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 reduced kidney function.
• 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 Qtern” below.
• 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 taking Qtern.

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. Contact your doctor if you encounter blistering of the skin, as it may be a sign for a condition called bullous pemphigoid. Your doctor may ask you to stop Qtern.

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.

Kidney function

Your kidneys should be checked before you start taking and whilst you are on this medicine.

Urine tests

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 medicines.

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:
  • Carbamazepine, phenobarbital or phenytoin. These may be used to control fits (seizures) or chronic pain.
  • 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.

Sodium content

Qtern contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free’.