«Package leaflet: Information for the patient Vokanamet 50 mg/850 mg film-coated tablets Vokanamet 50 mg/1000 mg film-coated tablets Vokanamet 150 ...»
Package leaflet: Information for the patient
Vokanamet 50 mg/850 mg film-coated tablets
Vokanamet 50 mg/1000 mg film-coated tablets
Vokanamet 150 mg/850 mg film-coated tablets
Vokanamet 150 mg/1000 mg film-coated tablets
This medicine is subject to additional monitoring. This will allow quick identification of new
safety information. You can help by reporting any side effects you may get. See the end of section 4
for how to report side effects.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Vokanamet is and what it is used for
2. What you need to know before you take 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 different active substances, canagliflozin and metformin. These are two medicines that work together in different ways to lower blood glucose (sugar) levels in adults with type 2 diabetes.
This medicine can be used by itself or along with other medicines you may be using to treat your type 2 diabetes (such as insulin, a DPP-4 inhibitor [such as sitagliptin, saxagliptin, or linagliptin], a sulphonylurea [such as glimepiride or glipizide], or pioglitazone) that lower blood sugar levels. You may already be taking one or more of these to treat your type 2 diabetes. Vokanamet is used when your blood sugar cannot be adequately controlled by metformin alone or together with other diabetes medicines. If you are already taking both canagliflozin and metformin as single tablets, Vokanamet can replace them in one tablet.
It is important to keep following advice about diet and exercise given by your doctor or nurse.
What is type 2 diabetes?
Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar.
When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical conditions such as heart disease, kidney disease, blindness, and amputation.
2. What you need to know before you take Vokanamet 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 kidney or liver problems
• if you have a severe infection
• if you have lost a lot of water from your body (dehydration), e.g. due to long-lasting or severe diarrhoea, or if you have vomited several times in a row
• if you have a diabetic pre-coma
• if you have diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, feeling sick [nausea], or being sick [vomiting])
• if you have recently had a heart attack or have severe blood circulation problems, such as ‘shock’ or breathing difficulties
• if you drink alcohol to excess (either every day or from time to time)
• if you have or have recently had heart failure.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment:
• about what you can do to prevent dehydration
• if you have type 1 diabetes (your body does not produce any insulin). Vokanamet should not be used to treat this condition.
• if you experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat, contact a doctor or the nearest hospital straight away. These symptoms could be a sign of “diabetic ketoacidosis” – a problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests. The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness.
• if you have ever had serious heart disease or if you have had a stroke
• if you are on medicines to lower your blood pressure (anti-hypertensives) or have ever had low blood pressure (hypotension). More information is given below in "Other medicines and Vokanamet".
Kidney function Your kidneys will be tested by a blood test before you start taking and while you are taking this medicine.
Look out for side effects Lactic acidosis is a medical emergency and must be treated in a hospital. If you experience some of the signs of lactic acidosis which include feeling sick (nausea) or being sick (vomiting), stomach ache, severe weakness, muscle cramps, unexplained weight loss, rapid breathing, or feeling cold or uncomfortable, stop taking Vokanamet immediately and contact a doctor or go to the nearest hospital straight away. See section 4.
Operations and X-rays
Tell your doctor you are taking Vokanamet if you are going to have:
• an operation under general, spinal, or peridural anaesthetic. You may need to stop taking Vokanamet for a couple of days before and after the operation.
• an X-ray where you will be injected with a dye. You will need to stop taking Vokanamet before, or at the time of the X-ray and for 2 or more days after. Before taking Vokanamet again, your kidney function should be tested.
Your doctor will decide whether you need any other treatment to control your blood sugar while you have stopped taking Vokanamet. It is important that you follow your doctor’s instructions carefully.
Children and adolescents Vokanamet is not recommended for children and adolescents under 18 years.
Other medicines and Vokanamet Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because this medicine can affect the way some other medicines work. Also, some other medicines can affect the way this medicine works.
In particular, tell your doctor if you are taking any of the following medicines:
• insulin or a sulphonylurea (such as glimepiride or glipizide) for diabetes – your doctor may want to reduce your dose in order to avoid your blood sugar level from getting too low (hypoglycaemia)
• medicines used to lower your blood pressure (anti-hypertensives), including diuretics (medicines used to remove levels of excess water in the body, also known as water tablets) since this medicine can also lower your blood pressure by removing levels of excess water in the body. Possible signs of losing too much fluid from your body are listed under “Dehydration” in section 4.
• St. John's wort (a herbal medicine used to treat depression)
• carbamazepine, phenytoin, or phenobarbital (medicines used to control seizures)
• efavirenz or ritonavir (medicines used to treat HIV infection)
• rifampicin (an antibiotic used to treat tuberculosis)
• cholestyramine (medicine used to reduce cholesterol levels in the blood). See section 3, “Taking this medicine”.
