Package leaflet: Information for the patient

Angioflux 600 ULS/2 ml injectable solution

sulodexide
Please read this leaflet carefully before using 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, pharmacist, or nurse.
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 could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Angioflux is and what it is used for
What you need to know before using Angioflux
How to use Angioflux
Possible side effects
How to store Angioflux
Contents of the pack and other information

1. What Angioflux is and what it is used for

The active substance in Angioflux is sulodexide, which belongs to the class of antithrombotic heparinic drugs.
Sulodexide (sulfated glucuronylglucosaminoglycan) is a purified mixture composed of 80% low molecular weight heparins (anticoagulant substances) and 20% of a substance similar to heparin called dermatan sulfate (an anticoagulant substance).
This medicine exerts an anticoagulant effect in the blood, helping to prevent or slow the progression of thrombotic diseases (formation of blood clots).
Sulodexide activates the system regulating the excessive production or deposition of coagulating factors in the bloodstream (circulating and vascular wall fibrinolytic system), reduces platelet aggregation (formation of barriers and clots), and favorably modifies blood fluid viscosity (plasma viscosimetric parameters).
Angioflux is indicated for the treatment of long-standing venous ulcers (chronic venous ulcers).
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Angioflux

Do not use Angioflux

if you are allergic to sulodexide or to any of the other ingredients of this medicine (listed in section 6);
if you are allergic to heparin or heparinoids (anticoagulant substances similar to this medicine);
if you have a severe tendency to bleed (hemorrhagic diathesis).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Angioflux.
Consult your doctor for instructions on the most appropriate way to administer this medicine.
As with all cases involving treatment with anticoagulant medicines, your doctor should periodically monitor your blood coagulation parameters (haemocoagulative parameters).

Children and adolescents
The safety and efficacy in children and adolescents under 18 years of age have not yet been established.

Other medicines and Angioflux
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention if you are taking other medicines that thin the blood (anticoagulants). The active substance in Angioflux is a molecule similar to heparin and may increase the anticoagulant effects of heparin itself and of oral anticoagulants (taken by mouth) if administered simultaneously.

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 using this medicine.
As a precautionary measure, it is preferable to avoid using Angioflux during pregnancy.
Angioflux must not be used during breastfeeding.
Animal studies do not indicate direct or indirect harmful effects on male and female fertility.

Driving and using machines
Angioflux does not affect or affects negligibly the ability to drive vehicles and use machines.

Angioflux contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is practically "sodium-free".

3. How to use Angioflux

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is: 1 vial daily, administered by intramuscular route (injection into the muscle) or
intravenous route (injection into the vein).
Your doctor may advise you to start treatment with the injectable solution and, after 15–20 days,
continue with Angioflux soft capsules for 30–40 days.
The complete treatment cycle should be repeated at least twice a year. The dose and frequency of
treatment may vary at the doctor's discretion.
If you use more Angioflux than you should
In case of accidental overdose of Angioflux, contact your doctor immediately or go to the nearest hospital.
If you forget to use Angioflux
Do not use a double dose to make up for the forgotten dose.
If you stop using Angioflux
If you have any doubts about using this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Frequency not known (frequency cannot be estimated from the available data)

pain, burning sensation, and bruising (blood clot) at the injection site. These side effects are generally transient. Following the instructions provided in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. You may also report side effects directly through the national reporting system at the following website:
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 Angioflux

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
The shelf life applies to the product in its original undamaged packaging, stored correctly.
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 Angioflux contains

The active substance is sulodexide. One vial contains 600 ULS of sulodexide.
The other components are: sodium chloride, water for injections.

Description of the appearance of Angioflux and pack contents
Angioflux is a solution for injection.
The pack contains 10 vials of 2 ml each.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aesculapius Farmaceutici S.r.l. - Via Cefalonia, 70 - 25124 Brescia
Manufacturers:
MITIM S.r.l. - Via Cacciamali, 34-36-38 - 25125 Brescia
Laboratorio Farmaceutico C.T. S.r.l - Via Dante Alighieri, 71 - 18038 Sanremo (IM)
Other sources of information
The latest approved information from the package leaflet of this medicinal product is available
by scanning the QR code on the outer packaging with a smartphone/device. The same information is also available at the following URL: https://qrco.de/bfu7qt
Angioflux 250 ULS soft capsules
Sulodexide