Patient Information Leaflet

Glyxambi 10mg/5mg Film-Coated Tablets

Glyxambi 25mg/5mg Film-Coated Tablets

empagliflozina/linagliptina

Read this leaflet carefully before you start taking this medicine because 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. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section4.

1.What is Glyxambi and what it is used for

2.What you need to know before you start taking Glyxambi

3.How to take Glyxambi

4.Possible side effects

5.Storage of Glyxambi

6.Contents of the pack and additional information

What is Glyxambi

Glyxambi contains two active ingredients called empagliflozina and linagliptina. Each belongs to a group of medications called “oral antidiabetic drugs”. These medications are taken by mouth to treat type2 diabetes.

What is type2 diabetes?

Type2 diabetes is a disease that comes from your genes and lifestyle. If you have type2 diabetes, your pancreas may not produce enough insulin to control the level of glucose in your blood, and your body is unable to use your own insulin effectively. This leads to high levels of glucose in your blood, which can cause medical problems such as heart disease, kidney disease, blindness, and poor circulation in your extremities.

How Glyxambi works

Empagliflozina belongs to a group of medications called sodium‑glucose cotransporter2 (SGLT2) inhibitors. It works by blocking the SGLT2 protein in the kidneys. This causes the sugar (glucose) from the blood to be eliminated with the urine.

Linagliptina works in a different way, specifically by making the pancreas produce more insulin to reduce blood glucose levels. This is achieved by blocking a protein called DPP‑4.

As a result, Glyxambi reduces the amount of glucose in the blood.

What is Glyxambi used for

• Glyxambi is added to metformin and/or a sulfonylurea (SU) to treat type2 diabetes in adult patients aged 18years or older, whose diabetes cannot be controlled when treated with metformin and/or a sulfonylurea in combination with empagliflozina, or when treated with metformin and/or a sulfonylurea in combination with linagliptina.

• Glyxambi can also be used as an alternative to taking empagliflozina and linagliptina as separate tablets. To avoid an overdose, if you are taking this medication, do not take separate empagliflozina and linagliptina tablets.

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

Do not take Glyxambi

• if you are allergic to empagliflozina, linagliptina, any other SGLT2 inhibitor (e.g., dapagliflozina, canagliflozina), any other DPP-4 inhibitor (e.g., sitagliptina, vildagliptina), or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting this medication and during treatment:

• if you have “type 1 diabetes”. This type of diabetes usually begins when you are young and your body does not produce any insulin. Do not take Glyxambi if you have type 1 diabetes.
• if you experience rapid weight loss, nausea, vomiting, stomach pain, excessive thirst, rapid and deep breathing, confusion, drowsiness or fatigue, sweet-smelling breath, sweet or metallic taste in the mouth, or a different odor in urine or sweat, contact a doctor or the nearest hospital immediately and stop taking this medication until you speak with your doctor. These symptoms may be a sign of “diabetic ketoacidosis”, a rare but serious, potentially life-threatening problem, that can occur with diabetes due to an increase in “ketone bodies” in your urine or blood, detected by analysis. The risk of developing diabetic ketoacidosis may increase with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose or a greater need for insulin due to major surgery or serious illness.
• if you are taking other diabetes medications known as “sulfonilureas” (e.g., glimepirida, glipizida) or using insulin. Your doctor may want to reduce your dose of these medications when you take them with Glyxambi to avoid low blood sugar (hypoglycemia).
• if you have or have had a pancreas disease.
• if you have severe kidney problems. Your doctor may limit your daily dose or ask you to take another medication (see also section 3, “How to take Glyxambi”).

• if you have severe liver problems. Your doctor may ask you to take another medication.

• if you may be at risk of dehydration, for example:
• • if you have nausea or vomiting, diarrhea or fever, or if you are unable to eat or drink
  • if you are taking medications that increase urine production (diuretics) or reduce blood pressure
  • if you are over 75 years old

The 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 (hematocrit), observed in blood clinical analysis (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 pain (abdominal pain). The possible signs are listed in section 4, “Possible side effects”. Your doctor may need to change your treatment.
• if you have a severe infection in the kidney or urinary tract with fever. Your doctor may ask you to stop taking Glyxambi until you recover.

