JARDIANCE empagliflozin 25 mg film-coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

30-12-2021

Summary of Product characteristics (SPC)

30-12-2021

Public Assessment Report (PAR)

27-11-2017

Active ingredient:

empagliflozin, Quantity: 25 mg

Available from:

Boehringer Ingelheim Pty Ltd

INN (International Name):

empagliflozin

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; colloidal anhydrous silica; hyprolose; croscarmellose sodium; magnesium stearate; lactose monohydrate; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 400

Administration route:

Oral

Units in package:

30, 10

Prescription type:

(S4) Prescription Only Medicine

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,In combination with other glucose?lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see Section 5.1 Pharmacodynamic properties - Clinical trials).,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 5.1 Pharmacodynamic properties - Clinical trials).,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 in adults for the treatment of symptomatic heart failure independent of left ventricular ejection fraction, as an adjunct to standard of care therapy (see Section 5.1 Pharmacodynamic properties - Clinical trials).,Chronic kidney disease,JARDIANCE is indicated to reduce the risk of kidney disease progression in adults with chronic kidney disease (CKD Stages 2 and 3A with urine ACR ?30 mg/g, or CKD Stages 3B, 4 and 5 irrespective of urine ACR).

Product summary:

Visual Identification: Pale yellow, oval, biconvex film-coated tablet, debossed with 'S25' on one side, the other side debossed with the BI company symbol; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2014-04-30

Patient Information leaflet

JARDIANCE
®
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING JARDIANCE?
Jardiance tablets contain the active ingredient empagliflozin.
Jardiance is used to lower blood sugar levels in people with type 2
diabetes mellitus. Jardiance can be used to help lower the risk of
dying from cardiovascular disease in patients with type 2 diabetes
mellitus and cardiovascular disease. Jardiance is also used to treat a
type of long-term heart failure in patients with or without type 2
diabetes mellitus. For more information, see Section 1. Why am I using
Jardiance? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE JARDIANCE?
Do not use if you have ever had an allergic reaction to empagliflozin
or any of the ingredients listed at the end of the CMI.
Do not use if you have poorly functioning kidneys since Jardiance
requires good functioning kidneys to work well.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Jardiance? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Jardiance and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE JARDIANCE?
Your doctor will tell you how many tablets you need to take each day.
The usual dose for adults is one tablet a day. More
instructions can be found in Section 4. How do I use Jardiance? in the
full CMI.
5.
WHAT SHOULD I KNOW WHILE USING JARDIANCE?
THINGS YOU
SHOULD DO
•
Check your blood sugar levels regularly to tell if your diabetes is
being controlled properly
•
Be careful when doing activities that can lower your sugar levels,
such as drinking alcohol, not eating
enough, or exercising suddenly or vigorously.
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Summary of Product characteristics

JARDIANCE PI0145-15
1
AUSTRALIAN
PRODUCT
INFORMATION
-
JARDIANCE®
EMPAGLIFLOZIN
FILM-COATED
TABLETS
1 NAME OF THE MEDICINE
empagliflozin
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
JARDIANCE 10 mg film-coated tablets contains 10 mg empagliflozin.
JARDIANCE 25 mg film-coated tablets contains 25 mg empagliflozin.
Excipients with known effect:
The
JARDIANCE
10
mg
tablet
contains
162.5
mg
of
lactose
monohydrate
and
the
JARDIANCE
25
mg
tablet
contains
113
mg
of
lactose
monohydrate
per
maximum
recommended daily dose.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
JARDIANCE are film-coated tablets for oral administration.
JARDIANCE 10 mg film-coated tablets are pale yellow, round, biconvex
and bevel-edged
tablets. One side is debossed with the code ‘S10’, the other side
is debossed with the
Boehringer Ingelheim company symbol.
JARDIANCE 25 mg film-coated tablets are pale yellow, oval, biconvex
tablets. One side is
debossed with the code ‘S25’, the other side is debossed with the
Boehringer Ingelheim
company symbol.
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
In combination with other glucose–lowering medicinal products
including insulin, when these,
together with diet and exercise, do not provide adequate glycaemic
control (see Section 5.1
Pharmacodynamic properties - Clinical trials).
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
5.1
Pharmacodynamic properties - Clinical trials).
JARDIANCE PI0145-15
2
To prevent cardiovascular deaths, JARDIANCE should be used in
conjunc

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