Vessel due f
Poland
Table of Contents
Package leaflet: Information for the user
VESSEL DUE F
250 LSU soft capsules
Sulodexidum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
- 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 you experience any adverse effects, including any 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 taking Vessel due F
- How to take 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 – a substance which, by acting on certain factors involved in blood coagulation, exerts an antithrombotic effect in both arterial and venous vessels. Sulodexide also normalizes increased blood viscosity in patients with vascular changes and thrombotic risk, and reduces lipid levels.
Vessel due F soft capsules are indicated 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 moderate chronic arterial occlusive disease of the lower limbs (Fontaine stage II), extended secondary prophylaxis of venous thromboembolic disease in patients who have completed standard anticoagulant therapy (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 Vessel due F
When not to take Vessel due F
- if you are 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 you have a bleeding tendency or diseases associated with bleeding.
Warnings and precautions
Before starting treatment with Vessel due F, discuss it with your doctor or pharmacist.
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
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. Vessel due F may enhance the effect of concomitantly administered heparin and oral anticoagulant drugs.
Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Pregnancy
For safety reasons, sulodexide is not recommended during pregnancy.
Breastfeeding
Vessel due F should not be used during breastfeeding.
Fertility
Animal studies have not shown any direct or indirect harmful effect on fertility in men and women.
Driving and operating machinery
This medicine has no effect or negligible effect on the ability to drive and operate machinery.
Vessel due F contains sodium ethyl parahydroxybenzoate (E 215), sodium propyl parahydroxybenzoate (E 217) and sodium
This medicine contains sodium ethyl parahydroxybenzoate (E 215) and sodium propyl parahydroxybenzoate (E 217), which may cause allergic reactions (including delayed-type reactions).
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning it is considered "sodium-free".
3. How to take Vessel due F
Always take this medicine exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Symptomatic treatment of primary and secondary chronic venous insufficiency:
2 capsules (500 LSU) twice daily between meals.
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 (Fontaine 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.
Extended secondary prophylaxis of venous thromboembolic disease in patients who have completed standard anticoagulant therapy (3 to 12 months) due to deep vein thrombosis or pulmonary embolism:
2 capsules (500 LSU) twice daily between meals.
The dosage and duration of treatment will be determined by the physician.
Treatment of hard exudates in patients with non-proliferative mild to moderate diabetic retinopathy: 1 capsule (250 LSU) twice daily between meals.
Taking more Vessel due F than prescribed
If you take more than the prescribed dose of Vessel due F, contact your doctor immediately. If bleeding occurs, go to the nearest hospital.
If you forget to take 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 questions about the use of 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 (affects 1 to 10 users in 100):
- dizziness,
- diarrhoea,
- stomach pain,
- rash.
Uncommon side effects (affects 1 to 10 users in 1,000):
- loss of consciousness,
- headache,
- gastrointestinal bleeding,
- itchy rash,
- itchy, red and dry skin,
- swelling, particularly of ankles and feet.
Frequency not known (cannot be estimated from available data):
- anaemia,
- disorders of metabolism of proteins present in the liquid part of blood called plasma (plasma protein metabolism disorders),
- disturbance in perception of the surrounding world,
- epileptic seizure,
- tremor,
- visual disturbances,
- palpitations,
- sudden flushing of the face,
- coughing up blood-stained sputum (haemoptysis),
- black stools due to gastrointestinal bleeding,
- vomiting,
- bloating,
- indigestion,
- nausea,
- feeling of discomfort in the abdominal area,
- rapidly increasing subcutaneous swelling,
- skin redness,
- purple bruise-like spots (purpura),
- red spots under the skin (petechiae),
- itching,
- difficulty in emptying the bladder,
- painful urination,
- excessive menstruation,
- genital swelling,
- redness of the skin around the genital organs,
- chest pain,
- pain.
If any of the side effects worsen or if you experience any side effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any adverse effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.
5. How to store Vessel due F
Keep out of the sight and reach of children.
Do not use Vessel due F after the expiry date stated on the packaging after "Expiry date (EXP)".
The expiry date refers to the last day of the stated month.
Store below 30°C.
Do not use this medicine if the packaging appears damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.
6. Contents of the package and other information
What Vessel due F contains
The active substance is sulodexide.
Other components are: sodium laurylsarcosinate, colloidal silicon dioxide, triacetin.
Capsule shell composition: gelatin, glycerol (E 422), sodium ethyl parahydroxybenzoate (E 215), sodium propyl parahydroxybenzoate (E 217), titanium dioxide (E 171), red iron oxide (E 172).
What Vessel due F looks like and contents of the pack
Brick-red, oval soft capsules containing a white to grey suspension.
Packaged in containers containing 25 or 50 soft capsules.
Not all pack sizes may be marketed.
Marketing Authorisation 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,
400 – 00071 Pomezia (RM), Italy
For further information, please contact the local representative of the Marketing Authorisation Holder:
Alfasigma Polska Sp. z o.o.
Al. Jerozolimskie 96
00-807 Warsaw
Tel. +48 (22) 824 03 64