The active substance is canagliflozin.
Each tablet contains 100 mg or 300 mg of canagliflozin.
Excipients/Inactive Ingredients: Tablet core: croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, and microcrystalline cellulose.
Film-coating: macrogol (3350), polyvinyl alcohol, talc, and titanium dioxide (E171). The 100 mg tablet also contains iron oxide yellow (E172).
Invokana contains the active substance canagliflozin which belongs to a group of medicines called "blood-glucose lowering drugs."
"Blood-glucose lowering drugs" are medicines used by adults to treat type 2 diabetes.
This medicine works by increasing the amount of sugar removed from the body in the urine. This reduces the amount of sugar in the blood.
Type 2 diabetes is a condition in which the body does not make enough insulin, and the insulin that the body produces does not work as well as it should. The body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medicinal conditions such as heart disease, kidney disease, blindness, and amputation.
Monotherapy and combination therapy: INVOKANA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
INVOKANA is indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease (CVD) or at least two risk factors for CVD.
Dosage: Adults 18 years of age and older: The recommended dose of INVOKANA is 100 mg or 300 mg once daily. The 300 mg dose may be considered for patients with an eGFR ≥60mL/min/1.73 m2 (CrCl ≥ 60 mL/min), who need tighter glycemic control and who have a low risk of adverse reactions associated with reduced intravascular volume with INVOKANA treatment.
A starting dose of 100 mg once daily should be used in patients on loop diuretics and elderly people (aged 75 and over). In patients with evidence of reduced intravascular volume, correcting this condition prior to initiation of INVOKANA is recommended. For those patients who are tolerating INVOKANA 100 mg and who need tighter glycemic control, the dose can be increased to INVOKANA 300 mg.
When INVOKANA is used as add-on therapy with insulin or an insulin secretagogue (e.g., sulfonylurea), a lower dose of insulin or the insulin secretagogue may be considered to reduce the risk of hypoglycemia.
Administration: INVOKANA should be taken orally once a day, preferably before the first meal of the day. Tablets are to be swallowed whole.
Missed dose: If a dose is missed, it should be taken as soon as the patient remembers; however, a double dose should not be taken on the same day.
Special populations: Pediatrics (< 18 years of age): The safety and efficacy of INVOKANA have not been established in pediatric patients.
Elderly: In patients ≥75 years of age, the starting dose of INVOKANA is 100 mg once daily. Renal function and risk of volume depletion should be taken into account (see Warnings, Precautions and Adverse Reactions).
Renal impairment: In patients with an estimated glomerular filtration rate (eGFR) 45 to < 60 mL/min/1.73 m2 [CrCl 45 to < 60 mL/min], the dose of INVOKANA is limited to 100 mg once daily. INVOKANA should not be initiated in patients with an eGFR < 45 mL/min/1.73 m2 [CrCl < 45 mL/min]. INVOKANA should be discontinued when eGFR is persistently < 45 mL/min/1.73 m2 [CrCl< 45 mL/min] (see Warnings, Precautions and Adverse Reactions).
INVOKANA should not be used in patients with an eGFR < 45 mL/min/1.73 m2 [CrCl < 45 mL/min] as it would not be effective in these patient populations (see Precautions).
Do not take Invokana: if the patient is allergic to canagliflozin or any of the other ingredients of this medicine (listed in Description).
This is a medicament.
Medicament is a product which affects the health and its consumption contrary to instructions is dangerous for the patient.
Follow strictly the doctor's prescription, the method of use and the instructions of the pharmacist who sold the medicament. The doctor and the pharmacist are the experts in medicines, their benefits and risks.
Do not interrupt the period of treatment prescribed.
Do not repeat the same prescription without consulting the doctor.
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. The patient can help by reporting any side effects he/she may get. See Side Effects for how to report side effects.
This medicine has been prescribed for the patient only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as the patient's.
Talk to the doctor, pharmacist or nurse before taking this medicine, and during treatment: about what the patient can do to prevent dehydration; if the patient has type 1 diabetes (the body does not produce any insulin). Invokana should not be used to treat this condition; if the patient experiences rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to the breath, a sweet or metallic taste in the mouth or a different odour to the urine or sweat, contact a doctor of the nearest hospital straight away. These symptoms could be a sign of "diabetic ketoacidosis" - a rare but serious, sometimes life-threatening problem the patient can get with diabetes because of increased levels of "ketone bodies" in the urine or blood, seen in tests. The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness; if the patient has diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea, or vomiting). Invokana should not be used to treat this condition; if the patient has severe kidney problems or is on dialysis; if the patient has severe liver problems; if the patient has ever had serious heart disease or if he/she has had a stroke; if the patient is on medicines to lower the blood pressure (anti-hypertensives) or has ever had low blood pressure (hypotension). More information is given as follows in Interactions; It is important to check the feet regularly and adhere to any other advice regarding foot care and adequate hydration given by the health care professional. The patient should notify the doctor immediately if he/she notices any wounds or discolouration, or if he/she experiences any tenderness or pain in the feet. Some studies indicate that taking canagliflozin may have contributed to the risk of lower limb amputation (mainly toe amputations).
If any of the previously mentioned apply to the patient (or the patient is not sure), talk to the doctor, pharmacist, or nurse before taking this medicine.
Kidney function: The kidneys will be tested by a blood test before the patient starts taking and while on this medicine.
Urine glucose: Because of how this medicine works, the urine will test positive for sugar (glucose) while the patient is on this medicine.
Invokana contains lactose: If the patient has been told by the doctor that he/she has an intolerance to some sugars, contact the doctor before taking this medicine.
Driving and using machines: Invokana has no or negligible influence on the ability to drive, cycle, and use tools or machines. However, dizziness or lightheadedness has been reported, which may affect the ability to drive, cycle, or use tools or machines.
Taking Invokana with other medicines for diabetes called sulphonylurea (such as glimepiride or glipizide) or insulin can increase the risk of having low blood sugar (hypoglycaemia). Signs include blurred vision, tingling lips, trembling, sweating, pale looking, a change in mood, or feeling anxious or confused. This may affect the ability to drive, cycle, and use any tools or machines. Tell the doctor as soon as possible if the patient gets any of the signs of low blood sugar.
Use in Children: Children and adolescents: Invokana is not recommended for children and adolescents under 18 years.
If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before taking or continuing to take this medicine. Invokana should not be used during pregnancy. Talk to the doctor about the best way to discontinue Invokana and control the blood sugar as soon as she knows that she is pregnant.
The patient should not take this medicine if she is breast-feeding. Talk to the doctor about whether to stop taking this medicine or to stop breast-feeding.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Invokana and see a doctor as soon as possible if the patient has any of the following serious side effects: Dehydration (uncommon, may affect up to 1 in 100 people): loss of too much fluid from the body (dehydration). This happens more often in elderly people (aged 75 and over), people with kidney problems, and people taking water tablets (diuretics).
Possible signs of dehydration are: feeling light-headed or dizzy; passing out (fainting) or feeling dizzy or faint when the patient stands up; very dry or sticky mouth, feeling very thirsty; feeling very weak or tired; passing little or no urine; fast heartbeat.
Contact a doctor or the nearest hospital straight away if the patient has any of the following side effects: Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people): These are the signs of diabetic ketoacidosis (see also Precautions): increased levels of "ketone bodies" in the urine or blood; rapid weight loss; feeling sick or being sick; stomach pain; excessive thirst; fast and deep breathing; confusion; unusual sleepiness or tiredness; a sweet smell to the breath, a sweet or metallic taste in the mouth or a different odour to the urine or sweat.
This may occur regardless of blood glucose level. The doctor may decide to temporarily or permanently stop the treatment with Invokana.
Tell the doctor as soon as possible if the patient has any of the following side effects: Hypoglycaemia (very common, may affect more than 1 in 10 people): low blood sugar levels (hypoglycaemia): when taking this medicine with insulin or a sulphonylurea (such as glimepiride or glipizide).
Possible signs of low blood sugar are: blurred vision; tingling lips; trembling, sweating, pale looking; a change in mood or feeling anxious or confused.
The doctor will tell the patient how to treat low blood sugar levels and what to do if the patient has any of the signs previously mentioned.
Other side effects: Very common (may affect more than 1 in 10 people): vaginal yeast infection.
Common (may affect up to 1 in 10 people): rash or redness of the penis or foreskin (yeast infection); urinary tract infections; changes in urination (including urinating more frequently or in larger amounts, urgent need to urinate, need to urinate at night); constipation; feeling thirsty; nausea; blood tests may show change in blood fat (cholesterol) levels and increases in amount of red blood cells in the blood (haematocrit).
Uncommon (may affect up to 1 in 100 people): rash or red skin: this may be itchy and include raised bumps, oozing fluid or blisters; hives; blood tests may show changes related to kidney function (creatinine or urea) or potassium); blood tests may show increases in the blood phosphate level; bone fracture; kidney failure (mainly as a consequence of loss of too much fluid from the body); lower limb amputations (mainly of the toe) especially if the patient is at high risk of heart disease.
Rare (may affect up to 1 in 1000 people): severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing).
Reporting of side effects: If the patient gets any side effects, talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed in this monograph. By reporting side effects, the patient can help provide more information on the safety of this medicine.
Tell the doctor or pharmacist if the patient is taking, has recently taken, or might take any other medicines. This is because this medicine can affect the way some other medicines work. Also, some other medicines can affect the way this medicine works.
In particular, tell the doctor if the patient is taking any of the following medicines: other antidiabetics: either insulin or a sulphonylurea (such as glimepiride or glipizide) - the doctor may want to reduce the dose in order to avoid the blood sugar level from getting too low (hypoglycaemia); medicines used to lower the blood pressure (anti-hypertensives), including diuretics (medicines used to remove levels of excess water in the body, also known as water tablets) since this medicine can also lower the blood pressure by removing levels of excess water in the body. Possible signs of losing too much fluid from the body are listed at Side Effects; St. John's wort (a herbal medicine to treat depression); carbamazepine, phenytoin, or phenobarbital (medicines used to control seizures); efavirenz or ritonavir (a medicine used to treat HIV infection); rifampicin (an antibiotic used to treat tuberculosis); cholestyramine (medicine used to reduce cholesterol levels in the blood). See Taking this medicine under Dosage & Administration; digoxin or digitoxin (medicines used for certain heart problems). The level of digoxin or digitoxin in the bleed may need to be checked if taken with Invokana; dabigatran (blood thinner medicine that lowers the risk of blood clot formation).
Do not store above 30°C.
Do not use Invokana if the packaging is damaged or shows signs of tampering.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
A10BK02 - canagliflozin ; Belongs to the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors. Used in the treatment of diabetes.
FC tab 100 mg (yellow, capsule-shaped, 11 mm long, with "CFZ" on one side and "100" on the other side) x 3 x 10's. 300 mg (white, capsule-shaped, 17 mm long, with "CFZ" on one side and "300" on the other side) x 3 x 10's.
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