100 mg and 300 mg film-coated tablets
canagliflozin
1. What Invokana is and what it is used for
Invokana contains the active substance kanagliflozin which belongs to a group of medicines called blood glucose-lowering agents.
Invokana is used for treating adults with type 2 diabetes.
This drug works by increasing the amount of sugar that is removed from the body with the urine. In this way, the amount of sugar in the blood decreases and can help prevent heart disease in patients with type 2 diabetes. The drug also helps to slow down the deterioration of kidney function in patients with type 2 diabetes through a mechanism that is not only related to lowered blood sugar.
Invokana can be used alone or in combination with other medicines that you may already be using to treat your type 2 diabetes (eg metformin, insulin, a DPP-4 inhibitor [eg sitagliptin, saxagliptin or linagliptin], a sulphonylurea [eg glimepiride or glipizide], or pioglitazone) and which lower blood sugar levels. You may already be taking one or more of these medicines to treat your type 2 diabetes.
It is also important that you continue to follow the advice on diet and exercise that you have received from your doctor or nurse.
What is type 2 diabetes?
Type 2 diabetes is a disease in which the body does not produce enough insulin and the insulin that the body produces does not work as well as it should. Your body can also produce too much sugar. When this happens, sugar ( glucose ) accumulates in the blood. It can lead to serious medical conditions such as heart disease, kidney disease, blindness, and amputation.
2. What you need to know before taking Invokana
Do not take Invokana:
- if you are allergic to kanagliflozin or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Invokana and during treatment:
- on what you can do to prevent dehydration (see section 4 for signs of dehydration).
- if you have type 1 diabetes , as Invokana should not be used for this disease.
- If you experience rapid weight loss, nausea or vomiting, abdominal pain, strong thirst, rapid and deep breathing, confusion, abnormal drowsiness or fatigue, a sweet breath, a sweet taste or a metallic taste in your mouth or a different smell of urine or sweat, you should talk to a doctor or see your nearest hospital immediately. These symptoms can be signs of “diabetic ketoacidosis” – a rare but serious, in some cases life-threatening problem you can get in diabetes due to elevated levels of “ketone bodies” in the urine or blood. This is shown in tests. The risk of developing diabetic ketoacidosis may increase with prolonged fasting, high alcohol consumption, dehydration, sudden decrease in insulin dose or a greater need for insulin. due to a major operation or a 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 against this condition.
- if you have severe kidney problems or are being treated with dialysis .
- if you have severe liver problems.
- if you have ever had a serious heart problem or had a stroke .
- if you are taking medicines to lower your blood pressure (antihypertensive drugs) or have ever had low blood pressure ( hypotension ) before . More information is given below under the heading “Other medicines and Invokana”.
- if you have undergone an amputation of a lower extremity .
- It is important to regularly check your feet and to follow all the advice on foot care and adequate fluid intake that you receive from your healthcare professional. You should contact your doctor immediately if you notice any sores or discoloration or if you feel sore or have pain in your feet. Some studies suggest that the use of kanagliflozin may have contributed to the risk of amputation of the lower extremities (especially amputations of the toes and metatarsals).
- Talk to your doctor immediately if you experience a combination of symptoms such as pain, tenderness, redness or swelling of the genitals or the area between the genitals and the rectum along with fever or general malaise. These symptoms can be a sign of a rare but serious and in the worst case life-threatening infection called necrotizing fasciitis of the perineum or Fournier’s gangrene which destroys tissue under the skin. Fournier’s gangrene must be treated immediately.
- if you have signs of a fungal infection in the abdomen, e.g. irritation, itching , different discharge or bad smell.
- if you have a serious infection of the kidneys or urinary tract with fever. Your doctor may ask you to stop taking Invokana until you recover.
If any of the above apply to you (or you are not completely sure), talk to your doctor, pharmacist or nurse before taking this medicine.
Renal function
Your kidneys will be checked with a blood test before you start taking, and while you are taking, this medicine.
Sugar in the urine
Due to the way this medicine works, your urine will give positive test results for sugar ( glucose ) while you are being treated with the medicine.
Children and young people
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. The reason for this is that this medicine may affect the way some other medicines work. Some other medicines may also affect the way this medicine works.
