QTERN 5/10 saxagliptin (as hydrochloride) / dapagliflozin (as propanediol monohydrate) 5 mg / 10 mg film-coated tablet blister pack

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

dapagliflozin propanediol monohydrate, Quantity: 12.3 mg (Equivalent: dapagliflozin, Qty 10 mg); saxagliptin, Quantity: 5 mg

Dostupné z:

AstraZeneca Pty Ltd

INN (Medzinárodný Name):

Dapagliflozin propanediol monohydrate,Saxagliptin

Forma lieku:

Tablet

Zloženie:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; lactose; croscarmellose sodium; silicon dioxide; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; indigo carmine aluminium lake; ethanol; Shellac; sulfuric acid

Spôsob podávania:

Oral

Počet v balení:

7, 28

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

QTERN 5/10 is indicated as an adjunct to diet and exercise, in combination with metformin, to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and dapagliflozin is appropriate.

Prehľad produktov:

Visual Identification: Light brown to brown, biconvex, round, film-coated tablet, with 5/10 printed on one side, and 1122 printed on the other side, in blue ink; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Stav Autorizácia:

Licence status A

Dátum Autorizácia:

2016-10-25

Príbalový leták

QTERN
® 5/10
Q
T
E
R
N
®
5
/
1
0
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING QTERN?
QTERN contains two active ingredients, saxagliptin and dapagliflozin.
QTERN is used to lower blood sugar levels in patients with
type 2 diabetes mellitus along with diet and exercise, in combination
with another medicine called metformin.
For more information, see Section 1. Why am I using QTERN? in the full
CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE QTERN?
Do not use if you have ever had an allergic reaction to saxagliptin or
dapagliflozin, or any other DPP-4 inhibitor medicine, or any of
the ingredients listed at the end of this leaflet.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
QTERN? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with QTERN and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE QTERN?
•
Swallow your QTERN tablet whole with a full glass of water.
•
The dose of QTERN is one tablet once a day.
More instructions can be found in Section 4. How do I use QTERN? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING QTERN?
THINGS YOU
SHOULD DO
•
Make sure that you, your friends, family and work colleagues can
recognise the symptoms of
hypoglycaemia (low blood sugar) and hyperglycaemia (high blood sugar)
and know how to treat them.
•
Talk to your doctor if you are having surgery to discuss when to stop
taking QTERN and when to start
taking it again.
•
Remind any doctor, dentist or pharmacist you visit that you are using
QTERN.
•
If you become pregnant while taking QTERN, tell your doctor
immediately.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking your medicine or change

Súhrn charakteristických

1 of 35
AUSTRALIAN PRODUCT INFORMATION
QTERN
® 5/10
(SAXAGLIPTIN/DAPAGLIFLOZIN) TABLETS
1
NAME OF THE MEDICINE
Saxagliptin (as hydrochloride) /dapagliflozin propanediol monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
QTERN 5/10 is available as a film-coated tablet containing 5 mg
saxagliptin as saxagliptin
hydrochloride and dapagliflozin propanediol monohydrate equivalent to
10 mg dapagliflozin.
_Excipient (s) with known effect: _
lactose
For the full list of excipients, see Section 6.1 List of Excipients
3
PHARMACEUTICAL FORM
Tablets.
QTERN 5/10 tablets are light brown to brown, biconvex, round,
film-coated tablet, with “5/10”
printed on one side, and “1122” printed on the other side, in blue
ink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
QTERN is indicated as an adjunct to diet and exercise, in combination
with metformin, to improve
glycaemic control in adults with type 2 diabetes mellitus when
treatment with both saxagliptin and
dapagliflozin is appropriate.
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dose of QTERN is one saxagliptin 5 mg/dapagliflozin10
mg tablet taken once
daily at any time of the day, with or without food. Tablet is to be
swallowed whole.
Please refer to Section 4.4 Special Warnings and Precautions for Use
for information regarding
combinations not studied.
Optimal medical management of patients with diabetes also involves
attention to diet, exercise,
blood glucose monitoring, assessment of complications and
co-morbidities. Regular assessment
and review of the compliance and benefit/risk of all therapies is
recommended.
SPECIAL POPULATIONS
_PATIENTS WITH RENAL IMPAIRMENT _
Assess renal function prior to initiation of QTERN and periodically
thereafter. No dose adjustment
is required for patients with eGFR ≥45 mL/min/1.73 m
2
.
The glycaemic efficacy of dapagliflozin is dependent on renal
function. QTERN should not be used
in patients with an estimated glomerular filtration rate (eGFR)
persistently <45 mL/min/1.73 m
2
as
calculated by the Modification of D