Glyxambi 25 mg/5 mg film-coated tablets

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Glyxambi 10mg/5mg film-coated tablets

Glyxambi 25mg/5mg film-coated tablets

empagliflozin/linagliptin

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Glyxambi is and what it is used for
2. What you need to know before taking Glyxambi
3. How to take Glyxambi
4. Possible side effects
5. How to store Glyxambi
6. Contents of the pack and other information

1. What Glyxambi is and what it is used for

What Glyxambi is

Glyxambi contains two active substances called empagliflozin and linagliptin. Each belongs to a group of medicines known as “oral antidiabetics”. These medicines are taken by mouth to treat type 2 diabetes.

What is type 2 diabetes?

Type 2 diabetes is a condition caused by your genes and your lifestyle. If you have type 2 diabetes, your pancreas may not produce enough insulin to control the level of glucose in your blood, and your body is unable to use its own insulin effectively. This leads to high levels of glucose in the blood, which can cause medical problems such as heart disease, kidney disease, blindness, and poor circulation in your limbs.

How Glyxambi works

Empagliflozin belongs to a group of medicines called sodium-glucose cotransporter 2 (SGLT2) inhibitors. It works by blocking the SGLT2 protein in the kidneys. This causes blood sugar (glucose) to be removed from the body through the urine.

Linagliptin works differently, specifically by making the pancreas produce more insulin to reduce blood glucose levels. This is achieved by blocking a protein called DPP-4.

Together, Glyxambi reduces the amount of glucose in the blood.

What Glyxambi is used for

• Glyxambi is added to metformin and/or a sulfonylurea (SU) to treat type 2 diabetes in adult patients aged 18 years and older whose diabetes cannot be controlled when treated with metformin and/or a sulfonylurea in combination with empagliflozin, or when treated with metformin and/or a sulfonylurea in combination with linagliptin.

• Glyxambi may also be used as an alternative to taking empagliflozin and linagliptin as separate tablets. To avoid overdose, if you are taking this medicine, do not continue taking empagliflozin and linagliptin tablets separately.

It is important that you follow the diet and exercise plan recommended by your doctor, pharmacist, or nurse.

2. What you need to know before taking Glyxambi

Do not take Glyxambi

• if you are allergic to empagliflozin, linagliptin, any other SGLT2 inhibitor (e.g., dapagliflozin, canagliflozin), any other DPP\‑4 inhibitor (e.g., sitagliptin, vildagliptin), or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before starting this medicine and during treatment:

• if you have “type 1 diabetes”. This type of diabetes usually starts at a young age and your body produces no insulin. You should not take Glyxambi if you have type 1 diabetes.

• if you experience rapid weight loss, nausea or vomiting, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual drowsiness or tiredness, sweet smell on your breath, sweet or metallic taste in your mouth, or unusual odor in your urine or sweat, contact your doctor or the nearest hospital immediately and stop taking this medicine until you speak with your doctor. These symptoms may be signs of “diabetic ketoacidosis”, a rare but serious, sometimes potentially fatal condition that can occur in diabetes due to increased levels of “ketone bodies” in your blood or urine, detected by laboratory tests. The risk of developing diabetic ketoacidosis may increase with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or increased insulin requirements due to major surgery or serious illness.

• if you are taking other antidiabetic medicines known as “sulfonylureas” (e.g., glimepiride, glipizide) or using insulin. Your doctor may want to reduce your dose of these medicines when taken together with Glyxambi to avoid blood sugar levels becoming too low (hypoglycaemia).

• if you have or have had a disease of the pancreas.

• if you have severe kidney problems. Your doctor may limit your daily dose or recommend another medicine (see also section 3, “How to take Glyxambi”).

• if you have severe liver problems. Your doctor may recommend another medicine.

• if you are at risk of dehydration, for example:

• if you have nausea or vomiting, diarrhoea, fever, or are unable to eat or drink

• if you are taking medicines that increase urine production (diuretics) or that lower blood pressure

• if you are over 75 years old

Possible signs are listed in section 4 under “dehydration”. Your doctor may ask you to stop taking Glyxambi until you recover to prevent excessive fluid loss. Ask about ways to avoid dehydration.

• if you have an increase in the proportion of red blood cells in your blood (haematocrit), observed in blood laboratory tests (see also section 4, “Possible side effects”).

Contact your doctor if you experience any of the following during treatment with Glyxambi:

• if you develop symptoms of acute pancreatitis, such as severe and persistent stomach (abdominal) pain. Possible signs are listed in section 4, “Possible side effects”. Your doctor may need to change your treatment.
• if you develop a serious infection in the kidney or urinary tract with fever. Your doctor may ask you to stop taking Glyxambi until you recover.
• if you notice blisters on the skin, which could be a sign of a condition called bullous pemphigoid. Your doctor may advise you to stop taking Glyxambi.

