Patient Medication Information: uses, side effects, how to take - Auro-Canagliflozin
Serious Warnings and Precautions
Diabetic Ketoacidosis (DKA)
- DKA may happen during or after stopping treatment with Auro-Canagliflozin. It is a serious and life-threatening condition, which may need urgent hospital care. Some cases of DKA have led to death. DKA is a complication of diabetes, where your body produces high levels of blood acids called ketones. It can happen in patients with type 2 diabetes mellitus (T2DM), with normal or high blood sugar (glucose) levels who are treated with Auro-Canagliflozin or with other sodium-glucose co-transporter-2 (SGLT2) inhibitors.
- Seek medical attention right away and stop taking Auro-Canagliflozin 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.
- If you have diabetic kidney disease, you may have a higher chance of DKA while you are taking Auro-Canagliflozin.
Do NOT use Auro-Canagliflozin if you have:
- type 1 diabetes.
- DKA or a history of DKA.
Lower Limb Amputation
- Auro-Canagliflozin may increase your risk of lower limb amputations. Amputations have happened mainly on the toe or part of the foot but could also involve the leg, below and above the knee. Some people had more than one amputation, some on both sides of the body.
- Tell your healthcare professional if you have ever had an amputation, blood vessel disease, nerve disease, or a foot ulcer (sore) caused by diabetes.
- Seek medical attention right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Your healthcare professional may decide to stop your Auro-Canagliflozin if you have any of these signs or symptoms. Talk to your healthcare professional about proper foot care and keeping hydrated.
What is Auro-Canagliflozin used for?
Auro-Canagliflozin is used along with diet and exercise to improve blood sugar levels in adults with type 2 diabetes. Auro-Canagliflozin can be used:
- alone, in patients who cannot take metformin;
- with metformin;
- with a sulfonylurea;
- with metformin and a sulfonylurea;
- with metformin and a pioglitazone;
- with metformin and sitagliptin; or
- with insulin (with or without metformin).
Auro-Canagliflozin can also be used, along with diet and exercise, if you have type 2 diabetes and:
- an increased cardiovascular risk. This means that you have or may have health problems due to your heart and blood vessels. Auro-Canagliflozin can be used to lower your risk of dying from events related to your heart or blood vessels. It may also lower your risk of having heart attacks and strokes.
- diabetic kidney disease. This is when your kidneys are damaged as a result of your diabetes. Auro-Canagliflozin can be used to lower the risk that your kidney function will worsen to the point where your kidneys fail and you need dialysis. As well, Auro-Canagliflozin may also lower your risk of dying from events related to your heart and blood vessels.
How does Auro-Canagliflozin work?
Auro-Canagliflozin belongs to a group of medicines called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to get rid of more sugar in the urine.
What are the ingredients in Auro-Canagliflozin?
Medicinal ingredients: Canagliflozin
Non-medicinal ingredients: Anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and polysorbate 80.
Tablet coating ingredients: 300 mg tablets - Opadry II White 85F18422 (which contains polyvinyl alcohol (Part-hydrolyzed), Macrogol /PEG 3350 Titanium dioxide, Talc) and 100 mg tablets - Opadry II Yellow 85F520110 (which contains polyvinyl alcohol (Part-hydrolyzed), Macrogol/PEG 3350, Titanium Dioxide, Talc, Iron oxide yellow).
Auro-Canagliflozin comes in the following dosage forms:
100 mg tablets: Yellow colored, matted finish capsule shaped, film coated tablets debossed with “T” on one side and “80” on the other side.
300 mg tablets: White colored, matted finish capsule-shaped, film coated tablets debossed with “T” on one side and “90” on the other side.
Do not use Auro-Canagliflozin if you:
- are allergic to canagliflozin or any other ingredients in Auro-Canagliflozin.
- have type 1 diabetes (your body does not produce any insulin).
- have or have had diabetic ketoacidosis (DKA). This is a complication of diabetes.
- are on dialysis.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Auro-Canagliflozin. Talk about any health conditions or problems you may have, including if you:
have any of the following conditions:
- liver problems.
- heart problems.
- intolerance to some milk sugars. Auro-Canagliflozin tablets contain lactose.
pregnant or are planning to have a baby. Auro-Canagliflozin should not be used during pregnancy. It is not known if Auro-Canagliflozin can harm your unborn baby.
