Patient Information Leaflet

Vokanamet 50 mg/850 mg Film-Coated Tablets

Vokanamet 50 mg/1.000 mg Film-Coated Tablets

Vokanamet 150 mg/850 mg Film-Coated Tablets

Vokanamet 150 mg/1.000 mg Film-Coated Tablets

canagliflozina/hidrocloruro de metformina

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as 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 others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. See section 4.

1. What you need to know before you take Vokanamet
2. How to take Vokanamet
3. Possible side effects

1. Storage of Vokanamet
2. Contents of the pack and additional information

Vokanamet contains two distinct active principles, canagliflozina and metformina. These are two medications that act together in different ways to decrease blood glucose (sugar) levels and may help prevent heart disease in adults with type 2 diabetes.

This medication is administered alone or in combination with other medications you may already be taking to treat your type 2 diabetes (such as insulin, a DPP-4 inhibitor [such as sitagliptina, saxagliptina, or linagliptina], a sulfonylurea [such as glimepiride or glipizide], or pioglitazona) that decrease blood sugar levels. It is possible that you are already taking one or more of these medications to treat your type 2 diabetes. Vokanamet is used when your blood sugar levels cannot be controlled adequately with metformina alone or in combination with other diabetes medications. If you are already taking canagliflozina and metformina as separate tablets, Vokanamet may replace them in one tablet.

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 as well as it should. It may 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 Vokanamet

• if you are allergic to canagliflozina, metformin, or any of the other ingredients of this medicine (listed in section 6)
• if you have liver problems
• if you have severe kidney function reduction
• if you have uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or ketoacidosis. Ketoacidosis is a disorder in which substances called "ketone bodies" accumulate in the blood, which can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or if your breath develops an unusual sweet odor
• if you have a severe infection
• if you have lost a lot of body fluid (dehydration), for example, due to severe or prolonged diarrhea or if you have vomited several times in a row
• if you have diabetic precoma
• if you have recently had a heart attack or have severe blood circulation problems, such as "shock" or difficulty breathing
• if you drink excessive alcohol (whether daily or occasionally)
• if you have or have had severe heart failure.

Warnings and precautions

Risk of lactic acidosis

Vokanamet may cause a very rare but serious side effect called lactic acidosis, especially if your kidneys do not function properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below for more information), liver problems, and any medical condition in which a part of the body has a reduced oxygen supply (such as acute and severe heart disease).

If any of the above applies to you, consult your doctor for further instructions.

Stop taking Vokanamet temporarily if you have a condition that may be associated with dehydration(significant loss of body fluids), such as intense vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal. Consult your doctor for further instructions.

Stop taking Vokanamet and speak with a doctor or go to the nearest hospital immediately if you experience any of the symptoms that produce lactic acidosis,as this condition can lead to coma.

The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort, with intense fatigue
• difficulty breathing
• reduction of body temperature and heart rate

Lactic acidosis is a medical emergency and should be treated in a hospital.

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

• to know what you can do to prevent dehydration (see section 4 for dehydration symptoms)
• if you have type 1 diabetes because Vokanamet should not be used to treat this disease
• if you experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, rapid and deep breathing, confusion, drowsiness, or fatigue, speak with your doctor or go to the nearest hospital immediately. These symptoms may be signs of diabetic ketoacidosis – a rare but serious, sometimes potentially fatal condition that can occur with diabetes due to increased levels of "ketone bodies" in your urine or blood, detected in tests. The risk of developing diabetic ketoacidosis may be increased 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 had severe heart disease or have had a stroke
• if you are taking blood pressure-lowering medications (antihypertensives) or have had low blood pressure (hypotension) at any time. You can find more information in the section "Other medicines and Vokanamet "
• if you have had a lower limb amputation
• It is essential to regularly monitor your feet and follow any other foot care advice, in addition to adequate 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 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 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 fatal infection, even gangrene of Fournier, which destroys tissue under the skin. Gangrene of Fournier 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 Vokanamet until you have recovered.

Renal function

Your kidneys will be reviewed through a blood test before starting to take Vokanamet. During treatment with Vokanamet, your doctor will check your kidney function at least once a year or more frequently if you are an older person and/or if your kidney function is worsening.

Surgery

If you need to undergo major surgery, you should stop taking Vokanamet while the procedure is being performed and for a period after it. Your doctor will decide when to interrupt the treatment with Vokanamet and when to restart it.