Contact your doctor immediately if you experience a combination of symptoms such as pain, tenderness, redness or swelling of the genitals or the area between the genitals and the anus, together with fever or general malaise. These symptoms could be signs of a rare but serious, even potentially fatal infection called necrotizing fasciitis of the perineum or Fournier’s gangrene, which destroys tissue under the skin. Fournier’s gangrene requires immediate treatment.

Foot care

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

Kidney function

Before starting treatment with Glyxambi, and regularly during treatment, your doctor will check how well your kidneys are working.

Glucose in urine

Because of how this medicine works, your urine will test positive for glucose while you are taking this medicine.

Children and adolescents

This medicine is not recommended for children and adolescents under 18 years of age because linagliptin is not effective in children and adolescents aged 10 to 17 years. It is unknown whether this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Glyxambi

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, you must tell your doctor if you are taking the following medicines:

• other antidiabetic medicines such as insulin or a sulfonylurea. Your doctor may decide to reduce the dose of these other medicines to prevent your blood glucose levels from becoming too low.
• medicines used to remove water from your body (diuretics). Your doctor may ask you to stop taking Glyxambi.
• medicines that could affect how empagliflozin or linagliptin are broken down in your body, such as rifampicin (an antibiotic used to treat tuberculosis) or certain medicines used to treat seizures (such as carbamazepine, phenobarbital or phenytoin). The effect of Glyxambi may be reduced.
• lithium, as Glyxambi may reduce the amount of lithium in your blood.

Pregnancy, breast-feeding and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, talk to your doctor before using this medicine.

It is unknown whether Glyxambi is harmful to the unborn baby. As a precautionary measure, it is preferable to avoid using this medicine during pregnancy.

It is unknown whether the active substances of Glyxambi pass into breast milk. Do not use this medicine if you are breast-feeding.

It is unknown whether Glyxambi has effects on fertility in humans.

Driving and using machines

The effect of Glyxambi on the ability to drive and use machines is minor.

Taking this medicine together with sulfonylureas or insulin may cause your blood glucose levels to become too low (hypoglycaemia), which may cause symptoms such as trembling, sweating and changes in vision that could affect your ability to drive and use machines. Do not drive or operate tools or machinery if you experience any of these symptoms while taking Glyxambi.

3. How to take Glyxambi

Follow exactly the instructions your doctor has given you for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

How much to take

The usual starting dose is one Glyxambi 10 mg/5 mg film-coated tablet (10 mg empagliflozin and 5 mg linagliptin) once daily.

Your doctor will decide whether your dose needs to be increased to one Glyxambi 25 mg/5 mg film-coated tablet (25 mg empagliflozin and 5 mg linagliptin) once daily. If you are already taking 25 mg empagliflozin and 5 mg linagliptin as separate tablets and are switching to Glyxambi, you may start directly with Glyxambi 25 mg/5 mg.

Renal impairment

Consult your doctor if you have kidney problems. Your doctor may limit your dose or decide to use an alternative medicine.

Hepatic impairment

Consult your doctor if you have severe hepatic impairment. The use of Glyxambi is not recommended, and your doctor may decide to use an alternative medicine.

How to take this medicine

• Swallow the tablet whole with water.
• You may take Glyxambi with or without food.
• You may take the tablet at any time of day. However, try to take it at the same time each day. This will help you remember to take it.

Your doctor may prescribe Glyxambi together with another antidiabetic medicine. Remember to take all your medicines exactly as your doctor has instructed to achieve the best results for your health.

Appropriate diet and exercise help your body use blood glucose more effectively. It is important to follow the diet and exercise plan recommended by your doctor while taking Glyxambi.

If you take more Glyxambi than you should

If you take more of this medicine than you should, consult a doctor or go to hospital immediately. Take the medicine pack with you.

If you forget to take Glyxambi

If you forget to take a tablet, what you should do depends on how long it is until your next dose:

• If there are 12 hours or more until your next dose, take Glyxambi as soon as you remember. Then take your next dose at the usual time.
• If there are less than 12 hours until your next dose, skip the missed dose. Then take your next dose at the usual time.
• Do not take a double dose of this medicine to make up for a missed dose.

If you stop taking Glyxambi

Do not stop taking this medicine without first consulting your doctor, unless you suspect you have diabetic ketoacidosis (see section 2 “Warnings and precautions”). Your blood glucose levels may increase if you stop treatment with Glyxambi.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact a doctor or the nearest hospital immediately if you experience any of the following side effects:

Diabetic ketoacidosis, reported rarely (may affect up to 1 in 1,000 people)

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

• increased levels of “ketone bodies” in your urine or blood
• rapid weight loss
• nausea or vomiting
• stomach pain
• excessive thirst
• fast and deep breathing
• confusion
• drowsiness or unusual tiredness
• sweet-smelling breath, sweet or metallic taste in the mouth, or unusual odour in urine or sweat

This may occur regardless of your blood glucose level. Your doctor may decide to temporarily or permanently discontinue treatment with this medicine.

Contact your doctor immediately if you notice any of the following side effects:

Allergic reactions, reported uncommonly (may affect up to 1 in 100 people)

This medicine may cause allergic reactions, which can be serious, including hives (urticaria) and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing (angioedema).

