Prescribing Information for the Patient

Invokana 100 mg Film-Coated Tablets

Invokana 300 mg Film-Coated Tablets

canagliflozina

Read this entire prescribing information carefully before starting to take this medicine, as it contains important information for you.

• Keep this prescribing information, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prescribing information. See section 4.

Invokana contains the active ingredient canagliflozina, which belongs to a group of medications known as “anti-hyperglycemics.”

Invokana is used:

• for the treatment of adult patients with type 2 diabetes.

This medication works by removing a greater amount of sugar from your body through your urine. This reduces the amount of sugar in your blood and may help prevent heart disease in patients with type 2 diabetes mellitus (DMT2). It also helps to delay the deterioration of kidney function in patients with DMT2 through a mechanism that goes beyond reducing blood glucose levels.mellitustype2 (DMT2). Also helps to delay the deterioration of kidney function in patients with DMT2 through a mechanism that goes beyond reducing blood glucose levels..

Invokana is administered as monotherapy or in combination with other medications you may already be taking to treat your type 2 diabetes (such as metformin, insulin, a DPP-4 inhibitor [such as sitagliptin, saxagliptin, or linagliptin], a sulfonylurea [such as glimepiride or glipizide], or pioglitazone) that reduce blood sugar levels. You may already be taking one or more of these medications to treat your type 2 diabetes.

It is essential that you do not stop following the dietary and exercise recommendations provided by your doctor or nurse.

What is type 2 diabetes?

Type 2 diabetes is a disorder in which the body does not produce enough insulin and the insulin it produces does not function properly. It can also be that your body produces too much sugar.

When this occurs, sugar (glucose) accumulates in the blood. This can produce serious medical diseases, such as heart disease, kidney disease, blindness, and amputations.

Do not take Invokana:

• if you are allergic to canagliflozina or any of the other components of this medication (listed in section 6).

• Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Invokana and during treatment:

• to know how to prevent dehydration (see section 4 for dehydration symptoms)
• if you have type 1 diabetes because Invokana should not be used to treat this disease
• if you experience rapid weight loss, nausea, vomiting, stomach pain, excessive thirst, rapid and deep breathing, confusion, drowsiness, or unusual fatigue, sweet-smelling breath, sweet or metallic taste in your mouth, or unusual odor of your urine or sweat, consult your doctor or go to the nearest hospital immediately. These symptoms may be signs of diabetic ketoacidosis – a rare but serious, sometimes life-threatening complication that can occur with diabetes due to increased levels of ketones in your urine or blood, detected in tests. The risk of developing diabetic ketoacidosis may increase with prolonged fasting, excessive alcohol consumption, dehydration, sudden reduction in insulin dose, or increased need for insulin due to major surgery or severe 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 disease
• if you have severe kidney problems or need dialysis
• if you have severe liver problems
• if you have had a severe heart disease or have had a stroke
• if you are taking medications to lower your blood pressure (anti-hypertensives) or have had low blood pressure (hypotension). You can find more information in the section“Other medications and Invokana”
• if you have had an amputation in a lower limb
• It is essential to regularly inspect your feet and follow any other foot care advice, in addition to adequate hydration that your doctor has recommended. You should immediately inform your doctor if you notice any wounds or discoloration, or if you experience any sensitivity or pain in your feet. Some studies indicate that taking canagliflozina may have contributed to the risk of lower limb amputation (mainly toe and midfoot amputations)
• Consult your doctor immediately if you present a combination of symptoms such as pain, tenderness, redness, or inflammation of the genitals or the area between the genitals and the anus, with fever or general discomfort. These symptoms may be a sign of a rare but potentially life-threatening infection, known as necrotizing fasciitis of the perineum or Fournier's gangrene, which destroys tissue under the skin. Fournier's gangrene should be treated immediately.
• if you have symptoms of a fungal genital infection such as irritation, itching, unusual discharge, or odor.
• if you have a severe kidney or urinary tract infection with fever. Your doctor may ask you to stop taking Invokana until you have recovered.

If any of the above situations apply to you (or if you are unsure), speak with your doctor, pharmacist, or nurse before taking this medication.

Renal function

You will have a kidney function review through a blood test before starting to take and while taking this medication.

Urine glucose

Due to how this medication works, your urine will test positive for sugar (glucose) while you are taking this medication.

Children and adolescents

Invokana is not recommended for children or adolescents under 18 years old.

Other medications and Invokana

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This medication may affect the mechanism of action of other medications. Additionally, other medications may affect the mechanism of action of this medication.

In particular, inform your doctor if you are taking any of the following medications:

• other antidiabetic medications, either insulin or a sulfonylurea (such as glimepiride or glipizide), your doctor may decide to reduce your dose to avoid excessive lowering of blood sugar levels (hypoglycemia)
• blood pressure-lowering medications (anti-hypertensives), including diuretics (medications used to eliminate excess fluids in your body) as this medication can also lower your blood pressure by eliminating fluids from your body. In section 4, possible symptoms of excessive fluid loss from your body are listed
• St. John's Wort or hypericum (a plant-based medication used to treat depression)

• carbamazepine, phenytoin, or phenobarbital (medications used to control seizures)
• lithium (medication used to treat bipolar disorder)

• efavirenz or ritonavir (medication used to treat HIV infection)
• rifampicin (antibiotic used to treat tuberculosis)
• colestiramine (medication used to reduce blood cholesterol levels). See section 3,“When taking this medication”
• digoxin or digitoxin (medications used for certain heart problems). If you takeInvokana, it may be necessary to measure the levels of digoxin or digitoxin in your blood
• dabigatran (blood-thinning medication that reduces the risk of blood clot formation).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Invokana should not be used during pregnancy. Consult your doctor on the best way to stop Invokana and control your blood sugar levels as soon as you know you are pregnant.

You should not take this medication if you are breastfeeding. Consult your doctor if you need to stop taking this medication or if you need to stop breastfeeding.

Driving and operating machinery

Invokana has no or negligible influence on your ability to drive, ride a bicycle, or use tools or machinery. However, some patients may experience dizziness or drowsiness, which may affect your ability to drive, ride a bicycle, or use tools or machinery.

Taking Invokana with other diabetes medications called sulfonylureas (such as glimepiride or glipizide) or insulin may increase the risk of low blood sugar (hypoglycemia). Symptoms include blurred vision, tingling in the lips, tremors, sweating, paleness, mood changes, anxiety, or confusion. This may affect your ability to drive, ride a bicycle, and use tools or machinery. Inform your doctor as soon as possible if you experience any symptoms of low blood sugar.

Invokana contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Invokana contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to take

• The recommended 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 the dose to 100 mg if you have kidney problems.
• Your doctor will prescribe the appropriate dose for you.

When taking this medication

• 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 it at the same time every day. This will help you remember to take it.
• If your doctor has prescribed canagliflozina along with a bile acid sequestrator such as cholestyramine (a medication to lower cholesterol), take canagliflozina at least 1 hour before or 4 to 6 hours after taking the bile acid sequestrator.

Your doctor may prescribe Invokana with another anti-hyperglycemic medication.

Remember to take all your medications as instructed 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 of your doctor, pharmacist, or nurse regarding diet and exercise. In particular, if you follow a weight-control diabetic diet, you should continue it while taking this medication.

If you take more Invokana than you should

If you take more medication than you should, consult your doctor or go immediately to the nearest hospital.

If you forget to take Invokana

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
• Do not take a double dose (two doses on the same day) to make up for the missed dose.

If you interrupt treatment with Invokana

Your blood sugar concentration may increase if you stop taking this medication. Do not stop using this medication without first talking to your doctor.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Invokana and consult a doctor or go immediately to the nearest hospital if you notice any of the following serious side effects:

Severe allergic reaction (rare, may affect up to 1 in 1,000 people)

Possible symptoms of a severe allergic reaction may include:

• Swelling of the face, lips, mouth, tongue, or throat that may cause difficulty breathing or swallowing.

Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people)

These are the symptoms of diabetic ketoacidosis (see also section 2):

• Increased levels of "ketone bodies" in your urine or blood
• Rapid weight loss
• Nausea or vomiting
• Abdominal pain
• Excessive thirst
• Deep and rapid breathing
• Confusion
• Unusual drowsiness or fatigue
• Sweet or metallic taste in your mouth, or a different odor of your urine or sweat.

This can occur regardless of your blood glucose levels. Diabetic ketoacidosis may occur more frequently as kidney function worsens. Your doctor may decide to temporarily or permanently discontinue Invokana treatment.

Dehydration (infrequent, may affect 1 in 100 people)

• Excessive loss of fluids from your body (dehydration). This effect is more commonin people aged 75 years or older, people with kidney problems, andpeople taking diuretics.

Possible symptoms of dehydration are:

- Dizziness or vertigo

- Loss of consciousness (fainting), dizziness, or fainting when standing up

- Very dry or sticky mouth, intense thirst

- Feeling extremely tired or weak

- Infrequent or no urination

- Rapid heartbeat.

Inform your doctor as soon as possible if you experience any of the following side effects:

Hypoglycemia (very common, may affect more than 1 in 10 people)

• Low blood sugar (hypoglycemia) – when taking this medicine with insulin or with a sulfonylurea (such as glimepiride or glipizide).

Possible symptoms of low blood sugar are:

- Blurred vision

- Tingling in the lips

- Trembling, sweating, paleness

- Change in mood or feeling anxious or confused.

Your doctor will explain how to treat low blood sugar and what to do if you experience any of the above symptoms.

Urinary tract infections (frequent, may affect up to 1 in 10 people)

• These are signs of a severe urinary tract infection, for example:

• Fever and/or chills
• Burning sensation when passing urine
• Pain in your back or side.

Although infrequent, if you notice blood in your urine, inform your doctor immediately.

Other side effects:

Very common (may affect more than 1 in 10 people)

• Vaginal yeast infections

Common (may affect up to 1 in 10 people)

• Skin rash or redness of the penis or foreskin (fungal infection)
• Changes in urine (such as more frequent urination or increased urine production, urgent need to urinate, need to urinate at night)
• Constipation
• Thirst
• Nausea
• Abnormal blood test results may show changes in lipid levels (cholesterol) and increased red blood cell count in blood (hematocrit).

Infrequent (may affect up to 1 in 100 people)

• Skin rash or redness, which may cause itching and include raised bumps, rash with exudation, or blisters
• Ingrown hairs
• Abnormal blood test results may show changes related to kidney function (elevated creatinine or urea) or elevated potassium
• Abnormal blood test results may show increased levels of phosphate in blood
• Fracture
• Renal failure (mainly as a consequence of significant loss of body fluids)
• Amputations of lower limbs (mainly toes of the feet) especially if you have a high risk of cardiovascular disease
• Foreskin phimosis – difficulty retracting the foreskin from the end of the penis
• Sunburn reactions.

Unknown frequency (cannot be estimated from available data)

• Fournier's gangrene or necrotizing fasciitis of the perineum, a severe infection of the soft tissues of the genitals or the area between the genitals and the anus.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack in the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use this medication if you observe visible signs of deterioration or tampering.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Invokana

• The active ingredient is canagliflozina.

-Each tablet contains canagliflozina hemihidrato, equivalent to 100 mg or 300 mg of canagliflozina.

• The other components are:
• • tablet core: lactose (see section 2 “Invokana contains lactose”), microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, and magnesium stearate.
  • film-coated: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, and talc. The 100 mg tablet also contains yellow iron oxide (E172).

Appearance of the product and contents of the pack

• Invokana 100 mg film-coated tablets (tablets) are yellow, capsule-shaped, 11 mm in length, with “CFZ” engraved on one face and “100” on the other face.
• Invokana 300 mg film-coated tablets (tablets) are white, capsule-shaped, 17 mm in length, with “CFZ” engraved on one face and “300” on the other face.

Invokana is available in pre-cut PVC/aluminum blisters. The pack sizes are cartons of 10 x 1, 30 x 1, 90 x 1, or 100 x 1 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Janssen-Cilag International NV Turnhoutseweg 30

B-2340 Beerse

Belgium

Responsible for manufacturing

Janssen-Cilag SpA

Via C. Janssen

Borgo San Michele

04100 Latina

Italy

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last date of revision of the summary of product characteristics:June 2023.

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu,and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).