Qtern

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Saxagliptin, dapagliflozin propanediol monohydrate

Available from:

Astra Zeneca AB

ATC code:

A10BD21

INN (International Name):

saxagliptin, dapagliflozin

Therapeutic group:

Drugs used in diabetes

Therapeutic area:

Diabetes Mellitus, Type 2; Diabetes Mellitus; Nutritional and Metabolic Diseases; Metabolic Diseases; Glucose Metabolism Disorders

Therapeutic indications:

Qtern, fixed dose combination of saxagliptin and dapagliflozin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Qtern do not provide adequate glycaemic control,when already being treated with the free combination of dapagliflozin and saxagliptin.(See sections 4.2, 4.4, 4.5 and 5.1 for available data on combinations studied.)

Product summary:

Revision: 11

Authorization status:

Authorised

Authorization date:

2016-07-15

Patient Information leaflet

36
B. PACKAGE LEAFLET
37
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
QTERN 5 MG/10 MG FILM-COATED TABLETS
saxagliptin/dapagliflozin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Qtern is and what it is used for
2.
What you need to know before you take Qtern
3.
How to take Qtern
4.
Possible side effects
5.
How to store Qtern
6.
Contents of the pack and other information
1.
WHAT QTERN IS AND WHAT IT IS USED FOR
Qtern contains the active substances saxagliptin and dapagliflozin.
Each belongs to a group of
medicines called “oral anti-diabetics”. These medicines are taken
by mouth for diabetes.
Qtern is used for a type of diabetes called “type 2 diabetes
mellitus” in adult patients (aged 18 years
and older). If you have type 2 diabetes, your pancreas does not make
enough insulin or your body is
not able to use the insulin it produces properly. This leads to a high
level of sugar in your blood. The
two active substances in Qtern work in different ways to help control
the level of sugar in your blood
and remove excess sugar from your body via your urine.
Qtern is used to treat type 2 diabetes when:
-
saxagliptin or dapagliflozin alone together with metformin and/or
sulphonylurea cannot control
your diabetes.
-
you are already being treated with saxagliptin and dapagliflozin as
single tablets. Your doctor
may ask you to switch to this medicine.
It is important to continue to follow the advice on diet and exercise
given to you by your doctor,
pharmacist or nurse.
2.
WHAT YOU NEED TO KN

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Qtern 5 mg/10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains saxagliptin hydrochloride equivalent to 5 mg
saxagliptin and dapagliflozin
propanediol monohydrate equivalent to 10 mg dapagliflozin.
Excipient with known effect
Each tablet contains 40 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Light brown to brown, biconvex, 0.8 cm 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, fixed dose combination of saxagliptin and dapagliflozin, is
indicated in adults aged 18 years and
older with type 2 diabetes mellitus:
-
to improve glycaemic control when metformin and/or sulphonylurea (SU)
and one of the
monocomponents of Qtern do not provide adequate glycaemic control,
-
when already being treated with the free combination of dapagliflozin
and saxagliptin.
(See sections 4.2, 4.4, 4.5 and 5.1 for available data on combinations
studied.)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one 5 mg saxagliptin/10 mg dapagliflozin
tablet once daily (see sections 4.5
and 4.8).
_Missed dose_
If a dose is missed and it is ≥ 12 hours until the next dose, the
dose should be taken. If a dose is missed
and it is < 12 hours until the next dose, the missed dose should be
skipped and the next dose taken at
the usual time.
_Special populations_
_Renal impairment_
Qtern should not be initiated in patients with a glomerular filtration
rate (GFR) < 60 mL/min and
should be discontinued at GFR persistently below 45 mL/min. It should
also not be used in patients
with end-stage renal disease (ESRD) (see sections 4.4, 4.8, 5.1 and
5.2).
No dose adjustment is recommended based on renal function.
3
_Hepatic impairment_
This medicinal product can be used in patients with mild or moderate
hepatic impairment.