QTERN 5 MG/10 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Qtern 5 mg/10 mg film-coated tablets

saxagliptin/dapagliflozina

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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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. Storage of 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 dapagliflozina. Both belong to a group of medicines called “oral antidiabetics”. These medicines are taken by mouth for diabetes.

Qtern is used to treat a type of diabetes called “type 2 diabetes mellitus” in adult patients (18 years or older). If you have type 2 diabetes, your pancreas does not produce enough insulin or your body is unable to use the insulin it produces properly. This results in a high level of sugar in the blood. The two active substances in Qtern work in two different ways to help control your blood sugar level and remove excess sugar from your body through urine.

Qtern is used to treat type 2 diabetes when:

• saxagliptin or dapagliflozina alone, along with metformin and/or sulfonylurea, cannot control your diabetes.
• you are already being treated with saxagliptin and dapagliflozina as separate tablets. Your doctor may ask you to switch to this medicine.

It is important that you continue with the diet and exercise recommendations provided 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, dapagliflozina, 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 (such as DPP-4 inhibitors like sitagliptin, linagliptina, alogliptina, or SGLT2 inhibitors like canagliflozina, empagliflozina) that you take to control blood sugar.

Do not take Qtern if you have any of the above conditions. If you are not sure, consult your doctor, pharmacist, or nurse before taking this medicine.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Qtern and during treatment:

• if you have or have had a pancreatic disease called pancreatitis. Possible signs of pancreatitis are included in section 4.
• if you are taking medicines to lower blood pressure (antihypertensives) or have a history of low blood pressure (hypotension). For more information, see the section “Taking Qtern with other medicines” below.
• if you have very high blood sugar levels that can cause dehydration (your body loses too much fluid). Possible signs of dehydration are included in section 4. Inform your doctor before starting to take Qtern if you have any of these signs.
• if you have nausea (feeling sick), vomiting, or fever, or are unable 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 have moderate or severe liver problems.
• if you experience rapid weight loss, nausea, vomiting, stomach pain, excessive thirst, rapid and deep breathing, confusion, drowsiness, and unusual fatigue, sweet smell on your breath, a sweet or metallic taste in your mouth, or a different smell in your urine or sweat, contact a doctor or the nearest hospital immediately. These symptoms may be a sign of “diabetic ketoacidosis” - a rare but serious, potentially life-threatening problem that occurs with diabetes due to an increase in “ketone bodies” in your urine or blood, which is detected in laboratory tests. The risk of developing diabetic ketoacidosis may increase with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or increased need for insulin due to major surgery or serious illness.
• if you have “type 1 diabetes” and your body does not produce any insulin. Qtern should not be used to treat this condition.
• if you have had a severe allergic reaction or suspect you have. Possible signs of a severe allergic reaction are included in section 4.
• if you often have urinary tract infections.
• if you have a history of severe heart disease.
• if you have heart failure or have 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, a growing feeling of shortness of breath, rapid weight gain, and swelling of the feet (ankle edema). You should contact your doctor, pharmacist, or nurse immediately if you experience any of these symptoms.
• if you have severe joint pain.
• if your body's ability to fight infections is reduced, for example, if you have a disease such as AIDS or have had an organ transplant.
• if you are taking another medicine to lower blood sugar, such as sulfonylureas (see “Other medicines and Qtern”).

If you have any of the above conditions (or are unsure), consult your doctor, pharmacist, or nurse before taking Qtern.

Diabetic skin lesions (skin damage such as wounds or ulcers) are a common complication of diabetes. Skin rash has been observed with saxagliptin and dapagliflozina when given separately (see section 4). You are advised to follow the skin care recommendations provided by your doctor or nurse. Contact your doctor if you find blisters on your skin, as it may be a sign of a disease called bullous pemphigoid. Your doctor may ask you to stop taking Qtern.

As with all diabetic patients, it is important that you regularly check your feet and follow any other foot care advice provided by your healthcare professional.

Consult your doctor immediately if you experience a combination of symptoms of pain, tenderness, redness, or swelling of the genitals or the area between the genitals and anus, with fever or general feeling of being unwell. These symptoms could be a sign of a rare but serious, potentially life-threatening infection called necrotizing fasciitis of the perineum or Fournier's gangrene, which destroys tissue under the skin. Fournier's gangrene requires immediate treatment.

