FORXIGA 5MG FILM-COATED TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Dapagliflozin Propanediol

Boleh didapati daripada:

ASTRAZENECA SDN. BHD.

INN (Nama Antarabangsa):

Dapagliflozin Propanediol

Unit dalam pakej:

28 Tablets

Dikeluarkan oleh:

AstraZeneca Pharmaceuticals LP

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
FORXIGA
® FILM-COATED TABLET
DAPAGLIFLOZIN (5MG AND 10MG)
1
WHAT IS IN THIS LEAFLET
1.
What Forxiga is used for
2.
How Forxiga works
3.
Before you use Forxiga
4.
How to use Forxiga
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Forxiga
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
12.
Serial Number
WHAT FORXIGA IS USED FOR
Forxiga is used in adult patients
(aged 18 years and older) to treat:
•
Type 2 diabetes mellitus if your
type 2 diabetes cannot be
controlled with diet and
exercise. Forxiga can be used on
its own or together with other
medicines to treat diabetes.
•
Heart failure when the heart
does not pump blood as well as
it should.
•
Chronic kidney disease with
reduced kidney function.
HOW FORXIGA WORKS
Forxiga 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 _
_Forxiga help? _
In type 2 diabetes your body does
not make enough insulin or is not
able to use the insulin it produces
properly. This leads to a high level
of sugar in your blood, which can
lead to serious medical problems
like heart disease, kidney disease,
blindness, and poor circulation in
your limbs. Forxiga works by
removing excess sugar from your
body. It can also help prevent
heart disease.
_What is heart failure and how does _
_Forxiga help? _
This type of heart failure occurs
when the heart does not pump
blood to the lungs and the rest of
the body as well as it should. This
can lead to serious medical
problems and need for hospital
care. The most common symptoms
of heart failure are breathlessness,
fatigue, tiredness and ankle
swelling. Forxiga helps protect
your heart from getting worse and
improves your symptoms. It can
lower t

Ciri produk

1
FORXIGA
®
5 MG & 10 MG FILM-COATED TABLETS
DAPAGLIFLOZIN
1.
NAME OF THE MEDICINAL PRODUCT
Forxiga 5 mg film-coated tablets
Forxiga 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
tablet
contains
dapagliflozin propanediol monohydrate
equivalent
to
5 mg or
10
mg
of
dapagliflozin.
_ _
_Excipient with known effect: _
Each tablet contains 25 mg or 50 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
5 mg: Yellow, biconvex, 0.7 cm diameter round, film-coated tablets
with “5” engraved on one side
and “1427” engraved on the other side.
10 mg: Yellow, biconvex, approximately 1.1 x 0.8 cm diagonally
diamond-shaped, film-coated tablets
with “10” engraved on one side and “1428” engraved on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TYPE 2 DIABETES MELLITUS
Forxiga is indicated in adults aged 18 years and older with type 2
diabetes mellitus as:
MONOTHERAPY
When diet and exercise alone do not provide adequate glycaemic control
in patients for whom use of
metformin is considered inappropriate due to intolerance.
ADD-ON COMBINATION THERAPY
In combination with
other glucose-lowering
medicinal
products
including insulin,
when
these,
together with diet and exercise, do not provide adequate glycaemic
control (see sections 4.4, 4.5 and
5.1 for available data on different combinations).
INITIAL COMBINATION
2
Forxiga is indicated for use as initial combination therapy with
metformin, as an adjunct to diet and
exercise, to improve glycemic control in patients with type 2 diabetes
mellitus when diet and exercise
have failed to provide adequate glycemic control and there are poor
prospects for response to
metformin monotherapy (for example, high initial HbA
1c
levels).
To reduce the risk of hospitalization for heart failure in adults with
type 2 diabetes mellitus and
established cardiovascular disease (CVD) or multiple cardiovascular
(CV) risk factors.
For
study
results
with
respect
to
combination
of
th