Your doctor will decide if you need any other treatment to control your blood sugar levels while you stop taking Vokanamet. It is essential to follow your doctor's instructions exactly.

Blood glucose in urine

Due to the way canagliflozina works, your urine will test positive for sugar (glucose) while you are taking this medicine.

Children and adolescents

Vokanamet is not recommended for children or adolescents under 18 years of age, as there is no data available for these patients.

Other medicines and Vokanamet

If you need to receive an intravenous injection of a contrast medium containing iodine, for example, in the context of an X-ray or examination, you should stop taking Vokanamet before the injection or at the time of the injection. Your doctor will decide when to interrupt the treatment with Vokanamet and when to restart it.

Inform your doctor if you are taking, have taken recently, or may need to take any other medicine. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Vokanamet. It is especially important to mention the following:

• insulin or a sulfonylurea (such as glimepiride or glipizide) for diabetes – your doctor may decide to reduce the dose to avoid excessive lowering of blood sugar levels (hypoglycemia)
• diuretics (medicines that increase urine production)
• St. John's Wort or hypericum (a plant-based 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 (medicines used to treat HIV infection)
• rifampicin (an antibiotic used to treat tuberculosis)
• colestiramine (a medicine used to reduce blood cholesterol levels). See section 3, "How to take this medicine"
• digoxin or digitoxin (medicines used for certain heart problems). If you take Vokanamet, it may be necessary to measure the concentration of digoxin or digitoxin in your blood
• dabigatran (an anticoagulant medicine that reduces the risk of blood clot formation)
• medicines containing alcohol. See section "Vokanamet with alcohol"
• cimetidine (a medicine used to treat stomach problems)
• corticosteroids (used to treat a range of conditions, such as severe skin inflammation or asthma) administered orally, by injection, or inhaled
• 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)
• some medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).

Taking Vokanamet with alcohol

Avoid excessive alcohol consumption while taking Vokanamet, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using or continuing to use this medicine.

Canagliflozina, one of the components of Vokanamet, should not be used during pregnancy. Consult your doctor for the best way to control your blood sugar levels without Vokanamet as soon as you know you are pregnant.

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

Driving and operating machinery

The influence of Vokanamet on your ability to drive, ride a bike, and use tools or machines is negligible or insignificant. However, dizziness or lightheadedness has been reported, which may affect your ability to drive, ride a bike, or use tools or machines.

Taking Vokanamet 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 in the lips, tremors, sweating, paleness, mood changes, anxiety, or confusion. This may affect your ability to drive, ride a bike, and use tools or machines. Inform your doctor as soon as possible if you experience any symptoms of low blood sugar.

Vokanamet contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much to take

• The dose of Vokanamet is one tablet twice a day.
• The concentration of Vokanamet you should take will vary depending on your condition and the amount of canagliflozina and metformina needed to control your blood sugar.
• Your doctor will prescribe the suitable dose for you.

How to take this medication

• Swallow the tablet whole with water.
• It is best to take the tablet with a meal. This will reduce the likelihood of stomach discomfort.
• Try to take it at the same time every day. This will help you remember to take it.
• If your doctor has prescribed this medication along with a cholesterol-lowering medication such as cholestyramine, you should take this medication at least 1 hour before or between 4 and 6 hours after taking the cholesterol-lowering medication.

Your doctor may prescribe Vokanamet with another medication to reduce glucose. Remember to take all medications as instructed by your doctor to achieve the best results for your health.

Diet and exercise

To help control your diabetes, you should also follow the dietary and exercise advice from your doctor, pharmacist, or nurse. In particular, if you are following a weight-control diabetic diet, you should continue it while taking this medication.

If you take more Vokanamet than you should

Since Vokanamet contains metformin, if you take more medication than you should, you may develop lactic acidosis. If this happens to you, you may need immediate hospital treatment, as lactic acidosis can cause coma. Symptoms of lactic acidosis include vomiting, stomach pain, muscle cramps, general feeling of discomfort with intense fatigue or difficulty breathing. Other symptoms are reduced body temperature and heart rate. Stop taking this medication immediately and contact a doctor or the nearest hospital (see section 2) right away. Bring the medication packaging 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 already time for the next dose, skip the missed dose.
• Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Vokanamet

Your blood sugar concentration may increase if you stop taking this medication. Do not stop taking 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 Vokanamet and speak with a doctor or go to the nearest hospital immediately 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.

