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.
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
It is essential that you follow the diet and exercise plan recommended by your doctor, pharmacist, or nurse.
Do not take Glyxambi
Warnings and precautions
Consult your doctor before starting this medication and during treatment:
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.
Contact your doctor if you experience any of the following during treatment with 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:
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
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 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”):
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:
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:
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:
Other side effects while taking Glyxambi:
Observed frequently
Observed with low frequency
Observed rarely
Observed very rarely
Frequency unknown (cannot be estimated from available data)
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
Glyxambi 25mg/5mg film-coated tabletswith film coating
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:
België/Belgique/Belgien Boehringer Ingelheim SComm Tél/Tel: +32 2 773 33 11 | Lietuva Boehringer Ingelheim RCV GmbH & Co KG Lietuvos filialas Tel: +3705 2595942 |
Luxembourg/Luxemburg Boehringer Ingelheim SComm | |
Ceská republika Boehringer Ingelheim spol. s r.o. Tel: +420 234 655 111 | Magyarország Boehringer Ingelheim RCV GmbH & Co KG Magyarországi Fióktelepe Tel: +36 1 299 89 00 |
Danmark Boehringer Ingelheim Danmark A/S Tlf: +45 39 15 88 88 | Malta Boehringer IngelheimIrelandLtd. Tel:+353 1 295 9620 |
Deutschland Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 800 77 90 900 Lilly Deutschland GmbH Tel. +49 (0) 6172 273 2222 | Nederland Boehringer Ingelheim B.V. Tel: +31 (0) 800 22 55 889 |
Eesti Boehringer Ingelheim RCV GmbH & Co KG Eesti filiaal Tel: +372 612 8000 | Norge Boehringer Ingelheim Danmark Norwegian branch Tlf: +47 66 76 13 00 |
Ελλ?δα Boehringer Ingelheim Ελλ?ς Μονοπρ?σωπη A.E. Tηλ: +30 2 10 89 06 300 | Österreich Boehringer Ingelheim RCV GmbH & Co KG Tel: +43 1 80 105‑7870 |
España Boehringer Ingelheim España, S.A. Tel: +34 93 404 51 00 | Polska Boehringer Ingelheim Sp. z o.o. Tel: +48 22 699 0 699 |
Francia Boehringer Ingelheim France S.A.S. Tél: +33 3 26 50 45 33 | Portugal Boehringer Ingelheim Portugal, Lda. Tel: +351 21 313 53 00 |
Hrvatska Boehringer Ingelheim Zagreb d.o.o. Tel: +385 1 2444 600 | România Boehringer Ingelheim RCV GmbH & Co KG Viena -Sucursala Bucuresti Tel: +40 21 302 28 00 |
Ireland Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9620 | Slovenija Boehringer Ingelheim RCV GmbH & Co KG Podružnica Ljubljana Tel: +386 1 586 40 00 |
Ísland Vistor ehf. Sími: +354 535 7000 | Slovenská republika Boehringer Ingelheim RCV GmbH & Co KG organizacná zložka Tel: +421 2 5810 1211 |
Italia Boehringer Ingelheim Italia S.p.A. Tel: +39 02 5355 1 | Suomi/Finland Boehringer Ingelheim Finland Ky Puh/Tel: +358 10 3102 800 |
Κ?προς Boehringer Ingelheim Ελλ?ς Μονοπρ?σωπη A.E. Tηλ: +30 2 10 89 06 300 | Sverige Boehringer Ingelheim AB Tel: +46 8 721 21 00 |
Latvija Boehringer Ingelheim RCV GmbH & Co KG Latvijas filiale Tel: +371 67 240 011 | United Kingdom(Northern Ireland) Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9620 |
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.
The average price of Glyxambi 10 mg/5 mg comprimidos recubiertos con pelicula in July, 2025 is around 92.26 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.