Patient counselling information

What is FDC of Empagliflozin Linagliptin Metformin and for which conditions it is used?

FDC of Empagliflozin Linagliptin Metformin is a prescription medicine that contains 2 diabetes medicines, empagliflozin and linagliptin. It can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes, in adults with type 2 diabetes who have known cardiovascular disease when empagliflozin, one of the medicines in this FDC, is needed to reduce the risk of cardiovascular death.

What you need to know before you take FDC of Empagliflozin Linagliptin Metformin? What are warnings and precautions to consider while using FDC of Empagliflozin Linagliptin Metformin?

Do not take FDC of Empagliflozin Linagliptin Metformin - if you are allergic to empagliflozin, linagliptin, metformin or any of the other ingredients of this medicine.

Warnings and precautions

Talk to your doctor, before taking this medicine, and during treatment:

• if you have “type 1 diabetes”. This type usually starts when you are young and your body does not produce any insulin. You should not take FDC of Empagliflozin Linagliptin Metformin if you have type 1 diabetes.
• If you feel very weak and tired, have unusual (not normal) muscle pain, have trouble breathing, have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea, have unusual sleepiness or sleep, longer than usual feel cold, especially in your arms and legs, feel dizzy or lightheaded, have a slow or irregular heartbeat, it could be symptoms of lactic acidosis, call your healthcare provider right away or go to the nearest hospital
• if you experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, 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, contact a doctor or the nearest hospital straight away and stop taking this medicine until further advice from your doctor. These symptoms could be a sign of “diabetic ketoacidosis” – a rare, but serious, sometimes life-threatening problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests. The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration or sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness.
• if you are taking other anti-diabetic medicines known as “sulphonylurea” (e.g. glimepiride, glipizide) and/or using insulin. Your doctor may want to reduce your dose of these medicines when you take them together with FDC of Empagliflozin Linagliptin Metformin , in order to avoid too low blood sugar (hypoglycaemia).
• if you have or have had a disease of the pancreas.
• if you have serious kidney problems. Your doctor may limit your daily dose or ask you to take a different medicine
• if you have serious liver problems. Your doctor may ask you to take a different medicine.
• if you might be at risk of dehydration, for example:
  • if you are being sick, have diarrhoea or fever, or if you are not able to eat or drink
  • if you are taking medicines that increase urine production [diuretics] or lower blood pressure
  • if you are over 75 years old
• Your doctor may ask you to stop taking FDC of Empagliflozin Linagliptin Metformin until you recover to prevent loss of too much body fluid. Ask about ways to prevent dehydration.
• if you have an increase in the proportion of red blood cells in your blood (haematocrit), seen in laboratory blood tests.
• Low level of vit B12 in your blood

Contact your doctor if you experience any of the following during treatment with FDC of Empagliflozin Linagliptin Metformin :

• if you develop symptoms of acute pancreatitis, like persistent, severe stomach ache (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 of the kidney or the urinary tract with fever. Your doctor may ask you to stop taking FDC of Empagliflozin Linagliptin Metformin until you have recovered.
• if you encounter blistering of the skin it may be a sign for a condition called bullous pemphigoid. Your doctor may ask you to stop FDC of Empagliflozin Linagliptin Metformin .

Talk to your doctor immediately if you develop a combination of symptoms of pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the anus with fever or feeling generally unwell. These symptoms could be a sign of a rare but serious or even life-threatening infection, called necrotising fasciitis of the perineum or Fournier´s gangrene which destroys the tissue under the skin. Fournier’s gangrene has to be treated immediately.

Foot care: Like for all diabetic patients it is important to check your feet regularly and adhere to any other advice regarding foot care given by your health care professional.

Kidney function: Before you start treatment with FDC of Empagliflozin Linagliptin Metformin and regularly during treatment, your doctor will check how well your kidneys are working.

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

Children and adolescents This medicine is not recommended for children and adolescents under 18 years as linagliptin is not effective in children and adolescents between the ages of 10 and 17 years. It is not known if this medicine is safe and effective when used in children younger than 10 years

Can Empagliflozin be used during Pregnancy and breast-feeding?

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not use FDC of Empagliflozin Linagliptin Metformin if you are pregnant. It is unknown if FDC of Empagliflozin Linagliptin Metformin is harmful to the unborn child. Do not use FDC of Empagliflozin Linagliptin Metformin if you are breast-feeding. It is not known if Empagliflozin/Linagliptin passes into human breast milk.

What is the dose of FDC of Empagliflozin Linagliptin Metformin ?

Take FDC OF EMPAGLIFLOZIN LINAGLIPTIN METFORMIN exactly as your healthcare provider tells you to take it. Take this FDC by mouth 1 time each day with a meal in the morning. Taking this FDC with a meal may lower your chance of having an upset stomach.

Swallow tablets whole. Do not break, cut, crush, dissolve, or chew. If you cannot swallow tablets whole, tell your healthcare provider.

You may see something that looks like the FDC OF EMPAGLIFLOZIN LINAGLIPTIN METFORMIN tablet in your stool (bowel movement). This is not harmful and should not affect the way it works to control your diabetes.

Your healthcare provider will tell you how much FDC OF EMPAGLIFLOZIN LINAGLIPTIN METFORMIN to take and when to take it. Your healthcare provider may change your dose if needed. Your healthcare provider may tell you to take FDC OF EMPAGLIFLOZIN LINAGLIPTIN METFORMIN along with other diabetes medicines.

Renal impairment

Talk to your doctor if you have kidney problems. Your doctor may limit your dose or decide to use an alternative medicine. Hepatic impairment Talk to your doctor in case you suffer from severe hepatic impairment. FDC of Empagliflozin Linagliptin Metformin is not recommended and your doctor may decide to use an alternative medicine.

How to take FDC of Empagliflozin Linagliptin Metformin?

Take FDC OF EMPAGLIFLOZIN LINAGLIPTIN METFORMIN exactly as your doctor tells you to take it.

• Take FDC 1 time each day in the morning, with or without food.
• If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take two doses of FDC at the same time.
• Your doctor may tell you to take FDC along with other diabetes medicines. Low blood sugar can happen more often when FDC is taken with certain other diabetes medicines. See “What are the possible side effects of FDC?
• If you take too much FDC OF EMPAGLIFLOZIN LINAGLIPTIN METFORMIN , call your doctor or local poison control center or go to the nearest hospital emergency room right away.
• When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine that you need may change. Tell your doctor right away if you have any of these conditions and follow your doctor’s instructions.
• Check your blood sugar as your doctor tells you to.
• Stay on your prescribed diet and exercise program while taking FDC
• Talk to your doctor about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and complications of diabetes.
• Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.
• When taking FDC, you may have sugar in your urine, which will show up on a urine test.

What if you forget to take FDC of Empagliflozin Linagliptin Metformin ?

What to do if you forget to take a tablet depends on how long it is until your next dose.

If it is 12 hours or more until your next dose, take FDC of Empagliflozin Linagliptin Metformin as soon as you remember. Then take your next dose at the usual time.

If it is 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 FDC of Empagliflozin Linagliptin Metformin to make up for a forgotten dose.

What If you stop taking FDC of Empagliflozin Linagliptin Metformin ?

Do not stop taking FDC of Empagliflozin Linagliptin Metformin without first consulting your doctor, unless you suspect you have ketoacidosis. If you have type 2 diabetes mellitus, your blood sugar levels may increase when you stop taking FDC of Empagliflozin Linagliptin Metformin.

What are the possible side effects of Empagliflozin/Linagliptin/Metformin?

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

Contact a doctor or the nearest hospital straight away if you have any of the following side effects:

Lactic acidosis, seen rarely

The signs and symptoms of the condition are

• feel very weak and tired,
• have unusual (not normal) muscle pain,
• have trouble breathing,
• have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea,
• have unusual sleepiness or sleep, longer than usual
• feel cold, especially in your arms and legs, feel dizzy or lightheaded,
• have a slow or irregular heartbeat,
• call your healthcare provider right away or go to the nearest hospital

Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1000 people)

These are the signs of diabetic ketoacidosis

• increased levels of “ketone bodies” in your urine or blood
• rapid weight loss
• feeling sick or being sick
• stomach pain
• excessive thirst
• 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.

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

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

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

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

Inflammation of the pancreas (pancreatitis), seen uncommonly

This medicine may cause pancreatitis, which usually shows as persistent, severe abdominal (stomach) pain that might reach through to your back, often accompanied by feeling sick or being sick. Your doctor will need to change your treatment.

Low blood sugar (hypoglycaemia), seen commonly (may affect up to 1 in 10 people)

If you take FDC of Empagliflozin Linagliptin Metformin with another medicine that can cause low blood sugar, such as a sulphonylurea or insulin, you are at risk of getting too low blood sugar (hypoglycaemia). The signs of too low blood sugar may include:

• shaking, sweating, feeling very anxious or confused, fast heart beat
• 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 signs above. If you have symptoms of low blood sugar, eat glucose tablets, a high sugar snack or drink fruit juice. Measure your blood sugar if possible and rest.

Urinary tract infection, seen commonly

The signs of urinary tract infection are:

• burning sensation when passing urine
• urine that appears cloudy
• pain in the pelvis, or mid-back pain (when kidneys are infected)

An urge to pass urine or more frequent urination may be due to the way this medicine works, but as they can also be signs of urinary tract infection, if you note an increase in such symptoms, you should also contact your doctor.

Loss of body fluid (dehydration), seen uncommonly

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

• unusual thirst
• lightheadedness or dizziness upon standing
• fainting or loss of consciousness

Amputations. SGLT2 inhibitors may increase your risk of lower limb amputations.

You may be at a higher risk of lower limb amputation if you:

• have a history of amputation
• have had blocked or narrowed blood vessels, usually in your leg
• have had diabetic foot infection, ulcers or sores

Call your healthcare provider right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Talk to your healthcare provider about proper foot care.

Low vitamin B (vitamin B deficiency). Using metformin for long periods of time may cause a decrease in the amount of vitamin B in your blood, especially if you have had low vitamin B blood levels before. Your healthcare provider may do blood tests to check your vitamin B levels.

Joint pain. Some people who take linagliptin, one of the medicines in this FDC, may develop joint pain that can be severe. Call your healthcare provider if you have severe joint pain.

Other side effects while taking FDC of Empagliflozin Linagliptin Metformin :

Seen commonly

• genital yeast infection like thrush
• inflamed nose or throat (nasopharyngitis)
• cough
• passing more urine than usual or needing to pass urine more often
• itching
• skin rash
• increased blood enzyme amylase
• increased pancreas enzyme lipase
• thirst
• constipation

Seen uncommonly

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

Seen rarely

• sore in the mouth
• necrotising fasciitis of the perineum or Fournier´s gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus

Seen very rarely

• inflammation of the kidneys (tubulointerstitial nephritis)
• Frequency not known (cannot be estimated from the available data)
• blistering of skin (bullous pemphigoid)

What precautions should I take if I have kidney disease?

If you have kidney disease, your healthcare provider will evaluate your condition to determine if empagliflozin/Linagliptin/metformin is suitable for you.

How will I know if I have a urinary or genital infection, and what should I do?

Symptoms of infection may include painful urination, itching, or unusual discharge. Contact your doctor if you notice any of these signs for prompt treatment.

What medications might interact with empagliflozin/Linagliptin/Metformin?

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. In particular, you should tell your doctor if you are using the following medicines:

• Other anti-diabetic medicines, such as insulin or a sulphonylurea. Your doctor may want to lower the dose of these other medicines, to prevent your blood sugar levels from getting too low.
• Medicines used to remove water from your body (diuretics). Your doctor may ask you to stop taking FDC of Empagliflozin Linagliptin Metformin.
• Medicines that might have an effect on the break down of empagliflozin or linagliptin 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 FDC of Empagliflozin Linagliptin Metformin may be reduced.
• Lithium because FDC of Empagliflozin Linagliptin Metformin can lower the amount of lithium in your blood.

Can empagliflozin cause low blood pressure, especially for older adults?

Yes, particularly in elderly patients or those on diuretics. Watch for symptoms like dizziness or fainting. Staying hydrated can help manage blood pressure while on empagliflozin

Does empagliflozin cause weight loss, and should I monitor my weight?

Some people may experience mild weight loss as empagliflozin helps remove excess glucose. Monitoring your weight can help track any unintended changes

Should I stop empagliflozin/Linagliptin/Metformin before surgery or a medical procedure?

It’s important to consult your doctor, as empagliflozin may need to be paused before surgery to reduce the risk of DKA. Follow their instructions closely

Can I use empagliflozin/Linagliptin/Metformin if I have type 1 diabetes?

Empagliflozin/Linagliptin is not approved for type 1 diabetes due to a higher risk of diabetic ketoacidosis. It’s only indicated for type 2 diabetes management

How often will my blood glucose and HbA1c levels need to be checked?

Your doctor may check your HbA1c every 3 to 6 months to monitor long-term glucose control. Regular self-monitoring of blood glucose may also be needed, especially if you’re adjusting doses

What to do if you are feeling unwell (vomiting, diarrhea, fever)?

Contact your treating physician immediately and then stop taking Empagliflozin Linagliptin as per his advise. Once you feel better, start taking Empagliflozin Linagliptin as per his advise.

What to do if you are having surgery?

Contact your treating physician immediately and then stop taking Empagliflozin Linagliptin as per his advise.

References

• Prescribing information Trijardy XR. Available from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71873567-9594-452a-bb92-34a129adecac. Cited on 19 Oct 2024
• Summary of Product characteristics. Available from https://www.ema.europa.eu/en/documents/product-information/FDC of Empagliflozin Linagliptin Metformin -epar-product-information_en.pdf Cited on 14 Oct 2024
• Sick Day Rules for people with type 2 diabetes taking a SGLT-2 Inhibitor https://www.dchft.nhs.uk/wp-content/uploads/2022/02/Sick-Day-Rules-for-people-with-Type-2-Diabetes.pdf Cited on 14 Oct 2024

Patient counselling information

What FDC of empagliflozin metformin is and what it is used for

FDC of empagliflozin metformin is a diabetes medicine that contains two active substances called empagliflozin and metformin.

• Empagliflozin works by blocking a protein in the kidneys called sodium glucose co-transporter 2 (SGLT2). SGLT2 prevents glucose (blood sugar) from being lost in urine by absorbing glucose back into the bloodstream as blood is being filtered in the kidneys. By blocking this protein, the medicine causes blood sugar to be removed via the urine. This helps to lower blood sugar levels, which are too high in patients with type 2 diabetes.
• Metformin works in a different way to lower blood sugar levels, mainly by blocking glucose production in the liver.

FDC of empagliflozin metformin is added to diet and exercise to treat type 2 diabetes in adult patients (aged 18 years and older) whose diabetes cannot be controlled by adding metformin alone or metformin with other medicines for diabetes.

FDC of empagliflozin metformin can also be combined with other medicines. These may be medicines taken by mouth or insulin given by injection.

In addition, FDC of empagliflozin metformin can be used as an alternative to taking both empagliflozin and metformin as single tablets. To avoid overdose, do not continue taking empagliflozin and metformin tablets separately, if you are taking this medicine.

It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or nurse.

What is type 2 diabetes?

Type 2 diabetes is a disease that comes from both your genes and your lifestyle. If you have type 2 diabetes, your pancreas does not make enough insulin to control the level of glucose in your blood, and your body is unable to use its own insulin effectively. This results in high levels of glucose in your blood which can lead to medical problems like heart disease, kidney disease, blindness, and poor circulation in your limbs.

What you need to know before you take FDC of empagliflozin metformin Do not take FDC of empagliflozin metformin:

• if you are allergic to empagliflozin, metformin or any of the other ingredients of this medicine
• if you have uncontrolled diabetes, with e.g. severe hyperglycaemia (high blood glucose), nausea, vomiting, dehydration, rapid weight loss or ketoacidosis. Ketoacidosis is 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, fast and deep breathing, sleepiness or unusual fruity odour of the breath;
• if you have had a diabetic pre-coma;
• if you have problems with your kidneys;
• if you have a severe infection such as an infection affecting your lung or bronchial system or your kidney. Severe infections may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Warnings and precautions');
• if you have lost a lot of water from your body (dehydration), e.g. due to long-lasting or severe diarrhoea, or if you have vomited several times in a row. Dehydration may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Warnings and precautions');
• if you are treated for acute heart failure or have recently had a heart attack, have severe problems with your circulation (such as shock) or have breathing difficulties. This may lead to a lack in oxygen supply to tissue which can put you at risk for lactic acidosis (see section ‘Warnings and precautions');
• if you have problems with your liver;
• if you drink alcohol to excess, either every day or only from time to time (see section “FDC of empagliflozin metformin with alcohol”).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment:

• if you have “type 1 diabetes” – this type usually starts when you are young and your body does not produce any insulin;
• if you experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, 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, contact a doctor or the nearest hospital straight away. These symptoms could be a sign of “diabetic ketoacidosis” – a problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests. The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness.
• if you are 75 years old or older, as increased passing of urine due to the medicine may affect fluid balance in your body and increase your risk of dehydration. Possible signs are listed in section 4, ‘Possible side effects’, dehydration;
• if you are 85 years old or older as you should not start taking FDC of empagliflozin metformin;
• if you are being sick, have diarrhoea or fever, or if you are not able to eat or drink. These conditions can cause dehydration. Your doctor may ask you to stop taking FDC of empagliflozin metformin until you recover to prevent loss of too much body fluid;
• if you have a serious infection of the kidney or the urinary tract with fever. Your doctor may ask you to stop taking FDC of empagliflozin metformin until you have recovered;
• if you need to have an injection of contrast agent that contains iodine, for example before an X-ray or scan. You will need to tell your doctor and stop taking this medicine before, or at the time of the X-ray and for 2 or more days after depending on how your kidneys are working. Treatment with iodinated contrast agent can reduce your kidney function and increase the risk of side effects due to the metformin component. Make sure to ask your doctor for advice regarding when you can start your treatment again;
• if you are going to have an operation under anaesthesia. You should stop taking FDC of empagliflozin metformin at least 48 hours before planned surgery with general, spinal or peridural anaesthesia and should not start again until at least 48 hours afterwards. Due to the metformin component, co-administration of anaesthesia can increase the risk of side effects. Follow your doctor’s instructions about stopping and re-starting your medicine.

Please note the following particular risk of lactic acidosis.

Due to the metformin component, FDC of empagliflozin metformin may cause a very rare, but very serious complication called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, prolonged fasting or alcohol intake, body fluid deficit (dehydration) due to severe diarrhoea or vomiting, liver problems and any medical conditions in which a region of the body is deprived with a lack of oxygen supply (such as acute severe heart diseases).

It is important to you to comply with your medication intake, dietary instructions and regular exercise program because this can reduce the risk of lactic acidosis.

The onset of lactic acidosis can be subtle and the symptoms can be non-specific such as vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. Further symptoms are reduced body temperature and heart beat. If you experience some of these symptoms, you should seek immediately medical attention, as lactic acidosis may lead to coma. Stop taking FDC of empagliflozin metformin immediately and contact a doctor or the nearest hospital straight away.

Kidney function

Your kidneys will be tested by a blood test before you start taking and while you are taking this medicine.

Urine glucose

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

Children and adolescents

This medicine is not recommended for use in children and adolescents under 18 years, because it has not been studied in these patients.

Other medicines and FDC of empagliflozin metformin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is important to tell your doctor if you are taking:

• a medicine used to remove water from the body (diuretic), as FDC of empagliflozin metformin may increase the risk of losing too much fluid. Your doctor may ask you to stop taking FDC of empagliflozin metformin. Possible signs of losing too much fluid from your body are listed in section 4 ‘Possible side effects’.
• other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine. Your doctor may want to lower the dose of these other medicines, to prevent your blood sugar levels from getting too low (hypoglycaemia).
• cimetidine, a medicine used to treat stomach problems.
• bronchodilators (beta-2 agonists) which are used to treat asthma.
• corticosteroids (given by mouth, as an injection, or inhaled), which are used to treat inflammation in diseases like asthma and arthritis.
• medicines that contain alcohol (see section ‘FDC of empagliflozin metformin with alcohol’).
• iodinated contrast agents (medicines used during an X-ray, see section 2 ‘Warnings and precautions’.

FDC of empagliflozin metformin with alcohol

There is an increased risk of lactic acidosis following excessive alcohol consumption (particularly in the case of fasting, malnutrition, or liver disease). Therefore, avoid consumption of alcohol and medicines containing alcohol when taking FDC of empagliflozin metformin (see section 4, ‘Possible side effects’).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take FDC of empagliflozin metformin if you are pregnant. It is unknown if this medicine is harmful to the unborn child.

Metformin passes into human milk in small amounts. It is not known whether empagliflozin passes into human breast milk. Do not take FDC of empagliflozin metformin if you are breast-feeding.

Driving and using machines

FDC of empagliflozin metformin has minor influence on the ability to drive and use machines.

Taking this medicine in combination with medicines called sulphonylureas or with insulin can cause blood sugar levels to drop too low (hypoglycaemia), which may cause symptoms such as shaking, sweating and change in vision, and may affect your ability to drive and use machines. Do not drive or use any tools or machines if you feel dizzy while taking FDC of empagliflozin metformin.

How to take FDC of empagliflozin metformin

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much to take

The dose of FDC of empagliflozin metformin varies depending on your condition and the doses of diabetes medicines you currently take. Your doctor will adjust your dose as necessary and tell you exactly which strength of the medicine to take.

Taking this medicine

• Swallow the tablet whole with water.
• Take the tablets with meals to lower your chance of an upset stomach.
• Take the tablet twice daily by mouth.

Your doctor may prescribe FDC of empagliflozin metformin together with another diabetes medicine. Remember to take all medicines as directed by your doctor to achieve the best results for your health. Your doctor may need to adjust your doses to control your blood sugar.

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 doctor while taking FDC of empagliflozin metformin.

If you take more FDC of empagliflozin metformin than you should

If you take more FDC of empagliflozin metformin tablets than you should have, you may experience lactic acidosis. Symptoms of lactic acidosis are non-specific such as feeling or being very sick, vomiting, stomach ache with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. Further symptoms are reduced body temperature and heart beat. If this happens to you, you may need immediate hospital treatment, as lactic acidosis can lead to coma. Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away. Take the medicine pack with you.

If you forget to take FDC of empagliflozin metformin

If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose of this medicine.

If you stop taking FDC of empagliflozin metformin

Do not stop taking FDC of empagliflozin metformin without first consulting your doctor. Your blood sugar levels may increase when you stop taking FDC of empagliflozin metformin.

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

What are the possible side effects

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

Stop taking FDC of empagliflozin metformin and see a doctor as soon as possible if you notice any of the following serious or potentially serious side effects:

Lactic acidosis. Metformin, one of the active substances in this medicine, can cause a very rare (may affect up to 1 in 10,000 people) but serious side effect called ‘lactic acidosis’. This is a build-up of lactic acid in the blood that can cause death. Lactic acidosis is a medical emergency and must be treated in hospital. It particularly affects patients whose kidneys are not working properly.

Signs of ‘lactic acidosis’ are:

• feeling or being very sick
• vomiting, stomach ache
• muscular cramps
• severe tiredness
• difficulty breathing

If this happens to you, you may need immediate hospital treatment, as lactic acidosis may lead to coma. Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away. Take the medicine pack with you.

Contact a doctor or the nearest hospital straight away if you have any of the following side effects:

Diabetic ketoacidosis, seen rarely (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 your urine or blood
• rapid weight loss
• feeling sick or being sick
• stomach pain
• excessive thirst
• 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.

This may occur regardless of blood glucose level. Your doctor may decide to temporarily or permanently stop your treatment with FDC of empagliflozin metformin.

Contact your doctor as soon as possible if you notice the following side effects:

Low blood sugar (hypoglycaemia), seen very commonly (may affect more than 1 in 10 people) If you take FDC of empagliflozin metformin with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is increased. The signs of low blood sugar may include:

• shaking, sweating, feeling very anxious or confused, fast heart beat
• 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 signs above. If you have symptoms of low blood sugar, eat glucose tablets, a high sugar snack or drink fruit juice. Measure your blood sugar if possible and rest.

Urinary tract infection, seen commonly (may affect up to 1 in 10 people)

The signs of urinary tract infection are:

• burning sensation when passing urine
• urine that appears cloudy
• pain in the pelvis, or mid-back pain (when kidneys are infected)

An urge to pass urine or more frequent urination may be due to the way FDC of empagliflozin metformin works, but as they can also be signs of urinary tract infection. If you note an increase in such symptoms, you should also contact your doctor.

Dehydration, seen uncommonly (may affect up to 1 in 100 people)

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

• unusual thirst
• lightheadedness or dizziness upon standing
• fainting or loss of consciousness

Other side effects while taking FDC of empagliflozin metformin:

Very common

• feeling sick (nausea), vomiting
• diarrhoea or stomach ache
• loss of appetite

Common

• genital yeast infection (thrush)
• passing more urine than usual or needing to pass urine more often
• itching
• changes the way things taste

Uncommon

• straining or pain when emptying the bladder

Very rare

• decreased vitamin B12 levels in the blood
• abnormalities in liver function tests, inflammation of the liver (hepatitis)
• redness of the skin (erythema) or an itchy rash (hives)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. By reporting side effects you can help provide more information on the safety of this medicine.

How to store FDC of empagliflozin metformin

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 blister and the carton after ‘EXP’. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What precautions should I take if I have kidney disease?

If you have kidney disease, your healthcare provider will evaluate your condition to determine if empagliflozin/Sitagliptin is suitable for you.

How will I know if I have a urinary or genital infection, and what should I do?

Symptoms of infection may include painful urination, itching, or unusual discharge. Contact your doctor if you notice any of these signs for prompt treatment.

What medications might interact with empagliflozin metformin?

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. In particular, you should tell your doctor if you are using the following medicines:

• Other anti-diabetic medicines, such as insulin or a sulphonylurea. Your doctor may want to lower the dose of these other medicines, to prevent your blood sugar levels from getting too low.
• Medicines used to remove water from your body (diuretics). Your doctor may ask you to stop taking Empagliflozin- Sitagliptin.
• Medicines that might have an effect on the break down of empagliflozin or sitagliptin 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 Empagliflozin-sitagliptinmay be reduced.
• Lithium because Empagliflozin-sitagliptincan lower the amount of lithium in your blood.

Can empagliflozin cause low blood pressure, especially for older adults?

Yes, particularly in elderly patients or those on diuretics. Watch for symptoms like dizziness or fainting. Staying hydrated can help manage blood pressure while on empagliflozin

Does empagliflozin cause weight loss, and should I monitor my weight?

Some people may experience mild weight loss as empagliflozin helps remove excess glucose. Monitoring your weight can help track any unintended changes

Should I stop empagliflozin metformin before surgery or a medical procedure?

It’s important to consult your doctor, as empagliflozin may need to be paused before surgery to reduce the risk of DKA. Follow their instructions closely

Can I use empagliflozin metformin if I have type 1 diabetes?

Empagliflozin/Sitagliptin is not approved for type 1 diabetes due to a higher risk of diabetic ketoacidosis. It’s only indicated for type 2 diabetes management

How often will my blood glucose and HbA1c levels need to be checked?

Your doctor may check your HbA1c every 3 to 6 months to monitor long-term glucose control. Regular self-monitoring of blood glucose may also be needed, especially if you’re adjusting doses

What to do if you are feeling unwell (vomiting, diarrhea, fever)?

Contact your treating physician immediately and then stop taking Empagliflozin Sitagliptin as per his advise. Once you feel better, start taking Empagliflozin Sitagliptin as per his advise.

What to do if you are having surgery?

Contact your treating physician immediately and then stop taking Empagliflozin metformin as per his advise.

References

• Prescribing information of Syndardy XR Available from https://www.ema.europa.eu/en/documents/referral/synjardy-article-20-procedure-annex-i-iii_en.pdf. cited on 19 Oct 2024
• Sick Day Rules for people with type 2 diabetes taking a SGLT-2 Inhibitor https://www.dchft.nhs.uk/wp-content/uploads/2022/02/Sick-Day-Rules-for-people-with-Type-2-Diabetes.pdf Cited on 14 Oct 2024