Kombiglyze XR

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Metformin hydrochloride 500mg;  ; Saxagliptin 5mg (as saxagliptin hydrochloride)

Available from:

AstraZeneca Limited

INN (International Name):

Metformin hydrochloride 500 mg

Dosage:

5mg/500mg

Pharmaceutical form:

Modified release tablet

Composition:

Active: Metformin hydrochloride 500mg   Saxagliptin 5mg (as saxagliptin hydrochloride) Excipient: Carmellose sodium Hydrochloric acid   Hypromellose Magnesium stearate Microcrystalline cellulose Opacode blue S-1-10619 Opadry butterscotch 85F17417 Opadry white 85F18422 Purified water    

Prescription type:

Prescription

Manufactured by:

Merck Sante SAS

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.

Product summary:

Package - Contents - Shelf Life: Blister pack, Al/Al - 28 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2014-05-21

Patient Information leaflet

Kombiglyze
®
XR Tablets CMI
Copyright
1(7)
181119
KOMBIGLYZE
_®_ XR_ _
SAXAGLIPTIN/METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLET
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 sulphonylurea (such as gliclazide) or a SGLT2 inhibitor
(such as dapagliflozin) along with diet
and exercise to treat type 2 diabetes.
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 anoth

Summary of Product characteristics

1
K
OMBIGLYZE
XR Data Sheet 181119
Copyright
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
KOMBIGLYZE
®
XR 5 mg saxagliptin/500 mg metformin HCL extended-release tablets
KOMBIGLYZE
®
XR 5 mg saxagliptin/1000 mg metformin HCL extended-release tablets
KOMBIGLYZE
®
XR 2.5 mg saxagliptin/1000 mg metformin HCL extended-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
KOMBIGLYZE
XR
is
available
for
oral
administration
as
extended
release
tablets
containing the following active ingredients:

KOMBIGLYZE XR 5 mg/500 mg: 5 mg saxagliptin (as saxagliptin
hydrochloride)
and 500 mg metformin hydrochloride

KOMBIGLYZE XR 5 mg/1000 mg: 5 mg saxagliptin (as saxagliptin
hydrochloride)
and 1000 mg metformin hydrochloride

KOMBIGLYZE
XR
2.5
mg/1000
mg:
2.5
mg
saxagliptin
(as
saxagliptin
hydrochloride) and 1000 mg metformin hydrochloride
3.
PHARMACEUTICAL FORM
Modified release tablets (referred to as extended release tablets).

KOMBIGLYZE XR 5 mg/500 mg (saxagliptin/metformin HCl extended 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 mg/1000 mg
(saxagliptin/metformin
HCl
extended-release)
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 mg/1000 mg (saxagliptin/metformin HCl
extended-release)
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.
For a full list of excipients, see section 6.1.
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.
2
K
OMBIGLYZE
XR Data Sheet 181119
Copyright
4.2
DOSE AND METHOD OF AD