Vokanamet

Package leaflet: Information for the patient

Vokanamet 50 mg/850 mg film-coated tablets, 50 mg/1,000 mg film-coated tablets, 150 mg/850 mg film-coated tablets, 150 mg/1,000 mg film-coated tablets

canagliflozin/metformin hydrochloride
Please read 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Vokanamet is and what it is used for
2. What you need to know before taking Vokanamet
3. How to take Vokanamet
4. Possible side effects
5. How to store Vokanamet
6. Contents of the pack and other information

1. What Vokanamet is and what it is used for

Vokanamet contains two active substances, canagliflozin and metformin. These are two medicines that work together through different mechanisms to reduce glucose (sugar) levels in the blood, helping to prevent heart disease in adults with type 2 diabetes.
This medicine can be used alone or in combination with other medicines you are taking for type 2 diabetes (such as insulin, a DPP-4 inhibitor [sitagliptin, saxagliptin or linagliptin], a sulphonylurea [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.
Vokanamet is used when blood sugar is not adequately controlled by metformin alone or in combination with other antidiabetic medicines. If you are already taking both canagliflozin and metformin as separate tablets, Vokanamet may replace them with a single tablet.
It is important that you continue to follow the advice you have received from your doctor or nurse regarding diet and physical exercise.
What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin or the insulin produced by the body does not work properly. The body may also produce too much sugar. When this happens, sugar (glucose) accumulates 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 Vokanet

Do not take Vokanamet

• if you are allergic to canagliflozin, metformin, or any of the other ingredients of this medicine (listed in section 6)
• if you have liver problems
• if you have severely reduced kidney function
• if you have uncontrolled diabetes associated, for example, with severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see below “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” accumulate in the blood and may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, and breath with an unusually fruity odour
• if you have a severe infection
• if you have lost a lot of fluid from your body (dehydration), e.g. due to prolonged or severe diarrhoea or if you have vomited several times consecutively
• if you have diabetic pre-coma
• if you have recently had a heart attack or have serious circulatory problems, such as “shock” or breathing difficulties
• if you drink alcohol excessively (either daily or occasionally)
• if you have had, or have recently had, a heart attack.

Warnings and precautions
Risk of lactic acidosis
Vokanamet may cause a very rare but very serious side effect called lactic acidosis,
particularly if the kidneys are not functioning properly. The risk of developing lactic acidosis is higher
in the presence of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption,
dehydration (see below for further information), liver problems, or any other medical condition
characterised by reduced oxygen supply to part of the body (such as in the case of severe heart disease).
If you have any of the medical conditions described above, consult your doctor for further instructions.
Contact your doctor immediately for further instructions if:

• you know you have a hereditary genetic disease affecting mitochondria (the components that produce energy within cells), such as MELAS syndrome (Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-like episodes, mitochondrial encephalomyopathy with lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD, Maternal Inherited Diabetes and Deafness);
• you experience any of the following symptoms after starting metformin: seizures, cognitive impairment, difficulty with body movements, symptoms indicating nerve damage (e.g. pain or numbness), headache, or deafness.

Temporarily stop taking Vokanamet if you have a medical condition that may be associated with
dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea,
fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further
instructions.
If you experience any of the symptoms of lactic acidosis, stop taking Vokanamet and
contact a doctor immediately or go to the nearest hospital, because lactic acidosis can lead to
coma.
Symptoms of lactic acidosis include:

• vomiting
• stomach ache (abdominal pain)
• muscle cramps
• general feeling of malaise associated with severe fatigue
• difficulty breathing
• reduced body temperature and slower heart rate

Lactic acidosis is a medical emergency and must be treated in hospital.
Consult your doctor, pharmacist, or nurse before taking Vokanamet and during treatment:

• to obtain information on how to prevent dehydration (see section 4 for signs of dehydration)
• if you have type 1 diabetes, as Vokanamet must 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, unusual drowsiness or fatigue, sweet-smelling breath, sweet or metallic taste in the mouth, or a different odour of urine or sweat, contact a doctor or go to the nearest hospital immediately. These symptoms may indicate “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 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 insulin requirement following major surgery or serious illness
• if you are undergoing major surgery or a procedure requiring prolonged fasting, ask your doctor whether you should stop taking Vokanamet and when to resume treatment
• if you have ever had severe 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 Vokanamet”
• if you have undergone amputation of the lower limbs
• it is important to regularly check your feet and follow healthcare professionals’ advice regarding their care and adequate hydration. Inform your doctor immediately if you notice wounds or changes in the colour of your feet, or if you experience discomfort or pain in your feet. Some studies indicate that taking canagliflozin may contribute to the risk of amputation of the lower limbs (mainly toes and metatarsal).
• speak immediately with your doctor if you develop a combination of symptoms such as pain, discomfort, redness, or swelling of the genitals or the area between the genitals and the anus, accompanied by fever or general malaise. These symptoms could be signs of a rare but serious, even life-threatening infection called necrotising fasciitis of the perineum or Fournier’s gangrene, which destroys subcutaneous tissue. Fournier’s gangrene must be treated immediately.
• if you have signs of genital yeast infection such as irritation, itching, unusual discharge, or odour.
• if you have a severe kidney or urinary tract infection with fever. Your doctor may ask you to stop taking Vokanamet until you have recovered.

