Qtern 5mg10mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Dapagliflozin propanediol monohydrate; Saxagliptin hydrochloride

Tilgjengelig fra:

AstraZeneca UK Ltd

ATC-kode:

A10BD21

INN (International Name):

Dapagliflozin propanediol monohydrate; Saxagliptin hydrochloride

Dosering :

10mg ; 5mg

Legemiddelform:

Tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 06010203; GTIN: 5000456013710

Informasjon til brukeren

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”.
•
This medicine is taken by mouth for diabetes.
•
This medicine is used if your diabetes cannot be controlled with other
oral diabetes
medicines, along with diet and exercise.
Qtern is used for a type of diabetes called “type 2 diabetes
mellitus” in adult patients (aged
18 years and older). “Type 2 diabetes mellitus” is the type of
diabetes that usually starts when
you are 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.
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 KNOW BEFORE YOU TAKE QTERN
DO NOT TAKE QTERN:
•
if you are allergic to saxagliptin, da

Preparatomtale

OBJECT 1
QTERN 5 MG/10 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 08-Dec-2017 | AstraZeneca
UK Limited
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 (as anhydrous).
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).
_Special populations _
_Renal impairment_
Qtern can be used in patients with mild renal impairment.
This medicinal product should not be used in patients with moderate to
severe renal impairment (patients
with creatinine clearance [CrCl] < 60 ml/min or estimated glomerular
filtration rate [eGFR] < 60
ml/min/1.73 m
2
, see sections 4.4, 4.8, 5.1 and 5.2). It should also not be used in
patients with end-stage
renal disease (ESRD) (see section 4.4, 4.8, and 5.2).
_Hepatic impairment_
This medicinal product can be used in patients with mild or moderate
hepatic impairment. Patients with
moderate hepatic impairment should be