Patient Medication Information: uses, side effects, how to take - Synjardy
Serious warnings and precautions box
Lactic acidosis
Diabetic ketoacidosis (DKA)
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What SYNJARDY 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:
whose diabetes is not controlled on:
- metformin alone
metformin in combination with:
- sulfonylurea
- pioglitazone
- insulin
whose diabetes is controlled and are currently taking:
- separate tablets of metformin and empagliflozin
separate tablets of metformin and empagliflozin with:
- sulfonylurea
- pioglitazone
- insulin
How SYNJARDY works:
SYNJARDY contains two diabetes medicines, empagliflozin and metformin.
- 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.
The ingredients in SYNJARDY are:
Medicinal ingredients: empagliflozin and metformin hydrochloride.
Non-medicinal ingredients:
12.5 mg/500 mg, 12.5 mg/850 mg and 12.5 mg/1000 mg: iron oxide yellow, macrogol 400, magnesium stearate, maize starch, silica - colloidal anhydrous, talc, titanium dioxide.
5 mg/500 mg, 5 mg/850 mg and 5 mg/1000 mg: copovidone, hypromellose, iron oxide black and iron oxide red, macrogol 400, magnesium stearate, maize starch, silica - colloidal anhydrous, talc, titanium dioxide.
SYNJARDY comes in the following dosage forms:
Tablets: 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.
Do not use SYNJARDY if:
- you are allergic to empagliflozin, metformin or any other ingredients in SYNJARDY
- you have type 1 diabetes (your body does not produce insulin)
- you 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)
- you have a build-up of acid in your body. This is known as metabolic acidosis
- you have a history of lactic acidosis (too much acid in your blood)
- you have had ketoacidosis with or without coma
- you are taking an insulin mix (regular or analogue)
- you are on dialysis
- you have severe kidney disease
- you have liver problems
- you 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)
- you are about to undergo surgery or during the recovery time after your surgery
- you are about to undergo or have just taken certain x-ray tests with iodinated dyes or contrast agents that are injected into your body. Talk to your healthcare professional about when to stop SYNJARDY and when to start again.
- you have abrupt failure of blood circulation. This is known as cardiovascular collapse
- you 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)
- you drink alcohol very often or drink a lot of alcohol in a short time. This is known as binge drinking
you are breast-feeding
- you are pregnant, or planning to become pregnant.
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 vitamin B12 deficiency
- have anemia (low levels of red blood cells)
- have low blood levels of calcium
- have hypothyroidism (low levels of thyroid hormones)
- have or have had severe kidney problems
- have or have had liver disease
- have heart problems, including congestive heart failure, especially if it needs treatment with medicines
- develop a serious medical condition, such as heart attack, severe infection, or a stroke
- develop or experience a worsening of heart disease or heart failure
- have low blood pressure
- are older than 65 years of age
have a higher 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
- need to have a procedure that requires long periods of fasting
- 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
have a genetic disease affecting mitochondria (the energy-producing components within cells) such as:
- MELAS syndrome (Mitochondrial Encephalopathy with Lactic Acidosis and Stroke-like episodes); or
- Maternally inherited diabetes and deafness (MIDD).
Other warnings you should know about:
- Low vitamin B12: SYNJARDY can cause your vitamin B12 level to be low. This can cause you to feel pins and needles in your hands and feet (called peripheral neuropathy).
Hypoglycemia (low blood sugar levels): SYNJARDY can cause hypoglycemia. It can happen if you:
- are 65 years of age or older
- do not eat enough
- drink alcohol
- exercise heavily and do not eat enough
- take other medications that lower blood sugar
- also have adrenal, pituitary or liver problems
- Increase in fats: SYNJARDY may cause changes in the amount of cholesterol or fats in your blood.
- Kidney problems: SYNJARDY may cause abnormal kidney function. This may happen shortly after you start taking SYNJARDY. Your healthcare professional will do blood tests to monitor how well your kidneys are working while you are taking SYNJARDY.
- Yeast infections: 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.
Fournier’s gangrene:
- SYNJARDY may cause a rare but serious and potentially life-threatening infection called Fournier’s gangrene. This requires urgent treatment and can affect both men and women taking medicines like SYNJARDY (SGLT2 inhibitors).
- 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 healthcare professional right away. These may be signs of Fournier’s gangrene.
Stopping treatment:
Your healthcare professional may temporarily stop your treatment with SYNJARDY:
- For at least 3 days before, and a period of time after certain types of surgery, or procedures associated with long periods of fasting.
- When you are hospitalized for a serious infection or illness.
If SYNJARDY is stopped, your healthcare professional will:
- Continue to monitor for signs and symptoms of DKA.