• if you find a blister on your skin, it could be a sign of a disease called bullous pemphigoid. Your doctor may indicate that you interrupt Glyxambi.

Contact your doctor immediately if you present a combination of symptoms of pain, tenderness, redness or inflammation of the genitals or the area between the genitals and the anus, with fever or general discomfort. These symptoms may be a sign of a rare but serious, potentially life-threatening infection, even gangrene of Fournier, which destroys tissue under the skin. Gangrene of Fournier must be treated immediately.

Foot care

As with all diabetic patients, it is essential to regularly monitor 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 your kidneys are functioning.

Urine glucose

Due to how this medication works, your urine will test positive for glucose while taking this medication.

Children and adolescents

This medication is not recommended for children and adolescents under 18 years old because linagliptina is not effective in children and adolescents between 10 and 17 years old. It is unknown if this medication is safe and effective when used in children under 10 years old.

Other medications and Glyxambi

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. In particular, you must inform your doctor if you are using the following medications:

• other diabetes medications, such as insulin or a sulfonilurea. Your doctor may decide to reduce the dose of these other medications to prevent your blood sugar levels from dropping too low.
• medications used to eliminate water from your body (diuretics). Your doctor may ask you to stop taking Glyxambi.
• medications that may affect the breakdown of empagliflozina or linagliptina in your body, such as rifampicina (an antibiotic used to treat tuberculosis) or certain medications used to treat seizures (such as carbamazepina, phenobarbital, or phenytoin). The effect of Glyxambi may be reduced.
• lithium, as Glyxambi may reduce the amount of lithium in your blood.

Pregnancy, breastfeeding, and fertility

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

It is unknown if Glyxambi is harmful to the fetus. As a precaution, it is recommended to avoid using this medication during pregnancy.

It is unknown if the active ingredients of Glyxambi pass into breast milk. Do not use this medication if you are breastfeeding.

It is unknown if Glyxambi has effects on human fertility.

Driving and operating machinery

The influence of Glyxambi on your ability to drive and operate machinery is small.

Taking this medication in combination with sulfonilureas or insulin may cause your blood sugar levels to drop too low (hypoglycemia), which can cause symptoms such as shakiness, sweating, and changes in vision that may affect your ability to drive and operate machinery. Do not drive or use tools or machinery if you experience any of these symptoms while taking Glyxambi.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How much to take

The usual initial dose is one film-coated tablet of Glyxambi 10mg/5mg (10mg of empagliflozina and 5mg of linagliptina) once a day.

Your doctor will decide if you need to increase your dose to one film-coated tablet of Glyxambi 25mg/5mg (25mg of empagliflozina and 5mg of linagliptina) once a day. If you already take 25mg of empagliflozina and 5mg of linagliptina in separate tablets and change to Glyxambi, you can start directly with Glyxambi 25mg/5mg.

Renal insufficiency

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

Liver insufficiency

Consult your doctor in case of severe liver insufficiency. The use of Glyxambi is not recommended and your doctor may decide to use an alternative medication.

How to take this medication

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

Your doctor may prescribe Glyxambi along with another antidiabetic medication. Remember to take all medications as indicated by your doctor to achieve the best results for your health.

A suitable diet and exercise help your body use glucose in your blood more effectively. It is essential 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 medication than you should, consult a doctor immediately or go to the hospital. Bring the packaging of the medication with you.

If you forget to take Glyxambi

If you forget to take a tablet, what you should do depends on the time until the next dose:

• If there are12hours or more until the next dose, take Glyxambi as soon as you remember. Then, take the next dose at the usual time.
• If there are less than12hours until the next dose, skip the missed dose. Then, take the next dose at the usual time.
• Do not take a double dose of this medication to compensate for the missed doses.

