Invokana

Package leaflet: Information for the patient

Invokana 100 mg film-coated tablets, 300 mg film-coated tablets

canagliflozin
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Invokana is and what it is used for
2. What you need to know before taking 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 is Invokana and what is it used for?

Invokana contains the active substance canagliflozin, which belongs to a group of medicines called
"antihyperglycaemic agents".
Invokana is used

• for the treatment of adult patients and children aged 10 years and older with type 2 diabetes.

This medicine works by increasing the amount of sugar removed from your body through the urine.
This reduces the level of sugar in the blood, helping to prevent heart disease in patients with type 2
diabetes mellitus (T2DM). In addition, in patients with T2DM, it slows the decline in kidney function
through a mechanism complementary to blood glucose reduction.
Invokana may be used alone or in combination with other medicines you are taking for type 2 diabetes
(such as metformin, insulin, a DPP-4 inhibitor [sitagliptin, saxagliptin or linagliptin], a sulfonylurea
[glimepiride or glipizide], or pioglitazone) that lower blood sugar levels. You may already be taking
one or more of these medicines for the treatment of type 2 diabetes.
It is also important that you continue to follow the advice given by your doctor or nurse regarding
diet and exercise.
What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin or the insulin the
body produces does not work properly. The body may also produce too much sugar. When this
happens, sugar (glucose) builds up in the blood. This can lead to serious health problems such as
heart and kidney disease, blindness, and amputations.

2. What you should know before taking Invokana

Do not take Invokana

• If you are allergic to canagliflozin or to 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:

• To receive information on how to prevent dehydration (see section 4 for signs of dehydration).
• If you have type 1 diabetes, because Invokana must not be used to treat this condition.
• If you experience rapid weight loss, nausea or vomiting, stomach pain, excessive thirst, deep and rapid breathing, confusion, unusual drowsiness or fatigue, sweet-smelling breath, sweet or metallic taste in the mouth, or a different smell in your urine or sweat, contact a doctor or go immediately to the nearest hospital. These symptoms may be signs of "diabetic ketoacidosis"—a rare but serious, sometimes life-threatening condition that can occur in diabetes due to increased levels of "ketone bodies" in urine or blood, detected by laboratory tests. The risk of developing diabetic ketoacidosis may increase during prolonged fasting, excessive alcohol consumption, dehydration, sudden reduction in insulin dose, or increased insulin requirement following major surgery or serious illness.
• If you are scheduled for major surgery or a procedure requiring prolonged fasting, ask your doctor whether you should stop taking Invokana and when to resume treatment.
• If you have diabetic ketoacidosis (a diabetes complication with high blood sugar levels, rapid weight loss, nausea, or vomiting). Invokana must 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 a stroke.
• If you are taking a medicine to lower blood pressure (antihypertensive) or have ever had low blood pressure (hypotension). More information is provided later in the section “Other medicines and Invokana”.
• If you have had an amputation of the lower limbs.
• It is important to regularly check your feet and follow healthcare professionals’ advice regarding foot care and adequate hydration. Immediately inform your doctor if you notice wounds or changes in the color of your feet, or if you experience discomfort or pain in your feet. Some studies indicate that taking canagliflozin may contribute to an increased risk of lower limb amputations (mainly toes and metatarsal).
• Immediately speak to your doctor if you develop a combination of symptoms such as pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the anus, accompanied by fever or a general feeling of being unwell. These symptoms could be signs of a rare but serious, potentially life-threatening infection called necrotizing fasciitis of the perineum, or Fournier's gangrene, which destroys subcutaneous tissue. Fournier's gangrene requires immediate treatment.
• If you have signs of genital yeast 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 conditions listed above apply to you (or you are unsure), inform your doctor, pharmacist, or nurse before taking this medicine.
Kidney function
Your kidney function will need to be checked through blood tests before starting and while taking this medicine.
Glucose in urine
Due to the way this medicine works, urine glucose (sugar) tests will be positive during treatment.
Children and adolescents
Invokana can be used in children aged 10 years and older. No data are available in children under 10 years of age. Invokana is not recommended for children under 10 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 is because this medicine may affect the action of certain other medicines, or those medicines may affect the action of this medicine.
In particular, you must inform your doctor if you are taking medicines containing the following active substances:

• Other antidiabetic medicines—insulin or a sulfonylurea (glimepiride or glipizide): your doctor may wish to reduce the dose to avoid blood sugar levels becoming too low (hypoglycaemia).
• Medicines used to lower blood pressure (antihypertensives), including diuretics (medicines used to remove excess fluid from the body), as this medicine can also lower blood pressure by eliminating excess water from the body. Possible signs of excessive fluid loss are listed in section 4.
• St. John’s wort (a herbal preparation used to treat depression).
• Carbamazepine, phenytoin, or phenobarbital (medicines used to control epileptic seizures).
• Lithium (a medicine used to treat bipolar disorder).
• Efavirenz or ritonavir (medicines used to treat HIV infection).
• Rifampicin (an antibiotic used to treat infections such as tuberculosis).
• Cholestyramine (a medicine used to reduce cholesterol levels in the blood). See section 3 “How to take Invokana”.
• Digoxin or digitoxin (medicines used for certain heart problems). The level of digoxin or digitoxin in the blood may need to be monitored if these medicines are taken with Invokana.
• Dabigatran (an anticoagulant medicine that reduces the risk of blood clot formation).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking or continuing to take this medicine. Invokana must not be used during pregnancy. Consult your doctor on the best way to stop Invokana and monitor blood glucose as soon as you know you are pregnant.
Do not take this medicine while breastfeeding. Inform your doctor if you wish to stop taking this medicine or if you wish to stop breastfeeding.
Driving and using machines
Invokana does not affect, or has a negligible effect on, the ability to drive or operate tools or machines. However, dizziness or a feeling of lightheadedness has been reported, which may affect these abilities.
Taking Invokana together with other diabetes medicines called sulfonylureas (glimepiride or glipizide) or together with insulin may increase the risk of low blood sugar levels (hypoglycaemia). Signs of hypoglycaemia include blurred vision, lip tingling, tremor, sweating, paleness, mood changes, feeling anxious or confused. This may affect your ability to drive, ride a bicycle, or use tools or machines. Inform your doctor as soon as possible if any signs of low blood sugar levels occur.
Invokana contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Invokana contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially “sodium-free”.

3. How to take Invokana

Take this medicine exactly as your doctor or pharmacist has told you. If
you are unsure, consult your doctor or pharmacist.
How much to take

• The starting dose of Invokana is one 100 mg tablet daily. Your doctor will decide whether your dose should be increased to 300 mg.
• Your doctor may reduce your dose to 100 mg if you have kidney problems.
• Your doctor will prescribe the appropriate dose for you.

Taking this medicine

• Swallow the tablet whole with water.
• You may 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 every day. This will help you remember to take it.
• If your doctor has prescribed canagliflozin together with any bile acid sequestrant such as cholestyramine (a medicine used to lower cholesterol levels), 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 together with another antidiabetic medicine. To achieve the
best health outcomes, remember to take all your medicines as directed by your doctor.
Diet and exercise
To manage diabetes, you must follow your doctor’s, pharmacist’s, or nurse’s advice regarding
diet and physical activity. In particular, if you are on a diabetic diet, continue to follow it while taking this medicine.
If you take more Invokana than you should
If you take more tablets than you should, contact your doctor immediately 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
If you stop taking this medicine, your blood sugar levels may rise. Do not stop taking Invokana without first talking to your doctor.
If you have any doubts about how to use this medicine, consult 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 consult 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 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 the signs of diabetic ketoacidosis (see also section 2):

• increased levels of "ketone bodies" in the urine or blood
• rapid weight loss
• nausea or vomiting
• stomach pain
• excessive thirst
• fast and deep breathing
• confusion
• unusual drowsiness or tiredness
• sweet breath odour, sweet or metallic taste in the mouth, or a different odour of urine or sweat.

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

Dehydration (not common, may affect up to 1 in 100 people)

• excessive loss of body fluids (dehydration). This occurs more frequently in elderly people aged 75 years or older, in people with kidney problems, and in people taking diuretics. Possible signs of dehydration include:
• feeling faint or dizzy
• fainting (loss of consciousness) or dizziness or fainting when standing up
• very dry or sticky mouth, excessive thirst
• feeling very weak or tired
• producing little or no urine
• rapid heartbeat.

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

Hypoglycaemia (very common, affects more than 1 in 10 people)

• low blood sugar levels (hypoglycaemia) when taking this medicine with insulin or a sulfonylurea (glimepiride or glipizide). Possible signs of low blood sugar levels include:
• blurred vision
• tingling around the lips
• trembling, sweating, paleness
• mood changes or feeling anxious or confused.

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

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

• Signs of a serious urinary tract infection may include, for example:
• fever and/or chills
• burning sensation during urination (micturition)
• back or side pain.

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

Other side effects:

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

• vaginal yeast infection.

Common (may affect up to 1 in 10 people)

• rash or redness of the penis or foreskin (yeast infection)
• changes in urination (urinating more frequently or in larger amounts, urgent need to urinate, need to urinate at night)
• constipation
• thirst
• nausea
• blood tests may show changes in cholesterol or blood fat levels and an increase in the number of red blood cells (haematocrit).

