DAPAZOX 5 (Dapagliflozin Film Coated Tablets 5mg)

País: Malàisia

Idioma: anglès

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

ingredients actius:

Dapagliflozin

Disponible des:

CAMBER LABORATORIES SDN. BHD.

Designació comuna internacional (DCI):

Dapagliflozin

Unidades en paquete:

2 x 14 Tablets

Fabricat per:

Hetero Labs Limited

Informació per a l'usuari

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DAPAZOX (DAPAGLIFLOZIN FILM COATED TABLETS)
Dapagliflozin (5mg and 10mg)
1
WHAT IS IN THIS LEAFLET
1.
What DAPAZOX
_ _
is used for
2.
How DAPAZOX
_ _
works
_3._
_ _
Before
you
use
DAPAZOX
_ _
4.
How to use DAPAZOX
_ _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
DAPAZOX
_ _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DAPAZOX_ _IS USED FOR
DAPAZOX
is
used
in
used
in
adult
patients (aged 18 years and older) to treat:
•
Type 2 diabetes if your type 2 diabetes
cannot
be
controlled
with
diet
and
exercise. DAPAZOX can be used on its
own or together with other medicines
to treat diabetes.
•
Heart failure in patients with symptoms
due to a weak pump function of the
heart.
•
Chronic kidney disease in patients with
reduced kidney function.
HOW DAPAZOX_ _WORKS
DAPAZOX contains the active substance
dapagliflozin. It belongs to a group of
medicines
called
sodium
glucose
co-
transporter-2 (SGLT2) inhibitors. They
work by blocking the SGLT2 protein in
your
kidney.
By
blocking
this
protein,
blood sugar (glucose), salt (sodium) and
water are removed from your body via the
urine.
_ _
_What is diabetes and how does DAPAZOX _
_help? _
In type 2 diabetes your body does not make
enough insulin or is not able to use the
insulin it makes properly. This leads to a
high level of sugar in your blood. This can
lead
to
serious
problems
like
heart
or
kidney
disease,
blindness,
and
poor
circulation in your arms and legs.
DAPAZOX
works
by
removing
excess
sugar from your body. It can also help
prevent heart disease.
_What _
_is _
_heart _
_failure _
_and _
_how _
_does _
_DAPAZOX help? _
This type of heart failure occurs when the
heart is weak and cannot pump enough
blood to the lungs and the rest of the body.
This can lead to serious medical problems
and
need
for
hospital
care.
The
most
common symptoms of heart failure are
feeling breathless, feeling tired or very
tired
all
the
time,
and
ankle
swelling.
DAPAZOX h

Fitxa tècnica

DAPAZOX 10 (DAPAGLIFLOZIN FILM COATED TABLETS 10MG)
DAPAZOX 5 (DAPAGLIFLOZIN FILM COATED TABLETS 5MG)
Font size: 7
ACTIVE INGREDIENT
DAPAZOX 10
Each film-coated tablet contains 10mg of Dapagliflozin.
DAPAZOX 5
Each film-coated tablet contains 5mg of Dapagliflozin.
DOSAGE FORM
Film-coated tablets
PRODUCT DESCRIPTION
DAPAZOX 10
Pink, round, biconvex, film-coated tablets debossed with “D33” on
one side and “H” on the other side.
DAPAZOX 5
Pink, round, biconvex, film-coated tablets debossed with "D32" on one
side and "H" on the other side.
PHARMACODYNAMICS
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Drugs used in diabetes, sodium-glucose
co-transporter 2 (SGLT2) inhibitors, ATC code: A10BK01.
MECHANISM OF ACTION
Dapagliflozin is a highly potent (Ki: 0.55 nM), selective and
reversible inhibitor of SGLT2.
Inhibition of SGLT2 by dapagliflozin reduces reabsorption of glucose
from the glomerular filtrate in the proximal renal tubule with a
concomitant reduction in sodium
reabsorption leading to urinary excretion of glucose and osmotic
diuresis. Dapagliflozin therefore increases the delivery of sodium to
the distal tubule which is believed
to increase tubuloglomerular feedback and reduce intraglomerular
pressure. This combined with osmotic diuresis leads to a reduction in
volume overload, reduced blood
pressure, and lower preload and afterload, which may have beneficial
effects on cardiac remodelling. Other effects include an increase in
haematocrit and reduction in
body weight. The cardiac benefits of dapagliflozin are not solely
dependent on the blood glucose-lowering effect and not limited to
patients with diabetes as demonstrated
in the DAPA-HF study.
Dapagliflozin improves both fasting and post-prandial plasma glucose
levels by reducing renal glucose reabsorption leading to urinary
glucose excretion. This glucose
excretion (glucuretic effect) is observed after the first dose, is
continuous over the 24-hour dosing interval and is sustained for the
duration of treatment. The amount of
glucose removed b