VESSEL DUE F 250 LSU CAPSULE

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

SULODEXIDE

Available from:

EP PLUS GROUP SDN. BHD.

INN (International Name):

SULODEXIDE

Units in package:

50 Capsule Capsules

Manufactured by:

ALFASIGMA S.p.A

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP) _
VESSEL DUE F 250 LSU CAPSULE
Sulodexide (250LSU)
1
WHAT IS IN THIS LEAFLET
1.
What VESSEL DUE F 250
LSU CAPSULE is used for
2.
How it works
3.
Before you use VESSEL
DUE F 250 LSU
CAPSULE
4.
How to use VESSEL DUE
F 250 LSU CAPSULE
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
VESSEL DUE F 250 LSU
CAPSULE
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
12.
Serial Number
WHAT VESSEL DUE F 250
LSU CAPSULE IS USED FOR
VESSEL DUE F 250 LSU
CAPSULE is used for vascular
pathologies with thrombotic
risk.
HOW VESSEL DUE F 250
LSU CAPSULE WORKS
VESSEL DUE F 250 LSU
CAPSULE contains sulodexide,
a substance which can avoid the
formation of thrombus (blood
clots) within the arteries and
veins. The antithrombotic
activity of sulodexide is due to
the inhibition of some
coagulation factors, especially
activated factor X as well as
platelet aggregation and by the
activation of circulatory and
wall fibrinolytic system.
Sulodexide also thins the blood
and can help to normalize the
level of lipids in the blood.
BEFORE YOU USE VESSEL DUE
F 250 LSU CAPSULE
-
_When you must not use it _
Do not take VESSEL DUE
F 250 LSU CAPSULE
•
If you are allergic
(hypersensitive) to
sulodexide or any of
the other ingredients of
VESSEL DUE F 250
LSU CAPSULE or
heparin or heparin-like
medicines.
•
If you have
hemorrhagic diseases
or hemorrhagic
diathesis.
-
_Before you start to use it _
Given the low toxicity of
the substance, there are no
particular precautions for
use. However, when
treatment with
anticoagulants is under
way, haemocoagulative
parameters should be
monitored periodically.
-
_Taking other medicines _
As sulodexide is a heparin-
like molecule, it may
increase the anticoagulant
effects of heparin itself and
of oral anticoagulants if
administered at the same
time.
Please ask your doctor or
pharmacist for advice
before taking any medicine
and tell them if you are
taking or have recently
taken any other medicines,
includin

Summary of Product characteristics

Antithrombotic drugs
Vessel Due F ampoules: Each ampoule contains: Sulodexide 600 LSU
Excipients: sodium chloride, water for injection.
Vessel Due F capsules: Each capsule contains: Sulodexide 250 LSU
Excipients: sodium lauryl sarcosinate, silicon dioxide, triacetin, gelatine, glycerol, sodium ethyl
parahydroxybenzoate, sodium propyl parahydroxybenzoate, titanium dioxide E171, red iron oxide E172.
Mechanisms of action:
Sulodexide has a relevant antithrombotic activity both in rats and rabbits. In the case of rats, Sulodexide is
able to prevent the formation of venous and arterial thrombus; it is also effective in reducing the weight of
pre-formed thrombi both by parenteral and oral administration.
The antithrombotic activity is related to:
a) A block of thrombin and cathepsin G platelet aggregation;
b) Inhibitory effect on platelet adhesives;
c) A block in platelet function;
d) Anticoagulant and pro-fibrinolytic activity shown both in vivo and in vitro in animals and in humans.
The mechanism of action of the antithrombotic activity is due to the simultaneous inhibition of circulating
thrombin through its affinity for anti-thrombin III and the thrombin bound to surfaces, such as the surface
of the thrombus, as well as through affinity for heparin cofactor II. This simultaneous action which catalyses
the thrombin inhibition reaction seems to be better than that observed with heparin and increases the
antithrombotic potential of Sulodexide. Furthermore, Sulodexide causes less bleeding than conventional
heparin at doses which are active on thrombosis. Affinity for fibrin both in vitro and in vivo, both after
intravenous and oral administration has been shown; in fact, Sulodexide labeled with fluorescent binds to
the fibrin of the thrombus and it is found to be still bound even several hours after administration. This
observation could mean that Sulodexide is able to carry out its antithrombotic action locally on the thrombus.
Sulodexide shows an anti-atherosclerotic activity in experimental models in rabbits.
The pha