Synjardy

Empagliflozin - metformin is a combination of 2 medications that work in different ways to reduce blood sugar. Both empagliflozin and metformin belong to the class of medications called oral hypoglycemics.

This medication is used by adults with type 2 diabetes who are already taking empagliflozin and metformin as separate tablets and have good glucose control. It may also be used along with insulin or other oral hypoglycemic medications if blood glucose hasn't been well controlled on metformin plus the other medication.

Empagliflozin - metformin is intended to be used as part of an overall diabetes management plan that includes diet and exercise.

Empagliflozin works by increasing the amount of glucose being removed from the body by the kidneys, which decreases the amount of sugar in the blood. Metformin works by reducing the amount of glucose made by the liver and by making it easier for glucose to enter into the tissues of the body.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended dose for empagliflozin - metformin is one tablet taken by mouth 2 times a day, with meals. You will start at the dose closest to the dose of empagliflozin and metformin that you are currently taking. Your doctor may adjust the dose up or down, depending on how effective it is and how well it is tolerated. The maximum total daily dose is 25 mg of empagliflozin and 2000 mg of metformin.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

5 mg/500 mg
Each orange-yellow, oval, biconvex film-coated tablet with one side debossed with "S5" and company symbol, and the other side debossed with "500", contains 5 mg of empagliflozin and 500 mg of metformin hydrochloride. Nonmedicinal ingredients: iron oxide yellow, macrogol 400, magnesium stearate, maize starch, silica – colloidal anhydrous, talc, and titanium dioxide.

5 mg/850 mg
Each yellowish-white, oval, biconvex film-coated tablet with one side debossed with "S5" and company symbol, and the other side debossed with "850", contains 5 mg of empagliflozin and 850 mg of metformin hydrochloride. Nonmedicinal ingredients: iron oxide yellow, macrogol 400, magnesium stearate, maize starch, silica – colloidal anhydrous, talc, and titanium dioxide.

5 mg/1000 mg
Each brownish-yellow, oval, biconvex film-coated tablet with one side debossed with "S5" and company symbol, and the other side debossed with "1000", contains 5 mg of empagliflozin and 1000 mg of metformin hydrochloride. Nonmedicinal ingredients: iron oxide yellow, macrogol 400, magnesium stearate, maize starch, silica – colloidal anhydrous, talc, and titanium dioxide.

12.5 mg/500 mg
Each pale brownish-purple, oval, biconvex film-coated tablet with one side debossed with "S12" and company symbol, and the other side debossed with "500", contains 12.5 mg of empagliflozin and 500 mg of metformin hydrochloride. Nonmedicinal ingredients: copovidone, hypromellose, iron oxide black, iron oxide red, macrogol 400, magnesium stearate, maize starch, silica – colloidal anhydrous, talc, and titanium dioxide.

12.5 mg/850 mg
Each pinkish-white, oval, biconvex film-coated tablet with one side debossed with "S12" and company symbol, and the other side debossed with "850", contains 12.5 mg of empagliflozin and 850 mg of metformin hydrochloride. Nonmedicinal ingredients: copovidone, hypromellose, iron oxide black, iron oxide red, macrogol 400, magnesium stearate, maize starch, silica – colloidal anhydrous, talc, and titanium dioxide.

12.5 mg/1000 mg
Each dark brownish-purple, oval, biconvex film-coated tablet with one side debossed with "S12" and company symbol, and the other side debossed with "1000", contains 12.5 mg of empagliflozin and 1000 mg of metformin hydrochloride. Nonmedicinal ingredients: copovidone, hypromellose, iron oxide black, iron oxide red, macrogol 400, magnesium stearate, maize starch, silica – colloidal anhydrous, talc, and titanium dioxide.

Do not take this medication if you:

• are allergic to empagliflozin, metformin or any ingredients of the medication
• are breast-feeding
• are experiencing physiological stress (e.g., severe infection, trauma, surgery or recovery after surgery)
• are in a state of physiologic shock
• are or may be pregnant
• are severely dehydrated
• consume excessive amounts of alcohol
• have acute or chronic metabolic acidosis
• have a history of ketoacidosis or lactic acidosis
• have an unusually low level of oxygen in the blood
• have moderate to severely decreased kidney function
• have severe heart problems or heart failure
• have severely decreased liver function
• have type 1 diabetes mellitus
• have uncontrolled type 2 diabetes mellitus
• have or are going to be treated with iodinated contrast materials for X-ray or CT scan

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• changed sense of taste
• constipation
• increased sensitivity to sunlight
• diarrhea
• dry mouth
• increased urination
• itching
• joint pain
• loss of appetite
• muscle spasms
• nausea
• stomach ache
• unusual thirst
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• pain or difficulty emptying your bladder
• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
• signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine, change of urine colour)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• signs of nerve damage (e.g., numbness, prickling, or tingling in feet or hands; sharp, jabbing, or throbbing pain into arms and legs)
• symptoms of low blood pressure (e.g., fainting, dizziness, lightheadedness, blurred vision, increased thirst, nausea)
• symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heartbeat, weakness
• symptoms of a urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain)
• symptoms of vaginal yeast infection (e.g., odour, white or yellowish vaginal discharge, itching)
• vitamin B12 deficiency (e.g., fatigue, shortness of breath, tingling or numbness of the fingers/toes, difficulty walking, irritability, confusion, lower leg pain)
• yeast infection of the penis (e.g., rash or redness of the penis or foreskin)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of sepsis (infection that has spread throughout the body; e.g., fever, low body temperature, chills, rapid breathing, rapid heartbeat, pain urinating, difficulty urinating)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of diabetic ketoacidosis (e.g., difficulty breathing, extreme thirst, vomiting, nausea, loss of appetite, confusion, unusual tiredness)
• signs of encephalopathy (e.g., muscle weakness in one area, poor decision making, concentration problems, twitching, tremors, trouble speaking, difficulty swallowing, seizures)
• signs of lactic acidosis (e.g., nausea, vomiting, increased breathing rate, abdominal pain, unusual tiredness, dizziness, rapid heart rate)
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• symptoms of infection in the groin area (e.g., pain, tenderness, redness, swelling of the genital or perineal area, fever, weakness, tiredness)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Alcohol consumption: Anyone taking metformin should avoid excessive alcohol intake.

Cholesterol: Empagliflozin may causes increases to cholesterol levels. If you have increased cholesterol, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Dehydration: Empagliflozin - metformin may cause a decrease in the amount of fluid in your body. This dehydration has effects throughout the body. Dehydration can cause decreased kidney function, which in turn reduces the effectiveness of this medication. It can cause decreased blood pressure, which may cause dizziness or fainting. Severely decreased blood pressure also contributes to heart problems. Certain other medications, such as diuretics (water pills), can cause dehydration. If you experience symptoms of dehydration, such as thirst, decreased urine or tear production, dizziness, or headaches, contact your doctor.

Diabetic ketoacidosis (DKA): Empagliflozin has been associated with DKA. This is a potentially life-threatening condition caused by not enough insulin in the blood to use the glucose in the bloodstream. When this happens, the body starts to burn ketones for fuel and can make the blood acidic. This condition is more likely to develop if you are following a very low carbohydrate diet, are dehydrated, or have consumed a large amount of alcohol. Symptoms of DKA include difficulty breathing, nausea, vomiting, abdominal pain, confusion, loss of appetite, excessive thirst, and unusual fatigue or sleepiness. If you experience these symptoms, get immediate medical help.

Dizziness: Some people taking empagliflozin may experience decreases in blood pressure. This occurs because the medication causes an increased amount of fluid, along with the glucose, to be removed from the body through the kidneys. These blood pressure drops could lead to dizziness, lightheadedness, and falls. This may occur when you shift your body position, such as rising from a sitting or lying position. If you experience this problem, try getting up more slowly. If it persists or if you faint, contact your doctor. Seniors and other individuals who are at risk of experiencing low blood pressure (e.g., dehydration, taking medications for high blood pressure) should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Dizziness/reduced alertness: Empagliflozin - metformin may cause low blood sugar, which may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how this medication affects you.

Dye or contrast agents: If you are going to have an X-ray procedure that uses dye or a contrast agent, you may need to stop taking this medication for a short time. Contact your doctor for instructions.

Glucose control: When empagliflozin is taken along with other medications for diabetes, glucose levels may drop too far, causing confusion, cold sweats, cool and pale skin, headache, fast heartbeat, or weakness. If you are using insulin, your doctor may suggest decreasing the dose of the insulin when you first start taking empagliflozin - metformin. If you take other medications for diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infection: Because empagliflozin causes glucose to be removed through the urine, there is an increased risk of urinary tract and perineal infections. Kidney and bladder infections can become severe if they are not treated. Report pain with urination, increased need to urinate, and low back or flank pain to your doctor as soon as possible.

Another type of infection, Fournier's gangrene, is a rare, but serious side effect of taking empagliflozin - metformin. If you experience pain or tenderness, redness, or swelling in the genital area, get immediate medical attention.

Kidney function: The effectiveness of empagliflozin depends on kidney function because it increases the amount of glucose eliminated through the kidneys. Over time, this medication may cause kidney problems. If you experience signs of kidney problems, such as puffy hands, face, or feet, high blood pressure, unusual muscle cramping, or darkened urine, this medication may be affecting how well your kidneys are working. If you notice any of these symptoms, contact your doctor as soon as possible.

Decreased kidney function or kidney disease can cause metformin to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Lactic acidosis: Lactic acidosis is a rare but serious problem that occurs due to metformin accumulation (i.e., the body doesn't get rid of it fast enough) during treatment. If you have severe kidney disease you are at higher risk of developing lactic acidosis. People with congestive heart failure are also at an increased risk of lactic acidosis. Since alcohol may increase the risk of lactic acidosis, do not drink a lot of alcohol over the short or long term while taking this medication. When it does occur (very rarely), it is fatal in 50% of cases. If you experience symptoms of lactic acidosis (e.g., weakness, tiredness, drowsiness, unusual muscle pain, trouble breathing, feeling cold, dizziness, light-headedness, slow or irregular heartbeat, or stomach pain with nausea, vomiting, or diarrhea), stop taking this medication and get immediate medical attention.

Liver function: Decreased liver function has been linked to lactic acidosis. This medication is not recommended for people with severely reduced liver function. If you have moderately reduced liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pancreatitis: Empagliflozin – metformin can cause the pancreas to become inflamed. Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

Reduced response: Over a period of time, you may become progressively less responsive to a particular treatment for diabetes because your diabetes worsens. If empagliflozin - metformin fails to lower blood sugar to target levels, talk to your doctor. Your doctor may want to stop metformin or recommend another medication.

Surgery: This medication should be stopped temporarily for surgery (except for minor surgery where food and fluid intake is not restricted). You will be restarted on this medication once you are eating and drinking and your kidney function has been tested and is normal. Talk to your doctor for specific instructions.

Thyroid disease: This medication may cause decreased thyroid gland function. If you experience symptoms of underactive thyroid, such as unexpectedly feeling cold, depression, constipation, or fatigue, let your doctor know. If you have a history of thyroid disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Vitamin B12 levels: Metformin may decrease vitamin B12 levels. Your doctor will monitor your B12 levels with blood tests while you are taking this medication.

Yeast infections: There is an increased risk of developing genital yeast infections when taking empagliflozin as a result of increased glucose in the urine. This is more likely to occur for uncircumcised men and for people who have a history of yeast infections.

Pregnancy: This medication should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if empagliflozin passes into breast milk. Metformin passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Breast-feeding is not recommended when you are taking this medication.

Children: The safety and effectiveness of this medication have not been established for children less than 18 years of age.

Seniors: Seniors are at an increased risk of experiencing side effects with this medication. Your doctor may suggest lower doses of this medication to reduce this risk. This medication may not work as well in older people due to age-related decreases in renal function.

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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