- breast-feeding. Auro-Canagliflozin should not be used during breast-feeding.
- current or history of low blood pressure (hypotension).
- often get urinary tract infections.
- are taking any of the medications listed in the drug interactions section below (see The following may interact with Auro-Canagliflozin).
have risk factors for developing DKA, 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 a lot of alcohol.
- have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas.
- are hospitalized for major surgery, or are about to have major surgery.
- are hospitalized for serious infection or serious medical illnesses.
- need to have a procedure that requires long periods of fasting.
- have an acute illness.
- have sudden reductions in insulin dose.
- have diabetic kidney disease.
- have a history of diabetic ketoacidosis (DKA).
have risk factors for needing an amputation, including if you:
- have a history of amputation.
- have heart disease or are at risk for heart disease.
- have had blocked or narrowed blood vessels, usually in your leg.
- have damage to the nerves (neuropathy) in your leg.
- have had diabetic foot ulcers or sores.
- have a lower limb infection.
- are dehydrated.
Other warnings you should know about:
Children and adolescents (under 18 years of age)
Auro-Canagliflozin is not recommended for use in patients under 18 years of age.
Adults aged 65 years of age and older
You could have more side effects with Auro-Canagliflozin.
Check-ups and testing
You will have regular visits with your healthcare professional before and during treatment with Auro-Canagliflozin to monitor your health. They may check:
- your blood sugar levels. Auro-Canagliflozin will cause your urine to test positive for sugar.
- that your kidneys are working properly.
- blood fat levels.
- the amount of red blood cells in your blood.
- the potassium levels in your blood.
- ketone levels in your blood or urine. Ketones are a type of chemical that your liver produces when it breaks down fats for energy.
- the levels of lithium in your blood.
Broken bones (fracture)
Taking Auro-Canagliflozin increases your risk of breaking a bone. Talk to your healthcare professional about factors that may increase your risk of bone fracture.
Surgery and illnesses
Tell your healthcare professional if you:
- have a serious medical illness.
- are going to have a surgery.
- are hospitalized for a serious infection or a serious medical illness.
- had major surgery.
Stopping treatment:
Your healthcare professional may temporarily stop your Auro-Canagliflozin treatment:
- before and after certain types of surgery or procedures associated with long periods of fasting. Your healthcare professional may stop your treatment for at least three days before you undergo these procedures or surgeries, or
- when you are hospitalized for a serious infection or illness.
If Auro-Canagliflozin is stopped, your healthcare professional will:
- continue to monitor for signs or symptoms of DKA.
- tell you when to start taking Auro-Canagliflozin again.
Driving and using machines
Auro-Canagliflozin may cause dizziness or light-headedness. Do NOT drive or use machines until you know how the medicine affects you.
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 Auro-Canagliflozin:
- digoxin, a medicine used to treat heart problems.
- furosemide or other diuretics (water pills), used to treat high blood pressure and other heart problems.
- Angiotensin-Converting Enzyme (ACE) inhibitors or Angiotensin Receptor Blockers (ARB) used to treat high blood pressure.
- insulin or a sulfonylurea (such as glimepiride, gliclazide, or glyburide), used to help control blood sugar.
- carbamazepine, phenytoin or phenobarbital, used to treat seizures.
- barbiturates, used as sedatives and sleep-aids.
- efavirenz or ritonavir, used to treat HIV infection.
- rifampin, an antibiotic used to treat bacterial infections such as Tuberculosis.
- lithium, used to treat bipolar disorder.
- St. John’s wort, an herbal product used to treat depression.
How to take Auro-Canagliflozin:
Take exactly as your healthcare professional tells you. Check with your healthcare
- professional if you are not sure.
Take once per day with or without food. It is best to take Auro-Canagliflozin before the first meal of the day and at the same time each day.
- Swallow the tablet(s) whole with water.
- Continue taking Auro-Canagliflozin for as long as your healthcare professional tells you to.
Your healthcare professional may temporarily stop your treatment for a minimum of three days if you are undergoing:
- a major surgery.
- procedures that are associated with long periods of fasting.
Your healthcare professional may prescribe Auro-Canagliflozin alone or together with another medicine.
Usual dose:
Adults: One 100 mg tablet per day.
Your healthcare professional may increase your dose to 300 mg once a day, if necessary.