Inflammation of the pancreas (pancreatitis), reported uncommonly

This medicine may cause pancreatitis, which usually presents as persistent, severe abdominal (stomach) pain that may extend to the back, often accompanied by nausea or vomiting. Your doctor will need to change your treatment.

Low blood sugar level (hypoglycaemia), reported frequently (may affect up to 1 in 10 people)

If you take Glyxambi with another medicine that can cause low blood glucose levels, such as a sulphonylurea or insulin, you are at risk of having blood glucose levels that are too low (hypoglycaemia). Signs of too low blood glucose levels include:

• trembling, sweating, feeling very anxious or confused, or rapid heartbeat
• excessive hunger, headache

Your doctor will advise you on how to treat low blood glucose levels and what to do if you experience any of the signs listed above. If you have symptoms of low blood glucose, take glucose tablets, eat a snack high in glucose, or drink fruit juice. Check your blood glucose if possible, and rest.

Urinary tract infection, reported frequently

Signs of a urinary tract infection include:

• burning sensation when urinating
• cloudy-looking urine
• pelvic pain or pain in the middle of the back (when the kidneys are infected)

The urgency to urinate or urinating more frequently may be due to how this medicine works, but they can also be signs of a urinary tract infection. If you experience an increase in these symptoms, contact your doctor.

Loss of body fluids (dehydration), reported uncommonly

Signs of dehydration are not specific, but may include:

• unusual thirst
• dizziness or lightheadedness when standing up
• fainting or loss of consciousness

Other side effects while taking Glyxambi:

Frequently observed

• genital fungal infections, such as candidiasis
• inflammation of the nose or throat (nasopharyngitis)
• cough
• urinating more than normal or need to urinate more often
• itching (pruritus)
• skin rash
• increased blood amylase enzyme
• increased pancreatic lipase enzyme
• thirst
• constipation

Uncommonly observed

• straining or pain when emptying the bladder
• blood tests may show changes in blood fat levels, an increase in the number of red blood cells (increased haematocrit), and changes related to kidney function (decrease in glomerular filtration rate and increase in blood creatinine)

Rarely observed

• mouth pain
• necrotizing fasciitis of the perineum or Fournier’s gangrene, a serious infection of the genital or perineal soft tissues

Very rarely observed

• inflammation of the kidneys (tubulointerstitial nephritis)

Frequency not known (cannot be estimated from available data)

• blisters on the skin (bullous pemphigoid)

Reporting of side effects

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

5. Storage of Glyxambi

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

Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice that the packaging is damaged or shows any signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Glyxambi

Glyxambi 10 mg/5 mg film-coated tablets

• The active substances are empagliflozin and linagliptin. Each film-coated tablet contains 10 mg of empagliflozin and 5 mg of linagliptin.
• Other components are:
  Tablet core: mannitol (E421), pregelatinized starch (from maize), maize starch, copovidone, crospovidone, talc, and magnesium stearate.
  Film coating: hypromellose, mannitol (E421), talc, titanium dioxide (E171), macrogol 6000, and yellow iron oxide (E172).

Glyxambi 25 mg/5 mg film-coated tablets

• The active substances are empagliflozin and linagliptin. Each film-coated tablet contains 25 mg of empagliflozin and 5 mg of linagliptin.
• Other components are:
  Tablet core: mannitol (E421), pregelatinized starch (from maize), maize starch, copovidone, crospovidone, talc, and magnesium stearate.
  Film coating: hypromellose, mannitol (E421), talc, titanium dioxide (E171), macrogol 6000, and red iron oxide (E172).

Appearance of the product and contents of the pack

Glyxambi 10 mg/5 mg film-coated tablets are pale yellow, triangular-shaped, flat-faced tablets with bevelled edges. They are marked with the inscription “10/5” on one side and the Boehringer Ingelheim logo on the other. Each face of the tablet measures 8 mm in length.

Glyxambi 25 mg/5 mg film-coated tablets are pale pink, triangular-shaped, flat-faced tablets with bevelled edges. They are marked with the inscription “25/5” on one side and the Boehringer Ingelheim logo on the other. Each face of the tablet measures 8 mm in length.

Glyxambi is available in single-dose, pre-cut PVC/PVDC/aluminium blisters.

Pack sizes are 7 × 1, 10 × 1, 14 × 1, 28 × 1, 30 × 1, 60 × 1, 70 × 1, 90 × 1, and 100 × 1 film-coated tablets.

Only certain pack sizes may be marketed in your country.

Marketing Authorization Holder

Boehringer Ingelheim International GmbH
Binger Str. 173
55216 Ingelheim am Rhein
Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
55216 Ingelheim am Rhein
Germany

Rottendorf Pharma GmbH
Ostenfelder Strasse 51 – 61
59320 Ennigerloh
Germany

Further information on this medicinal product is available upon request from the local representative of the Marketing Authorization Holder.

Date of the most recent review of this leaflet: {MM/YYYY}.

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