Kidney function

A review of kidney function should be performed before starting to take Qtern. During treatment with this medicine, your doctor will check your kidney function once a year or more frequently if your kidney function is worsening.

Urinalysis

Due to the way Qtern works, your urine will test positive for glucose while you are taking this medicine.

Children and adolescents

Qtern is not recommended for children and adolescents under 18 years of age, as it has not been studied in these patients.

Other medicines and Qtern

Taking Qtern with other medicines. Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

Especially inform your doctor:

• if you are taking a medicine used to increase the amount of fluid your body eliminates (diuretic).
• if you are taking another medicine that lowers blood sugar, such as sulfonylurea (e.g., glimepiride). Your doctor may want to reduce the dose of this and other medicines to avoid low blood sugar levels (hypoglycemia).
• if you are taking lithium, as Qtern may reduce the amount of lithium in your blood.
• if you are taking medicines that contain any of the following active substances, which may affect the breakdown of Qtern in your body. Your doctor may ask you to check your blood sugar levels more frequently while taking these medicines.
• Carbamazepine, phenobarbital, or phenytoin. These may be used to control seizures (convulsions) or chronic pain.
• Dexamethasone - a steroid medicine. It may be used to treat inflammation in different parts of the body and organs.
• Rifampicin. This is an antibiotic used to treat infections such as tuberculosis.
• Ketoconazole. It may be used to treat fungal infections.
• Diltiazem. This is a medicine used to treat angina (chest pain) and to lower blood pressure.

If you have any of the above conditions (or are unsure), consult 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 if you become pregnant, your doctor will ask you to stop taking this medicine. Consult your doctor about the best way to control your blood sugar during pregnancy.

Do not use Qtern if you are breast-feeding. It is not known if this medicine passes into human breast milk. Consult your doctor if you wish to or are breast-feeding before taking this medicine.

Driving and using machines

Qtern is unlikely to affect your ability to drive or use tools or machines. If you feel dizzy while taking this medicine, do not drive or use tools or machines. Taking this medicine with another medicine that lowers blood sugar, such as sulfonylurea, may cause low blood sugar levels (hypoglycemia). This can cause symptoms such as shaking, sweating, and changes in vision that may affect your ability to drive or use machines.

Qtern contains lactose

Qtern contains lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Qtern contains sodium

Qtern contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

3. How to take Qtern

Follow exactly the administration instructions of this medicine given by your doctor. If you are not sure, consult your doctor, pharmacist, or nurse again.

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 of the day. However, try to take it at the same time each day. This will help you remember to take it.

Your doctor may prescribe other medicines to lower blood sugar. Remember to take this (these) other medicine(s) following your doctor's instructions. This will help you get the best results for your health.

Diet and exercise

To control your diabetes, you should continue with diet and exercise, even when taking this medicine. Therefore, it is important that you continue with the diet and exercise recommendations provided by your doctor, pharmacist, or nurse. In particular, if you follow a weight-control diet for diabetics, continue with it while taking Qtern.

If you take more Qtern than you should

If you take more Qtern tablets than you should, consult your doctor or go to the hospital immediately. Take the medicine package with you.

If you forget to take Qtern

What to do if you forget to take a tablet.

• If it has been less than 12 hours since you should have taken the dose, take a dose of Qtern as soon as you remember. Then take the next dose at the usual time.
• If it has been more than 12 hours since you should have taken the dose, skip the missed dose. Take the next dose at the usual time.
• Do not take a double dose of Qtern to make up for missed doses.

If you stop taking Qtern

Do not stop taking Qtern without first consulting your doctor. Your blood sugar levels may increase without this medicine.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stop taking Qtern and consult a doctor immediately if you notice any of these serious adverse effects:

• Symptoms of a severe allergic reaction (anaphylactic reaction, angioedema), observed rarely, (may affect up to 1 in 1,000 people), which may include:
• skin rash,
• red raised hives on the skin (wheals),
• swelling of the face, lips, tongue, and throat that can cause difficulty breathing or swallowing.

Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.

• Pancreatitis,occurs infrequently (may affect up to 1 in 100 people): severe and persistent abdominal pain (stomach area) that can reach the back, as well as nausea and vomiting that could be a sign of pancreas inflammation.

• Urinary tract infection, occurs frequently (may affect up to 1 in 10 people).

These are the signs of a severe urinary tract infection:

• fever and/or chills,
• burning sensation when urinating,
• back pain or side pain.

