INVOKANA 100 mg FILM-COATED TABLETS

2. What you need to know before you take Invokana

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 and during treatment with Invokana:

• to know what you can do to prevent dehydration (see section 4 for symptoms of dehydration)
• if you have type 1 diabetes because Invokana should not be used to treat this condition
• if you experience rapid weight loss, nausea, or vomiting, stomach pain, excessive thirst, rapid and deep breathing, confusion, drowsiness, or unusual fatigue, sweet smell on your breath, sweet or metallic taste in your mouth, or different smell of your urine or sweat, consult your doctor or go immediately to the nearest hospital. These symptoms may be signs of a rare but serious problem, sometimes potentially life-threatening, called diabetic ketoacidosis – a condition that can occur with diabetes due to increased levels of “ketone bodies” in your urine or blood, detected in laboratory 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 serious illness.
• if you are going to have major surgery or a procedure that requires prolonged fasting, ask your doctor if you should stop taking Invokana and when you should start taking it again.
• if you have diabetic ketoacidosis (a complication of diabetes with high sugar levels, rapid weight loss, nausea, or vomiting). Invokana should not be used to treat this condition
• if you have severe kidney problems or need dialysis
• if you have severe liver problems
• if you have had serious heart disease or have had a stroke
• if you are taking medicines to lower your blood pressure (antihypertensives) or have had low blood pressure (hypotension) in the past. You can find more information in the section “Other medicines and Invokana”
• if you have had a lower limb amputation
• It is essential that you regularly check your feet and follow any other advice about foot care, in addition to proper hydration, that your doctor has given you. You should inform your doctor immediately if you notice any wounds or discoloration or if you experience any sensitivity 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 experience a combination of symptoms such as pain, tenderness, redness, or swelling of the genitals or the area between the genitals and anus, with fever or general feeling of being unwell. These symptoms could be a sign of a rare but serious infection, sometimes potentially life-threatening, called 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 genital fungal 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), talk to your doctor, pharmacist, or nurse before taking this medicine.

Kidney function

You will have a kidney check through a blood test before starting and while taking this medicine.

Glucose in urine

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

Children and adolescents

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

Other medicines and Invokana

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This medicine may affect how other medicines work. Also, other medicines may affect how this medicine works.

In particular, tell your doctor if you are taking any of the following medicines:

• other anti-diabetic medicines, either insulin or a sulfonylurea (such as glimepiride or glipizide), your doctor may decide to reduce your dose to avoid excessively low blood sugar levels (hypoglycemia)
• medicines to lower your blood pressure (antihypertensives), including diuretics (medicines used to remove excess fluid from your body), as this medicine may also lower your blood pressure by removing fluid from your body. Section 4 lists possible symptoms of excessive fluid loss from your body
• St. John's Wort or hypericum (a herbal medicine used to treat depression)
• carbamazepine, phenytoin, or phenobarbital (medicines used to control seizures)
• lithium (a medicine used to treat bipolar disorder)
• efavirenz or ritonavir (a medicine used to treat HIV infection)
• rifampicin (an antibiotic used to treat tuberculosis)
• colestyramine (a medicine used to lower cholesterol levels in the blood). See section 3, “When taking this medicine”
• digoxin or digitoxin (medicines used for certain heart problems). If you take Invokana, it may be necessary to measure the levels of digoxin or digitoxin in your blood
• dabigatran (an anticoagulant medicine that reduces 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 this medicine. Invokana should not be used during pregnancy. Ask your doctor about the best way to stop taking Invokana and control your blood sugar levels as soon as you know you are pregnant.

You should not take this medicine if you are breast-feeding. Ask your doctor if you should stop taking this medicine or stop breast-feeding.

Driving and using machines

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

Taking Invokana with other diabetes medicines called sulfonylureas (such as glimepiride or glipizide) or insulin may increase the risk of low blood sugar levels (hypoglycemia). Symptoms include blurred vision, tingling of the lips, tremor, sweating, pallor, mood change, anxiety, or confusion. All these may affect your ability to drive, ride a bicycle, or use tools or machines. Tell your doctor as soon as possible if you have any symptoms of low blood sugar.

Invokana contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Invokana contains sodium

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

3. How to take Invokana

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

How much to take

• The recommended starting dose of Invokana is one 100 mg tablet once daily. 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 dose that is right for you.

When taking this 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 it at the same time each day. This will help you remember to take it.
• If your doctor has prescribed canagliflozin with a bile acid sequestrant such as colestyramine (a medicine to lower cholesterol), you should take canagliflozin at least 1 hour before or 4 to 6 hours after taking the bile acid sequestrant.

Your doctor may prescribe Invokana with another anti-diabetic medicine.

Remember to take all your medicines as instructed by your doctor to get 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 about diet and exercise. In particular, if you follow a weight-control diet, you should continue it while taking this medicine.

If you take more Invokana than you should

If you take more medicine than you should, talk to 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 your next dose, skip the missed dose.
• Do not take a double dose (two doses on the same day) to make up for a forgotten dose.

If you stop taking Invokana

Your blood sugar levels may increase 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 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 go immediately to the nearest hospital if you experience 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 which may cause difficulty in breathing or swallowing.

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

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

• increased levels of “ketone bodies” in your urine or blood
• rapid weight loss
• nausea or vomiting
• stomach pain
• excessive thirst
• rapid and deep breathing
• confusion
• drowsiness or unusual fatigue
• sweet smell on your breath, sweet or metallic taste in your mouth, or different smell of your urine or sweat.

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

Dehydration (uncommon, may affect up to 1 in 100 people)

• excessive loss of fluids from your body (dehydration). This side effect is more common in elderly people (≥ 75 years), people with kidney problems, and people taking diuretics.

Possible symptoms of dehydration are:

• feeling dizzy or lightheaded
• loss of consciousness (fainting), dizziness, or fainting when standing up
• very dry or sticky mouth, feeling very thirsty
• feeling very tired or weak
• passing little or no urine
• fast heartbeat.

Tell 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 levels (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 of the lips
• tremor, sweating, pallor
• mood change, anxiety, or confusion.

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

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

• These are signs of a severe urinary tract infection, e.g.,

• fever and/or chills
• burning sensation when passing urine
• back or side pain.

Although uncommon, if you notice blood in your urine, tell your doctor immediately.

Other side effects:

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

• genital fungal infections

Common (may affect up to 1 in 10 people)

• fungal infection of the penis or foreskin (e.g., balanitis or balanoposthitis)
• changes in urine (such as needing to urinate more often or producing more urine, needing to urinate urgently, needing to urinate at night)
• constipation
• feeling thirsty
• nausea
• blood tests may show changes in lipid (cholesterol) levels and increased red blood cell count (hematocrit).

Uncommon (may affect up to 1 in 100 people)

• skin rash or redness, which may cause itching and include raised bumps, rash with blistering, or peeling
• hives
• blood tests may show changes related to kidney function (elevated creatinine or urea) or high potassium levels
• blood tests may show increased phosphate levels
• bone fracture
• kidney failure (mainly as a consequence of significant fluid loss from your body)
• lower limb amputations (mainly toe and midfoot amputations), especially if you have a high risk of heart disease
• phimosis – difficulty retracting the foreskin from the tip of the penis
• skin reactions after exposure to sunlight.

Frequency not known (cannot be estimated from the available data)

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

Reporting of side effects

If you experience 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 national reporting system listed in Appendix V.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 on the carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice visible signs of deterioration or tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Invokana

• The active substance is canagliflozin.

• Each tablet contains canagliflozin hemihydrate, equivalent to 100 mg or 300 mg of canagliflozin.
  • The other ingredients are:
  • • tablet core: lactose (see section 2 "Invokana contains lactose"), microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, and magnesium stearate.
    • film coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, and talc. The 100 mg tablet also contains yellow iron oxide (E172).

Appearance and Package Contents of the Product

• 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 precut unit-dose blisters of PVC/aluminum. The pack sizes are cardboard boxes of 10 x 1, 30 x 1, 90 x 1, or 100 x 1 tablets.

Only some 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

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Date of last revision of this leaflet: September 2024.

Other sources of information

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