Glyxambi® 5 mg Film-Coated Tablets

GLYXAMBI is used to lower blood sugar levels in patients with type 2 diabetes mellitus. GLYXAMBI may be used when diet plus exercise do not provide adequate blood sugar level control either alone or with certain other medicines for diabetes such as metformin. Type 2 diabetes mellitus develops if the body does not make enough insulin or if the insulin that your body makes does not work as well as it should. Insulin is a substance which helps to lower the level of sugar in your blood, especially after meals. When the level of sugar builds up in your blood, this can cause damage to the body’s cells and lead to serious problems with your heart, brain, eyes, circulation, nerves or kidneys. GLYXAMBI contains two different active ingredients:

• empagliflozin, which belongs to a group of medicines called SGLT2 (sodium glucose co - transporter 2) inhibitors, and
• linagliptin, which belongs to a group of medicines called DPP - 4 (dipeptidyl peptidase 4) inhibitors.

Do not take GLYXAMBI

• if you are hypersensitive (allergic) to empagliflozin, linagliptin or any of the other ingredients of GLYXAMBI (listed in Section 6).
• if your doctor has told you that you have severe problems with your kidneys.

• Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
• Tell your doctor if you have or have had any of the following medical conditions:
  • type 1 diabetes, a condition where your body does not produce insulin.
  • diabetic ketoacidosis, a condition in which substances called 'ketone bodies' accumulate in the blood and which can lead to diabetic pre - coma. Symptoms include: rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat.
  • kidney problems.
  • if you have or have had a disease of the pancreas.
  • illnesses that will make you dehydrated (e.g. diarrhoea or a severe infection).
  • frequent genital or urinary tract infections (infections of the bladder, kidney, or tubes that carry urine).
  • increased urine loss which may affect the fluid balance in your body.
• Tell your doctor if you have heart problems, history of low blood pressure or are 75 years of age or older. Increased passing of urine due to GLYXAMBI may affect fluid balance in your body and increase your risk of dehydration.

• If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking GLYXAMBI.
• Tell any other doctors, dentists, and pharmacists who treat you that you are taking GLYXAMBI.
• If you become pregnant while taking GLYXAMBI, tell your doctor immediately.
• If you are about to have any blood or urine tests, tell your doctor that you are taking GLYXAMBI. It may interfere with the results of some tests.
• Keep all of your doctor's appointments so that your progress can be checked. Your doctor may do some tests from time to time to make sure GLYXAMBI is working and to prevent unwanted side effects.
• Follow your healthcare provider’s advice on diet, drinking alcohol and exercise. Diet and exercise can help your body use its blood sugar better. It is important to stay on the diet and exercise program recommended by your healthcare provider while taking GLYXAMBI.
• Make sure you check your blood glucose regularly. This is the best way to tell if your diabetes is being controlled properly. Your doctor or diabetes educator will show you how and when to do this.
• Check your feet regularly and see your doctor if you notice any problems. Follow any other advice regarding foot care given by your doctor.
• Talk to your doctor about when to stop taking GLYXAMBI and when to start taking it again if you are about to have surgery.
• Tell your healthcare provider right away if you have unexplained muscle pain, tenderness or weakness and dark or discoloured urine. Muscle problems including muscle breakdown can be serious and may cause kidney damage. The risk may be higher if you have abnormal kidney function or when taking other medicines such as ‘statins’ or colchicine.

• medicines used to treat high blood pressure known as ‘water pills’ (diuretics).
• rifampicin (an antibiotic medicine used to treat certain infections such as tuberculosis).
• carbamazepine, phenobarbital (phenobarbitone) or phenytoin (medicines used to control fits (seizures) or chronic pain).
• a medicine used to treat and prevent mood disorders (lithium).

Do not share medicines prescribed for you with any other person. Always take GLYXAMBI exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual starting dose is one GLYXAMBI 10/5 mg tablet once a day. Your doctor may increase your dose to one GLYXAMBI 25/5 mg tablet once a day. Your doctor will prescribe GLYXAMBI alone or in combination with another anti - diabetic medicine if that medicine alone is not sufficient to control your blood sugar level. Swallow the tablet whole with a full glass of water. Take GLYXAMBI at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it. It does not matter if you take GLYXAMBI before or after food. Your doctor will tell you how long your treatment with GLYXAMBI will last. Do not stop treatment early because your blood sugar levels may increase if you stop taking GLYXAMBI. GLYXAMBI helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well. If you have the impression that the effect of GLYXAMBI is too strong, or too weak, tell your doctor or pharmacist. If you take more GLYXAMBI than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. If you forget to take GLYXAMBI If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally. Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect. If you are not sure what to do, ask your doctor or pharmacist. If you stop taking GLYXAMBI Do not stop taking GLYXAMBI or lower the dosage without checking with your doctor.

GLYXAMBI can have side effects. Not all side effects reported for GLYXAMBI are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking GLYXAMBI, please consult your healthcare provider for advice. If any of the following happens, stop taking GLYXAMBI and tell your doctor immediately or go to the casualty department at your nearest hospital:

• develop blisters or the breakdown of the outer layer of your skin (erosion). These may be signs of a skin reaction called bullous pemphigoid or another severe skin reaction. Your doctor may tell you to stop taking GLYXAMBI.
• allergic reaction (shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other part of the body, rash, itching or hives on the skin). These are all very serious side effects that occur less frequently. If you have them, you may have had a serious reaction to GLYXAMBI. You may need urgent medical attention or hospitalisation.
• rapid weight loss, feeling sick or being sick, stomach pain, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat. In rare cases, empagliflozin, one of the active substances in GLYXAMBI can cause a serious side effect called diabetic ketoacidosis.
• severe upper stomach pain, radiating to the back, nausea, vomiting and fever (which may be symptoms of an inflamed pancreas – pancreatitis).
• experience muscle pain, tenderness or weakness with dark or discoloured urine which may be symptoms of rhabdomyolysis.
• experience pain or tenderness, itching, swelling in the genital or back passage area, fever or are generally feeling unwell. These may be symptoms of a serious and life - threatening infection called Fournier’s gangrene. Your doctor may tell you to stop taking GLYXAMBI.
• experience swelling of the penis that makes it difficult to pull back the skin around the tip of the penis (uncircumcised men).

• any of the symptoms of low blood sugar such as sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, a fast pounding heartbeat. Low blood sugar may frequently occur in people who already take another medication to treat diabetes, such as a sulphonylurea or insulin. The dose of your sulphonylurea or insulin medicine may need to be reduced while taking GLYXAMBI.

• burning sensation when passing urine
• urine that appears cloudy
• pain in the pelvis, or mid - back pain
• straining or pain when passing urine
• swelling of the nose or throat (nasopharyngitis)
• cough
• painful, swollen joints
• genital burning, redness, pain and discharge which may be signs of a genital yeast infection
• itching
• passing more urine than normal
• constipation
• increased blood fats (lipids)
• increased blood enzyme amylase
• increased pancreas enzyme lipase.

• signs of dehydration including unusual thirst, light - headedness or dizziness upon standing, fainting or loss of consciousness
• mouth ulceration.

Store at or below 30 °C. Store all medicines out of reach of children. Keep your tablets in the pack until it is time to take them. If you store the tablets out of the pack they may not keep well. Do not store GLYXAMBI in the bathroom or near a sink. Do not leave it on a windowsill or in the car. Heat and dampness can destroy some medicines. Do not take GLYXAMBI after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).