You should especially tell your doctor if you are taking any of the following medicines:
- other antidiabetic agents – either insulin or a sulfonylurea (e.g., glimepiride or glipizide) -läkaren may wish to reduce the dose of one to avoid blood sugar level becomes low ( hypoglycemia )
- medicines used to lower your blood pressure (antihypertensive medicines), including diuretics (medicines used to remove excess water from the body, also known as diuretic tablets) as this medicine can also lower blood pressure by reducing the levels of excess water out of the body. Possible signs of losing too much fluid from the body are listed in section 4.
- St. John’s wort (a herbal remedy for treating mild depression and mild anxiety)
- carbamazepine, phenytoin , phenobarbital (medicines used to control seizures)
- efavirenz or ritonavir (medicine used for treatment of HIV – infection )
- rifampicin (an antibiotic used for tuberculosis )
- cholestyramine (a drug used to reduce blood cholesterol levels). See section 3, “Taking the medicine”.
- digoxin or digitoxin (medicines used to treat certain heart problems). The level of digoxin or digitoxin in the blood may need to be checked if taken at the same time as Invokana.
- dagibatran (blood-thinning drug that reduces the risk of blood clots)
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking or continuing to use this medicine.
Invokana should not be used during pregnancy. Talk to your doctor about the best way to discontinue Invokana and check your blood sugar as soon as you know you are pregnant.
You should not take this medicine if you are breastfeeding. Discuss with your doctor if you should stop taking this medicine or if you should stop breastfeeding.
Driving and using machines
Invokana has no or negligible effect on the ability to drive, cycle and use tools or machines. However, dizziness has been reported, which may affect your ability to drive, cycle or use tools or machines.
Taking Invokana along with other medicines for diabetes called sulfonylureas (eg, glimepiride and glipizide) or insulin may increase the risk of low blood sugar ( hypoglycemia ). Signs of this can be blurred vision, tingling in the lips, tremors, sweating, pallor, changes in mood, anxiety, or confusion. This could affect your ability to drive, cycle and use tools or machines. Talk to your doctor as soon as possible if you get any symptoms 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, ie essentially ‘sodium-free.
How to take Invokana
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
How much to take
- The starting dose of Invokana is one 100 mg tablet per day. Your doctor will decide if you should increase the dose to 300 mg.
- Your doctor may limit your dose to 100 mg if you have kidney problems.
- Your doctor will prescribe the strength that is right for you.
Taking the medicine
- Swallow the tablet whole with water.
- You can take the tablet with or without food. It is best to take the tablet before the first meal of the day.
- Try to take the tablet at the same time each day. This will help you remember to take it.
- If your doctor has prescribed kanagliflozin with any bile acid sequestrant such as cholestyramine (a cholesterol-lowering drug), you should take canagliflozin at least 1 hour before or 4 to 6 hours after the bile acid sequestrant.
Your doctor may have prescribed Invokana with another blood-glucose-lowering agent. Remember to take all medicines according to your doctor’s instructions to achieve the best results for your health.
Diet and exercise
To control your diabetes, you still need to follow the advice you get from your doctor, pharmacist, or nurse about diet and exercise. This is especially true if you are following a diabetic diet to control your weight, continue to follow it as long as you are taking this medicine.
If you take more Invokana than you should
If you have taken too much of this medicine, talk to a doctor immediately or go to the nearest hospital.
If you forget to take Invokana
- If you forget to take a dose , take it as soon as you remember. But if it’s almost time for the next dose , skip the missed dose .
- Do not take a double dose (two doses on the same day) to compensate for a missed dose .
If you stop taking Invokana
Your blood sugar may rise if you stop taking this medicine. Do not stop taking this medicine without talking to a doctor first.
If you have any further questions on the use of this product, 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 see your nearest hospital immediately if you get any of the following serious side effects:
Severe allergic reaction (rare, may affect up to 1 in 1,000 people)
Possible signs of a severe allergic reaction may include:
- swelling of the face, lips, mouth, tongue or throat which may lead to difficulty breathing or swallowing.
Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people)
These are signs of diabetic ketoacidosis (see also section 2):
- elevated levels of “ketone bodies” in the urine or blood
- rapid weight loss
- nausea or vomiting
- abdominal pain
- strong thirst
- rapid and deep breathing
- confusion
- abnormal drowsiness or fatigue
- a sweet breath, a sweet taste or metallic taste in the mouth or a different smell from your urine or sweat.
This can occur regardless of blood sugar levels. Diabetic ketoacidosis can occur more often as renal function deteriorates. Your doctor may decide to temporarily or permanently discontinue your treatment with Invokana.
Dehydration (uncommon, may affect up to 1 in 100 people)
- loss of too much fluid from the body (dehydration). This happens more often in the elderly (75 years and older), people with kidney problems and people taking diuretic tablets ( diuretics ).Possible signs of dehydration are:
- feeling dizzy or dizzy
- fainting or dizziness when getting up
- dry or sticky mouth, very thirsty
- feeling of lethargy or fatigue
- that you urinate very little or nothing at all
- fast heartbeat.
Contact a doctor as soon as possible if you get any of the following side effects:
Hypoglycaemia (very common, may affect more than 1 in 10 people)
- low blood sugar ( hypoglycaemia ) when you take this medicine with insulin or a sulphonylurea (eg glimepiride or glipizide).Possible signs of low blood sugar are:
- dimsyn
- tingling in the lips
- trembling, sweating, pallor
- altered mood or anxiety or confusion.
Your doctor will tell you how to treat low blood sugar and what to do if you have any of the above signs.
Urinary tract infections (common, may affect up to 1 in 10 people)
- These are signs of a serious infection of the urinary tract, such as:
- fever and / or chills
- burning when urinating
- back or side pain.
If you see blood in your urine, even if it is unusual, you must contact a doctor immediately.
Other side effects:
Very common (may affect more than 1 in 10 people)
- fungal infection of the vagina.
Common side effects (may affect up to 1 in 10 people)
- skin rash or redness of the penis or foreskin (fungal infection)
- changes in urination (eg urinating more often or in large quantities, urinating, urinating at night)
- constipation
- thirst
- nausea
- Blood tests can show changes in blood fats ( cholesterol ) and increased red blood cell count in your blood ( hematocrit ).
Uncommon (may affect up to 1 in 100 people)
- rash or redness – this may itch and include rashes with raised bumps, rash or blisters
- hives
- Blood tests may show changes related to kidney function (increased creatinine or urea ) or increased potassium .
- Blood tests may show elevated levels of blood phosphate
- bone fracture
- kidney failure (mainly as a result of excessive fluid loss from the body).
- amputations of the lower extremities (especially toes), especially if you have a high risk of heart disease.
- fimos – difficulty pulling back the foreskin around the glans at the far end of the penis
- skin reactions after exposure to sunlight.
No known frequency (can not be calculated from the available data)
- necrotizing fasciitis of the perineum or Fournier’s gangrene, a severe soft tissue infection of the genitals or the area between the genitals and the rectum.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
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 the carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Do not use Invokana if the packaging is damaged or shows any signs of tampering.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is kanagliflozin.
- Each tablet contains canagliflozin hemihydrate equivalent to 100 mg or 300 mg canagliflozin.
- Other ingredients are:
- tablet core: lactose (see section 2 “Invokana contains lactose”), microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium and magnesium stearate.
- film coating: poly (vinyl alcohol), titanium dioxide (E171), macrogol 3350 and talc. The 100 mg tablet also contains yellow iron oxide (E172).
What the medicine looks like and contents of the pack
- Invokana 100 mg immediate- release film-coated tablets are yellow, capsule-shaped, 11 mm long, with “CFZ” on one side and “100” on the other side.
- Invokana 300 mg immediate- release film-coated tablets are white, capsule-shaped, 17 mm long, with “CFZ” on one side and “300” on the other side.
Invokana is supplied as perforated PVC / aluminum single dose blisters. The pack sizes are cartons of 10×1, 30×1, 90×1 or 100×1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Janssen Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Manufacturer
Janssen-Cilag SpA
Via C. Janssen
Borgo San Michele
04100 Latina
Italy
Contact the representative of the marketing authorization holder to find out more about this medicine: