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EPAR summary for the public
saxagliptin / dapagliflozin
This is a summary of the European public assessment report (EPAR) for Qtern. It explains how the
Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is
not intended to provide practical advice on how to use Qtern.
For practical information about using Qtern, patients should read the package leaflet or contact their
doctor or pharmacist.
What is Qtern and what is it used for?
Qtern is used to treat adults with type 2 diabetes to improve control of their blood glucose (sugar)
levels. It contains the active substances saxagliptin and dapagliflozin.
Qtern is used in patients whose blood glucose levels are not satisfactorily controlled with:
metformin and one of the components of Qtern;
a sulphonylurea and one of the components of Qtern;
metformin, a sulphonylurea and one of the components of Qtern.
Qtern can also be used to replace saxagliptin and dapagliflozin taken as separate tablets.
How is Qtern used?
Qtern is available as tablets (5 mg saxagliptin and 10 mg dapagliflozin) and can only be obtained with
a prescription. The recommended dose is one tablet taken once a day. For further information, see the
How does Qtern work?
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the levels
of glucose in the blood or when the body is unable to respond to insulin effectively. This leads to high
levels of glucose in the blood.
Qtern contains two different active substances, which work in different ways:
dapagliflozin works by blocking a protein in the kidneys called sodium-glucose co-transporter 2
(SGLT2). As blood is filtered by the kidneys, SGLT2 stops glucose in the bloodstream from being
passed out into the urine. By blocking the action of SGLT2, dapagliflozin causes more glucose to be
removed via the kidney, through the urine, thereby reducing the levels of glucose in the blood.
Dapagliflozin has been authorised in the European Union (EU) as Forxiga since 2012;
saxagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor. It works by blocking the breakdown of
incretin hormones in the body. These hormones are released after a meal and stimulate the
pancreas to produce insulin. By increasing levels of incretin hormones in the blood, saxagliptin
stimulates the pancreas to produce more insulin when blood glucose levels are high. Saxagliptin
does not work when the blood glucose is low. Saxagliptin also reduces the amount of glucose made
by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Saxagliptin has been authorised in the EU as Onglyza since 2009.
As a result of the action of both active substances, the blood glucose is reduced and this helps to
control type 2 diabetes.
What benefits of Qtern have been shown in studies?
Dapagliflozin in combination with saxagliptin (the same combination as in Qtern) was evaluated in 3
main studies involving 1,169 adults with type 2 diabetes. The main measure of effectiveness was the
change after 24 weeks of treatment in the level of a substance in the blood called glycosylated
haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
The first study included patients whose blood glucose levels were not satisfactorily controlled with
metformin alone. Results showed that when saxagliptin and dapagliflozin were taken together with
metformin, they decreased HbA1c levels by 1.5 percentage points after 24 weeks, compared with a
reduction of 0.9 percentage points with saxagliptin and metformin and 1.2 percentage points with
dapagliflozin and metformin. HbA1c levels were on average around 9% at the start of the study.
The second study included patients whose blood glucose levels were not satisfactorily controlled with
metformin and dapagliflozin. Results showed that adding saxagliptin to treatment with dapagliflozin
and metformin for 24 weeks reduced HbA1c levels by 0.5 percentage points, compared with a
reduction of 0.2 percentage points when placebo (a dummy treatment) was added to treatment with
dapagliflozin and metformin. HbA1c levels were around 8% at the start of the study.
A further study, which included patients not controlled with metformin and saxagliptin, showed that
adding dapagliflozin to treatment with saxagliptin and metformin for 24 weeks reduced HbA1c levels by
0.8 percentage points, compared with a reduction of 0.1 percentage points when placebo was added to
saxagliptin and metformin.
The company also provided studies that were used in the authorisation of Forxiga and Onglyza where
saxagliptin or dapagliflozin were used together with a sulphonylurea.
What are the risks associated with Qtern?