• digoxin or digitoxin (medicines used for certain heart problems). The level of digoxin or digitoxin in your blood may need to be checked if taken with Vokanamet.
• dabigatran (blood thinner medicine that lowers the risk of blood clot formation)
• medicines that contain alcohol. See section “Vokanamet with alcohol”.
• iodinated contrast agents (medicines used during an X-ray). See section “Operations and X-rays”.
• cimetidine (medicine used to treat stomach problems) corticosteroids (used to treat a variety of conditions, such as severe inﬂammation of the skin or • in asthma) that are given by mouth, as an injection, or inhaled
• beta-2 agonists (such as salbutamol or terbutaline) used to treat asthma.
Vokanamet with alcohol Avoid consumption of large amounts of alcohol, or medicines containing alcohol, when taking this medicine. This is because you are at an increased risk of getting a build-up of lactic acid in your blood (lactic acidosis) if you have too much alcohol. This is more likely if you are already fasting, have malnutrition, or liver problems. See section “Look out for side effects” and section 4.
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 or continuing to take this medicine.
Canagliflozin, one of the ingredients in Vokanamet, should not be used during pregnancy. Talk to your doctor about the best way to control your blood sugar without Vokanamet as soon as you know that you are pregnant.
You should not take this medicine if you are breast-feeding. Talk to your doctor about whether to stop taking this medicine or to stop breast-feeding.
3 Driving and using machines Vokanamet has no or negligible influence on the ability to drive, cycle, and use tools or machines.
However, dizziness or lightheadedness has been reported, which may affect your ability to drive, cycle, or use tools or machines.
Taking Vokanamet with other medicines for diabetes called sulphonylureas (such as glimepiride or glipizide) or insulin can increase the risk of having low blood sugar (hypoglycaemia). Signs include blurred vision, tingling lips, trembling, sweating, pale looking, a change in mood, or feeling anxious or confused. This may affect your ability to drive, cycle, and use any tools or machines. Tell your doctor as soon as possible if you get any signs of low blood sugar.
3. How to take Vokanamet Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
• The dose of Vokanamet is one tablet twice a day.
• The strength of Vokanamet that you will take varies depending on your condition and the amount of canagliflozin and metformin needed to control your blood sugar.
• Your doctor will prescribe the strength that is right for you.
Taking this medicine
• Swallow the tablet whole with at least a half glass of water.
• It is best to take your tablet with a meal. This will lower your chance of having an upset stomach.
• Try to take it at the same times each day. This will help you remember to take it.
• If your doctor has prescribed this medicine along with any medicine for lowering cholesterol such as cholestyramine you should take this medicine at least 1 hour before or 4 hours to 6 hours after the cholesterol-lowering medicine.
Your doctor may prescribe Vokanamet together with another glucose-lowering medicine. Remember to take all medicines as directed by your doctor to achieve the best results for your health.
Diet and exercise To help control your diabetes, you still need to follow the advice about diet and exercise from your doctor, pharmacist or nurse. In particular, if you are following a diabetic weight control diet, continue to follow it while you are taking this medicine.
If you take more Vokanamet than you should If you take more of this medicine than you should, talk to a doctor straight away.
If you forget to take Vokanamet
• If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.
If you stop taking Vokanamet Your blood sugar levels may rise 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 medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Vokanamet immediately and contact a doctor or go to the nearest hospital straight
away if you have any of the following serious side effects:
Lactic acidosis (very rare, may affect up to 1 in 10,000 people)
• too much lactic acid in your blood (lactic acidosis). This happens more often in people with kidney problems. Lactic acidosis may also be caused by excessive alcohol intake or prolonged fasting.
Possible signs of lactic acidosis are:
- feeling sick (nausea) or being sick (vomiting)
- stomach ache
- severe weakness
- muscle cramps
- unexplained weight loss
- rapid breathing
- feeling cold or uncomfortable.
Stop taking Vokanamet and contact a doctor as soon as possible if you have any of the following
serious side effects:
Dehydration (uncommon, may affect up to 1 in 100 people)
• loss of too much fluid from your body (dehydration). This happens more often in elderly people (aged 75 and over), people with kidney problems, and people taking water tablets (diuretics).
Possible signs of dehydration are:
- feeling light-headed or dizzy
- passing out (fainting) or feeling dizzy or faint when you stand up
- very dry or sticky mouth, feeling very thirsty
- feeling very weak or tired
- passing little or no urine
- fast heartbeat.
Contact a doctor or the nearest hospital straight away if you have any of the following side
Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people)