Empagliflozin and metformin (Oral)

The drug empagliflozin and metformin combination is used together with a balanced diet and exercise programme to treat patients with type 2 diabetes.

Overview

In the US, empagliflozin and metformin combination is sold under the brand name, Synjardy. This medication is used as part of a holistic treatment programme that includes an exercise programme and dietary advice and tackles the symptoms caused by type 2 diabetes mellitus.

The drug works in two ways. The metformin component reduces the amount of glucose that is absorbed from the stomach into the bloodstream, prevents stored glucose from being released from the liver, and enables the body to make more efficient use of any glucose that it metabolises. The empagliflozin element of the drug works on the kidneys to stop them from absorbing too much blood sugar. In combination, these two drugs help to lower and control blood sugar.

It should be noted that this drug is not effective in people with type 1, insulin-dependent diabetes.

In people whose diabetes is not controlled and whose blood sugar levels become very high, serious health problems may result, including kidney damage, neurological problems, blindness and loss of sexual function. Heart attack and strokes are also common complications in patients with high blood sugar.

Empagliflozin and metformin combination is available in tablet or extended-release tablet form on prescription from your medical practitioner.

Conditions treated

  • Type 2 diabetes

Type of medicine

  • Tablet
  • Extended release tablet

Side effects

Some medications can cause effects that are not desired, as well as those that are. Not every patient notices these side effects, but if they do happen, you may need to seek further medical attention.

If you experience any of the effects in the list that follows, you must check with your treating physician straight away:

  • Yellow skin or eyes
  • Weight gain
  • Vomiting
  • Unusual weakness or tiredness
  • Unexplained weight loss
  • Thick, creamy vaginal discharge with or without a mild smell
  • Swelling, redness, pain, or itching of the penis
  • Swelling of the lower legs, face, or fingers
  • Stomach pain, continuing
  • Stomach or abdominal discomfort
  • Slurred speech
  • Sleepiness
  • Shortness of breath
  • Shakiness
  • Seizures
  • Redness, itching, or stinging of the vaginal area
  • Rapid, shallow breathing
  • Rapid heartbeat
  • Pain in the lower back or side
  • Overall feeling of discomfort
  • Nightmares
  • Nausea
  • Muscle cramps or pain
  • Loss of consciousness
  • Loss of appetite
  • Light-colored stools
  • Itching of the genitals
  • Increased thirst
  • Increased appetite
  • Headache
  • Fruit-like breath odor
  • Frequent urge to urinate
  • Foul discharge from the penis
  • Flushed, dry skin
  • Feeling dizzy, faint, or lightheaded when getting up suddenly from a prone or sitting position
  • Dry mouth
  • Dizziness
  • Depression
  • Decreased appetite
  • Decreased amount of urine or frequency
  • Dark-colored urine
  • Cool, pale skin
  • Confusion
  • Coma
  • Cloudy or bloody urine
  • Chills
  • Burning, painful or difficult
  • Blurred vision
  • Bladder pain

Some of the effects that accompany empagliflozin and metformin combination will just go away on their own, once your body gets used to the new drug. Your GP may also be able to give you some advice on how to prevent or manage these unwanted effects. However, if the effects do persist or are especially troubling, have a chat with your doctor.

  • Diarrhea
  • Flatulence
  • Indigestion
  • Stomach discomfort

You should note that the side effects mentioned in this guide are not necessarily the only ones that may occur. If you experience any other unexpected or odd effects, you should check with your medical practitioner.

Dosage

It is important that you only take this drug as your doctor has directed you to. Do not be tempted to take more than you have been prescribed, use it more frequently, or take it for a longer duration than you have been told to.

You will be given a medication guide when you collect your prescription of empagliflozin and metformin combination. Read the instructions for use of the drug that are given in the guide. If there is anything that you do not understand, ask your pharmacist or GP.

In order to prevent some of the unwanted stomach upsets that may occur in some patients, during the first couple of weeks of using this medication, the tablets should always be taken with meals. Take the tablets whole, without chewing, sucking, breaking or crushing them.

Be sure to follow the dietary advice you are given by your GP. This is key in diabetes control and will also ensure that your prescription of empagliflozin and metformin combination works correctly. Take regular exercise and remember to attend your doctor for urine and blood testing.

The dose that you are prescribed will vary between patients. Only take the dose you have been told to take by your GP. The information given here is based on the average dose of this drug. If your dose varies from this, you should not change it unless your GP tells you to.

The dose that you take will depend on the strength of the tablets you are given. The number of tablets you take every day, the time you leave between taking each dose, and the total length of your course of empagliflozin and metformin combination will depend on how your body reacts to the medication.

Extended-release tablets for type 2 diabetes:

Each extended-release tablet contains 10 or 25 mg empagliflozin and 1000 mg metformin, or 5 mg empagliflozin and 1000 mg metformin.