Uncommon (may affect up to 1 in 100 people)

• skin rash or redness of the skin, which may be itchy and may include blistering, oozing or sores
• hives
• blood tests may show changes related to kidney function (increased creatinine or urea) or increased potassium levels
• blood tests may show an increase in blood phosphate levels
• bone fracture
• kidney failure (mainly as a consequence of excessive fluid loss from the body)
• amputations of the lower limbs (mainly toes), particularly if you are at high risk of cardiovascular disease
• phimosis – difficulty retracting the foreskin over the tip of the penis
• skin reactions after exposure to sunlight.

Not known (frequency cannot be estimated from the available data)

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. 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 stated on the blister and carton after "Exp.". The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not use Invokana if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Invokana contains

• The active substance is canagliflozin.
• Each tablet contains canagliflozin hemihydrate, equivalent to 100 mg or 300 mg of canagliflozin.
• The other components are:
  • tablet core: lactose (see section 2 “Invokana contains lactose”), microcrystalline cellulose (E460[i]), hydroxypropylcellulose (E463), croscarmellose sodium (E468) and magnesium stearate (E572).
  • coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol/PEG 3350 (E1521) and talc (E553b). The 100 mg tablet also contains yellow iron oxide (E172).

Description of the appearance of Invokana and contents of the pack

• Invokana 100 mg film-coated tablets, yellow, capsule-shaped, 11 mm long, marked “CFZ” on one side and “100” on the other side.
• Invokana 300 mg film-coated tablets, white, capsule-shaped, 17 mm long, marked “CFZ” on one side and “300” on the other side.

Invokana is available in perforated PVC/aluminum blisters for single-dose use. The packs consist of cartons containing 10x1, 30x1, 90x1 or 100x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen-Cilag SpA
Via C. Janssen
04100 Borgo San Michele
Latina
Italy

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Menarini Benelux NV/SA UAB "JOHNSON & JOHNSON"
Tél/Tel: +32 (0)2 721 4545 Tel: +370 5 278 68 88
[email protected] [email protected]

България Luxembourg/Luxemburg
“Берлин-Хеми/А. Менарини България” Menarini Benelux NV/SA
EООД Tél/Tel: +32 (0)2 721 4545
Тел.: +359 2 454 0950 [email protected]
[email protected]

Česká republika Magyarország
Berlin-Chemie/A.Menarini Ceska republika Janssen-Cilag Kft.
s.r.o. Tel.: +36 1 884 2858
Tel: +420 267 199 333 [email protected]
[email protected]

Danmark Malta
Berlin-Chemie AG AM MANGION LTD
Tlf: +45 78 71 31 21 Tel: +356 2397 6000

Deutschland Nederland
Berlin-Chemie AG Menarini Benelux NV/SA
Tel: +49 (0)30 6707-0 Tel: +32 (0)2 721 4545
[email protected]

Eesti Norge
UAB "JOHNSON & JOHNSON" Eesti filiaal Berlin-Chemie AG
Tel: +372 617 7410 Tlf: +45 78 71 31 21
[email protected]

Ελλάδα Österreich
MENARINI HELLAS AE A. Menarini Pharma GmbH
Tηλ: +30 210 8316111-13 Tel: +43 1 879 95 85-0
[email protected] [email protected]

España Polska
Laboratorios Menarini, S.A. Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel: +34 93 462 88 00 Tel.: +48 22 566 21 00
[email protected] [email protected]

France Portugal
MENARINI France A. Menarini Portugal – Farmacêutica, S.A.
Tél: +33 (0)1 45 60 77 20 Tel: +351 210 935 500
[email protected] [email protected]

Hrvatska România
Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL
Tel: +385 1 6610 700 Tel: +40 21 207 1800
[email protected]

Ireland Slovenija
A. Menarini Pharmaceuticals Ireland Ltd Johnson & Johnson d.o.o.
Tel: +353 1 284 6744 Tel: +386 1 401 18 00
[email protected] [email protected]

Ísland Slovenská republika
Janssen-Cilag AB Berlin-Chemie / A. Menarini Distribution
c/o Vistor ehf. Slovakia s.r.o
Sími: +354 535 7000 Tel: +421 2 544 30 730
[email protected] [email protected]

Italia Suomi/Finland
Laboratori Guidotti S.p.A. Berlin-Chemie/A. Menarini Suomi Oy
Tel: +39 050 971011 Puh/Tel: +358 403 000 760
[email protected] [email protected]

Κύπρος Sverige
MENARINI HELLAS AE Berlin-Chemie AG
Τηλ: +30 210 8316111-13 Tfn: +45 78 71 31 21
[email protected]

Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561
[email protected]

Other sources of information
More detailed information about this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.