Overdose:
if you think you, or a person you are caring for, have taken too much Auro-Canagliflozin, 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.
Missed dose:
If you forget to take a dose of Auro-Canagliflozin, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose and follow your usual schedule.
Do not take two doses on the same day to make up for a forgotten dose.
What are possible side effects from using Auro-Canagliflozin?
These are not all the possible side effects you may feel when taking Auro-Canagliflozin. If you experience any side effects not listed here, contact your healthcare professional.
Changes in urination such as:
- urinating more often or in larger amounts.
- an urgent need to urinate.
- a need to urinate at night.
- Nausea.
- Feeling thirsty.
Serious side effects and what to do about them
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Vaginal yeast infection: vaginal odor, white or yellowish vaginal discharge and/or itching | √ | ||
| Hypoglycemia (low blood sugar), especially if you are also taking a sulfonylurea or insulin: shaking, sweating, pale skin, rapid heartbeat, change in vision, hunger, headache and change in mood, feeling anxious or confused | √ | ||
| COMMON | |||
| Balanitis (yeast infection of the penis): red, swollen, itchy head of penis, thick, lumpy discharge under foreskin, unpleasant odour, difficulty retracting foreskin, pain passing urine or during sex | √ | ||
Urinary tract infection: burning sensation when passing urine, pain in the pelvis, or mid-back pain, or increased need to urinate | √ | ||
| Constipation | √ | ||
| Bone fracture (broken bones) | √ | ||
Skin Ulcer (a break or sore on the skin with tissue breakdown) predominantly of the lower leg: It may start off red then get swollen and tender. Next, blisters can form with loss of skin layers. It can lead to an open round crater with a bad smell. Ulcers take a long time or may not heal. | √ | ||
| UNCOMMON | |||
Peripheral Ischemia (blocked or narrow blood vessels): Leg pain with walking that gets better with rest. Poor circulation, bluish, cold skin, and poor nail and hair growth. It can lead to Skin Ulcers and Lower Leg or Toe Amputation. | √ | ||
| Dehydration (not having enough water in your body): feeling very thirsty, weak or tired, passing little or no urine and/or fast heartbeat; it can be from nausea, vomiting and/or diarrhea or not drinking enough liquids | √ | ||
| Hypotension (low blood pressure): dizziness, fainting or light- headedness; may occur when you go from lying to sitting to standing up. | √ | ||
| Rash or hives | √ | ||
| Kidney problems: nausea, vomiting, diarrhea; muscle cramps; swelling of the legs, ankles, feet, face and/or hands; shortness of breath due to extra fluid on the lungs; more frequent urination or in greater amounts than usual, with pale urine; or, less frequent urination, or in smaller amounts than usual, with dark coloured urine. | √ | ||
| RARE | |||
Severe hypoglycemia (low blood sugar), especially when used with insulin or a sulfonylurea: disorientation, loss of consciousness, seizure | √ | ||
| Diabetic Ketoacidosis (when your body produces high levels of blood acids called ketones): difficulty breathing, nausea, vomiting, stomach pain, loss of appetite, confusion, feeling very thirsty and feeling unusual tiredness, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat | √ | ||
| Anaphylactic reaction (Severe allergic reaction):swelling of the face, lips, mouth, tongue or throat that may lead to difficulty breathing or swallowing | √ | ||
Acute kidney infection: painful, urgent or frequent urination, lower back (flank) pain, fever or chills, cloudy or foul-smelling urine, blood in your urine | √ | ||
| Urosepsis (severe infection that spreads from the urinary tract and throughout the body): fever or low body temperature, rapid breathing, chills, rapid heartbeat, pain with urination, difficulty urinating, frequent urination | √ | ||
Pancreatitis (inflammation of the pancreas): severe stomach pain that lasts and gets worse when you lie down, nausea, vomiting | √ | ||
| Fournier’s gangrene (a serious infection affecting soft tissue around the groin): pain or tenderness, redness of the skin, or swelling in the genital or perineal area, with or without fever or feeling very weak, tired, or uncomfortable | √ | ||
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:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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 20°C to 25°C. Protect from moisture.
- Keep out of the reach and sight of children.
Do not use Auro-Canagliflozin after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
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.
If you want more information about Auro-Canagliflozin:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.auropharma.ca or by calling 1-855-648-6681