- Tell you when to start taking SYNJARDY again.
- Measuring blood sugars: 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.
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).
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with SYNJARDY:
- 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;
- Lithium, because SYNJARDY can lower the amount of lithium in your blood;
- Antibiotics used to treat tuberculosis, such as rifampin or isoniazid;
- Blood thinners, known as anticoagulants (phenprocoumon or other antivitamin K anticoagulants);
- Cationic medicines. For example, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin;
Medicines that can increase the blood sugar and may lead to loss of blood sugar control. These medicines 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 medicines, such as phenothiazines (known as antipsychotics);
- Thiazide and other diuretics (water pills);
- Thyroid hormone replacement medicines e.g., levothyroxine. They are used to treat problems with the thyroid gland;
- Estrogens or estrogens plus progestogen (female hormones);
- Birth control pills;
- Medicines used to stimulate the sympathetic nervous system called sympathomimetics;
- Calcium channel blockers such as nifedipine used to treat angina, amlodipine, felodipine, verapamil, diltiazem;
- Medicines 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).
How to take SYNJARDY:
- Take exactly as directed by your healthcare professional. Talk to your healthcare professional if you are not sure.
Take with food. Taking SYNJARDY with meals may lower your chance of having an upset stomach.
- Swallow the tablet whole with water.
- 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 healthcare professional while taking SYNJARDY.
- Do not stop taking SYNJARDY without first consulting your healthcare professional. Your blood sugar levels may increase when you stop taking SYNJARDY.
Usual dose:
Your healthcare professional 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 healthcare professional.
Overdose:
In general, an overdose may lead to increased symptoms including stomach-ache, nausea, vomiting, diarrhea, drowsiness, weakness, dizziness, malaise, and headache.
Lactic acidosis may also occur. This is a serious, life-threatening condition that must be treated in a hospital.
| If you think you, or a person you are caring for, have taken too much SYNJARDY, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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Missed Dose:
- If you missed a dose of SYNJARDY, take it as soon as you remember. But if it is almost time for your next dose, skip the missed dose and continue with your next scheduled dose. Go back to the regular dosing schedule.
- Do NOT take two doses at the same time to make up for a dose you have missed.
Possible side effects from using SYNJARDY:
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.
Side effects may include:
- Constipation
- Dehydration
- Dry mouth
- Joint pain
- Muscle spasms
- Skin is sensitive to sunlight
- Unusual thirst
SYNJARDY can cause abnormal blood and urine test results. Your healthcare professional will decide when to perform tests and will interpret the results. They may check your ketone levels, blood fat levels, the amount of red blood cells in your blood, check your eyes, heart, liver and kidney function.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Very common | |||
| Hypoglycemia (low blood sugar): 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 (infection in urinary system including kidneys, ureters, bladder and urethra): 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): dry or sticky mouth, headache, dizziness, urinating less often than normal. | ✓ | ||
| Genital yeast infections: itching, burning, soreness, irritation, pain during intercourse and/or urination, vaginal discharge, difficulty retracting foreskin for males. | ✓ | ||
| 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. | ✓ | ||
| Sepsis (severe infection that spreads from urinary tract throughout body): 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 sleepy, 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 (inflammation of the liver): 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, backache. | ✓ | ||
| 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 (high levels of acid in the blood): 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. | |||
Worsening of Mitochondrial Disease (a disease affecting energy producing components within cells): seizure, reduction in a person’s mental abilities (memory lapses, difficulty concentrating, trouble finding words or following conversations, poor judgment or decision-making, confusion), difficulty with body movements, muscle pain or weakness, pain, numbness, migraine, deafness | ✓ | ||
| Liver problems: yellowing of your skin and eyes (jaundice), right upper stomach area pain or swelling, nausea or vomiting, unusual dark urine, unusual tiredness. | ✓ | ||
| 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. | ✓ | ||
| Hypothyroidism (underactive/low thyroid): weight gain, tiredness, hair loss, muscle weakness, feeling cold, dry skin, constipation, puffy face, heavier than normal or irregular menstrual periods, enlarged thyroid gland. | ✓ | ||
| Photosensitivity (sensitivity to sunlight): itchy, red skin when exposed to sunlight. | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
- Store at room temperature (15-30°C).
- Keep out of reach and sight of children.
- 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.
If you want more information about SYNJARDY:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (https://www.boehringer-ingelheim.ca), or by calling the manufacturer, Boehringer Ingelheim (Canada) Ltd., at: 1-800-263-5103, extension 84633.
The information in this leaflet is current up to the time of the last authorization date shown below, but more current information may be available from the manufacturer.
Date of Authorization: 2026-10-28