JARDIAMET 5 mg / 500 mg empagliflozin/metformin hydrochloride 5mg/500mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

empagliflozin, Quantity: 5 mg; metformin hydrochloride, Quantity: 500 mg

Available from:

Boehringer Ingelheim Pty Ltd

INN (International Name):

empagliflozin,Metformin hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: maize starch; copovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 400

Administration route:

Oral

Units in package:

14, 60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

JARDIAMET is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin is appropriate (see Sections 4.2 Dose and method of administration and 5.1 Pharmacodynamic properties - Clinical trials).,Empagliflozin is indicated in adults 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, empagliflozin should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.

Product summary:

Visual Identification: Orange yellow, oval, biconvex film-coated tablets. One side is debossed with the BI company symbol and "S5" the other side is debossed with "500".; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-07-24

Patient Information leaflet

JARDIAMET
®
_FILM-COATED TABLETS_
_empagliflozin / metformin hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Jardiamet.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Jardiamet
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
This leaflet was last updated on the
date at the end of this leaflet. More
recent information may be available.
The latest Consumer Medicine
Information is available from your
pharmacist, doctor, or from
www.medicines.org.au and may
contain important information about
the medicine and its use of which
you should be aware.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT JARDIAMET IS
USED FOR
Jardiamet is used to lower blood
sugar levels in patients with type 2
diabetes mellitus.
It may be used when diet plus
exercise do not provide adequate
blood sugar level control either:
•
alone as a single medicine, or
•
in combination with certain other
anti-diabetic medicines such as:
•
sulfonylurea
•
pioglitazone
•
insulin
•
linagliptin.
If you have type 2 diabetes mellitus
and cardiovascular disease,
empagliflozin (one of the active
ingredients in Jardiamet) can be used
to reduce your risk of dying from
your cardiovascular disease.
Type 2 diabetes mellitus is also
called non-insulin-dependent
diabetes mellitus or NIDDM. Type 2
diabetes develops if the body does
not make enough insulin, or if the
insulin that your body makes does
not work as well as it should.
Insulin is a substance which helps to
lower the level of sugar in your
blood, especially after meals.
When the level of sugar builds up in
your blood, this can cause damage to
the body's cells and lead to serious
problems with your heart, eyes,
circulation or kidneys.
_HOW JARDIAMET WORKS_
Jardia

Summary of Product characteristics

JARDIAMET PI0157-15
1
AUSTRALIAN PRODUCT INFORMATION - JARDIAMET EMPAGLIFLOZIN AND METFORMIN
HYDROCHLORIDE FILM COATED TABLETS
1 NAME OF THE MEDICINE
empagliflozin and metformin hydrochloride
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
•
JARDIAMET
5 mg/500 mg
contains
5 mg
empagliflozin
and
500 mg
metformin
hydrochloride
•
JARDIAMET
5 mg/850 mg
contains
5 mg
empagliflozin
and
850 mg
metformin
hydrochloride
•
JARDIAMET
5 mg/1000 mg
contains
5 mg
empagliflozin
and
1000 mg
metformin
hydrochloride
•
JARDIAMET 12.5 mg/500 mg contains 12.5 mg empagliflozin and 500 mg
metformin
hydrochloride
•
JARDIAMET 12.5 mg/850 mg contains 12.5 mg empagliflozin and 850 mg
metformin
hydrochloride
•
JARDIAMET 12.5 mg/1000 mg contains 12.5 mg empagliflozin and 1000 mg
metformin
hydrochloride.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
JARDIAMET are film-coated tablets for oral administration and are
available in six strengths:
JARDIAMET 5 mg/500 mg – orange yellow, oval, biconvex film-coated
tablets. One side is
debossed with the Boehringer Ingelheim company symbol and "S5" the
other side is debossed
with "500".
JARDIAMET 5 mg/850 mg *– yellowish white, oval, biconvex film-coated
tablets. One side is
debossed with Boehringer Ingelheim company symbol and “S5”, the
other side is debossed
with “850”.
JARDIAMET 5 mg/1000 mg – brownish yellow, oval, biconvex film-coated
tablets. One side
is debossed with Boehringer Ingelheim company symbol and “S5”, the
other side is debossed
with “1000”.
JARDIAMET 12.5 mg/500 mg – pale brownish purple, oval, biconvex
film-coated tablets. One
side is debossed with Boehringer Ingelheim company symbol and
“S12”, the other side is
debossed with “500”.
JARDIAMET 12.5 mg/850 mg *– pinkish white, oval, biconvex
film-coated tablets. One side
is debossed with Boehringer Ingelheim company symbol and “S12”,
the other side is
debossed with “850”.
JARDIAMET 12.5 mg/1000 mg – dark brownish purple, oval, biconvex
film-c