VESSEL 600 ULS/2 ML Injectable solution

Зміст інструкції

1. Vessel 250 ULS soft capsules
   1. What Vessel is and what it is used for
   2. What you need to know before you take Vessel
   3. How to take Vessel
   4. Possible side effects
   5. How to store Vessel
   6. Contents of the pack and other information
2. Vessel 600 ULS/2 ML injectable solution
   1. What Vessel is and what it is used for
   2. What you need to know before you use Vessel
   3. How to use Vessel
   4. Possible side effects
   5. How to store Vessel
   6. Contents of the pack and other information

Vessel 250 ULS soft capsules

Sulodexide

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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
heparin-based antithrombotic agents.
This medicine is indicated in adults for the treatment of skin ulcerations (chronic venous
ulcers) that form as a result of diseases affecting the veins of the legs.
Sulodexide works by fighting the formation of blood clots in the arteries and veins.

2. What you need to know before you take Vessel

Do not use Vessel

• if you are allergic to the active ingredient (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 bleeding disorders.

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 increase the anticoagulant effect of medicines based on heparin and other oral anticoagulants
when taken at the same time.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
As a precaution, it is preferable to avoid the use of sulodexide during pregnancy.
Vessel should not be used during breastfeeding.
Studies in animals do not indicate any direct or indirect harmful effects regarding male and female
fertility.

Driving and operating machinery
This medicine does not affect or has a negligible effect on the ability to drive vehicles or
operate machinery.

Vessel contains sodium ethyl hydroxybenzoate (E215), sodium propyl hydroxybenzoate and sodium
Vessel contains sodium ethyl hydroxybenzoate (E215) and sodium propyl hydroxybenzoate 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 following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is 1 capsule 2 times a day, away from meals.
As a 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 therapeutic cycle should be repeated at least twice a year.
At the doctor's discretion, the dosage may be varied in quantity and frequency

If you use more Vessel than you should
Immediately inform your doctor if you have taken a dose of Vessel higher than that prescribed. If you take more Vessel than recommended, you may have a higher risk of bleeding. If bleeding occurs, go to the nearest emergency room.

If you forget to take Vessel
Do not take a double dose to make up for a missed dose.

If you stop taking Vessel
If you have any doubts about the use of this medicine, ask 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 (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

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

• Anemia
• Disorder of protein metabolism in the blood
• Feeling of perceiving reality in a distorted way (derealization)
• Convulsive crisis
• Tremors
• Vision disorders
• Palpitations
• Hot flushes
• Coughing up blood (hemoptysis)
• Stomach pain (epigastralgia)
• Nausea
• Vomiting
• Passing gas
• Digestive problems
• Emission of dark stools due to the presence of blood
• Subcutaneous swelling
• Blood infiltration under the skin (ecchymosis)
• Skin redness
• Itching
• Appearance of dark red spots on the skin (purpura)
• Difficulty emptying the bladder
• Difficulty urinating
• Genital edema
• Skin irritation around the genitals
• Too frequent menstruation
• Chest pain
• Pain

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through
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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Vessel contains

• The active ingredient is sulodexide
• The other ingredients are: sodium lauryl sarcosinate, silicon dioxide, triacetin, gelatin, glycerol, sodium ethyl hydroxybenzoate (E 215), sodium propyl hydroxybenzoate, titanium dioxide (E 171), red iron oxide (E 172)

Description of the appearance of Vessel and contents of the pack
Vessel is presented in the form of soft capsules packaged in cardboard boxes containing 2 blisters of
25 soft capsules each.

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)
Alfasigma S.p.A. – Via Pontina km 30,400 – 00071 Pomezia (RM)

Vessel 600 ULS/2 ML injectable solution

Sulodexide

Read this leaflet carefully before you start to use 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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
antithrombotic heparinic agents.
This medicine is indicated in adults for the treatment of skin ulcerations (chronic venous
ulcers) that form as a result of diseases affecting the veins of the legs.
Sulodexide works by fighting the formation of blood clots in the arteries and veins.

2. What you need to know before you use Vessel

Do not use Vessel

• if you are allergic to the active ingredient (sulodexide) or to any of the other ingredients of this medicine (listed in section 6), to heparin or heparanoids (medicines that reduce blood clotting). if you are at risk of bleeding or if you suffer from bleeding 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 increase the anticoagulant effect of medicines based on heparin and other oral anticoagulants
when taken at the same time.
When administered together with other drugs, Vessel may cause chemical reactions. The substances
usually used in association and which are incompatible in intravenous therapy
are:

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect 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 precaution, it is preferable to avoid the use of sulodexide during pregnancy.
Vessel should not be used during breastfeeding.
Studies in animals do not indicate direct or indirect harmful effects regarding male and female fertility.

Driving and operating machinery
This medicine does not affect or has a negligible effect on the ability to drive vehicles or
operate 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 following the instructions of your doctor or pharmacist exactly. If you have any
doubts, consult your doctor or pharmacist.
The recommended dose is 1 vial per day, by intramuscular or intravenous route.
As a 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 therapeutic cycle should be repeated at least twice a year.
At the doctor's discretion, the dosage may be varied in quantity and frequency.

If you use more Vessel than you should
Immediately inform your doctor if you have used a dose of Vessel higher than that prescribed. If you use
more Vessel than recommended, you may have a higher risk of bleeding. If bleeding occurs, go to the nearest
emergency room.

If you forget to take Vessel
If you do not receive the prescribed dose, a double dose should not be administered to compensate for
forgetting the dose.

If you stop taking Vessel
If you have any doubts 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 (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
• Stomach bleeding
• Skin inflammation
• Allergic skin reaction
• Fluid retention in legs and ankles
• Bleeding at the injection site

Not known (frequency cannot be estimated from available data)

• Anaemia
• Protein metabolism disorder in the blood
• Feeling of perceiving reality in a distorted way (derealisation)
• Convulsive seizure
• Tremors
• Vision disorders
• Palpitations
• Hot flushes
• Cough with blood (hemoptysis)
• Stomach pain (epigastralgia)
• Nausea
• Vomiting
• Passing gas
• Digestive problems
• Dark stools due to the presence of blood
• Subcutaneous swelling
• Blood infiltration under the skin (ecchymosis)
• Skin redness
• Itching
• Appearance of dark red spots on the skin (purpura)
• Difficulty emptying the bladder
• Difficulty urinating
• Genital oedema
• Skin irritation around the genitals
• Too frequent menstruation
• Chest pain
• Pain
• Pain at the injection site

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Vessel contains

• The active ingredient is sulodexide
• The other ingredients are: sodium chloride, water for injections

Description of the appearance of Vessel and contents of the pack
Vessel is presented as an injectable solution.
Vessel is supplied in a cardboard box containing a polystyrene tray with 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)