ONGLYZA saxagliptin (as hydrochloride) 2.5 mg film-coated tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
19-10-2017
Active ingredient:
saxagliptin, Quantity: 2.5 mg
Available from:
AstraZeneca Pty Ltd
INN (International Name):
Saxagliptin
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: microcrystalline cellulose; croscarmellose sodium; magnesium stearate; lactose monohydrate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; indigo carmine aluminium lake; ethanol; Shellac; sulfuric acid; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350
Administration route:
Oral
Units in package:
28, 7
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Add-on combination: ONGLYZA is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicines, when these together with diet and exercise, do not provide adequate glycaemic control (see Clinical Trials and Precautions for available data on different add-on combination therapies).,Initial combination: ONGLYZA is indicated for use as initial combination therapy with metformin, in patients with type 2 diabetes mellitus, to improve glycaemic control as an adjunct to diet and exercise, when dual saxagliptin and metformin therapy is appropriate (i.e. high initial HbA1c levels and poor prospects for response to monotherapy).
Product summary:
Visual Identification: Pale yellow biconvex round tablets 2.5 on one side & 4214 on reverse; 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:
2014-03-21
Patient Information leaflet
ONGLYZA
®
_Saxagliptin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ONGLYZA. 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 ONGLYZA
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 ONGLYZA IS
USED FOR
ONGLYZA is used to lower blood
sugar levels in patients with type 2
diabetes mellitus. ONGLYZA is used
in combination with certain other
medicines (metformin, medicines
such as rosiglitazone and
pioglitazone, insulin, a sulfonylurea
medicine such as glimepiride or
glibenclamide or metformin plus a
sulfonylurea or a SGLT2 inhibitor
such as dapagliflozin) to help lower
blood sugar levels. ONGLYZA is
used when diet plus exercise and the
single medicine do not provide
adequate blood sugar level control.
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.
ONGLYZA is a member of a class of
medicines you take by mouth called
DPP-4 inhibitors (dipeptidyl
peptidase-4 inhibitors) that lowers
blood sugar levels in patients with
type 2 diabetes mellitus.
•
ONGLYZA helps to improve the
levels of insulin after a meal.
•
ONGLYZA decreases the amount
of sugar made by the body.
•
ONGLYZA works when blood
sugar is high, especially after a
meal.
Read the complete document
Summary of Product characteristics
1 of 34
AUSTRALIAN PRODUCT INFORMATION
ONGLYZA
®
(SAXAGLIPTIN) TABLETS
1
NAME OF THE MEDICINE
Saxagliptin (as hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of ONGLYZA contains either 2.5 mg or 5 mg of
saxagliptin free base (as
saxagliptin hydrochloride).
_Excipients with known effect_
: lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients
3
PHARMACEUTICAL FORM
Film-coated tablets.
ONGLYZA (saxagliptin) 2.5 mg tablets are pale yellow to light yellow,
biconvex, round, film-
coated tablets with “2.5” printed on one side and “4214”
printed on the other side, in blue ink.
ONGLYZA (saxagliptin) 5 mg tablets are pink, biconvex, round,
film-coated tablets with “5”
printed on one side and “4215” printed on the other side, in blue
ink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADD-ON COMBINATION
ONGLYZA is indicated in patients with type 2 diabetes mellitus to
improve glycaemic control in
combination with other glucose lowering medicines, when these together
with diet and exercise, do
not provide adequate glycaemic control (
_see Sections 5.1 Pharmacodynamic properties- Clinical _
_Trials _
and
_ 4.4 Special warnings and precautions for use_
for available data on different add-on
combination therapies).
INITIAL COMBINATION
ONGLYZA is indicated for use as initial combination therapy with
metformin, in patients with type
2 diabetes mellitus, to improve glycaemic control as an adjunct to
diet and exercise, when dual
saxagliptin and metformin therapy is appropriate. (i.e. high initial
HbA1c levels and poor prospects
for response to monotherapy).
4.2
DOSE AND METHOD OF ADMINISTRATION
ONGLYZA tablets must not be split or cut.
ONGLYZA can be taken with or without food.
2 of 34
ADD-ON COMBINATION THERAPY
The recommended dose of ONGLYZA is 5 mg once daily as add-on dual
combination therapy with
metformin, a thiazolidinedione or a sulfonylurea or as a component of
triple oral therapy with
metformin and a sulfonylurea or a sodium-glucose
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