5 mg / 10 mg film-coated tablets
saxagliptin / dapagliflozin
What Qtern is and what it is used for
Qtern contains the active substances saxagliptin and dapagliflozin. Both belong to a group of drugs called “oral antidiabetics”. These drugs are taken by mouth for diabetes.
Qtern is used for a type of diabetes called “type 2 diabetes mellitus” in adult patients (18 years and older). If you have type 2 diabetes, your pancreas does not produce enough insulin or your body cannot use the insulin that is formed properly. This leads to a high blood sugar level. The two active substances in Qtern work in different ways to help control your blood sugar levels and remove excess sugar from the body via the urine.
Qtern is used to treat type 2 diabetes when:
- saxagliptin or dapagliflozin alone or in combination with metformin and/or sulfonylureas cannot control your diabetes.
- You are already being treated with saxagliptin and dapagliflozin, but taking them separately. 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.
What you need to know before taking 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 severe allergic reaction to any other similar medicine (for example, DPP-4 inhibitors such as sitagliptin, linagliptin, and alogliptin, or SGLT-2 inhibitors such as canagliflozin and empagliflozin) that you are taking to control your blood sugar.
Do not take Qtern if any of the above apply to you. If you have any further questions, ask your doctor, pharmacist, or nurse before taking this medicine.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Qtern and during treatment:
- if you have or have had a disease of the pancreas called pancreatitis. Possible symptoms of pancreatitis are listed in section 4.
- if you are taking medicines that lower blood pressure (blood pressure-lowering drugs) and have had low blood pressure ( hypotension ). For more information, see the section “Other medicines and Qtern” below.
- if you have very high levels of sugar in your blood that can cause you to become dehydrated (lose too much body fluid). Possible symptoms of dehydration are listed at the beginning of section 4. Tell your doctor before taking Qtern if you have any of these signs.
- if you get nausea, vomiting, or fever or if you can not eat or drink. These conditions can cause dehydration. Your doctor may ask you to stop taking Qtern until you have recovered to prevent dehydration.
- if you have moderate or severe liver disease.
- if you experience rapid weight loss, nausea or vomiting, abdominal pain, severe thirst, rapid and deep breathing, confusion, unusual sleepiness or fatigue, a sweet breath, a sweet taste or metallic taste in the mouth, or a different smell of urine or sweat, contact a doctor or the nearest hospital immediately. These symptoms can be signs of “diabetic ketoacidosis” – a rare but serious, sometimes life-threatening problem that you can get in diabetes due to increased levels of “ketone bodies” in the urine or blood. This is shown in tests. The risk of developing diabetic ketoacidosis may increase with prolonged fasting, high alcohol consumption, dehydration, sudden decrease in insulin dose, or a greater need for insulin due to major surgery or a serious illness.
- if you have type 1 diabetes it means that your body does not produce any insulin. Qtern should not be used to treat this condition.
- if you have or have had a severe hypersensitivity reaction ( allergic reaction ) or if one is suspected. Signs of a severe allergic reaction are listed in section 4.
- if you often get urinary tract infections.
- if you have had a serious heart condition.
- if you have heart failure or other risk factors for developing heart failure such as kidney problems. Your doctor will inform you about the signs and symptoms of heart failure. Symptoms may include but are not limited to, increased shortness of breath, rapid weight gain, and swollen feet (foot edema). You should contact your doctor, pharmacist, or nurse immediately if you experience any of these symptoms.
- if you have severe joint pain.
- if you have a condition that reduces your body’s ability to fight infection, for example, if you have a disease such as AIDS or if you have undergone an organ transplant.
- if you are taking medicines to lower your blood sugar such as sulfonylureas (see “Other medicines and Qtern”).
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Qtern.
Diabetic skin lesions (such as ulcers or rot) are a common complication of diabetes. Skin rashes have occurred with both saxagliptin and dapagliflozin when given separately (see section 4). You are advised to follow the skincare recommendations given to you by your doctor or nurse. Contact your doctor if you have blisters on your skin as it may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking Qtern.
As with all diabetic patients, it is important to check your feet regularly and follow the advice on foot care provided by healthcare professionals.
Talk to your doctor immediately if you experience a combination of symptoms such as pain, tenderness, redness, or swelling in the genitals or the area between the genitals and the rectum along with fever or general malaise. These symptoms can be a sign of a rare but serious and in the worst-case life-threatening infection called necrotizing fasciitis of the perineum or Fournier’s gangrene which destroys the tissue under the skin. Fournier’s gangrene must be treated immediately.
Your kidneys should be checked before you start taking Qtern. During treatment with this medicine, your doctor will check your kidney function once a year, or more often if your kidney function deteriorates.
Because of the way Qtern works, your urine will show positive test results for sugar when you take this medicine.
Children and young people
Qtern is not recommended for use in children and adolescents below 18 years of age, as 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 medicines.
In particular, tell your doctor:
- If you are taking a medicine that is used to increase the amount of fluid that you expel from the body ( diuretics ). Your doctor may ask you to stop taking Qtern. Possible symptoms of loss of excess fluid from the body are listed at the beginning of section 4.