  • Adults: Initially take one or two tablets every day with a meal. Your GP may adjust your dose as required.
  • Children: Your doctor will confirm your child's dose.

Tablets for type 2 diabetes:

  • Adults: Initially take one tablet twice daily with a meal. Your GP may adjust your dose as required. The dose does not usually exceed 12.5 mg empagliflozin and 1000 mg of metformin twice daily.
  • Children: Your doctor will confirm your child's dose.

If you forget to take one of your doses, try to have it as soon as you can. If it is nearly time for your scheduled dose, leave out the one you forgot and revert to your usual dosing regimen. Never take double the prescribed dose.

Overdose

If someone has overdosed on empagliflozin and metformin, they may show the following symptoms:

  • Severe vomiting
  • Severe nausea
  • Severe diarrhea
  • Rapid breathing
  • Loss of consciousness
  • Irregular or very slow heartbeat
  • Feeling very sleepy

These signs could mean that the person has developed a life-threatening condition called lactic acidosis. In these circumstances, you should call 911 immediately.

Never share your prescription medication with anyone else.

Do not stop taking the medication, even if you start to feel better within a few days of beginning your course. Even though you may feel perfectly normal and well, your blood sugar levels may begin to fluctuate if you stop using the drug, leaving you vulnerable to dangerous side effects.

Tell your GP if you do not feel any better after taking the medicine for a week or so, check with your doctor immediately if you start feeling worse.

Interactions

Many drugs can interact with each other if taken together. This interaction can change how the different drugs work and can also present an increased risk of side effects. Tell your doctor if you are currently using any other prescription or over the counter drugs, including herbal preparations and vitamin products. Do not stop taking any of your medications without discussing it with your doctor first.

It is not recommended that you take empagliflozin and metformin with any of the drugs listed below. Your doctor may opt to change one or both of your medicines or may decide not to prescribe you empagliflozin and metformin:

  • Tyropanoate Sodium
  • Metrizoic Acid
  • Metrizamide
  • Ipodate
  • Ioxitalamic Acid
  • Ioxaglate
  • Ioversol
  • Iotroxic Acid
  • Iotrolan
  • Iothalamate
  • Iotasul
  • Iosimide
  • Ioseric Acid
  • Iopronic Acid
  • Iopromide
  • Iophendylate
  • Iopentol
  • Iopanoic Acid
  • Iopamidol
  • Iomeprol
  • Iohexol
  • Ioglycamic Acid
  • Ioglicic Acid
  • Iodoxamic Acid
  • Iodopyracet
  • Iodohippuric Acid
  • Iodixanol
  • Iodipamide
  • Iodamide
  • Iocetamic Acid
  • Iocarmic Acid
  • Iobitridol
  • Iobenzamic Acid
  • Ethiodized Oil
  • Diatrizoate
  • Acetrizoic Acid
  • Vandetanib
  • Tosufloxacin
  • Thioctic Acid
  • Sparfloxacin
  • Rufloxacin
  • Ritonavir
  • Prulifloxacin
  • Pefloxacin
  • Pazufloxacin
  • Pasireotide
  • Paritaprevir
  • Ombitasvir
  • Ofloxacin
  • Octreotide
  • Norfloxacin
  • Nadifloxacin
  • Moxifloxacin
  • Lomefloxacin
  • Levofloxacin
  • Lanreotide
  • Gemifloxacin
  • Gatifloxacin
  • Flumequine
  • Fleroxacin
  • Enoxacin
  • Dolutegravir
  • Dofetilide
  • Dasabuvir
  • Ciprofloxacin
  • Bupropion
  • Besifloxacin
  • Balofloxacin
  • Aspirin
  • Tranylcypromine
  • Timolol
  • Sotalol
  • Selegiline
  • Safinamide
  • Rifampin
  • Rasagiline
  • Ranolazine
  • Psyllium
  • Propranolol
  • Procarbazine
  • Practolol
  • Pindolol
  • Phenelzine
  • Penbutolol
  • Patiromer
  • Oxprenolol
  • Nialamide
  • Nebivolol
  • Nadolol
  • Moclobemide
  • Metoprolol
  • Metipranolol
  • Methylene Blue
  • Linezolid
  • Levobunolol
  • Labetalol
  • Isocarboxazid
  • Iproniazid
  • Guar Gum
  • Glucomannan
  • Furazolidone
  • Fenugreek
  • Esmolol
  • Celiprolol
  • Carvedilol
  • Carteolol
  • Bitter Melon
  • Bisoprolol
  • Betaxolol
  • Atenolol
  • Acebutolol

Some medicines should not be taken while you are eating certain food types, using tobacco or drinking alcohol. You should discuss this aspect of your treatment programme with your GP before you begin using empagliflozin and metformin.

Warnings

Before you begin using a new drug, you should discuss the benefits and risks of doing so with your GP or specialist.

Be sure to mention to your doctor any allergic or unusual reactions that you have experienced when taking empagliflozin and metformin or any other drug. You should also mention if you have any allergies to particular foods, food colors, preservatives or animal by-products.

Geriatric patients

Although empagliflozin and metformin do not present any specific risk to geriatric patients, the drug should be used with caution, as elderly people are more likely to have kidney conditions. The dose of this medication should, therefore, be adjusted accordingly.

Pregnancy and breastfeeding

Although using this drug does not necessarily present a danger to the fetus, you should discuss the risks and benefits of its use with your doctor before you begin taking empagliflozin and metformin. Pregnancy can cause your diabetes to become worse. It is therefore important that you discuss a plan to manage your blood sugar while you are pregnant.

Metformin can cause disruption to the menstrual cycle, encouraging ovulation and thus increasing the risk of your becoming pregnant. Talk to your GP about using reliable forms of contraception while you are taking metformin.

Studies have shown that small quantities of metformin may pass into breast milk, potentially causing side effects in a nursing infant. While you are taking this medication, you should stop breastfeeding. Do not express breast milk for later use. Ask your midwife or GP for advice on alternative feeding options for your child until at least a fortnight after you have stopped using empagliflozin and metformin.

Medical history

Some existing and historical medical conditions can affect the use of empagliflozin and metformin. Be sure to discuss your medical history in full with your doctor before you start taking this medication.

This medication should be used with extreme caution in patients who have a history of any of the following conditions as it may make the side effects much worse:

  • Weak physical condition
  • Sepsis
  • Poorly nourished condition
  • Underactive pituitary gland
  • Pancreatic insulin deficiency
  • Acute heart attack
  • Severe dehydration
  • Congestive heart failure
  • Cardiovascular collapse
  • Alcohol abuse
  • Underactive adrenal gland

Empagliflozin and metformin is not recommended for use in people who have a history of any of the following health conditions, as it could make these problems worse:

  • Vitamin B12 deficiency
  • Pyelonephritis, urinary tract infections, urosepsis
  • Kidney disease
  • Hypovolemia (low blood volume)
  • Hypotension (low blood pressure)
  • Hypercholesteremia (high cholesterol)
  • Genital yeast infection
  • Balanitis
  • Balanoposthitis
  • Vulvovaginitis
  • Dehydration
  • Anemia (low levels of red blood cells)

Empagliflozin and metformin should not be used in patients who have a current or previous history of the following conditions:

  • Type 1 diabetes
  • Patients receiving dialysis
  • Metabolic acidosis (acid in the blood)
  • Liver disease
  • Moderate or severe kidney disease
  • Diabetic ketoacidosis (high ketones and acid in the blood)

It should be noted that using this medication can cause problems in controlling blood sugar levels:

  • Trauma
  • Surgery
  • Infection
  • Fever

While you are being treated with empagliflozin and metformin, you will be required to attend your GP clinic or hospital specialist for regular progress checks, particularly when you first begin using the medicine. You will also be required to undertake urine and blood tests so that your treating specialist can check for any unwanted side effects that the drug may be having.

Note that drinking alcohol while taking this medication can cause serious side effects. If you consume alcohol habitually or to excess, you must discuss this with your doctor.

Do not use any other medicines unless your doctor has cleared their use first. You should especially avoid over the counter products, including diet pills, aspirin, cough and cold medicines, asthma drugs, sinus and hay fever products.

Counseling

People suffering from diabetes will benefit from attending specialist counselling to help them cope with the side effects and lifestyle changes that will be required to manage the disease. Counseling regarding pregnancy and contraception are also advised, because of the issues that can arise for diabetes sufferers if they become pregnant.

Travel

If you are travelling abroad or interstate, carry a recent prescription with you, together with your medical history. When changing time zones, remember to take this into account regarding your usual dosage schedule and try to keep your meal times in line with your regular routine as much as possible.

Always carry a medical identification card and wear a medical identification pendant or bracelet at all times. These ID forms should state that you are diabetic and should also have a list of all the drugs that you take for your condition. This information could be vital in an emergency that is either related to your diabetes or in a situation where you are unconscious and not able to communicate with emergency responders.

Potential complications of using empagliflozin and metformin

Taking too much metformin can cause a very serious complication called lactic acidosis. This condition is usually a risk when kidney failure or heart attack occurs. Any or all of the following symptoms all indicate that you could be suffering from lactic acidosis. In these circumstances, call 911 immediately:

  • Stomach or abdominal pain
  • Poor appetite
  • Diarrhea
  • Rapid or shallow breathing
  • Feeling generally ill
  • Muscle cramps or pain
  • Sleepiness
  • Feeling weak or tired

This medication can cause dehydration. If you suffer from low blood pressure, kidney disease, or if you are taking diuretics, you may become dehydrated more easily than other people. Drink plenty of water, especially when the weather is hot or if you are exercising. If you suffer from persistent diarrhea or vomiting, tell your doctor as this could exacerbate the problem of dehydration.

A condition called ketoacidosis (high levels of acid an ketones in the blood) can sometimes occur in patients who are taking empagliflozin and metformin. This is a potentially life-threatening condition. If you experience any of the following symptoms, call 911 immediately:

  • Nausea
  • Vomiting
  • Breathing problems
  • Increased urination
  • Increased thirst

Empagliflozin and metformin can cause kidney problems. You must tell your doctor immediately if you notice any of the following symptoms:

  • Decrease in frequency or volume of urine
  • Painful or problematic urination
  • Pain in your side or lower back
  • Chills
  • Fever
  • Swelling of the lower legs, fingers, or face

If you are due to attend hospital or your dentist, tell your medic that you are taking empagliflozin and metformin. You may be advised to stop taking the medication before you undergo diagnostic tests, especially those that may use a contrast dye, or before you have surgery.

Note that some test results may be affected by this medicine, including urine glucose tests. Tell the treating physician or nurse that you are taking empagliflozin and metformin before undergoing tests.

In some patients, this medication can cause low blood sugar (hypoglycemia). This more commonly occurs when other diabetes drugs are also being used, including insulin, glyburide, and glipizide. If your blood sugar becomes too low, you may lose consciousness. The following signs could mean that are becoming hypoglycemic and you should take action immediately:

  • Appearing drunk
  • Blurred vision
  • Cold sweats
  • Confusion
  • Cold, pale skin
  • Problems with thinking coherently
  • Sleepiness
  • Nausea
  • Persistent headache
  • Extreme hunger
  • Rapid heartbeat
  • Shakiness
  • Slurring your speech
  • Feeling unusually weak or tired

Your doctor will give you advice on what to do if you become hypoglycemic.

If you forget or miss a dose of your medication, your blood sugar levels may become too high. Hyperglycemia can also occur if you eat too much, if you wander from your diet plan, fail to exercise properly or contract a fever or infection. The following are signs that your blood sugar is too high. Check your blood sugar and contact your GP for guidance:

  • Unusual thirst
  • Tiredness
  • Rapid and deep breathing
  • Nausea or vomiting
  • Loss of appetite
  • Ketones in the urine
  • Increased frequency and amount of urination
  • Fruit-like breath odor
  • Flushed and dry skin
  • Dry mouth
  • Drowsiness
  • Blurred vision

In women and men who have a history of genital yeast infections, this medication can cause more yeast infections. Women may notice a discharge from the vagina, itching or odor. Men may experience reddening, swelling, itching, discharge, a strong smell or pain around the penis. You should contact your doctor if you experience any of these symptoms.

Empagliflozin and metformin can increase your risk of contracting urinary tract infections, including urosepsis and pyelonephritis. If you notice that your urine is cloudy or bloody, if you feel a burning sensation or pain when urinating, or if you have pain in your side or lower back, contact your doctor.

Some people taking this medicine may feel dizzy. If you are affected in this way, you must not drive, operate machinery, or take part in any activities that require you to be alert. You may find that standing up slowly can reduce feelings of faintness and dizziness.

Storage

You should keep your supply of empagliflozin and metformin tablets somewhere secure, where children and pets cannot gain access to them. If a pet does eat any of your tablets, you should contact your vet as soon as possible.

The place you choose should also be away from sources of heat and out of direct sunlight. Do not allow the tablets to become moist. Keep them dry and at room temperature.

Do not take any tablets that appear damaged or damp, or whose packaging has been opened. Do not use out of date medication.

You must dispose of unused medicine responsibly. If you are unsure of how to do so, ask your pharmacist or GP for guidance.

Summary

Empagliflozin and metformin in combination is a drug that is generally used to treat patients who have type 2 diabetes mellitus. The medication is used in conjunction with a balanced diet and an exercise regimen in order to help maintain correct blood sugar levels.

Patients who have type 1 diabetes cannot be treated with this drug.

There are a great many drugs, including over the counter preparations that should not be used with empagliflozin and metformin. In addition, this drug can potentially cause problems in patients who have a history of many different health conditions. For this reason, you should be sure to disclose your full medical history to your GP when deciding whether or not you wish to be treated with this medicine.

Throughout the course of your treatment, you will need to attend your doctor for check-ups in order to make sure that the drug is working properly and to deal with any side effects that it may be causing. You will also need to check your blood sugar levels regularly to make sure that the drug is controlling them properly.