Vessel due F

Package Leaflet: Information for the User

VESSEL DUE F

250 LSU Soft Capsules

Sulodexide

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your 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 you experience any side effects, including those not listed in this leaflet, inform your 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 taking V F
• 3. How to take V F
• 4. Possible side effects
• 5. How to store V F
• 6. Contents of the pack 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 system. Sulodexide also normalizes increased blood viscosity in patients with vascular changes and a risk of thrombosis, and reduces lipid levels. V F soft capsules are used for the symptomatic treatment of primary and secondary chronic venous insufficiency, treatment of venous leg ulcers as an adjunct to local therapy, symptomatic treatment of chronic obstructive arterial disease of the lower limbs of moderate severity (stage II of the Fontaine classification), and extended secondary prevention of venous thromboembolic disease in patients who have completed standard anticoagulant treatment (3 to 12 months) due to deep vein thrombosis or pulmonary embolism, and treatment of hard exudates in patients with non-proliferative mild to moderate diabetic retinopathy.

2. Important information before taking V D F

When not to take V D F

Warnings and precautions

Before starting treatment with V D F, discuss it with your doctor or pharmacist.
.

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

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor before taking this medicine.
Pregnancy
For safety reasons, sulodexide is not recommended during pregnancy.
Breastfeeding
V D F should not be taken 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 ethyl parahydroxybenzoate (E 215), sodium propyl parahydroxybenzoate (E 217), and sodium

The medicine contains sodium ethyl parahydroxybenzoate (E 215) and sodium propyl parahydroxybenzoate (E 217), which may cause allergic reactions (possible late reactions).
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take V D F

Take this medicine always as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Symptomatic treatment of primary and secondary chronic venous insufficiency:
2 capsules (500 LSU) twice a day between meals.
Treatment of venous leg ulcers 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.
Extended secondary prevention of venous thromboembolic disease in patients who have completed standard anticoagulant treatment (3 to 12 months) due to deep vein thrombosis or pulmonary embolism:
2 capsules (500 LSU) twice a day between meals.
The dose and duration of treatment will be decided by your doctor.
Treatment of hard exudates in patients with non-proliferative mild to moderate diabetic retinopathy: 1 capsule (250 LSU) twice a day between meals.

Overdose of V D F

In case of overdose, consult your doctor immediately. If bleeding occurs, go to the nearest hospital.

Missed dose of V D F

Do not take a double dose to make up for a missed dose.

Stopping treatment with V D F

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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.

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,
• hemoptysis (coughing up blood),
• black stools due to gastrointestinal bleeding,
• vomiting,
• bloating,
• indigestion,
• nausea,
• abdominal discomfort,
• rapidly spreading 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,
• genital swelling,
• redness of the skin around the genitals,
• chest pain,
• pain.

If any of the side effects get worse or if you experience any side effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store V D F

Store in a place out of sight and reach of children.
Do not take V F after the expiry date stated on the packaging, after:
"Expiry date (EXP)".
The expiry date refers to the last day of the given month.
Store at a temperature not above 30°C.
Do not take this medicine if you notice that 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 V D F contains

The active substance of the medicine is sulodexide.
The other ingredients are: sodium laurylsarcosinate, colloidal silica, triacetin.
Shell composition: gelatin, glycerol (E 422), sodium ethyl parahydroxybenzoate (E 215), sodium propyl parahydroxybenzoate (E 217), titanium dioxide (E 171), iron oxide red (E 172).

What V D F looks like and contents of the pack

Red-brown, oval soft capsules containing a white to gray suspension.
The pack contains 25 or 50 soft capsules.
Not all pack sizes may be marketed.

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

For further information, contact the local representative of the marketing authorization holder:
Alfasigma Polska Sp. z o.o.
Al. Jerozolimskie 96
00-807 Warsaw
Phone: +48 (22) 824 03 64

Date of last revision of the leaflet: