FORXIGA dapagliflozin (as propanediol monohydrate) 10 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

10-09-2021

Summary of Product characteristics (SPC)

10-09-2021

Public Assessment Report (PAR)

28-11-2017

Active ingredient:

dapagliflozin propanediol monohydrate, Quantity: 12.3 mg (Equivalent: dapagliflozin, Qty 10 mg)

Available from:

AstraZeneca Pty Ltd

INN (International Name):

Dapagliflozin propanediol monohydrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: silicon dioxide; microcrystalline cellulose; magnesium stearate; crospovidone; purified water; lactose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350

Administration route:

Oral

Units in package:

28, 7

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Type 2 diabetes mellitus,Glycaemic control,FORXIGA is indicated in adults with type 2 diabetes mellitus:,? as monotherapy as an adjunct to diet and exercise in patients for whom metformin is otherwise indicated but was not tolerated.,? as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycaemic control when diet and exercise have failed to provide adequate glycaemic control and there are poor prospects for response to metformin monotherapy (for example, high initial haemoglobin A1c [HbA1c] levels).,? in combination with other anti-hyperglycaemic agents to improve glycaemic control, when these together with diet and exercise, do not provide adequate glycaemic control (see section 5.1 Pharmacodynamic properties ? Clinical trials and section 4.4 Special warnings and precautions for use for available data on different add-on combination therapies).,Prevention of hospitalisation for heart failure,FORXIGA is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalization for heart failure (see section 5.1 Pharmacodynamic properties ? Clinical trials). Heart failure,FORXIGA is indicated in adults for the treatment of symptomatic heart failure independent of left ventricular ejection fraction, as an adjunct to standard of care therapy (see section 5.1 Pharmacodynamic properties). Chronic kidney disease,FORXIGA is indicated to reduce the risk of progressive decline in kidney function in adults with proteinuric chronic kidney disease (CKD Stage 2,3 or 4 and urine ACR ? 30 mg/g)

Product summary:

Visual Identification: Yellow, biconvex, diamond, film coated tablets with '10' engraved on one side and '1428' debossed on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2012-10-22

Patient Information leaflet

FORXIGA
®
_Dapagliflozin (dap-ah-gli-flows-in)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FORXIGA. 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 FORXIGA
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 FORXIGA IS
USED FOR
FORXIGA is a prescription medicine
used with diet, exercise and
sometimes other medicines (which
may include metformin; insulin; a
sulfonylurea medicine such as
gliclazide, glimepiride and
glibenclamide; or a dipeptidyl
peptidase-4 inhibitor [DPP 4
inhibitor] such as sitagliptin or
saxagliptin or a glucagon like peptide
1 [GLP-1] receptor agonist such as
exenatide) to control the levels of
blood sugar (glucose) in adults with
type 2 diabetes mellitus. It can also
reduce hospitalisation for heart
failure in adults with type 2 diabetes.
FORXIGA is also used with other
medicines to treat heart failure and to
slow the progression of kidney
disease in adults.
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 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.
FORXIGA is a member of a class of
medicines you take by mouth called
SGLT-2 (Sodium Glucose
Cotransp

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Summary of Product characteristics

1(58)
AUSTRALIAN PRODUCT INFORMATION
FORXIGA
®
(dapagliflozin propanediol monohydrate) Tablets
1
NAME OF THE MEDICINE
The active ingredient in FORXIGA is dapagliflozin propanediol
monohydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dapagliflozin drug substance is a white to off-white powder, is
non-hygroscopic, crystalline.
Dapagliflozin is non-ionizable; thus, its aqueous solubility and
partition coefficient are not
affected by changes in pH. Dapagliflozin is a Biopharmaceutical
Classification System
(BCS) Class III drug.
Each film-coated tablet of FORXIGA contains 10 mg of dapagliflozin (as
dapagliflozin
propanediol monohydrate).
_Excipient with known effect_
: lactose
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
FORXIGA (dapagliflozin) 10 mg tablets are yellow, biconvex, diamond,
film coated tablets.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
TYPE 2 DIABETES MELLITUS
_GLYCAEMIC CONTROL _
FORXIGA is indicated in adults with type 2 diabetes mellitus:
•
as monotherapy as an adjunct to diet and exercise in patients for whom
metformin is
otherwise indicated but was not tolerated.
•
as initial combination therapy with metformin, as an adjunct to diet
and exercise, to
improve glycaemic control when diet and exercise have failed to
provide adequate
glycaemic control and there are poor prospects for response to
metformin
monotherapy (for example, high initial haemoglobin A1c [HbA1c]
levels).
•
in combination with other anti-hyperglycaemic agents to improve
glycaemic control,
when these together with diet and exercise, do not provide adequate
glycaemic control
(see section 5.1 Pharmacodynamic properties – Clinical trials and
section 4.4 Special
warnings and precautions for use for available data on different
add-on combination
therapies).
2(58)
_PREVENTION OF HOSPITALISATION FOR HEART FAILURE _
FORXIGA is indicated in adults with type 2 diabetes mellitus and
established cardiovascular
disease or risk factors for cardiovascular disease to reduce the risk

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