- If you are taking other medicines that reduce the amount of sugar in your blood such as sulphonylureas (eg glimepiride). Your doctor may need to lower the dose of one of the other medicines to prevent your blood sugar levels from getting too low (hypoglycemia).
- If you are taking medicines containing any of the following active substances, which may affect the breakdown of Qterns in your body. Your doctor may ask you to check your blood sugar levels more often while you are taking these medicines.
- Carbamazepine, phenobarbital or phenytoin . These drugs can be used to control seizures or chronic pain.
- Dexamethasone – a cortisone preparation. This drug can be used to treat inflammation in various parts of the body and organs.
- Rifampicin. This is an antibiotic used to treat infections such as tuberculosis.
- Ketoconazole. This can be used to treat fungal infections.
- Diltiazem. This is a medicine used to treat angina (chest pain) and to lower blood pressure.
If any of the above apply to you (or you are not sure), talk to your doctor before taking Qtern.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, 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 breastfeeding. It is not known if this medicine passes into breast milk. Talk to your doctor if you want to breastfeed or if you are breastfeeding before taking this medicine.
Driving and using machines
Qtern is not expected to affect your ability to drive or use tools or machines. If you feel dizzy while taking this medicine, do not drive or use any tools or machines. Your blood sugar may drop to too low levels (hypoglycemia) if you take this medicine with other medicines that lower your blood sugar, e.g. sulfonylurea. This can cause symptoms such as tremors, sweating and vision changes 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.
Qtern contains sodium
Qtern contains less than 1 mmol (23 mg) sodium per liter dose, ie it is essentially ‘sodium-free’.
How to take Qtern
Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
How much to take
- The recommended dose is one tablet per day.
How to take this medicine
- Swallow the tablet whole with half a glass of water.
- You can take the tablet with or without food.
- You can take the tablet at any time during the day. However, try to take it at the same time each day. It will help you remember to take it.
Your doctor may prescribe other medicines to lower your blood sugar. Remember to take these other medicines according to your doctor’s instructions. It gives the best result for your health.
Diet and exercise
To control your diabetes, you need to eat the right diet and exercise, even while taking this medicine. Therefore, it is important to continue to follow the advice on diet and exercise that you have received from a doctor, pharmacist, or nurse. Especially if you are following a diabetic weight control diet, you should continue to follow it while taking Qtern.
If you take more Qtern than you should
If you have taken too many Qtern tablets, talk to a doctor or see 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 take your dose, take a dose of Qtern as soon as you remember. Then take the next dose at the usual time.
- If it is more than 12 hours since you would take your dose, skip the missed dose. Then take the 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 rise if you do not take this medicine.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Qtern and see a doctor as soon as possible if you notice any of the following serious side effects:
- Symptoms of a severe allergic reaction ( anaphylactic reaction, angioedema) are rare (may affect up to 1 in 1,000 people), which may include:
- raised red spots on your skin ( hives ),
- swelling of the face, lips, tongue, and throat, which may make it difficult to breathe or swallow.
Your doctor may prescribe a medicine to treat your allergic reaction and switch to another medicine for your diabetes.
- Pancreatitis is less common (may affect up to 1 in 100 people): Severe and persistent pain in the abdomen (stomach), which may radiate to the back, as well as nausea and vomiting, as this may be a sign of inflamed pancreas.
- Dehydration (loss of too much fluid from the body) is less common. Signs of dehydration are:
- very dry or sticky mouth, feeling of strong thirst,
- very sleepy or tired,
- little or no urine,
- fast heartbeat.
- Urinary tract infection is common (may affect up to 1 in 10 people). The following are symptoms of severe urinary tract infection:
- fever and/or chills,
- burning sensation when urinating (urination),
- back or side pain. Although uncommon, tell your doctor immediately if you notice blood in your urine.
- Low blood sugar levels (hypoglycemia) are very common (may affect more than 1 in 10 people) if you are taking other diabetes medicines that are known to cause hypoglycemia. The following are symptoms of low blood sugar:
- tremors, sweating, strong anxiety, rapid heartbeat,
- feeling hungry, headache, vision changes,
- mood swings or feelings of confusion. Your doctor can tell you how to treat low blood sugar levels and what to do if you get any of the above symptoms.
- Diabetic ketoacidosis , rare.These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions):
- elevated levels of “ketone bodies” in urine or blood,
- rapid weight loss,
- nausea or vomiting,
- abdominal pain,
- strong thirst,
- rapid and deep breathing,
- unusual drowsiness or fatigue,
- a sweet smell on the breath, a sweet taste or metallic taste in the mouth, or a different smell of urine or sweat. This can occur regardless of blood glucose level. Your doctor may decide to temporarily or permanently discontinue treatment with Qtern.
- Necrotizing fasciitis of the perineum or Fournier’s gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the rectum, is very rare (may affect up to 1 in 10,000 people).
Stop taking Qtern and see a doctor or nurse immediately if you notice any of the above serious side effects.