The most common side effects with Qtern (which may affect more than 1 in 10 people) are upper
respiratory tract infection (such as nose and throat infections) and, when used with a sulphonylurea,
hypoglycaemia (low blood glucose levels). For the full list of all side effects reported with Qtern, see
the package leaflet.
Qtern must not be used in people who are hypersensitive (allergic) to saxagliptin, dapagliflozin, any of
the other ingredients or who have ever had a serious allergic reaction to any DPP-4 or SGLT2 inhibitor.
Why is Qtern approved?
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Qtern’s benefits
are greater than its risks and recommended that it be approved for use in the EU.
The CHMP concluded that Qtern is effective when using it to replace saxagliptin and dapagliflozin taken
as separate tablets. The CHMP also considered Qtern to be effective at controlling blood glucose levels
when used in patients who were not satisfactorily controlled with metformin plus either saxagliptin or
dapagliflozin. Although both components of Qtern contribute to lowering blood glucose levels, the
effects of each may vary in different patients. The CHMP therefore considered that Qtern should only
be used in patients already receiving at least one component to avoid over-treatment and so that the
value of each component can be judged individually.
On the basis of previous studies with the individual components of Qtern used together with a
sulphonylurea, the CHMP also approved the combination of Qtern with a sulphonylurea.
Regarding its safety profile, Qtern was well tolerated with side effects being characteristic of SGLT2
and DDP-4 inhibitors.
What measures are being taken to ensure the safe and effective use of
Recommendations and precautions to be followed by healthcare professionals and patients for the safe
and effective use of Qtern have been included in the summary of product characteristics and the
Other information about Qtern
The European Commission granted a marketing authorisation valid throughout the European Union for
Qtern on 15 July 2016.
The full EPAR for Qtern can be found on the Agency’s website: ema.europa.eu/Find medicine/Human
medicines/European public assessment reports. For more information about treatment with Qtern, read
the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This summary was last updated in 07-2016.
B. PACKAGE LEAFLET
Package leaflet: Information for the patient
Qtern 5 mg/10 mg film-coated tablets
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:
What Qtern is and what it is used for
What you need to know before you take Qtern
How to take Qtern
Possible side effects
How to store Qtern
Contents of the pack and other information
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.
What you need to know before you take Qtern
Do not take Qtern:
if you are allergic to saxagliptin, dapagliflozin or any of the other ingredients of this medicine
(listed in section 6).
if you have had a serious allergic reaction to any other similar medicines (for example DPP-4
inhibitors like sitagliptin, linagliptin, alogliptin, or SGLT2 inhibitors like canagliflozin,
empagliflozin) that you take to control your blood sugar.
Do not take Qtern if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist,
or nurse before taking Qtern.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Qtern, and during treatment:
if you have “type 1 diabetes” (the type that usually starts when you are young, and your body
does not produce any insulin).
if you have or have had a disease of the pancreas.
if you have moderate or severe kidney problems.
if you have a condition that reduces your body’s ability to fight infections, such as a disease like
AIDS or from medicines that you might take after an organ transplant.
if you have moderate or severe liver problem.
if you experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst,
fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath,
a sweet or metallic taste in your mouth, or a different odour to your urine or sweat, contact a
doctor or the nearest hospital straight away. These symptoms could be a sign of “diabetic
ketoacidosis” – a rare but serious, sometimes life-threatening problem you can get with diabetes
because of increased levels of “ketone bodies” in your urine or blood, seen in tests. The risk of
developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol
consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to
major surgery or serious illness.
if you have or have had a serious hypersensitivity reaction or is suspected.
if you have a history of serious heart disease.
if you suffer from heart failure or you have other risk factors for developing heart failure such as
problems with your kidneys. Your doctor will advise you of the signs and symptoms of heart
failure. Symptoms can include, but are not limited to, increasing shortness of breath, rapid
increase in weight and swelling of the feet (pedal oedema). You should call your doctor,
pharmacist or nurse immediately if you experience any of these symptoms.
if you are on medicines to lower your blood pressure (anti-hypertensives) and have a history of
low blood pressure (hypotension). For more information, see section “Other medicines and
if you have very high levels of sugar in your blood which may make you dehydrated (lose too
much body fluid). Possible signs of dehydration are listed at the top of section 4. Tell your
doctor before you start taking Qtern if you have any of these signs.
if you have or develop nausea (feeling sick), vomiting or fever or if you are not able to eat or
drink. These conditions can cause dehydration. Your doctor may ask you to stop taking Qtern
until you recover to prevent dehydration.
if you often get infections of the urinary tract or have a serious infection of the urinary tract,
including urosepsis or pyelonephritis, which can cause fever and/or chills, burning sensation
when passing water (urinating), blood in urine, pain in your back or side. You should call your
doctor, pharmacist or nurse immediately if you experience any of these symptoms.
if you are 75 years old or older.
if you are taking a medicine to lower your blood sugar, such as insulin or sulphonylureas.
if you are taking another medicine for diabetes that contains “pioglitazone”.
if you have an increase in the amount of red blood cells in your blood, seen in tests.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before
Diabetic skin lesions (skin damage such as sores or ulcers) are a common complication of diabetes.
Rash has been seen with both saxagliptin and dapagliflozin when given separately (see section 4). You
are advised to follow the recommendations for skin care that you are given by your doctor or nurse.
Like for all diabetic patients it is important to check your feet regularly and adhere to any other advice
regarding foot care given by your health care professional.
Talk to your doctor immediately if you develop a combination of symptoms of pain, tenderness,
redness, or swelling of the genitals or the area between the genitals and the anus with fever or feeling
generally unwell. These symptoms could be a sign of a rare but serious or even life-threatening
infection, called necrotising fasciitis of the perineum or Fournier’s gangrene which destroys the tissue
under the skin. Fournier’s gangrene has to be treated immediately.
Your kidneys should be checked before you start taking and whilst you are on this medicine.
Because of how Qtern works, your urine will test positive for sugar while you are on this medicine.
Children and adolescents
Qtern is not recommended for children and adolescents under 18 years of age, because it has not been
studied in these patients.
Other medicines and Qtern
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other
Especially tell your doctor:
if you are taking a medicine used to increase the amount of water you pass out of the body
(diuretic). Your doctor may ask you to stop taking Qtern. Possible signs of losing too much fluid
from your body are listed at the top of section 4.
if you are using medicines containing any of the following active substances:
phenobarbital or phenytoin.
These may be used to control fits (seizures) or
Dexamethasone – a steroid medicine. This may be used to treat inflammation in different
body parts and organs.
Rifampicin. This is an antibiotic used to treat infections such as tuberculosis.
Ketoconazole. This may be used to treat fungal infections.
Diltiazem. This is a medicine used to treat angina (chest pain) and lower blood pressure.
If any of the above apply to you (or if you are not sure), talk to your doctor before taking Qtern.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine. Qtern is not recommended during
pregnancy and your doctor will ask you to stop taking this medicine if you become pregnant. Talk to
your doctor about the best way to control your blood sugar while you are pregnant.
You should not use Qtern if you are breast-feeding. It is not known if this medicine passes into human
breast milk. Talk to your doctor if you would like to or are breast-feeding before taking this medicine.
Driving and using machines
Qtern is not expected to affect you being able to drive a car or use any tools or machines. If you feel
dizzy while taking Qtern, do not drive or use any tools or machines. Taking this medicine can cause
blood sugar levels to fall too low (hypoglycaemia), which may cause symptoms such as shaking,
sweating and change in vision, and may affect your ability to drive and use machines.
Qtern contains lactose
Qtern contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicine.
How to take Qtern
Always take this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or
nurse if you are not sure.
How much to take
The recommended dose is one tablet a day.
Taking this medicine
Swallow the tablet whole with half a glass of water.
You can take your tablet with or without food.
You can take the tablet at any time of the day. However, try to take it at the same time each day.
This will help you to remember to take it.
Your doctor may prescribe other medicines to lower the amount of sugar in your blood. Remember to
take other medicine(s) as your doctor has told you. This will help get the best results for your health.
Diet and exercise
To control your diabetes, you still need to keep to diet and exercise, even when you are taking this
medicine. So it is important to keep following the advice about diet and exercise from your doctor,
pharmacist or nurse. In particular, if you are following a diabetic weight control diet, continue to
follow it while you are taking Qtern.
If you take more Qtern than you should
If you take more Qtern tablets than you should, talk to a doctor or go to a hospital straight away. Take
the medicine pack with you.
If you forget to take Qtern
What to do if you forget to take a tablet.
If it is less than 12 hours since you should have taken your dose, take a dose of Qtern as soon as
you remember. Then take your next dose at the usual time.
If it is more than 12 hours since you should have taken your dose, skip the missed dose. Then
take your next dose at the usual time.
Do not take a double dose of Qtern to make up for a forgotten dose.
If you stop taking Qtern
Do not stop taking Qtern without talking to your doctor first. Your blood sugar may increase without
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms need immediate medical attention:
Stop taking Qtern and see a doctor straight away if you notice any of the following serious side
Symptoms of a serious allergic reaction seen rarely, (may affect up to 1 in 1,000 people), which
Raised red patches on your skin (hives)
Swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or
may prescribe a medicine to treat
allergic reaction and a different
medicine for your diabetes.
Pancreatitis, seen uncommonly (may affect up to 1 in 100 people): severe and persistent pain in
the abdomen (stomach area) which might reach through to your back, as well as nausea and
vomiting, as it could be a sign of an inflamed pancreas.
Dehydration, (loss of too much fluid from your body), seen uncommonly (may affect up to
1 in 100 people).
These are signs of dehydration:
- very dry or sticky mouth, feeling very thirsty
- feeling very sleepy or tired
- passing little or no water (urine)
- fast heart beat.
Urinary tract infection, seen commonly (may affect up to 1 in 10 people).
These are signs of a severe infection of the urinary tract:
- fever and/or chills
- burning sensation when passing water (urinating)
- pain in your back or side.
Although uncommon, if you see blood in your urine, tell your doctor immediately.
Low blood sugar levels (hypoglycaemia), seen very commonly (may affect more than 1 in
10 people) if used with other diabetes medicines known to cause hypoglycaemia.
These are the signs of low blood sugar:
- shaking, sweating, feeling very anxious, fast heart beat
- feeling hungry, headache, change in vision
- a change in your mood or feeling confused.
Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the
Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people)
These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions):
- increased levels of “ketone bodies” in your urine or blood
- rapid weight loss
- feeling sick or being sick
- stomach pain
- excessive thirst
- fast and deep breathing
- unusual sleepiness or tiredness
- a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to
your urine or sweat.
This may occur regardless of blood glucose level. Your doctor may decide to temporarily or
permanently stop your treatment with Qtern.
Necrotising fasciitis of the perineum or Fournier’s gangrene, a serious soft tissue infection of the
genitals or the area between the genitals and the anus.
Stop taking Qtern and see a doctor or nurse straight away, if you notice any of the serious side effects
Other side effects when taking Qtern alone or in combination with metformin:
genital infection (thrush) of your penis or vagina (signs may include irritation, itching, unusual
discharge or odour)
passing more water (urine) than usual or needing to pass water more often
changes in the amount of cholesterol or fats in your blood (shown in tests)
increases in the amount of red blood cells in your blood (shown in tests)
decreases in creatinine renal clearance (shown in tests)
severe joint pain (arthralgia)
infection of the upper chest or lungs
infection of the sinuses with a feeling of pain and fullness behind your cheeks and eyes
inflamed nose or throat (nasopharyngitis) (signs of this may include a cold or a sore throat)
stomach ache and indigestion (dyspepsia)
inflamed stomach or gut usually caused by an infection (gastroenteritis)
headache, muscle pain (myalgia)
vomiting, inflammation of the stomach (gastritis)
changes in laboratory tests (for example creatinine renal clearance decreased or haematocrit
awakening from sleep at night to pass urine
increases in creatinine or urea (shown in laboratory blood tests)
decrease in kidney function
skin rash that may include raised bumps, skin irritation, or unpleasant itchiness
difficulties in getting or maintaining an erection (erectile dysfunction).
itching in the genital area (pruritus genital or vulvovaginal pruritus) or discomfort while
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the national reporting
system listed in Appendix V. By reporting side effects you can help provide more information on the
safety of this medicine.
How to store Qtern
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the blister and carton after ‘EXP’.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.
Contents of the pack and other information
What Qtern contains
The active substances are saxagliptin and dapagliflozin.
Each tablet contains saxagliptin hydrochloride equivalent to 5 mg saxagliptin and
dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.
The other ingredients are:
tablet core: microcrystalline cellulose (E460i), croscarmellose sodium (E468), anhydrous
lactose (see section 2 ‘Qtern contains lactose’), magnesium stearate (E470b), dental type silica
film-coating: polyvinyl alcohol (E1203), macrogol 3350, titanium dioxide (E171), talc
(E553b), yellow iron oxide (E172), red iron oxide (E172).
printing ink: shellac, indigo carmine aluminium lake (E132).
What Qtern looks like and contents of the pack
Qtern 5 mg/10 mg film-coated tablets are light brown to brown, biconvex, round, film-coated tablets,
with “5/10” printed on one side, and “1122” printed on the other side, in blue ink.
Qtern 5 mg/10 mg tablets are available in aluminium blisters in pack sizes of 14, 28, or 98 film-coated
tablets in calendar blisters and 30 film-coated tablets in blister.
Not all pack sizes may be marketed in your country.
Marketing Authorisation Holder
SE-151 85 Södertälje
SE-151 85 Södertälje
AstraZeneca UK Limited
Silk Road Business Park
Cheshire SK10 2NA
Tinsdaler Weg 183
For any information about this medicine, please contact the local representative of the Marketing
Tel: +32 2 370 48 11
UAB AstraZeneca Lietuva
Tel: +370 5 2660550
АстраЗенека България ЕООД
Тел.: +359 2 4455000
Tél/Tel: +32 2 370 48 11
AstraZeneca Czech Republic s.r.o.
Tel: +420 222 807 111
Tel.: +36 1 883 6500
Tlf: +45 43 66 64 62
Associated Drug Co. Ltd
Tel: +356 2277 8000
Tel: +49 41 03 7080
Tel: +31 79 363 2222
Tel: +372 6549 600
Tlf: +47 21 00 64 00
Τηλ: +30 2 106871500
AstraZeneca Österreich GmbH
Tel: +43 1 711 31 0
AstraZeneca Farmacéutica Spain, S.A.
Tel: +34 91 301 91 00
AstraZeneca Pharma Poland Sp. z o.o.
Tel.: +48 22 245 73 00
Tél: +33 1 41 29 40 00
AstraZeneca Produtos Farmacêuticos, Lda.
Tel: +351 21 434 61 00
Tel: +385 1 4628 000
AstraZeneca Pharma SRL
Tel: +40 21 317 60 41
AstraZeneca Pharmaceuticals (Ireland) DAC
Tel: +353 1609 7100
AstraZeneca UK Limited
Tel: +386 1 51 35 600
Sími: +354 535 7000
AstraZeneca AB, o.z.
Tel: +421 2 5737 7777
Tel: +39 02 9801 1
Puh/Tel: +358 10 23 010
Αλέκτωρ Φαρµακευτική Λτδ
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SIA AstraZeneca Latvija
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AstraZeneca UK Ltd
Tel: +44 1582 836 836
This leaflet was last revised in
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: