KOMBIGLYZE XR 2.5/1000 tablets 2.5 mg saxagliptin (as hydrochloride) immediate release and 1000 mg metformin hydrochloride modified release

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metformin hydrochloride, Quantity: 1000 mg; saxagliptin, Quantity: 2.5 mg

Available from:

AstraZeneca Pty Ltd

INN (International Name):

Metformin hydrochloride,Saxagliptin

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: hypromellose; magnesium stearate; carmellose sodium; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; indigo carmine aluminium lake; ethanol; Shellac; sulfuric acid; iron oxide yellow

Administration route:

Oral

Units in package:

56 tablets (trade pack), 14 tablets (sample pack)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

KOMBIGLYZE XR is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate (see Clinical Trials and Dosing and Administration for data on combinations studied).

Product summary:

Visual Identification: Pale yellow to light yellow, biconvex, capsule shaped, film-coated tablet, with 2.5/1000 printed on one side and 4222 printed on the other side, in blue ink; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-10-10

Patient Information leaflet

KOMBIGLYZE
® XR
_Saxagliptin/metformin hydrochloride modified release_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about KOMBIGLYZE XR.
It does not contain all of 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
KOMBIGLYZE XR against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT KOMBIGLYZE
XR IS USED FOR
KOMBIGLYZE XR is used to lower
blood sugar levels in patients with
type 2 diabetes mellitus along with
diet and exercise. KOMBIGLYZE
XR may also be used in combination
with other medicines including
insulin, a sulfonylurea (such as
gliclazide) or a SGLT2 inhibitor
(such as dapagliflozin) along with
diet and exercise to treat type 2
diabetes.
TYPE 2 DIABETES MELLITUS
Type 2 diabetes mellitus is a
condition in which your body does
not make enough insulin and the
insulin that your body produces does
not work as well as it should. Your
body can also make too much sugar.
When this happens, sugar (glucose)
builds up in the blood and can lead to
serious medical problems.
The main goal of treating diabetes is
to lower your blood sugar to a
normal level. Lowering and
controlling blood sugar may help
prevent or delay complications of
diabetes, such as heart disease,
kidney disease, blindness and
amputation.
KOMBIGLYZE XR contains two
active ingredients, saxagliptin and
metformin hydrochloride (modified
release). Saxagliptin is a member of a
class of medicines called DPP-4
inhibitors (dipeptidyl peptidase-4
inhibitors), and metformin belongs to
a class of medicines called
biguanides. Saxagliptin and
metformin work together to lower
blood sugar levels in patients with
type 2 diabetes mellitus.
Your doctor may have prescribed this
medicine for another reason. Ask
your doctor if you have

Summary of Product characteristics

1 of 38
AUSTRALIAN PRODUCT INFORMATION
KOMBIGLYZE
® XR (SAXAGLIPTIN/METFORMIN HYDROCHLORIDE) MODIFIED RELEASE
TABLETS
1
NAME OF THE MEDICINE
Saxagliptin (as hydrochloride)/ metformin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
KOMBIGLYZE XR is available as:
•
KOMBIGLYZE XR 5/500 tablets containing 5 mg saxagliptin (as
hydrochloride) immediate
release and 500 mg metformin hydrochloride modified release
•
KOMBIGLYZE XR 5/1000 tablets containing 5 mg saxagliptin (as
hydrochloride)
immediate release and 1000 mg metformin hydrochloride modified release
•
KOMBIGLYZE XR 2.5/1000 tablets containing 2.5 mg saxagliptin (as
hydrochloride)
immediate release and 1000 mg metformin hydrochloride modified release
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Modified release tablets.
•
KOMBIGLYZE XR 5/500 modified release tablets are light brown to brown,
biconvex, capsule
shaped, film-coated tablets, with “5/500” printed on one side and
“4221” printed on the other
side, in blue ink.
•
KOMBIGLYZE XR 5/1000 modified tablets are pink, biconvex, capsule
shaped, film-coated
tablets, with “5/1000” printed on one side and “4223” printed
on the other side, in blue ink.
•
KOMBIGLYZE XR 2.5 /1000 modified tablets are pale yellow to light
yellow, biconvex,
capsule shaped, film-coated tablets, with “2.5/1000” printed on
one side and “4222” printed on
the other side, in blue ink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
KOMBIGLYZE XR is indicated as an adjunct to diet and exercise to
improve glycaemic control in
adults with type 2 diabetes mellitus when treatment with both
saxagliptin and metformin is
appropriate (
_see Sections 5.1 Pharmacodynamic properties - Clinical Trials_
and
_4.2 Dose and _
_method of administration_
for data on combinations studied).
4.2
DOSE AND METHOD OF ADMINISTRATION
LIFE THREATENING LACTIC ACIDOSIS CAN OCCUR DUE TO ACCUMULATION OF
METFORMIN. THE MAIN RISK
FACTOR IS RENAL IMPAIRMENT, OTHER RISK FACTORS INCLUD