Active ingredient
- canagliflozin hemihydrate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 00242/0698 .
Invokana 100 mg and 300 mg film-coated tablets
Package leaflet: Information for the patient
Invokana 100 mg film-coated tablets
Invokana 300 mg film-coated tablets
canagliflozin
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Invokana is and what it is used for
2. What you need to know before you take Invokana
3. How to take Invokana
4. Possible side effects
5. How to store Invokana
6. Contents of the pack and other information
1. What Invokana is and what it is used for
Invokana contains the active substance canagliflozin which belongs to a group of medicines called “blood-glucose lowering drugs.”
Invokana is used:
This medicine works by increasing the amount of sugar removed from your body in your urine. This reduces the amount of sugar in your blood and can help prevent heart disease in patients with type 2 diabetes mellitus (T2DM). It also helps to slow down deterioration of kidney function in patients with T2DM by a mechanism beyond blood glucose lowering.
Invokana can be used by itself or along with other medicines you may be using to treat your type 2 diabetes (such as metformin, insulin, a DPP-4 inhibitor [such as sitagliptin, saxagliptin, or linagliptin], a sulphonylurea [such as glimepiride or glipizide], or pioglitazone) that lower blood sugar levels. You may already be taking one or more of these to treat your type 2 diabetes.
It is also important to keep following advice about diet and exercise given by your doctor or nurse.
What is type 2 diabetes?
Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical conditions such as heart disease, kidney disease, blindness, and amputation.
2. What you need to know before you take Invokana
Do not take Invokana
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Invokana, and during treatment:
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:
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’.
3. How to take Invokana
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
Taking this medicine
Your doctor may prescribe Invokana together with another glucose-lowering medicine. Remember to take all medicines as directed by your doctor to achieve the best results for your health.
Diet and exercise
To control your diabetes, you still need to follow the advice about diet and exercise from your doctor, pharmacist or nurse. In particular, if you are following a diabetic weight control diet, continue to follow it while you are taking this medicine.
If you take more Invokana than you should
If you take more of this medicine than you should, talk to a doctor or go to the nearest hospital immediately.
If you forget to take Invokana
If you stop taking Invokana
Your blood sugar levels may rise if you stop taking this medicine. Do not stop taking this medicine without talking to your doctor first.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Invokana and talk to a doctor or go to the nearest hospital immediately if you have any of the following serious side effects:
Severe allergic reaction (rare, may affect up to 1 in 1,000 people)
Possible signs of severe allergic reaction may include:
Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people)
These are the signs of diabetic ketoacidosis (see also section 2):
This may occur regardless of blood glucose level. Diabetic ketoacidosis may occur more frequently as the kidney function gets worse. The doctor may decide to temporarily or permanently stop the treatment with Invokana.
Dehydration (uncommon, may affect up to 1 in 100 people)
Tell your doctor as soon as possible if you have any of the following side effects:
Hypoglycaemia (very common, may affect more than 1 in 10 people)
Your doctor will tell you how to treat low blood sugar levels and what to do if you have any of the signs above.
Urinary tract infections (common, may affect up to 1 in 10 people)
Although uncommon, if you see blood in your urine, tell your doctor immediately.
Other side effects:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Not known (frequency cannot be estimated from the available data)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Invokana
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Invokana contains
What Invokana looks like and contents of the pack
Invokana is available in PVC/aluminium perforated unit dose blisters. The pack sizes are cartons of 10 x 1, 30 x 1, 90 x 1, or 100 x 1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the distributor:
For information in large print, tape, CD or Braille, telephone 0800 7318450
This leaflet was approved in 12/2021.
Cambridge Science Park, Milton Road, Cambridge, Cambridgeshire, CB4 0GW
+44 (0)1223 424 444