Jardiance Duo 12.5mg 850mg Film-coated tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

METFORMIN HYDROCHLORIDE; Empagliflozin

Boleh didapati daripada:

BOEHRINGER INGELHEIM (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

METFORMIN HYDROCHLORIDE; Empagliflozin

Unit dalam pakej:

60tablet Tablets; 10tablet Tablets; 30 tablets Tablets

Dikeluarkan oleh:

BOEHRINGER INGELHEIM ELLAS A.E

Risalah maklumat

JARDIANCE DUO
®
Film-coated tablets
Empagliflozin/Metformin (5mg/500mg, 12.5mg/500mg, 12.5mg/850mg &
12.5mg/1000mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
_ _
_ _
_ _
_ _
WHAT IS IN THIS LEAFLET
1.
What Jardiance Duo is used for
2.
How Jardiance Duo works
3.
Before you use Jardiance Duo
4.
How to use Jardiance Duo
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Jardiance
Duo
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
12.
Serial number
1. WHAT JARDIANCE DUO_ _IS USED FOR
Jardiance Duo is used along with diet
and exercise to improve blood sugar
control in adults with type 2 diabetes
mellitus
•
when treatment with both
empagliflozin and metformin is
appropriate
•
inadequately controlled with
metformin or empagliflozin alone
•
inadequately controlled with
empagliflozin or metformin in
combination with other glucose-
lowering products including insulin
•
already treated with empagliflozin
and metformin co-administered as
separate tablets
Jardiance Duo is used to reduce the risk
of cardiovascular death in adult patients
with type 2 diabetes and established
heart (cardiovascular) disease.
What is type 2 diabetes?
Type 2 diabetes is a disease that comes
from both your genes and your lifestyle.
If you have type 2 diabetes, your
pancreas does not make enough insulin
to control the level of glucose in your
blood, and your body is unable to use its
own insulin effectively. This results in
high levels of glucose in your blood
which can lead to medical problems like
heart disease, kidney disease, blindness,
and poor circulation in your limbs.
2. HOW JARDIANCE DUO WORKS
Jardiance Duo is a diabetes medicine that
contains two active substances called
empagliflozin and metformin.
•
Empagliflozin works by blocking a
protein in the kidneys called sodium
glucose co-transporter 2 (SGLT2).
SGLT2 prevents glucose (blood
sugar) from being lost in urine by
absorbing glucose back into the
bloodstream as blood is being filtered
in the kidneys.

Ciri produk

1
JARDIANCE DUO
®
Abcd
1. NAME OF THE MEDICINAL PRODUCT
JARDIANCE DUO 5mg/ 500mg film-coated tablets
JARDIANCE DUO 12.5mg/ 500mg film-coated tablets
JARDIANCE DUO 12.5mg/ 850mg film-coated tablets
JARDIANCE DUO 12.5mg/ 1000mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
JARDIANCE DUO 5mg/ 500mg film-coated tablets
Each tablet contains 5 mg empagliflozin and 500 mg metformin
hydrochloride.
JARDIANCE DUO 12.5mg/ 500mg film-coated tablets
Each tablet contains 12.5 mg empagliflozin and 500 mg metformin
hydrochloride.
JARDIANCE DUO 12.5mg/ 850mg film-coated tablets
Each tablet contains 12.5 mg empagliflozin and 850 mg metformin
hydrochloride.
JARDIANCE DUO 12.5mg/ 1000mg film-coated tablets
Each tablet contains 12.5 mg empagliflozin and 1000 mg metformin
hydrochloride.
3. PHARMACEUTICAL FORM
5mg/ 500mg
Orange yellow, oval, biconvex film-coated tablets, one side debossed
with Boehringer Ingelheim
company symbol and “S5”, the other side is debossed with
“500”.
12.5mg/ 500mg
Pale brownish purple, oval, biconvex film-coated tablets, one side
debossed with Boehringer Ingelheim
company symbol and “S12”, the other side is debossed with
“500”.
12.5mg/850mg
Pinkish white, oval, biconvex film-coated tablets, one side debossed
with Boehringer Ingelheim
company symbol and “S12”, the other side is debossed with
“850”.
12.5mg/ 1000mg
Dark brownish purple, oval, biconvex film-coated tablets, one side
debossed with Boehringer Ingelheim
company symbol and “S12”, the other side is debossed with
“1000”.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Glycaemic control
2
JARDIANCE DUO is indicated as an adjunct to diet and exercise to
improve glycaemic control in adult
patients with type 2 diabetes mellitus:
-
when treatment with both empagliflozin and metformin is appropriate
(see
CLINICAL TRIALS
and
POSOLOGY AND METHOD OF ADMINISTRATION
).
-
Inadequately controlled with metformin or empagliflozin alone
-
Inadequately controlled with empagliflozin or metformin in combination
with o