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