XIGDUO XR TABLET 10500MG

Šalis: Malaizija

kalba: anglų

Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Veiklioji medžiaga:

METFORMIN HYDROCHLORIDE; Dapagliflozin Propanediol

Prieinama:

ASTRAZENECA SDN. BHD.

INN (Tarptautinis Pavadinimas):

METFORMIN HYDROCHLORIDE; Dapagliflozin Propanediol

Vienetai pakuotėje:

28tablet Tablets

Pagaminta:

AstraZeneca Pharmaceuticals LP

Pakuotės lapelis

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
XIGDUO
® XR TABLET
_ _
Dapagliflozin/Metformin Hydrochloride (5/1000 mg, 10/500 mg & 10/1000
mg)
1
WHAT IS IN THIS LEAFLET
1.
What XIGDUO XR is used for
2.
How XIGDUO XR works
3.
Before you use XIGDUO XR
4.
How to use XIGDUO XR
5.
While you are using it
6.
Side effects
7.
Storage and disposal of XIGDUO XR
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
WHAT XIGDUO XR IS USED FOR
XIGDUO XR is a prescription
medicine used with diet, exercise and
sometimes other medicines such as
insulin, a sulfonylurea, or a dipeptidyl
peptidase (DPP-4) inhibitor to control
the levels of blood sugar (glucose) in
patients with type 2 diabetes mellitus.
Dapagliflozin can also reduce
hospitalisation for heart failure in
patients with type 2 diabetes.
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.
HOW XIGDUO XR WORKS
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 belongs to a class of
medicines called biguanides.
Dapagliflozin 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 ANY
QUESTIONS ABOUT WHY THIS MEDICIN

Prekės savybės

1 (46)
XIGDUO
® XR
dapagliflozin propanediol monohydrate/metformin hydrochloride
1
NAME OF THE MEDICINE
XIGDUO XR (dapagliflozin propanediol monohydrate/metformin
hydrochloride) modified release
tablets contain two oral antihyperglycaemic drugs used in the
management of type 2 diabetes:
dapagliflozin propanediol monohydrate and metformin hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DAPAGLIFLOZIN
Dapagliflozin
drug
substance
is
a
white
to
off-white
powder,
is
non-hygroscopic,
crystalline.
Dapagliflozin is non-ionisable; thus, its aqueous solubility and
partition coefficient are not affected by
changes in pH. Dapagliflozin is a Biopharmaceutical Classification
System (BCS) Class III drug.
METFORMIN HYDROCHLORIDE
Metformin hydrochloride is a white to off-white crystalline compound.
Metformin hydrochloride is
freely soluble in water, slightly soluble in alcohol, and is
practically insoluble in acetone, ether, and
chloroform. The pKa of metformin
is 12.4. The pH of a 1% aqueous
solution
of metformin
hydrochloride is 6.68.
XIGDUO XR
XIGDUO XR is available for oral administration as tablets containing
the following active ingredients:
•
XIGDUO XR 10/500: 10 mg dapagliflozin (as dapagliflozin propanediol
monohydrate) and 500
mg metformin hydrochloride.
•
XIGDUO XR 10/1000: 10 mg dapagliflozin (as dapagliflozin propanediol
monohydrate) and 1000
mg metformin hydrochloride.
•
XIGDUO XR 5/1000: 5 mg dapagliflozin (as dapagliflozin propanediol
monohydrate) and 1000
mg metformin hydrochloride.
Each film-coated tablet of XIGDUO XR contains the following inactive
ingredients: carmellose
sodium, hypromellose, magnesium stearate, microcrystalline cellulose,
lactose, crospovidone, silicon
dioxide, polyvinyl alcohol, macrogol 3350, titanium dioxide, purified
talc, iron oxide red CI77491
(XIGDUO XR 10/500 and XIGDUO XR 5/1000 tablets), iron oxide yellow
CI77492 (XIGDUO XR
10/1000 tablets).
3
PHARMACEUTICAL FORM
•
XIGDUO XR 10/500 (dapagliflozin 10 mg /metformin HCl extended release
500 mg) tablets are
pink bicon