Other side effects when using Qtern alone or in combination with metformin:
- upper respiratory tract infections included:
- infection of the upper part of the chest or lungs,
- a sinus infection with a feeling of pain and pressure behind the cheeks and eyes ( sinusitis ),
- inflamed nose or throat ( nasopharyngitis ) (signs of this may include a cold or sore throat).
- genital infection (fungus) on the penis or vagina (may cause irritation, itching, abnormal discharge, or odor)
- back pain
- the greater amount of urine than usual or need to urinate more often
- changes in blood cholesterol or blood fat levels (shown by tests)
- increases in the number of red blood cells in the blood (shown by tests)
- decreased renal excretion of creatinine (shown by tests) at the beginning of treatment
- severe joint pain ( arthralgia )
- abdominal pain and indigestion ( dyspepsia )
- inflamed stomach or intestine, usually caused by an infection ( gastroenteritis )
- headache, muscle pain ( myalgia )
- vomiting, inflammation of the stomach ( gastritis )
- waking up at night to pee
- dry mouth
- weight loss
- increase in creatinine (shown in laboratory blood tests) at the beginning of treatment
- increase in urea (shown in laboratory blood tests)
- skin rash that may include raised spots, skin irritation, or unpleasant itching
- difficulty getting or maintaining an erection ( erectile dysfunction )
- fungal infection
- hypersensitivity reaction er
- genital itching (genital itching or vulvovaginal itching ) or discomfort when urinating.
No known frequency (can not be calculated from the available data)
- blisters on the skin (bullous pemphigoid )
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 the carton after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
- 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.
- Other ingredients are:
- core of the tablet: microcrystalline cellulose (E460i), croscarmellose sodium (E468) (see section 2 “Qtern contains sodium”), lactose (see section 2 “Qtern contains lactose”), magnesium stearate (E470b), dental type silica (E551).
- film coating: poly (vinyl alcohol) (E1203), macrogol (3350), titanium dioxide (E171), talc (E553b), yellow iron oxide (E172), red iron oxide (E172).
- printing ink: shellac, indigo carmine aluminum lacquer (E132).
What the medicine looks like and the contents of the pack
Qtern 5 mg / 10 mg film-coated tablets are light brown to brown, biconvex, 0.8 cm round, film-coated tablets with “5/10” printed on one side and “1122” printed on the other side with blue ink.
Qtern 5 mg / 10 mg tablets are available in aluminum blisters in pack sizes of 14, 28, or 98 film-coated tablets in calendar blisters and 30 film-coated tablets in blisters.
Not all pack sizes may be marketed in your country.
Marketing Authorisation Holder
SE-151 85 Södertälje
Contact the representative of the marketing authorization holder to find out more about this medicine
|Belgium / Belgique / BelgienAstraZeneca SA / NVTel: +32 2 370 48 11||LithuaniaUAB AstraZeneca LietuvaTel: +370 5 266 0550|
|BulgariaAustralia Bulgaria ЕООДTel: +359 2 4455000||Luxembourg / LuxemburgAstraZeneca SA / NVTel: +32 2 370 48 11|
|Czech RepublicAstraZeneca Czech Republic sroTel: +420 222 807 111||HungaryAstraZeneca Kft.Tel: +36 1 883 6500|
|DenmarkAstraZeneca A / STel: +45 43 66 64 62||MaltaAssociated Drug Co. Ltd.Tel: +356 2277 8000|
|GermanyAstraZeneca GmbHTel: +49 40 809034100||The NetherlandsAstraZeneca BVTel: +31 79 363 2222|
|EestiAstraZenecaTel: +372 6549 600||NorwayAstraZeneca ASTel: +47 21 00 64 00|
|GreeceAstraZeneca AECall: +30 2 106871500||AustriaAstraZeneca Österreich GmbHTel: +43 1 711 31 0|
|SpainAstraZeneca Pharmacéutica Spain, SATel: +34 91 301 91 00||PolandAstraZeneca Pharma Poland Sp. z ooTel: +48 22 245 73 00|
|FranceAstraZenecaTel: +33 1 41 29 40 00||PortugalAstraZeneca Pharmaceutical Products, Lda.Tel: +351 21 434 61 00|
|CroatiaAstraZeneca dooTel: +385 1 4628 000||RomaniaAstraZeneca Pharma SRLTel: +40 21 317 60 41|
|IrelandAstraZeneca Pharmaceuticals (Ireland) DACTel: +353 1609 7100||SloveniaAstraZeneca UK LimitedTel: +386 1 51 35 600|
|IcelandVistor hf.Tel: +354 535 7000||Slovak RepublicAstraZeneca AB, ozTel: +421 2 5737 7777|
|ItalyAstraZeneca SpATel: +39 02 9801 1||Finland / FinlandAstraZeneca OyTel: +358 10 23 010|
|.ΠροςAlexander the GreatCall: +357 2249 0305||SwedenAstraZeneca ABTel: +46 8 553 26 000|
|LatviaSIA AstraZeneca LatvijaTel: +371 67377100||United Kingdom (Northern Ireland)AstraZeneca UK LtdTel: +44 1582 836 836|