Dapiga 10mg Film Coated Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Dapagliflozin

Boleh didapati daripada:

NOVUGEN PHARMA SDN. BHD.

INN (Nama Antarabangsa):

Dapagliflozin

Unit dalam pakej:

10 Tablets; 30 Tablets; 100 Tablets; 500 Tablets; 1000 Tablets; 14 Tablets; 28 Tablets; 56 Tablets; 84 Tablets; 112 Tablets; 168 Tablets; 60 Tablets

Dikeluarkan oleh:

NOVUGEN PHARMA SDN. BHD.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
DAPIGA 10MG FILM COATED TABLETS
Dapagliflozin 10mg
1
WHAT IS IN THIS LEAFLET
1.
What Dapiga is used for
2.
How Dapiga works
3.
Before you use Dapiga
4.
How to use Dapiga
5.
While you are using Dapiga
6.
Side effects
7.
Storage and Disposal of Dapiga
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT DAPIGA IS USED FOR
Dapiga
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.
Dapiga 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 DAPIGA WORKS
Dapiga
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.
BEFORE YOU USE DAPIGA
−
_When you must not use it _
Do not take Dapiga:
•
if you are allergic to
dapagliflozin or any of the other
ingredients of this medicine
(listed in section ‘Product
description’).
−
_ Before you start to use it _
Talk to your doctor, pharmacist or
nurse
before
taking
Dapiga,
and
during treatment:
•
if you have “type 1 diabetes” –
the type that usually starts when
you are young, and your body
does not produce any insulin.
•
if you have diabetes and have a
kidney problem – your doctor
may ask you to take additional or
a different medicine to control
your blood sugar.
•
if you have a liver problem - your
doctor may start you on a lower
dose.
•
if you are on medicines to lower
your blood pressure (anti-
hypertensives) and have a history
of low blood pressure
(hypotension). More information
is given below under ‘Taki

Ciri produk

DAPIGA 10MG FILM COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Dapiga 10mg Film Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg of Dapagliflozin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film Coated Tablets.
Yellow, round film-coated tablet debossed with ‘C 43’ on one side
and plain on the
other side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
TYPE 2 DIABETES MELLITUS
Dapiga 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
Dapiga 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.
HEART FAILURE
Dapiga is indicated to reduce the risk of cardiovascular death and
hospitalization for
heart failure in adults with heart failure (NYHA class II-IV) with
reduced ejection
fraction.
CHRONIC KIDNEY DISEASE
Dapiga is indicated in adults for the treatment of chronic kidney
disease.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
TYPE 2 DIABETES MELLITUS
Monotherapy and add-on combination therapy
The recommended dose is 10 mg dapagliflozin once daily.
When dapagliflozin is used in co