Do not take Invokana

• if you are allergic to canagliflozin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Invokana, and during treatment:

• about what you can do to prevent dehydration (see section 4 for signs of dehydration).
• if you have type 1 diabetes because Invokana should not be used to treat this condition.
• if you experience 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 your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat, talk to a doctor or go to the nearest hospital immediately. These symptoms could be a sign of “diabetic ketoacidosis” – a rare but serious, sometimes life-threatening problem you can get with diabetes because of increased levels of “ketone bodies” in your 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 you have 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 you have severe kidney problems or are on dialysis.
• if you have severe liver problems.
• if you have ever had serious heart disease or if you have had a stroke.
• if you are on medicines to lower your blood pressure (anti-hypertensives) or have ever had low blood pressure (hypotension). More information is given below in “Other medicines and Invokana”.
• if you have had a lower limb amputation.
• It is important to check your feet regularly and adhere to any other advice regarding foot care and adequate hydration given by your healthcare professional. You should notify your doctor immediately if you notice any wounds or discolouration, or if you experience any tenderness or pain in your feet. Some studies indicate that taking canagliflozin may have contributed to the risk of lower limb amputation (mainly toe and midfoot amputations).
• Talk to your doctor immediately if you develop a combination of symptoms of pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the anus with fever or feeling generally unwell. These symptoms could be a sign of a rare but serious or even life-threatening infection, called necrotising fasciitis of the perineum or Fournier’s gangrene which destroys the tissue under the skin. Fournier’s gangrene has to be treated immediately.
• if you have signs of a genital yeast infection such as irritation, itching, unusual discharge or odour.
• if you have a serious infection of the kidney or the urinary tract with fever. Your doctor may ask you to stop taking Invokana until you have recovered.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist, or nurse before taking this medicine.

Kidney function

Your kidneys will be tested by a blood test before you start taking and while you are on this medicine.

Urine glucose

Because of how this medicine works, your urine will test positive for sugar (glucose) while you are on this medicine.

Children and adolescents

Invokana is not recommended for children and adolescents under 18 years.

Other medicines and Invokana

Tell your doctor or pharmacist if you are taking, have 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 your doctor if you are taking any of the following medicines:

• other antidiabetics – either insulin or a sulphonylurea (such as glimepiride or glipizide) – your doctor may want to reduce your dose in order to avoid your blood sugar level from getting too low (hypoglycaemia)
• medicines used to lower your 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 your blood pressure by removing levels of excess water in the body. Possible signs of losing too much fluid from your body are listed in section 4.
• St. John’s wort (an 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 section 3, “Taking this medicine”.
• digoxin or digitoxin (medicines used for certain heart problems). The level of digoxin or digitoxin in your blood may need to be checked if taken with Invokana.
• dabigatran (blood thinner medicine that lowers the risk of blood clot formation).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking or continuing to take this medicine. Invokana should not be used during pregnancy. Talk to your doctor about the best way to discontinue Invokana and control your blood sugar as soon as you know that you are pregnant.

You should not take this medicine if you are breast-feeding. Talk to your doctor about whether to stop taking this medicine or to stop breast-feeding.

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 your ability to drive, cycle, or use tools or machines.

Taking Invokana with other medicines for diabetes called sulphonylureas (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 your ability to drive, cycle, and use any tools or machines. Tell your doctor as soon as possible if you get any of the signs of low blood sugar.

Invokana contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

Invokana contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.