DOXIUM 500 CAPSULES

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CALCIUM DOBESILATE

Boleh didapati daripada:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

CALCIUM DOBESILATE

Unit dalam pakej:

30Capsule Capsules; 60Capsule Capsules; 30 Capsules; 60 Capsules

Dikeluarkan oleh:

OM PHARMA S.A.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
DOXIUM
® 500 CAPSULES
Calcium dobesilate 500mg
Page
1
of
2
WHAT IS IN THIS LEAFLET
1. What DOXIUM is used for
2. How DOXIUM works
3. Before you use DOXIUM
4. How to take DOXIUM
5. While you are using it
6. Side effects
7. Storage and Disposal
8. Product Description
9. Manufacturer
10. Product Registration Holder
11. Date of Revision
12. Serial Number
WHAT DOXIUM IS USED FOR
DOXIUM 500 is indicated in the
following cases:
-
Microangiopathies,
in
particular diabetic retinopathy.
(Disorders of the small blood
vessels of the retina in diabetic
patients),
-
Clinical
signs
of
chronic
venous
insufficiency
in
the
lower
limbs
(condition
when
the
veins
have
problems
sending blood from the leg to
heart)
with
pain,
cramps,
paresthesia (tingling, pricking,
chilling,
burning
or
numb
sensation on the skin) oedema
(swelling),
stasis
dermatosis
(skin inflammation)
-
As
adjuvant
in
superficial
thrombophlebitis (infammatory
condition of the veins due to a
blood
clot
just
below
the
surface of the skin)
-
Haemorrhoids
-
Micro-circulation
disorders
of
arteriovenous
origin
(poor
blood
circulation
from
arteri
and veins)
HOW DOXIUM WORKS
Calcium dobesilate acts on small
blood vessels – the capillaries – to
normalise
the
resistance
and
permeability
of
their
walls.
It
improves blood flow in the veins
and,
in
disorders
of
the
venous
circulation,
helps
to
reduce
swelling
of
the
ankles
(oedema)
and alleviates the pins and needles,
pain and cramps.
BEFORE YOU USE DOXIUM
_- When you must not take it _
If you are allergic (hypersensitive)
to calcium dobesilate or any of the
other
ingredients
of
DOXIUM
500.
During
pregnancy
and
during
breast-feeding.
DOXIUM 500 is not indicated for
children.
_- Before you start to take it _
_ _
If you know or presume that you
are
pregnant
ask
your
doctor
or
pharmacist
for
advice
before
taking any medicine.
If you suffer from kidney problems
requiring dialysis, the dose should
be reduced in these cases.
If
you
develop
high
fever,
infections of the oral cav

Ciri produk

Doxium ®500
Regulator of the capillary functions
Product Description
Hard gelatin capsule (cap: opaque dark green; body: opaque yellow) with a white powder fill.
Composition
Active principle: Calcium dobesilate monohydrate 500 mg.
Excipients: Maize starch, magnesium stearate. Capsule shell’s composition: gelatin, yellow ferric oxide
(E172), titanium dioxide (E171), Indigotin (E132)
Properties/Effects
Calcium dobesilate acts on the capillary walls by regulating its impaired physiological functions –
increased permeability and decreased resistance. It increases erythrocyte flexibility, inhibits platelet
hyperaggregation and, in diabetic retinopathy, it r educes plasma and blood hyperviscosity, thus improving
blood rheological properties and tissue irrigation. These effects allow to correct capillary dysfunctions
either of functional origin or caused by constitutional or acquired metabolic disorders.
Calciu m dobesilate contributes to reduce oedema.
Pharmacokinetics
After oral administration of 500 mg of calcium dobesilate, its blood level is above 6 μg/ml between the 3 rd
and 10th hour, with a maximum (Cmax) of 8 μg/ml on the average after 6 hours (tmax). Tw enty four hours
after intake blood level is about 3 μg/ml. The rate of protein- binding is 20 - 25%. In animals, calcium
dobesilate does not cross the haematoencephalic or the placental barrier, but it is not known whether this
is also the case in humans. C alcium dobesilate enters the maternal milk in very low quantities (0.4 μg/ml
after intake of 1500 mg as observed in one study). Calcium dobesilate does not enter the enterohepatic
cycle and is excreted mainly unchanged with only 10% being excreted as metabolites. About 50% of the
orally administered dose are eliminated in the first 24- hour urine and about 50% in the faeces. Plasma
half -life is around 5 hours.
Kinetics in particular clinical situations
Kidney failure
The safety and efficacy of calcium dobesilate have not been studied in patients with kidney disorders. As
the medication is excreted