Vessel

Patient Information Leaflet

Vessel 250 ULS soft capsules

Sulodexide
Please read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Vessel is and what it is used for
2. What you need to know before taking Vessel
3. How to take Vessel
4. Possible side effects
5. How to store Vessel
6. Contents of the pack and other information

1. What Vessel is and what it is used for

Vessel contains sulodexide, a substance belonging to a class of medicines called heparinic antithrombotics.
This medicine is indicated in adults for the treatment of skin ulcers (chronic venous ulcers) that develop as a consequence of diseases affecting the veins of the legs.
Sulodexide works by preventing the formation of blood clots in the arteries and veins.

2. What you should know before taking Vessel

Do not use Vessel

• if you are allergic to the active substance (sulodexide) or to any of the other ingredients of this medicine (listed in section 6), to heparin or to heparinoids (medicines that reduce blood clotting).
• if you are at risk of bleeding or suffer from hemorrhagic diseases.

Warnings and precautions
Talk to your doctor or pharmacist before taking Vessel.
Children and adolescents
The safety and efficacy in children and adolescents under 18 years of age have not been established. No data are available.
Other medicines and Vessel
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Vessel may enhance the anticoagulant effect of heparin-containing medicines and other oral anticoagulants when taken concomitantly.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
As a precautionary measure, it is preferable to avoid using sulodexide during pregnancy.
Vessel must not be used during breastfeeding.
Animal studies do not indicate direct or indirect harmful effects with regard to male and female fertility.
Driving and using machines
This medicine has no effect or has a negligible effect on the ability to drive vehicles or operate machinery.
Vessel contains sodium ethylhydroxybenzoate (E215), sodium propylhydroxybenzoate and sodium
Vessel contains sodium ethylhydroxybenzoate (E215) and sodium propylhydroxybenzoate, which may cause allergic reactions (including delayed reactions).
Vessel contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is essentially “sodium-free”.

3. How to take Vessel

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 capsule twice daily, taken away from meals.
As a general guideline, therapy should be started with the ampoules and, after 15–20 days, continued
with capsules for a further 30–40 days. The complete therapeutic course should be repeated at least twice a year.
According to the doctor's judgment, the dosage may be adjusted in terms of amount and frequency.
If you take more Vessel than you should
Inform your doctor immediately if you have taken a dose of Vessel higher than prescribed. If
you take more Vessel than recommended, you may have an increased risk of bleeding. If
bleeding occurs, go immediately to the nearest emergency room.
If you forget to take Vessel
Do not take a double dose to make up for a forgotten dose.
If you stop using Vessel
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Common side effects (may affect up to 1 in 10 people):

• Dizziness
• Upper abdominal pain
• Diarrhoea
• Skin rash

Uncommon side effects (may affect up to 1 in 100 people):

• Headache
• Fainting
• Gastrointestinal bleeding
• Skin inflammation
• Allergic skin reaction
• Fluid retention in legs and ankles

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

• Anaemia
• Disorder of protein metabolism in the blood
• Feeling of perceiving reality in a distorted way (derealisation)
• Seizure
• Tremor
• Vision disorders
• Palpitations
• Hot flushes
• Coughing up blood (haemoptysis)
• Stomach pain (epigastralgia)
• Nausea
• Vomiting
• Passage of intestinal gas
• Digestive problems
• Passage of dark stools due to presence of blood
• Subcutaneous swelling
• Bleeding under the skin (bruising)
• Skin redness
• Itching
• Appearance of dark red spots on the skin (purpura)
• Difficulty emptying the bladder
• Difficulty urinating
• Genital oedema
• Irritation of the skin around the genitals
• Menstruation occurring too frequently
• Chest pain
• Pain

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vessel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Vessel contains

• The active substance is sulodexide.
• The other components are: sodium lauryl sarcosinate, silica, triacetin, gelatin, glycerol, sodium ethylhydroxybenzoate (E 215), sodium propylhydroxybenzoate, titanium dioxide (E 171), red iron oxide (E 172).

