Xigduo XR

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Dapagliflozin propanediol monohydrate 12.3mg equivalent to Dapagliflozin 10 mg;  ; Metformin hydrochloride 500mg (with 0.5% Magnesium stearate);  

Available from:

AstraZeneca Limited

INN (International Name):

Dapagliflozin propanediol monohydrate 12.3 mg (equivalent to Dapagliflozin 10 mg)

Dosage:

10mg/500mg

Pharmaceutical form:

Modified release tablet

Composition:

Active: Dapagliflozin propanediol monohydrate 12.3mg equivalent to Dapagliflozin 10 mg   Metformin hydrochloride 500mg (with 0.5% Magnesium stearate)   Excipient: Carmellose sodium Colloidal silicon dioxide Crospovidone Hypromellose Microcrystalline cellulose (PH302) Hypromellose (2910) Lactose Magnesium stearate Microcrystalline cellulose Opadry Pink 85F94333

Prescription type:

Prescription

Manufactured by:

Swords Laboratories Limited Subsidiary of Bristol-Myers Squibb Company

Therapeutic indications:

Glycaemic control XIGDUO XR is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control when treatment with both dapagliflozin and metformin is appropriate (see sections 5.1 and 4.4 for available data on the combination therapy). Prevention of hospitalisation for heart failure Dapagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalisation for heart failure (see section 5.1 Pharmacodynamic properties – Clinical Efficacy and Safety). Prevention of new or worsening nephropathy Dapagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease for the prevention of new or worsening nephropathy (see section 5.1 Pharmacodynamic properties – Clinical Efficacy and Safety).

Product summary:

Package - Contents - Shelf Life: Blister pack, Al/Al - 7 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Al/Al - 28 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2014-12-11

Patient Information leaflet

Xigduo XR Tablets
Copyright
1(8)
180520
XIGDUO
® XR
DAPAGLIFLOZIN/METFORMIN HYDROCHLORIDE MODIFIED RELEASE TABLETS
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about XIGDUO XR. 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
XIGDUO 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 XIGDUO XR IS USED FOR
XIGDUO XR is a prescription medicine used with diet, exercise and
sometimes other medicines such
as insulin , a sulphonylurea, or a dipeptidyl peptidase (DPP-4)
inhibitor or a glucagon like peptide 1
(GLP-1) receptor agonist such as exenatide, to control the levels of
blood sugar (glucose) in patients
with type 2 diabetes mellitus. It can also help prevent
hospitalisation for heart failure and kidney
disease in patients with type 2 diabetes mellitus.
TYPE 2 DIABETES MELLITUS
Type 2 diabetes mellitus (also called non-insulin-dependent diabetes
mellitus or NIDDM) is the
condition of having high levels of blood sugar (hyperglycaemia). This
is usually because your body
does not make enough insulin and /or the insulin that your body
produces does not work as well as it
should. Left uncontrolled, the build-up of high levels of sugar in
your blood can lead to serious
medical problems. The main goal of treating type 2 diabetes mellitus
is to control your blood sugar to
a normal level. Lowering and controlling blood sugar may help prevent
or delay complications of
diabetes, which include kidney disease, blindness and amputation.
XIGDUO XR contains two active ingredients, dapagliflozin and metformin
hydrochloride. Dapagliflozin
is
a
member
of
a
class
of
medicines
you
take
by
mouth
called
SGLT-2
(Sodium
Glucose
Cotransporter-2)
inhibitors
and
metformin
belo

Summary of Product characteristics

1
XIGDUO
®
XR Data Sheet 070623
Copyright
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
X
IGDUO
®
XR 5mg/1000mg, modified release tablet
X
IGDUO
®
XR 10mg/500mg, modified release tablet
X
IGDUO
®
XR 10mg/1000mg, modified release tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
X
IGDUO
XR
5 mg/1000 mg:
Each
film-coated
tablet
contains
5 mg
dapagliflozin
as
dapagliflozin propanediol and 1000 mg metformin HCl extended-release.
X
IGDUO
XR
10 mg/500 mg: Each film-coated
tablet
contains
10 mg
dapagliflozin as
dapagliflozin propanediol and 500 mg metformin HCl extended-release.
X
IGDUO
XR 10 mg/1000 mg: Each film-coated tablet contains 10 mg dapagliflozin
as
dapagliflozin propanediol and 1000 mg metformin HCl extended-release.
For the full list of excipients see section 6.1 - List of Excipients.
3.
PHARMACEUTICAL FORM
X
IGDUO
XR 5 mg/1000 mg tablets are pink to dark pink, biconvex, oval shaped,
film-coated
tablets debossed with “1071” and “5/1000” on one side and
plain on the other side.
X
IGDUO
XR 10 mg/500 mg tablets are pink, biconvex, capsule shaped,
film-coated tablets
debossed with “1072” and “10/500” on one side and plain on the
other side.
X
IGDUO
XR 10 mg/1000 mg tablets are yellow to dark yellow, biconvex, oval
shaped,
film-coated tablets debossed with “1073” and “10/1000” on one
side and plain on the other
side.
DAPAGLIFLOZIN
Dapagliflozin
is
described
chemically
as
(1_S_)-1,5-anhydro-1-C-[4-chloro-3-[(4-
ethoxyphenyl)methyl]phenyl]-D-glucitol, (_S_)-propylene glycol,
monohydrate.
The chemical structure of dapagliflozin propanediol monohydrate is:
O
HO
H
Cl
O
CH
3
OH
HO
HO
H
3
C
OH
OH
H
.
.
H
2
O
2
XIGDUO
®
XR Data Sheet 070623
Copyright
METFORMIN HYDROCHLORIDE
The
chemical
structure
of
metformin
hydrochloride
(_N,N_-dimethylimidodicarbonimidic
diamide hydrochloride) is:
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
GLYCAEMIC CONTROL
X
IGDUO
XR is indicated in adults with type 2 diabetes mellitus as an adjunct
to diet and
exercise to improve glycemic control when treatment with b