10 mg / 5 mg, 25 mg / 5 mg film-coated tablets
empagliflozin / linagliptin
1. What Glyxambi is and what it is used for
What Glyxambi is
Glyxambi contains two active substances called empagliflozin and linagliptin.
Both belong to a group of drugs called “oral antidiabetics”. These are medicines that are taken by mouth to treat type 2 diabetes.
What is type 2 diabetes?
Type 2 diabetes is a condition caused by both genes and lifestyle. If you have type 2 diabetes, your pancreas may not be producing enough insulin to control the level of glucose in your blood, and your body will not be able to use its own insulin effectively. This causes high blood sugar levels which can lead to medical problems such as heart disease, kidney disease, blindness, and poor circulation in the arms and legs.
How Glyxambi works
Empagliflozin belongs to a class of drugs called sodium-glucose -kotransportör 2 (SGLT2) inhibitors. It works by blocking the SGLT2‑ protein in the kidneys. This causes blood sugar ( glucose ) to be removed through the urine.
Linagliptin works in a different way, namely by enabling the pancreas to make more insulin to lower blood glucose levels. It does this by blocking a protein called DPP ‑ 4.
In this way, Glyxambi reduces the amount of sugar in the blood.
What Glyxambi is used for
- Glyxambi is co-administered with metformin and / or sulphonylurea (SU) to treat type 2 diabetes in adult patients aged 18 years and older whose diabetes cannot be controlled by metformin and / or sulphonylurea in combination with empagliflozin, or by treatment with metformin and / or sulphonylurea in combination with linagliptin.
- Glyxambi can also be used as an alternative to taking both empagliflozin and linagliptin as separate tablets. To avoid overdose, do not continue to take empagliflozin and linagliptin tablets separately, if you are taking this medicine.
It is important that you continue to follow the diet and exercise advice recommended by your doctor, pharmacist, or nurse.
What you need to know before you take Glyxambi
Do not take Glyxambi
- if you are allergic to empagliflozin, linagliptin, any other SGLT2 inhibitor (eg dapagliflozin, kanagliflozin), any other DPP ‑ 4 inhibitor (eg sitagliptin, vildagliptin) or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor before taking this medicine and during treatment:
- if you have type 1 diabetes (your body does not make insulin ). Glyxambi should not be used to treat type 1 diabetes .
- if you experience rapid weight loss, nausea or vomiting, abdominal pain, strong thirst, rapid and deep breathing, confusion, unusual sleepiness or fatigue, a sweet breath, a sweet taste or metallic taste in the mouth or a different smell of sweat or urine. Contact a doctor or nearest hospital immediately as these symptoms may be signs of “diabetic ketoacidosis” – a rare but serious, sometimes life-threatening,problems you can get in diabetes due to elevated levels of “ketone bodies” in urine or blood, which can be detected in tests. The risk of developing diabetic ketoacidosis may increase with prolonged fasting, high alcohol consumption, dehydration, a sudden decrease in insulin dose or a greater need for insulin as a result of major surgery or a serious illness.
- if you are taking other medicines for diabetes , so-called sulphonylureas (eg glimepiride, glipizide) and / or use insulin . Your doctor may want to reduce the dose of one of these medicines when you take them with Glyxambi to prevent your blood sugar from getting 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 ask you to take another medicine (see also section 3, “How to take Glyxambi”).
- if you have severe liver problems. Your doctor may ask you to take another medicine.
- if you may be at risk of dehydration, for example:
- if you vomit, have diarrhea or fever, or if you can not eat or drink
- if you are taking medicines which increase urine production ( diuretics ) or lowers blood pressure et
- if you are over 75 years old
- if you are 75 years of age or older, do not start taking Glyxambi.
- if blood tests have shown that you have an increase in the number of red blood cells in your blood ( hematocrit ) (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 abdominal pain. Possible signs are listed in section 4, “Possible side effects”. Your doctor may need to change your treatment.
- if you have a serious infection in the kidneys or urinary tract along with fever. Your doctor may ask you to stop taking Glyxambi until you have recovered.
- If you get blisters on your skin, it could be a sign of a condition called bullous pemphigoid . Your doctor may tell you to stop taking Glyxambi.
Talk to 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 rectum along with fever or general malaise. These symptoms can be a sign of a rare but serious and in the worst-case life-threatening infection called necrotizing fasciitis of the perineum or Fournier’s gangrene which destroys the tissue under the skin. Fournier’s gangrene must be treated immediately.
Chiropody
For all patients with diabetes, it is important to regularly check your feet and follow all other advice on foot care provided by healthcare professionals.
Renal function
Before starting treatment with Glyxambi and regularly during treatment, your doctor will check how well your kidneys are working.
Urine glucose
Urine tests will give a positive answer for sugar while you are taking this medicine, due to the way this medicine works.
Children and young people
This medicine is not recommended for children and adolescents under 18 years of age, as it has not been studied in these patients.
Other medicines and Glyxambi
Tell your doctor or pharmacist if you have recently taken or might take any other medicines. It is especially important to tell your doctor if you are taking the following medicines:
- other medicines for diabetes such as insulin or a sulphonylurea. Your doctor may want to lower the dose of one of these other medicines to prevent your blood sugar levels from getting too low.
- diuretics ( diuretics ). Your doctor may ask you to stop taking Glyxambi.
- drugs that can affect the breakdown of empagliflozin or linagliptin in the body such as rifampicin (an antibiotic used to treat tuberculosis ) or certain anticonvulsant drugs (such as carbamazepine, phenobarbital or phenytoin ). The effect of Glyxambi may be weakened.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
It is unknown whether Glyxambi is harmful to the unborn baby. As a precautionary measure, it is best to avoid the use of this medicine during pregnancy.
It is not known whether the active substances in Glyxambi pass into breast milk. Do not use this medicine if you are breastfeeding.
It is not known whether Glyxambi affects human fertility.
Driving and using machines
Glyxambi has little effect on the ability to drive and use machines.
Taking this medicine in combination with medicines called sulphonylureas or with insulin may cause excessive blood sugar (hypoglycemia), which may cause symptoms such as tremors, sweating, and vision changes and may affect your ability to drive and use machines. Do not drive or use any tools or machines if you experience any of these symptoms while taking Glyxambi.
3. How to take Glyxambi
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
How much to take
The usual starting dose is a film-coated tablet of Glyxambi 10 mg / 5 mg (10 mg empagliflozin and 5 mg linagliptin) once daily.
Your doctor will decide if you need to increase the dose of one to one film-coated tablet Glyxambi 25 mg / 5 mg (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 you are switching to Glyxambi, you can start immediately with Glyxambi 25 mg / 5 mg.
Renal impairment:
Talk to your doctor if you have kidney problems. Your doctor may limit your dose or decide to use another medicine.
Hepatic impairment:
Talk to your doctor if you suffer from severe hepatic impairment. Glyxambi is not recommended in this condition and your doctor may decide to use another medicine.
Older:
There is not much experience from patients aged 75 years and older. Treatment with Glyxambi should not be started in patients over 75 years of age.
Taking this medicine
- 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 each day. This will help you remember to take it.
Your doctor may prescribe Glyxambi together with another diabetes medicine. Remember to take all medicines according to your doctor’s instructions to achieve the best possible results for your health.
Proper diet and exercise will help your body make better use of your blood sugar. It is important to continue with the diet and exercise programs recommended by your doctor when taking Glyxambi.
If you take more Glyxambi than you should
If you have taken too much of this medicine, talk to a doctor immediately or go to a hospital immediately. Take the medicine pack with you.
If you forget to take Glyxambi
What to do if you forget to take a tablet depends on how long it takes until the next dose:
- If it is 12 hours or more until the next dose , take Glyxambi as soon as you remember. Then take your next dose at the usual time.
- If it is less than 12 hours until the 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 forgotten dose .
If you stop taking Glyxambi
Do not stop taking this medicine without first discussing it with your doctor. Your blood sugar levels may rise when you stop taking Glyxambi.
If you have any further questions on the use of this product, 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 your doctor or nearest hospital immediately if you get any of the following side effects:
Rare diabetic ketoacidosis (may affect up to 1 in 1,000 people)
These are the signs of diabetic ketoacidosis (see also section 2, “Warnings and precautions”):
- increased levels of “ketone bodies” in the urine or blood
- rapid weight loss
- nausea or vomiting
- abdominal pain
- strong thirst
- rapid and deep breathing
- confusion
- unusual drowsiness or fatigue
- a sweet smell on the breath, a sweet taste or metallic taste in the mouth or a different smell on sweat or urine.
This can occur regardless of blood sugar levels. Your doctor may decide to temporarily or permanently discontinue your treatment with this medicine.
Contact a doctor immediately if you notice any of the following side effects:
Allergic reactions, uncommon (may affect up to 1 in 100 people)
This medicine can cause allergic reactions that 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 ), less common
This drug can cause pancreatitis, which usually manifests as persistent, severe abdominal pain that can radiate to the back and is often accompanied by nausea or vomiting. Your doctor may need to change your treatment.
Low blood sugar (hypoglycemia), common (may affect up to 1 in 10 people)
If you take Glyxambi with another medicine that may cause low blood sugar, such as sulphonylurea or insulin, you may have hypoglycaemia (hypoglycemia). Signs of too low blood sugar can be:
- tremors, sweating, strong feeling of anxiety or confusion, rapid heartbeat
- excessive hunger, headache
Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the above signs. If you have symptoms of low blood sugar; eat grape sugar tablets, a sugary snack, or drink fruit juice. If possible, measure your blood sugar and rest.
Urinary tract infection, common
Signs of urinary tract infection are:
- a burning sensation when urinating
- cloudy urine
- pain in the pelvis, or in the middle of the back (when the kidneys are infected)
Urinary incontinence or the need to urinate more often may be due to the way this medicine works, but may also be a sign of a urinary tract infection. If you notice an increase in these symptoms, contact your doctor.
Loss of body fluid (dehydration), less common
Signs of dehydration are not specific, but may include:
- unusual thirst
- dizziness or dizziness when standing up
- fainting spells or unconsciousness
Other side effects when taking Glyxambi:
Usual
- fungal infection, e.g. candida , around the genitals
- inflammation of the nose or throat ( nasopharyngitis )
- cough
- greater amount of urine than usual or having to urinate more often
- itching
- rash
- increased levels of amylase enzyme in the blood
- increased content of lipase enzyme in the pancreas
- thirst
Less common
- exertion or pain when emptying the bladder
- blood tests may show changes in blood fat levels, an increase in the amount of red blood cells (increased hematocrit ) and changes linked to kidney function (decreased filtration rate and increased blood creatinine)
Rare
- sores in the mouth
No known frequency (can not be calculated from the available data)
- blisters on the skin (bullous pemphigoid )
- necrotizing fasciitis of the perineum or Fournier’s gangrene, a severe soft tissue infection of the genitals or the area between the genitals and the rectum
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency, By reporting side effects, you can help increase drug safety information.
5. How to store Glyxambi
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Do not use this medicine if the package is damaged or shows signs of being opened earlier.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
Glyxambi film-coated tablets 10 mg / 5 mg
- The active substances are empagliflozin and linagliptin. Each film-coated tablet contains 10 mg empagliflozin and 5 mg linagliptin.
- The other ingredients are:
Tablet core: mannitol (E421), pregelatinized starch (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 film-coated tablets 25 mg / 5 mg
- The active substances are empagliflozin and linagliptin. Each film-coated tablet contains 25 mg empagliflozin and 5 mg linagliptin.
- The other ingredients are:
Tablet core: mannitol (E421), pregelatinized starch (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).
What the medicine looks like and contents of the pack
Glyxambi 10 mg / 5 mg film-coated tablets (tablets) are pale yellow, rounded triangular, and smooth with a beveled edge. They have “10/5” on one side and the Boehringer Ingelheim logo on the other side. Each side of the tablet is 8 mm long.
Glyxambi 25 mg / 5 mg film-coated tablets (tablets) are pale pink, triangular in shape, and smooth with a beveled edge. They have “25/5” on one side and the Boehringer Ingelheim logo on the other side. Each side of the tablet is 8 mm long.
Glyxambi is available in perforated single-dose blisters of PVC / PVDC / aluminum.
Pack sizes of 7 x 1, 10 x 1, 14 x 1, 28 x 1, 30 x 1, 60 x 1, 70 x 1, 90 x 1 and 100 x 1 film-coated tablets.
Not all pack sizes may be marketed in your country.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation 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