GLYXAMBI 25 mg/5 mg empagliflozin/linagliptin 25mg/5mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

linagliptin, Quantity: 5 mg; empagliflozin, Quantity: 25 mg

Available from:

Boehringer Ingelheim Pty Ltd

INN (International Name):

empagliflozin,Linagliptin

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: purified talc; hypromellose; mannitol; crospovidone; titanium dioxide; magnesium stearate; copovidone; pregelatinised maize starch; macrogol 6000; iron oxide red; maize starch

Administration route:

Oral

Units in package:

30, 10 (sample pack)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

GLYXAMBI tablets are 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 linagliptin is appropriate (see Sections 4.2 Dose and method of administration and 5.1 Pharmacodynamic properties ? Clinical trials).

Product summary:

Visual Identification: Pale pink, arc triangular, flat-faced, bevel-edged, film-coated tablets. One side debossed with the BI company symbol, the other debossed with "25/5".; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-12-19

Patient Information leaflet

GLYXAMBI
®
_10 MG/5 MG AND 25 MG/5 MG_
_empagliflozin and linagliptin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Glyxambi. 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 Glyxambi
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 GLYXAMBI IS
USED FOR
Glyxambi is used to lower blood
sugar levels in patients with type 2
diabetes mellitus.
Glyxambi may be used when diet
plus exercise do not provide adequate
blood sugar level control either:
alone or with certain other medicines
for diabetes such as metformin.
Type 2 diabetes mellitus is also
called non-insulin-dependent
diabetes mellitus or NIDDM.
Type 2 diabetes mellitus 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, brain,
eyes, circulation, nerves or kidneys.
_HOW GLYXAMBI WORKS_
Glyxambi contains two different
active ingredients:
•
empagliflozin, which belongs to a
group of medicines called SGLT2
(sodium glucose co-transporter 2)
inhibitors, and
•
linagliptin, which belongs to a
group of medicines called DPP-4
(dipeptidyl peptidase 4)
inhibitors.
Both m

Summary of Product characteristics

GLYXAMBI PI0160-12
1
AUSTRALIAN PRODUCT INFORMATION – GLYXAMBI (EMPAGLIFLOZIN AND
LINAGLIPTIN)
FILM-COATED TABLETS
1 NAME OF THE MEDICINE
empagliflozin and linagliptin
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
GLYXAMBI are film-coated tablets for oral administration:
•
GLYXAMBI 25 mg/5 mg contains 25 mg empagliflozin and 5 mg linagliptin
•
GLYXAMBI 10 mg/5 mg contains 10 mg empagliflozin and 5 mg linagliptin.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
GLYXAMBI 10 mg/5 mg film-coated tablets are pale yellow, arc
triangular, flat-faced, bevel-
edged, film-coated tablets. One side is debossed with the Boehringer
Ingelheim company
symbol, the other side is debossed with “10/5”.
GLYXAMBI 25 mg/5 mg film-coated tablets are pale pink, arc triangular,
flat-faced, bevel-
edged, film-coated tablets. One side is debossed with the Boehringer
Ingelheim company
symbol, the other side is debossed with “25/5”.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
GLYXAMBI tablets are 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
linagliptin is appropriate (see Sections 4.2 Dose and method of
administration and 5.1
Pharmacodynamic properties – Clinical trials).
4.2 DOSE AND METHOD OF ADMINISTRATION
The recommended starting dose is GLYXAMBI 10 mg/5 mg (empagliflozin 10
mg / linagliptin
5 mg) once daily. In patients tolerating GLYXAMBI 10 mg/5 mg once
daily and requiring
additional
glycaemic
control,
the
dose
can
be
increased
to
GLYXAMBI
25 mg/5 mg
(empagliflozin 25 mg / linagliptin 5 mg) once daily. In patients
already on empagliflozin, the
dose of GLYXAMBI should provide the dose of empagliflozin similar to
the dose already been
taken by the patient. GLYXAMBI can be taken with or without food and
at any time of day.
COMBINATION THERAPY
When GLYXAMBI is used in combination with a sulfonylurea or with
insulin, a lower dose of
the sulfonylurea or insulin may be c