If you interrupt treatment with Glyxambi

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Get in touch with a doctor or the nearest hospital immediately if you experience any of the following side effects:

Diabetic ketoacidosis, which has been observed rarely (may affect up to 1 in 1,000 people)

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

• an 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 drowsiness or fatigue
• a sweet odor of the breath, a sweet or metallic taste in the mouth, or a different odor in the urine or sweat.

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

Get in touch with your doctor immediately if you observe any of the following side effects:

Allergic reactions, observed with low frequency (may affect up to 1 in 100 people)

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

Pancreatitis, observed with low frequency

This medicine may cause pancreatitis, which usually presents as persistent and intense stomach pain that may radiate to the back, often accompanied by nausea or vomiting. Your doctor will need to change your treatment.

Low blood sugar (hypoglycemia), observed frequently (may affect up to 1 in 10 people)

If you take Glyxambi with another medicine that may cause low blood sugar, such as a sulfonylurea or insulin, you are at risk of having very low blood sugar (hypoglycemia). The signs of very low blood sugar include:

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

Your doctor will instruct you on how to treat low blood sugar and what to do if you experience any of the above symptoms. If you have symptoms of low blood sugar, take glucose tablets, eat a high-glucose snack, or drink fruit juice. Measure your blood sugar if possible and rest.

Urinary tract infections, observed frequently

The signs of a urinary tract infection are:

• burning sensation while urinating
• urine with a cloudy appearance
• pelvic or mid-back pain (when the kidneys are infected)

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

Fluid loss (dehydration), observed with low frequency

The signs of dehydration are not specific, but may include:

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

Other side effects while taking Glyxambi:

Observed frequently

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

Observed with low frequency

• difficulty or pain when urinating
• blood tests may show changes in blood fat levels, an increase in red blood cells (increased hematocrit), and changes related to kidney function (decreased glomerular filtration rate and increased creatinine in the blood)

Observed rarely

• mouth pain
• fasciitis necroticans of the perineum or Fournier's gangrene, a severe infection of the soft tissues of the genitals or the area between the genitals and the anus

Observed very rarely

• inflammation of the kidneys (tubulointerstitial nephritis)

Frequency unknown (cannot be estimated from available data)

• blistering skin (bullous pemphigoid)

Reporting of side effects

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

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

Do not use this medication after the expiration date that appears on the blister pack and on the box after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not use this medication if you observe that the packaging is damaged or shows visible signs of manipulation.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. This will help protect the environment.

Composition of Glyxambi

Glyxambi 10mg/5mg film-coated tablets

• The active ingredients are empagliflozina and linagliptina. Each film-coated tablet contains 10mg of empagliflozina and 5mg of linagliptina.
• The other components are:
  Core tablet: mannitol (E421), pregelatinized maize starch, maize starch, copovidone, crospovidone, talc, and magnesium stearate.
  Film coating: hypromellose, mannitol (E421), talc, titanium dioxide (E171), macrogol6000, and yellow iron oxide (E172).

Glyxambi 25mg/5mg film-coated tabletswith film coating

• The active ingredients are empagliflozina and linagliptina. Each film-coated tablet contains 25mg of empagliflozina and 5mg of linagliptina.
• The other components are:
  Core tablet: mannitol (E421), pregelatinized maize starch, maize starch, copovidone, crospovidone, talc, and magnesium stearate.
  Film coating: hypromellose, mannitol (E421), talc, titanium dioxide (E171),macrogol6000, and red iron oxide (E172).

Appearance of the product and contents of the pack

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

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

Glyxambi is available in PVC/PVDC/aluminium perforated unit dose blisters.

The pack sizes are 7x1, 10x1, 14x1, 28x1, 30x1, 60x1, 70x1, 90x1, and 100x1film-coated tablet.

Only some pack sizes may be marketed in your country.

Marketing authorisation holder

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

Manufacturer responsible for batch release

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

Rottendorf Pharma GmbH

Ostenfelder Strasse 51 – 61

59320 Ennigerloh

Germany

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of the summary of product characteristics:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.