide.
1 ml of injection solution contains 300 LSU sulodexide.
The other ingredients are: sodium chloride, water for injections.

What Vessel Due F looks like and contents of the pack
2 ml vials of injection solution.
The pack contains 10 vials.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing authorisation number in the Czech Republic, the country of export: 85/670/92-C
Parallel import authorisation number: 230/16