Description of the appearance of Vessel and contents of the package
Vessel is available as soft capsules, packaged in cardboard boxes containing 2 blisters of
25 soft capsules each.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Alfasigma S.p.A. - Via Ragazzi del ‘99, n. 5 - 40133 Bologna (BO)
Manufacturers:
Alfasigma S.p.A. – Via E. Fermi, n. 1 – 65020 Alanno (PE)
Alfasigma S.p.A. – Via Pontina km 30,400 – 00071 Pomezia (RM)

Patient Information Leaflet

Vessel 600 ULS/2 ML injectable solution

Sulodexide
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Vessel is and what it is used for
2. What you need to know before using Vessel
3. How to use Vessel
4. Possible side effects
5. How to store Vessel
6. Contents of the pack and other information

1. What Vessel is and what it is used for

Vessel contains sulodexide, a substance belonging to a class of medicines called heparinic antithrombotics.
This medicine is indicated in adults for the treatment of skin ulcerations (chronic venous ulcers) that develop as a consequence of diseases affecting the veins of the legs.
Sulodexide works by preventing the formation of blood clots in the arteries and veins.

2. What you need to know before using Vessel

Do not use Vessel

• if you are allergic to the active substance (sulodexide) or to any of the other ingredients of this medicine (listed in section 6), to heparin or to heparinoids (medicines that reduce blood clotting), if you are at risk of bleeding or if you suffer from hemorrhagic disorders.

Warnings and precautions
Talk to your doctor or pharmacist before starting treatment with Vessel.
Children and adolescents
The safety and efficacy in children and adolescents under 18 years of age have not been established. No data are available.
Other medicines and Vessel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Vessel may enhance the anticoagulant effect of heparin and other oral anticoagulant medicines if taken concomitantly.
When administered together with other drugs, Vessel may cause chemical reactions. Substances commonly used in combination that are incompatible in intravenous therapy are:

• vitamins (vitamin K, B-complex vitamins),
• corticosteroids (hydrocortisone),
• hyaluronidase (a substance used in medicine to facilitate drug injection),
• calcium gluconate (used in case of calcium deficiency in the blood),
• disinfectants (quaternary ammonium salts),
• certain types of antibiotics (chloramphenicol, tetracyclines, streptomycin).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
As a precautionary measure, it is preferable to avoid using sulodexide during pregnancy.
Vessel must not be used during breastfeeding.
Animal studies do not indicate any direct or indirect harmful effects regarding male and female fertility.
Driving and using machines
This medicine has no effect or a negligible effect on the ability to drive vehicles or use machinery.
Vessel contains sodium
Vessel contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is essentially “sodium-free”.

3. How to use Vessel

Use this medicine exactly as prescribed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 1 vial per day, administered intramuscularly or intravenously.
As a general guideline, it is advisable to start therapy with the vials and, after 15–20 days, continue with the
capsules for 30–40 days. The complete treatment cycle should be repeated at least twice a year.
The physician may, at their discretion, adjust the dosage in terms of amount and frequency.
If you use more Vessel than you should
Inform your doctor immediately if you have used a dose of Vessel higher than prescribed. If you use
more Vessel than recommended, you may have an increased risk of bleeding. If bleeding occurs, go to the nearest emergency room.
If you forget to take Vessel
If you miss the prescribed dose, do not administer a double dose to make up for the missed dose.
If you stop treatment with Vessel
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Common side effects (may affect up to 1 in 10 people):

• Dizziness
• Upper abdominal pain
• Diarrhoea
• Skin rash

Uncommon side effects (may affect up to 1 in 100 people):

• Headache
• Fainting
• Bleeding from the stomach
• Skin inflammation
• Allergic skin reaction
• Fluid retention in legs and ankles
• Bleeding at the injection site

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

• Anaemia
• Disorder of protein metabolism in the blood
• Feeling of perceiving reality in a distorted way (derealisation)
• Seizure
• Tremors
• Vision disorders
• Palpitations
• Hot flushes
• Coughing up blood (haemoptysis)
• Stomach pain (epigastralgia)
• Nausea
• Vomiting
• Passage of intestinal gas
• Digestive problems
• Passage of dark stools due to presence of blood
• Subcutaneous swelling
• Blood infiltration under the skin (bruising)
• Redness of the skin
• Itching
• Appearance of dark red spots on the skin (purpura)
• Difficulty emptying the bladder
• Difficulty urinating
• Genital oedema
• Irritation of the skin around the genitals
• Menstruation occurring too frequently
• Chest pain
• Pain
• Pain at the injection site

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vessel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Vessel contains

• The active substance is sulodexide
• The other components are: sodium chloride, water for injections

Description of the appearance of Vessel and pack contents
Vessel is a solution for injection.
Vessel is supplied in a cardboard box containing a polystyrene tray holding 10 dark glass vials.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Alfasigma S.p.A. - Via Ragazzi del ‘99, n. 5 - 40133 Bologna (BO)
Manufacturer:
Alfasigma S.p.A. – Via E. Fermi, n. 1 – 65020 Alanno (PE)