Vessel due F

Leaflet attached to the packaging: information for the user

VESSEL DUE F

300 LSU/ml solution for injection

Sulodexide

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

• Please 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 specifically for you and should not be given to others, as it may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is V D F and what is it used for

V F contains sulodexide, a substance that, by acting on some of the factors responsible for the blood clotting process, has an antithrombotic effect in the arterial and venous vessels. Sulodexide also normalizes increased blood viscosity in people with vascular changes and a risk of thrombosis, and reduces lipid levels. V F solution for injection is used to treat venous ulcers of the lower limbs as an adjunct to local therapy and to treat symptomatic chronic obstructive arterial disease of the lower limbs of moderate severity (II degree according to Fontaine's classification).

2. Important information before using V D F

When not to use V D F

• if the patient is allergic to the active substance (sulodexide) or 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 disorder or diseases with bleeding.

Warnings and precautions

Before starting to use V D F, the patient should discuss it with their doctor or pharmacist. 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 of the B group, hydrocortisone, hyaluronidase (a substance used in medicine to improve the distribution of medicines in the body), calcium gluconate (used in case 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 V D F in children and adolescents under 18 years of age have not been established. There are no available data.

V D F and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. V D F may enhance the effect of heparin and oral anticoagulants given at the same time.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine. Pregnancy: For safety reasons, the use of sulodexide is not recommended in pregnant women. Breastfeeding: V D F should not be used during breastfeeding. Fertility: Animal studies have not shown any direct or indirect harmful effects on female and male fertility.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines.

V F contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per ampoule, which means that the medicine is considered "sodium-free".

3. How to use V D F

This medicine should always be used exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. Treatment of venous ulcers of the lower limbs 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 (II degree according to Fontaine's 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. The doctor will decide on the dose and duration of treatment.

Using a higher dose of V D F than recommended

In case of using a higher dose of V F than prescribed, the patient should immediately consult their doctor. If bleeding occurs, the patient should go to the nearest hospital.

Missing a dose of V D F

The patient should not take a double dose to make up for a missed dose.

Stopping the use of V D F

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, V F can cause side effects, although not everybody gets them. Common side effects (affecting 1 to 10 patients in 100):

• dizziness,
• diarrhea,
• stomach pain,
• rash.

Uncommon side effects (affecting 1 to 10 patients in 1000):

• loss of consciousness,
• headache,
• gastric bleeding,
• itching rash,
• itching, red, and dry skin,
• swelling, especially of the ankles and feet,
• hematoma at the injection site.

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

• anemia,
• disorders of protein metabolism in the liquid part of the blood called plasma (disorders of plasma protein metabolism),
• perception disorders,
• seizures,
• tremors,
• vision disorders,
• palpitations,
• sudden flushing of the face,
• coughing up blood-stained sputum (hemoptysis),
• black stools due to gastrointestinal bleeding,
• vomiting,
• bloating,
• indigestion,
• nausea,
• discomfort in the abdominal cavity,
• rapidly increasing swelling under the skin,
• redness of the skin,
• purple spots like bruises (purpura),
• blood spots under the skin (ecchymoses),
• itching,
• difficulty urinating,
• painful urination,
• excessive menstrual bleeding,
• swelling of the genitals,
• redness of the skin around the genitals,
• chest pain,
• pain,
• pain at the injection site.

If any of the side effects get worse or if the patient experiences any side effects not listed in this leaflet, they should inform their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store V D F

Keep out of sight and reach of children. Do not use V F after the expiry date stated on the packaging, after: "Expiry date (EXP)". The expiry date refers to the last day of the month stated. Do not store above 30°C. Do not use this medicine if the packaging is damaged. Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 V D F contains

The active substance of V D F is sulodexide. The other ingredients are: sodium chloride, water for injections.

What V D F looks like and contents of the packaging

Ampoules of 2 ml of clear, sterile solution, colored not more than brown-yellow. The packaging contains 10 ampoules.

Marketing authorization holder

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

Alfasigma S.p.A. Via Pontina km 30,

• 00071 Pomezia (RM), Italy

To obtain more detailed information, the patient should contact the local representative of the marketing authorization holder: Alfasigma Polska Sp. z o.o. Al. Jerozolimskie 96 00-807 Warsaw Tel. +48 (22) 824 03 64

Date of last revision of the leaflet: