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Details for: SYNJARDY

Company: BOEHRINGER INGELHEIM (CANADA) LTD LTEE

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02456575SYNJARDYMETFORMIN HYDROCHLORIDE; EMPAGLIFLOZIN500 MG; 5 MGTABLETORAL
02456605SYNJARDYEMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE12.5 MG; 500 MGTABLETORAL
02456583SYNJARDYEMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE5 MG; 850 MGTABLETORAL
02456613SYNJARDYEMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE12.5 MG; 850 MGTABLETORAL
02456591SYNJARDYEMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE5 MG; 1000 MGTABLETORAL
02456621SYNJARDYEMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE12.5 MG; 1000 MGTABLETORAL
Search Reported Side Effects Report a Side Effect

Summary Reports

Regulatory Decision Summary
Summary Safety Review - SGLT2 Inhibitors (canagliflozin, dapagliflozin, empagliflozin) - Assessing the Potential Risk of Bone-Related Side Effects
Summary Safety Review - SGLT2 Inhibitors (canagliflozin, dapagliflozin, empagliflozin) - Assessing the Risk of the Body Producing High Levels of Acids in the Blood (diabetic ketoacidosis)
Summary Safety Review - SGLT2 inhibitors - Assessing the potential risk of a rare brain condition (posterior reversible encephalopathy syndrome) in patients who have developed high levels of acids in the blood (diabetic ketoacidosis)
Summary Safety Review - Sodium/glucose cotransporter 2 (SGLT2) inhibitors - Assessing the potential risk of inflammation of the pancreas (acute and chronic pancreatitis)

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

SYNJARDY is used along with diet and exercise to improve control of blood sugar in adults with type 2 diabetes.

SYNJARDY can be used:

  • In patients who are not controlled on metformin alone or on a combination of metformin with:
    • A sulfonylurea;
    • Pioglitazone;
    • Insulin.
  • In patients who are currently treated with combinations of separate tablets of metformin and empagliflozin (JARDIANCE), or a combination of metformin and empagliflozin (JARDIANCE) with:
    • A sulfonylurea;
    • Pioglitazone;
    • Insulin.
What it does

SYNJARDY contains two drugs.
Empagliflozin: removes excess glucose from the body and passes it through the urine. Metformin: helps to lower the amount of sugar made by your liver and helps to lower the amount of sugar your intestines absorb.

When it should not be used

  • Have type 1 diabetes (your body does not produce insulin);
  • Have a complication of diabetes with increased ketones in the blood or urine, known as diabetic ketoacidosis (DKA) (with or without coma) or a history of DKA (with or without coma);
  • Have a build-up of acid in your body. This is known as metabolic acidosis;
  • Have a history of lactic acidosis (too much acid in your blood);
  • Are taking an insulin mix (regular or analogue);
  • Are on dialysis;
  • Have kidney problems (kidney disease or impairment);
  • Have liver problems (liver dysfunction or liver disease);
  • Are stressed, have severe infections or are experiencing trauma;
  • You suffer from severe dehydration (have lost a lot of water from your body);
  • You are hypertensive (have a high blood pressure);
  • Are prior to surgery or during the recovery time after your surgery;
  • Are prior to or just after certain x-ray tests with iodinated dyes or contrast agents that are injected into your body;
  • Have abrupt failure of blood circulation. This is known as cardiovascular collapse;
  • Have heart and lungs that do not function properly. This is known as cardiorespiratory insufficiency, a disease state that can cause hypoxemia (low oxygen in the blood);
  • Drink alcohol very often, or drink a lot of alcohol in a short time. This is known as binge drinking;
  • Are breast-feeding;
  • Are pregnant, or planning to become pregnant;
  • Are under 18 years of age;
  • Are allergic to any of the ingredients in SYNJARDY.
What the medicinal ingredient is

empagliflozin and metformin hydrochloride

What the non-medicinal ingredients are

copovidone, hypromellose, iron oxide black and iron oxide red (SYNJARDY 12.5 mg/500 mg, 12.5 mg/850 mg and 12.5 mg/1000 mg), iron oxide yellow (SYNJARDY 5 mg/500 mg, 5 mg/850 mg and 5 mg/1000 mg), macrogol 400, magnesium stearate, maize starch, silica - colloidal anhydrous, talc, titanium dioxide.

What dosage form it comes in

Empagliflozin and metformin hydrochloride:

  • 5 mg/500 mg, 5 mg/850 mg, 5 mg/1000 mg;
  • 12.5 mg/500 mg, 12.5 mg/850 mg, 12.5 mg/1000 mg.
Warnings and precautions

Serious Warnings and Precautions

  • SYNJARDY can cause a rare but serious side effect called lactic acidosis. This is a buildup of lactic acid in the blood. There is an increased risk after excessive alcohol consumption. This is more common if you are also fasting, malnourished, or have liver disease. Lactic acidosis is a medical emergency and must be treated in a hospital. It can cause coma or death. Therefore, you should not drink alcohol if you take SYNJARDY.
  • Diabetic ketoacidosis (DKA) is a serious and life-threatening condition that requires urgent hospitalization. DKA has been reported in patients with type 2 diabetes mellitus (T2DM), with normal or high blood sugar levels, who are treated with SYNJARDY or with other sodium-glucose co-transporter 2 (SGLT2) inhibitors. Some cases of DKA have led to death.
  • Seek medical attention right away and stop taking SYNJARDY immediately if you have any of the following symptoms (even if your blood sugar levels are normal): difficulty breathing, nausea, vomiting, stomach pain, loss of appetite, confusion, feeling very thirsty, feeling unusually tired or sleepy, a sweet smell to the breath, a sweet or metallic taste in the mouth or a different odour to urine or sweat.
  • Do not use SYNJARDY if you have type 1 diabetes or DKA.
  • SYNJARDY should not be used to treat DKA or if you have a history of DKA.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you start taking SYNJARDY. Talk about any health conditions or problems you may have, including if you:

  • Have or have had any kidney problems;
  • Have or have had any cases of liver disease;
  • Have congestive heart failure, especially if it needs treatment with medicines;
  • Have heart problems, or low blood pressure;
  • Are older than 65 years old. And, if you are 85 years old or older you should not start taking SYNJARDY;
  • Have an increased chance of developing diabetic ketoacidosis (DKA) (increased levels of ketones in your blood or urine, seen in tests), including if you:
    • Are dehydrated or suffer from excessive vomiting, diarrhea, or sweating;
    • Are on a very low carbohydrate diet;
    • Have been fasting for a while;
    • Are eating less, or there is a change in your diet;
    • Drink alcohol very often, or drink a lot of alcohol over a short period of time (binge drinking);
    • Have/have had problems with your pancreas, including pancreatitis or surgery on your pancreas;
    • Have sudden reductions in insulin dose;
    • Have an acute illness;
    • Are going to have surgery and after surgery;
    • Are hospitalized for major surgery, serious infection, or serious medical illnesses;
    • Have a history of DKA.

If you are going to have a surgery and after your surgery, or if you are hospitalized for a serious infection, a serious medical illness, or a major surgery, your doctor may stop your SYNJARDY. Talk to your doctor about when to stop taking SYNJARDY and when to start it again. Your doctor will check for ketones in your blood or urine.

Other warnings you should know about

You have a higher chance of getting lactic acidosis if you:

  • Have any of the first three conditions from the bulleted list just above;
  • Have metabolic acidosis (e.g. diabetic ketoacidosis);
  • Drink alcohol very often, or drink a lot of alcohol over a short period of time (binge drinking);
  • Are dehydrated or suffer from excessive vomiting, diarrhea, or sweating;
  • Have certain x-ray tests with iodinated dyes or contrast agents that are injected into your body;
  • Have surgery (before surgery and the recovery period following the surgery);
  • Have a heart attack, severe infection, or stroke;
  • Are 80 years of age or older and have NOT been assessed for kidney function

You should tell your doctor if you have any other medical condition including: Vitamin B12 deficiency or anemia, excessive alcohol use, allergies, or hypothyroidism (low levels of thyroid hormones).

SYNJARDY may cause changes in the amount of cholesterol or fats in your blood.

SYNJARDY may cause abnormal kidney function. Your doctor will do blood tests to monitor how well your kidneys are working while you are taking SYNJARDY.

SYNJARDY increases the chance of getting a yeast infection of the penis or vagina. This is more likely in people who have had yeast infections in the past.

SYNJARDY may cause necrotizing fasciitis of the perineum (area between and around the anus and genitals). This is a rare, but serious and potentially life-threatening infection that can affect both men and women with diabetes taking SGLT2 inhibitors. It is also known as Fournier’s gangrene and requires urgent treatment. If you experience tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, especially if you also have a fever or are feeling unwell, contact your doctor right away. These may be signs of Fournier’s gangrene.

Driving and using machines: SYNJARDY may cause dizziness or light-headedness. Do not drive or use machines until you know how the medicine affects you. Do not drive or operate machines if you develop hypoglycemia (low blood sugar levels).

Do not start or stop any medicine without the approval of your healthcare professional.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Interactions with this medication
  • Diuretics, known as water pills, such as furosemide. They are used to remove excess water from the body in conditions like edema (fluid retention) and hypertension (high blood pressure). Diuretics, especially loop diuretics, may increase the risk of lactic acidosis due to their potential to decrease kidney function;
  • Nifedipine (a calcium channel blocker used to treat angina, high blood pressure, Raynaud’s phenomenon);
  • Medicines used to lower blood sugar levels, such as glyburide, gliclazide or glimepiride (sulfonylureas) or insulin. Taking SYNJARDY with any of these medicines can increase the risk of having low blood sugar (hypoglycemia);
  • Medicines used to lower high blood pressure; such as angiotensin converting enzyme (ACE) inhibitors. ACE inhibitors may lower blood glucose and the combination with SYNJARDY should be carefully monitored;
  • Antibiotics used to treat tuberculosis, such as rifampin or isoniazid;
  • Blood thinners, known as anticoagulants (phenprocoumon or other antivitamin K anticoagulants);
  • Cationic drugs. For example, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin;
  • Drugs that can increase the blood sugar and may lead to loss of blood sugar control. These drugs include:
    • Corticosteroids, an anti-inflammatory medicine such as prednisone. They are used to treat inflammation in diseases like asthma or arthritis;
    • Isoniazid (medicine used to treat active tuberculosis infections);
    • Tranquilizing drugs, such as phenothiazines (known as antipsychotics);
    • Thiazide and other diuretics (water pills);
    • Thyroid hormone replacement drugs e.g., levothyroxine. They are used to treat problems with the thyroid gland;
    • Estrogens or estrogens plus progestogen (female hormones);
    • Birth control pills;
    • Sympathomimetics;
    • Calcium channel blockers such as nifedipine used to treat angina, amlodipine, felodipine, veramapil, diltiazem;
    • Drugs used to control seizures, such as phenytoin (medicine used to treat epilepsy);
    • Niacin, also known as vitamin B3 or nicotinic acid (medicine used to prevent and treat niacin deficiency);
    • Bronchodilators used to treat asthma like salbutamol or formoterol (known as beta-2- agonists).

Before using any drugs or herbal products, consult your healthcare professional.

Prior to Surgery: Stop SYNJARDY for 2 days before any surgery that limits what you eat and drink. You can re-start SYNJARDY once you can eat and drink and your doctor decides that your kidneys are working.

Prior to Certain X-ray Tests with Iodinated Dyes or Contrast Agents that are Injected Into Your Body: Stop SYNJARDY at the time of the test or just before. Re-start SYNJARDY 48 hours after the test and your doctor decides that your kidneys are working.

Proper use of this medication

Your doctor will tell you how much SYNJARDY to take. The amount of SYNJARDY that you take depends on your condition and the doses you currently take of metformin and/or individual tablets of empagliflozin and metformin. Take only the dose that has been prescribed to you. If you are not sure what your dose is, ask your doctor.

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 SYNJARDY.

Taking SYNJARDY with meals may lower your chance of having an upset stomach.

Do not stop taking SYNJARDY without first consulting your doctor. Your blood sugar levels may increase when you stop taking SYNJARDY.

Recommended Adult Dose: One tablet two times a day with food. Swallow the tablet whole with water.

Overdose

In general, an overdose may lead to increased symptoms including stomach ache, nausea, vomiting, diarrhea, drowsiness, weakness, dizziness, malaise, and headache.

A serious, life-threatening condition called lactic acidosis may also occur (see Serious Warnings and Precautions box).

If you think you have taken too much SYNJARDY, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

  • If you forget to take a dose of SYNJARDY, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.
  • Do not take a double dose to make up for a forgotten dose. Never take two doses of SYNJARDY at the same time.

Side effects and what to do about them

These are not all the possible side effects you may feel when taking SYNJARDY. If you experience any side effects not listed here, contact your healthcare professional. Please also see the Serious Warnings and Precautions box.

Side effects may include:

  • Constipation;
  • Dehydration;
  • Unusual thirst;
  • Dry mouth;
  • Joint pain;
  • Muscle spasms

Tell your doctor if the side effects bother you a lot, last for more than a few weeks, come back after they have gone away, or start later in treatment. You may need a lower dose or need to stop taking the medicine for a short period or for good.

After you are on the same dose for several days or weeks, if any of the side effects come back, tell your doctor immediately. A late reappearance of stomach symptoms may be due to lactic acidosis.

Lactic Acidosis is a serious medical condition. It has occurred mostly in people whose kidneys were not working normally. Although very rare, if lactic acidosis does occur, it can be fatal in up to half of the people who develop it. It is also important for your liver to be working normally when you take SYNJARDY. Your liver helps remove lactic acid from your blood. Make sure you tell your doctor before you use SYNJARDY if you have any kidney or liver problems.

You should also stop using SYNJARDY and call your doctor immediately if you have any of the symptoms of lactic acidosis described below in the serious side effect table under Lactic Acidosis. Lactic acidosis is a medical emergency that must be treated in a hospital.

Hypoglycemia (low blood sugar) can occur if you do not eat enough, if you drink alcohol, or if you take other medicines to lower blood sugar. Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs described below. 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.

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

Diabetic Ketoacidosis (DKA) is a serious, life-threatening medical condition that may lead to death. DKA can occur with normal or high blood glucose levels. DKA has happened in people who have type 1 diabetes or type 2 diabetes, or in people with diabetes who were sick or who had surgery, during treatment with SYNJARDY. DKA requires immediate treatment in a hospital. DKA can happen with SYNJARDY even if your blood sugar is at normal or near normal levels. Stop taking SYNJARDY immediately and get immediate medical help if you have any of the symptoms described in the table below under DKA, even if your blood glucose levels are normal.

SYNJARDY will cause your urine to test positive for sugar (glucose). This is expected when you take SYNJARDY. You should use a different way to monitor your diabetes.

SYNJARDY can cause abnormal blood test results. Your doctor will decide when to perform tests and will interpret the results. They may check your blood fat levels, the amount of red blood cells in your blood, check your eyes, heart, liver and kidney function.

Your skin may be more sensitive to sunlight when you take SYNJARDY. Protect your skin from the sun.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
VERY COMMON
Low blood sugar (hypoglycemia): shaking; sweating; feeling very anxious or confused; fast heartbeat; feeling excessive hunger; headache.   ✔  
Nausea ✔    
Vomiting ✔    
Diarrhea ✔    
Stomach ache ✔    
Loss of appetite ✔    
COMMON
Urinary tract infection: burning sensation when passing urine; urine that appears cloudy; pain in the pelvis; or mid -back pain when kidneys are infected.   ✔  
Volume depletion (loss of needed fluids from the body, dehydration, especially in patients older than 75 years of age): dry or sticky mouth; headache; dizziness; urinating less often than normal.   ✔  
Genital yeast infections (reported more frequently in female patients): itching; burning; soreness; irritation; pain during intercourse and/or urination; vaginal discharge   ✔  
Increased urination: passing more urine than usual or needing to pass urine more often. ✔    
Itching ✔    
Changes in taste ✔    
Allergic skin reactions: rash, redness of the skin, hives, swelling of your lips, face, throat or tongue that may cause difficulty in breathing or swallowing.     ✔
UNCOMMON
Low Blood Pressure: dizziness; fainting; light -headedness. May occur when you go from lying to sitting to standing up.   ✔  
Dysuria: straining or pain when emptying the bladder.   ✔  
Kidney problems: any change in the amount, frequency or colour (pale or dark) of urine.   ✔  
Acute kidney infection: painful, urgent or frequent urination, lower back (flank) pain, fever or chills, cloudy or foul smelling urine, blood in your urine.     ✔
Severe infection that spreads from urinary tract throughout body (sepsis): fever or low body temperature, chills, rapid breathing, rapid heartbeat, pain with urination, difficulty urinating, frequent urination.     ✔
RARE
Diabetic Ketoacidosis (DKA): increased levels of ketones in urine or blood, rapid weight loss, feeling sick or being sick, difficulty breathing or fast and deep breathing , feeling very thirsty , vomiting , stomach pain , nausea , loss of appetite , confusion , feeling unusually tired or sleeply , a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat.     ✔
Vitamin B12 deficiency (decreased vitamin B12 levels in the blood): fatigue; shortness of breath; tingling or numbness of the fingers or toes; difficulty walking properly; irritability; confusion; tender calves.   ✔  
Hepatitis: yellowing of the skin or eyes; dark urine; abdominal pain; nausea; vomiting; loss of appetite.   ✔  
Pancreatitis (inflammation of the pancreas): prolonged severe abdominal pain which may be accompanied by vomiting; pain may spread out towards the back.     ✔
Hemolytic anemia (when red blood cells are destroyed faster than bone marrow can replace them): symptoms may include fatigue, pale color, rapid heartbeat, shortness of breath, dark urine, chills, back ache.     ✔
Encephalopathy (disease of the brain that severely alters thinking): possible neurological symptoms include: muscle weakness in one area, poor decision -making or concentration, involuntary twitching, trembling, difficulty speaking or swallowing, seizures.     ✔
Peripheral neuropathy (a result of damage to your peripheral nerves): signs and symptoms might include gradual onset of numbness, prickling or tingling in your feet or hands, which can spread upward into your legs and arms, sharp, jabbing, throbbing, freezing or burning pain, extreme sensitivity to touch, lack of coordination and falling, muscle weakness or paralysis if motor nerves are affected.     ✔
VERY RARE
Lactic Acidosis: feel very weak or tired; have unusual muscle pain; have trouble breathing or fast breathing; have unusual fatigue, drowsiness or sleepiness or sleep longer than usual; have sudden stomach or intestinal problems with nausea and vomiting or diarrhea; feel cold, especially in your arms and legs; feel dizzy or light-headed; have a slow or irregular heartbeat; a medical condition suddenly changes; you develop or experience a worsening of heart problems and in particular heart failure.     ✔
UNKNOWN
Fournier’s gangrene (a serious infection affecting soft tissue): fever, feeling weak, tired or uncomfortable; tenderness, redness, or swelling in and around the genitals or anus.     ✔

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

How to store

Keep out of reach and sight of children. Store at room temperature (15-30°C).
Do not use this medicine after the expiry date which is stated on the blister and the carton.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose medicines you no longer use. These measures will help protect the environment.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

This leaflet was prepared by Boehringer Ingelheim (Canada) Ltd. The information in this leaflet is current up to the time of the last revision date shown below, but more current information may be available from the manufacturer.

Last revised: April 28, 2020

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Boehringer Ingelheim (Canada) Ltd.
Burlington, ON, Canada L7L 5H4

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Eli Lilly Canada Inc.
Toronto, ON, Canada M1N 2E8

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