Although it is infrequent, if you notice blood in your urine, inform your doctor immediately.

• Low blood sugar levels (hypoglycemia), observed very frequently (may affect more than 1 in 10 people) if used with other anti-diabetic medicines that are known to cause hypoglycemia.

The signs of low blood sugar are:

• chills, sweating, feeling of great anxiety, rapid heartbeat,
• feeling of hunger, headache, vision changes,
• mood changes or feeling of confusion.

Your doctor will explain how to treat low blood sugar levels and what to do if you experience any of the above signs.

• Diabetic ketoacidosis, has been observed rarely

These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions):

• increase in "ketone bodies" in your urine or blood,
• rapid weight loss,
• nausea or vomiting,
• stomach pain,
• excessive thirst,
• rapid and deep breathing,
• confusion,
• unusual sleepiness and fatigue,
• sweet smell in your breath, a sweet or metallic taste in your mouth, or a different smell in your urine or sweat.

This can occur regardless of blood glucose levels. Your doctor must decide whether to temporarily or permanently interrupt your treatment with Qtern.

• Necrotizing fasciitis of the perineumor Fournier's gangrene, a severe infection of the soft tissues of the genitals or the area between the genitals and the anus, seen very rarely (may affect up to 1 in 10,000 people).

Stop taking Qtern and consult a doctor or nurse immediately, if you notice any of the above serious adverse effects.

Other adverse effects of treatment with Qtern alone or in combination with metformin:

Very common

• upper respiratory tract infections including:
• chest infection or pneumonia,
• nasal sinus infection with a feeling of pain or pressure behind the cheekbones and eyes (sinusitis),
• inflammation of the nose or throat (nasopharyngitis) (the signs may also include runny nose or sore throat).

Common

• genital infections (candidiasis) of the penis or vagina (the signs may include irritation, itching, and abnormal discharge or odor)
• back pain
• increased urine production or need to urinate more frequently
• changes in cholesterol or lipid levels in the blood (observed in laboratory tests)
• increase in red blood cells in the blood (observed in laboratory tests)
• decrease in renal creatinine clearance (observed in laboratory tests) at the start of treatment
• dizziness
• fatigue
• severe joint pain (arthralgia)
• stomach pain and indigestion (dyspepsia)
• nausea
• diarrhea
• inflammation of the stomach or intestine usually caused by an infection (gastroenteritis)
• headache, muscle pain (myalgia)
• vomiting, stomach inflammation (gastritis)
• rash

Uncommon

• excessive loss of body fluids (dehydration, the signs may be very dry or sticky mouth, little or no urine; or rapid heartbeat)
• thirst
• constipation
• nocturnal awakenings due to the need to urinate
• dry mouth
• weight loss
• increase in creatinine (observed in blood tests) at the start of treatment
• increase in urea (observed in blood tests)
• skin rash that may include bumps, skin irritation, or unpleasant itching
• difficulty achieving or maintaining an erection (erectile dysfunction)
• fungal infection
• hypersensitivity reactions
• genital itching (genital pruritus or vulvovaginal pruritus) or discomfort while urinating.

Rare

• kidney inflammation (tubulointerstitial nephritis)

Unknown (frequency cannot be estimated from available data)

• appearance of blisters on the skin (bullous pemphigoid)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Qtern

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister pack and carton after EXP/CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Qtern

• The active substances are saxagliptin and dapagliflozin.

Each tablet contains saxagliptin hydrochloride equivalent to 5 mg of saxagliptin and dapagliflozin propanediol monohydrate equivalent to 10 mg of dapagliflozin.

• The other ingredients are:

• tablet core: microcrystalline cellulose (E460i), sodium croscarmellose (E468), (see section 2 "Qtern contains sodium"), lactose (see section 2 "Qtern contains lactose"), magnesium stearate (E470b), dental silica (E551).
• film coating: polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E553b), yellow iron oxide (E172), red iron oxide (E172).
• printing ink: shellac; aluminum lake indigo carmine (E132).

Appearance of the product and package contents

The film-coated Qtern 5 mg/10 mg tablets are light brown to brown, biconvex, round, 0.8 cm, film-coated. They are marked "5/10" on one side and "1122" on the other, in blue ink.

The 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 in packs of 30 film-coated tablets in blisters.

Not all pack sizes may be marketed in your country.

Marketing authorization holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of the last revision of this leaflet:

Other sources of information

Detailed information about this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/