Kidney function
Kidney function should be monitored through blood tests before and during treatment with
Vokanamet. Your doctor will check your kidney function at least once a year, or more frequently if you are elderly and/or if kidney function worsens.
Surgery
If you are undergoing major surgery, you must stop taking
Vokanamet during the procedure and for a certain period afterwards. Your doctor
will decide when to stop and when to resume treatment with Vokanamet.
Your doctor will decide whether you need alternative treatment to control blood sugar levels while you have stopped taking Vokanamet. It is important that you follow your doctor’s instructions carefully.
Glucose in urine
Due to the way canagliflozin works, urine glucose tests will be
positive during treatment.
Children and adolescents
Vokanamet is not recommended for children and adolescents under 18 years of age, as data are not available for these patients.
Other medicines and Vokanamet
If you are to receive an iodinated contrast agent injected into the bloodstream, for
example for an X-ray, you must stop taking Vokanamet before or during the injection. Your doctor will decide when to stop and when to resume treatment with
Vokanamet.
Inform your doctor or pharmacist if you are taking or have recently taken any other
medicines. This is because this medicine may affect the action of certain medicines, or these may affect the action of this medicine. You may need more frequent blood glucose and kidney function tests, or your doctor may decide to adjust the dose of Vokanamet. It is particularly important to mention the following:

• insulin or a sulphonylurea (glimepiride or glipizide) for diabetes: your doctor may reduce the dose to avoid blood sugar levels becoming too low (hypoglycaemia)
• medicines that increase urine production (diuretics)
• 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 tuberculosis)
• colestyramine (a medicine used to reduce cholesterol levels in the blood). See section 3 “How to take Vokanamet”
• digoxin or digitoxin (medicines used for certain heart conditions). Blood levels of digoxin or digitoxin may need to be monitored if these medicines are taken with Vokanamet
• dabigatran (an anticoagulant medicine that reduces the risk of blood clots)
• medicines containing alcohol. See section “Vokanamet with alcohol”
• cimetidine (a medicine used to treat stomach problems)
• corticosteroids (used to treat a variety of conditions, such as severe skin inflammation or asthma) administered orally, by injection, or by inhalation
• beta-2 agonists (such as salbutamol or terbutaline) used to treat asthma
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).

Vokanamet with alcohol
Avoid excessive alcohol consumption during treatment with Vokanamet, as this may
increase the risk of lactic acidosis (see section “Warnings and precautions”).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking or continuing to take this
medicine.
Canagliflozin, one of the active substances in Vokanamet, must not be used during pregnancy.
Consult your doctor on the best method to control blood glucose without Vokanamet as soon as you know you are pregnant.
You must not take this medicine if you are breastfeeding. Inform your doctor if you wish
to stop taking this medicine or if you wish to stop breastfeeding.
Driving and using machines
Vokanamet does not affect, or affects negligibly, the ability to drive and use tools or machines. However, dizziness or lightheadedness have been reported, which may affect these abilities.
Taking Vokanamet with other diabetes medicines called sulphonylureas (such as glimepiride or
glipizide) or together with insulin may increase the risk of low blood sugar levels
(hypoglycaemia). Signs of this include: blurred vision, tingling around the lips, tremor, sweating, paleness, mood changes, feeling anxious or confused. This may affect your ability to drive, cycle, or use tools or machines. Inform your doctor as soon as possible if any of the signs of low blood sugar levels occur.
Vokanamet contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially “sodium-free”.

3. How to take Vokanamet

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
How much to take

• The dose of Vokanamet is one tablet twice daily.
• The dose of Vokanamet you will need depends on your condition and the amount of canagliflozin and metformin required to control your blood sugar.
• Your doctor will prescribe the appropriate dose for you.

Taking this medicine

• Swallow the tablet whole with water.
• It is best to take the tablet with a meal. This will reduce the likelihood of stomach upset.
• Try to take the tablet at the same time each day. This will help you remember to take it.
• If your doctor has prescribed this medicine together with any medicine used to lower cholesterol levels, you must take this medicine at least 1 hour before or from 4 to 6 hours after taking the cholesterol-lowering medicine.

Your doctor may prescribe Vokanamet together with another antihyperglycaemic 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 following a diabetes control diet, continue to do so while taking
this medicine.
If you take more Vokanamet than you should
Since Vokanamet contains metformin, taking more than the prescribed amount may cause lactic
acidosis. If this occurs, you may require immediate hospital treatment, as lactic acidosis can lead to
coma. Symptoms of lactic acidosis include vomiting, stomach pain, muscle cramps, a general feeling of
malaise with severe tiredness or difficulty breathing. Additional symptoms may include a drop in body
temperature and heart rate. Stop taking the medicine immediately and contact a doctor immediately or
go to the nearest hospital (see section 2). Take the medicine pack with you.
If you forget to take Vokanamet

• 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 to make up for the forgotten dose.

If you stop taking Vokanamet
If you stop taking this medicine, your blood sugar levels may rise. Do not stop taking this medicine
without first talking to your doctor.
If you have any questions about how to use 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 Vokanamet and consult a doctor or go to the nearest hospital immediately 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.

Lactic acidosis (very rare, may affect up to 1 in 10,000 people)
Vokanamet may cause a very rare (may occur in up to 1 in 10,000 people) but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Vokanamet and consult a doctor or go to the nearest hospital immediately, because lactic acidosis can lead to coma.

Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people)
These are the signs of diabetic ketoacidosis (also see section 2):

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

This may occur regardless of blood glucose levels. Your doctor may decide to temporarily or permanently discontinue treatment with Vokanamet.

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

• excessive loss of fluids from the body (dehydration). This is more likely in elderly people aged 75 years or older, in people with kidney problems, and in people taking diuretics. Possible signs of dehydration include:
• feeling lightheaded or dizzy
• fainting or feeling dizzy or fainting when standing up
• very dry mouth or feeling sticky, 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, may affect more than 1 in 10 people)

• low blood sugar levels (hypoglycaemia) when taking this medicine with insulin or a sulphonylurea (such as glimepiride or glipizide). Possible signs of low blood sugar levels include:
• blurred vision
• tingling of 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 when passing urine (urination)
• back or side pain.

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

Other side effects when taking canagliflozin alone

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
• feeling unwell (nausea)
• blood tests may show changes in blood cholesterol or fat levels and an increase in red blood cell count (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 blisters
• hives (urticaria)
• blood tests may show changes in 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)
• lower limb amputations (mainly toes) especially if you are at high risk of cardiovascular disease
• phimosis – difficulty in pulling back 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 tissues of the genitals or the area between the genitals and the anus.

Side effects when taking metformin alone that have not been described for canagliflozin

• very common: nausea, vomiting, diarrhoea, stomach ache and loss of appetite
• common: metallic taste (disturbance of taste), decreased vitamin B levels (which may cause anaemia – low red blood cell count)
• very rare: abnormalities in liver function tests, hepatitis (a liver problem) and itching.

Reporting of side effects
If you experience any side effect, 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 listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vokanamet

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and the carton after "Exp.". The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not use Vokanamet 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 Vokanamet contains

• The active substances are canagliflozin and metformin hydrochloride.
• Each 50 mg/850 mg tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin and 850 mg of metformin hydrochloride.
• Each 50 mg/1,000 mg tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin and 1,000 mg of metformin hydrochloride.
• Each 150 mg/850 mg tablet contains canagliflozin hemihydrate, equivalent to 150 mg of canagliflozin and 850 mg of metformin hydrochloride.
• Each 150 mg/1,000 mg tablet contains canagliflozin hemihydrate, equivalent to 150 mg of canagliflozin and 1,000 mg of metformin hydrochloride.
• The other components are:
• Tablet core: microcrystalline cellulose, hypromellose, croscarmellose sodium, and magnesium stearate.
• Coating:
• 50 mg/850 mg tablets: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide (E171), red iron oxide (E172), and black iron oxide (E172).
• 50 mg/1,000 mg tablets: macrogol (3350), polyvinyl alcohol, talp, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172).
• 150 mg/850 mg tablets: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide (E171), and yellow iron oxide (E172).
• 150 mg/1,000 mg tablets: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide (E171), red iron oxide (E172), and black iron oxide (E172).

Description of the appearance of Vokanamet and contents of the pack

• Vokanamet 50 mg/850 mg film-coated tablets (tablets) are pink, capsule-shaped, 20 mm long, with "CM" printed on one side and "358" on the other.
• Vokanamet 50 mg/1,000 mg film-coated tablets (tablets) are beige, capsule-shaped, 21 mm long, with "CM" printed on one side and "551" on the other.
• Vokanamet 150 mg/850 mg film-coated tablets (tablets) are light yellow, capsule-shaped, 21 mm long, with "CM" printed on one side and "418" on the other.
• Vokanamet 150 mg/1,000 mg film-coated tablets (tablets) are purple, capsule-shaped, 22 mm long, with "CM" printed on one side and "611" on the other.

Vokanamet is available in HDPE bottles with child-resistant closures. The packs contain
20 and 60 tablets, and multiple packs of 180 tablets (3 bottles containing 60 tablets each).
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
Borgo San Michele
04100 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
Janssen-Cilag GmbH Menarini Benelux NV/SA
Tel: 0800 086 9247 / +49 2137 955 6955 Tel: +32 (0)2 721 4545
[email protected] [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 on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.