Lactic acidosis (very rare, may affect up to 1 in 10,000 people)

Vokanamet may cause a very rare but serious side effect (may affect up to 1 user in 10,000), called lactic acidosis (see "Warnings and precautions" section). If this happens to you,you should stop taking Vokanamet and speak with a doctor or go to the nearest hospitalimmediately, as lactic acidosis can lead to coma.

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 smell of your urine or sweat.

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

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

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

Possible symptoms of dehydration are:

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 you take 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, e.g.:
• • Fever and/or chills
  • Burning sensation when passing urine
  • Back or side pain.

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

Other side effects of treatment with canagliflozin alone:

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

• Vaginal yeast infection.

Common (may affect up to 1 in 10 people)

• Skin rash or redness of the penis or foreskin (fungal infection)
• Changes in urine (including more frequent urination or increased urine production, urgent need to urinate, need to urinate at night)
• Constipation
• Feeling thirsty
• Feeling sick (nausea)
• blood tests may indicate alterations in lipid levels (cholesterol) and an increase in red blood cell count in your blood (hematocrit).

Infrequent (may affect up to 1 in 100 people)

• Skin rash or redness of the skin - this may cause itching and include raised bumps, rash with exudation or blisters
• hives
• blood tests may show alterations related to kidney function (increased creatinine or urea) or increased potassium
• blood tests may show increased levels of phosphate in your blood
• bone fracture
• kidney failure (mainly as a result of significant loss of fluids from your body)
• amputations in lower limbs (mainly toes of the feet) especially if you have a high risk of heart disease
• phimosis – difficulty retracting the foreskin from the end of the penis.
• skin reactions after exposure to sunlight.

Unknown frequency (cannot be estimated from available data)

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

Side effects during treatment with metformin alone that were not described for canagliflozin:

• Very common: feeling sick (nausea), vomiting, diarrhea, abdominal pain, loss of appetite
• common: metallic taste (alteration of taste),decrease in levels of?vitamin B12(may cause anemia – low red blood cell count)

• Very rare: alteration of liver function tests, hepatitis (liver problem) and itching.

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 directlythrough the national 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 bottle and the box after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30° C.

Do not use Vokanamet if you observe visible signs of deterioration or manipulation.

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

Composition of Vokanamet

• The active ingredients are canagliflozina and metformin hydrochloride.

• • Each 50 mg/850 mg tablet contains canagliflozina hemihydrate, equivalent to 50 mg of canagliflozina and 850 mg of metformin hydrochloride.
  • Each 50 mg/1.000 mg tablet contains canagliflozina hemihydrate, equivalent to 50 mg of canagliflozina and 1.000 mg of metformin hydrochloride.
  • Each 150 mg/850 mg tablet contains canagliflozina hemihydrate, equivalent to 150 mg of canagliflozina and 850 mg of metformin hydrochloride.
  • Each 150 mg/1.000 mg tablet contains canagliflozina hemihydrate, equivalent to 150 mg of canagliflozina and 1.000 mg of metformin hydrochloride.
• The other components are:
• • Tablet core: microcrystalline cellulose, hypromellose, croscarmellose sodium, and magnesium stearate.
  • Cover:
  • • 50 mg/850 mg tablets: macrogol 3350, polyvinyl alcohol, talc, titanium dioxide (E171), iron oxide red (E172), and iron oxide black (E172).

Appearance of Vokanamet and packaging contents

• Vokanamet 50 mg/850 mg film-coated tablets are pink, capsule-shaped, 20 mm in length, with "CM" engraved on one side and "358" on the other side.
• Vokanamet 50 mg/1.000 mg film-coated tablets are beige, capsule-shaped, 21 mm in length, with "CM" engraved on one side and "551" on the other side.
• Vokanamet 150 mg/850 mg film-coated tablets are pale yellow, capsule-shaped, 21 mm in length, with "CM" engraved on one side and "418" on the other side.
• Vokanamet 150 mg/1.000 mg film-coated tablets are purple, capsule-shaped, 22 mm in length, with "CM" engraved on one side and "611" on the other side.

Vokanamet is available in HDPE bottles with child-resistant closures. The packaging sizes are boxes of 20 and 60 tablets, and multi-pack containers of 180 tablets (3 bottles containing 60 tablets each).

Only some packaging 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 revision date of this leaflet: June 2023.

Other sources of information

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