Jardiance 10mg film coated tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Empagliflozin

Boleh didapati daripada:

BOEHRINGER INGELHEIM (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Empagliflozin

Unit dalam pakej:

10tablet Tablets; 30tablet Tablets

Dikeluarkan oleh:

BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG

Risalah maklumat

JARDIANCE
®
Film-Coated Tablets
Empagliflozin (10mg, 25mg)
1
Consumer Medication Information Leaflet (RiMUP)
What is in this leaflet
1.
What Jardiance is used for
2.
How Jardiance works
3.
Before you use Jardiance
4.
How to use Jardiance
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Jardiance
8.
Product Description
9.
Manufacturer
10. Product Registration Holder
11. Date of revision
12. Serial number
1. What Jardiance is used for
Type 2 diabetes mellitus
Your doctor has prescribed this medicine
to help lower your blood sugar.
 Jardiance
is
used
to
treat
type
2
diabetes
in
adult patients
(aged 18
years
and
older)
that
cannot
be
controlled by diet and exercise alone.
 Jardiance can be used without other
medicines in patients who cannot take
metformin
(another
diabetes
medicine).
 Jardiance can also be used with other
medicines.
This
may
be
medicines
taken by mouth or insulin given by
injection.
 Jardiance is used to reduce the risk of
cardiovascular death in adult patients
with type 2 diabetes and established
heart (cardiovascular) disease.
It is important that you continue with
your diet and exercise plan as told by
your doctor, pharmacist or nurse.
Heart failure
Jardiance is indicated to
reduce the risk
of
cardiovascular
death
and
hospitalization for heart failure in adults
with heart failure (NYHA class II-IV),
when
the
heart
cannot
pump
enough
blood to the rest of your body.
2. How Jardiance works
Jardiance contains the active substance
empagliflozin which works by blocking a
protein
in
the
kidney
called
sodium-
glucose
co-transporter
2
(SGLT2).
SGLT2
prevents
glucose
from
being
excreted in urine by absorbing glucose
into the bloodstream as blood is being
filtered in the kidneys. By blocking this
protein,
the
medicine
causes
glucose
(blood sugar), to be removed via urine and
blood glucose level, which are too high
because
of
your
type
2
diabetes,
are
thereby
reduced.
It
can
reduce
left
ventricular
wall
stress
and
beneficial
effects
on
cardiac
remodeling,
filling
pressures
and

Ciri produk

1
Jardiance
®
1. NAME OF THE MEDICINAL PRODUCT
Jardiance 10 mg film-coated tablets
Jardiance 25 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg or 25 mg empagliflozin.
Excipient with known effect:
Each tablet contains lactose monohydrate equivalent to 154.3 mg (10 mg
Empagliflozin) or 107.4 mg
(25 mg Empagliflozin) lactose anhydrous.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
3.1 Product description
Jardiance 10 mg: Round, pale yellow, biconvex, bevel-edged film-coated
tablet debossed with “S10”
on one side and the Boehringer Ingelheim logo on the other (tablet
diameter: 9.1 mm).
Jardiance 25 mg: Oval, pale yellow, biconvex film-coated tablet
debossed with “S25” on one side and
the Boehringer Ingelheim logo on the other (tablet length: 11.1 mm,
tablet width: 5.6 mm).
4. CLINICAL PARTICULARS
4.1
Therapeutic indications
Type 2 diabetes mellitus
Glycaemic control
Jardiance is indicated in the treatment of type 2 diabetes mellitus to
improve glycaemic control in adults
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
2
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).
Prevention of cardiovascular death
Jardiance is indicated in patients with type 2 diabetes mellitus and
established cardiovascular disease to
reduce the risk of cardiovascular death (see section 5, Clinical
efficacy and safety).
To prevent cardiovascular deaths, Jardiance should be used in
conjunction with other measures to
reduce cardiovascular risk in line with the current standard of care.
Heart failure
Jardiance is indicated to reduce the risk of cardiovascular death and
hospitalization for heart failure