Active ingredient
- metformin hydrochloride
- canagliflozin hemihydrate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/14/918/001, EU/1/14/918/002, EU/1/14/918/003.
Vokanamet 50 mg/850 mg and 50 mg/1000 mg film-coated tablets
Package leaflet: Information for the patient
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
canagliflozin/metformin hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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 and can help prevent heart disease 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
Warnings and precautions
Risk of lactic acidosis
Vokanamet may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).
If any of the above applies to you, talk to your doctor for further instructions.
Temporarily stop taking Vokanamet if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions.
Stop taking Vokanamet and talk to a doctor or go to the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Symptoms of lactic acidosis include:
Lactic acidosis is a medical emergency and must be treated in a hospital.
Talk to your doctor, pharmacist or nurse before taking Vokanamet, and during treatment:
Kidney function
Your kidneys will be tested by a blood test before you start taking 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 you have worsening kidney function.
Surgery
If you need to have major surgery you must stop taking Vokanamet during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Vokanamet.
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.
Urine glucose
Because of the way canagliflozin works, your urine will test positive for sugar (glucose) while you are taking this medicine.
Children and adolescents
Vokanamet is not recommended for children and adolescents under 18 years, because data are not available in these patients.
Other medicines and Vokanamet
If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Vokanamet before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treament with 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. 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:
Vokanamet with alcohol
Avoid excessive alcohol intake while taking this medicine since this may increase the risk of lactic acidosis. See section “Warning and precautions”.
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.
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.
Vokanamet contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.
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
Taking this 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
As Vokanamet contains metformin, if you take more of this medicine, you may experience lactic acidosis. If this happens to you, you may need immediate hospital treatment, as lactic acidosis may lead to coma. Symptoms of lactic acidosis include vomiting, stomach ache, muscle cramps, a general feeling of not being well with severe tiredness, or difficulty breathing. Further symptoms are reduced body temperature and heartbeat. Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away (see section 2). Take the medicine pack with you.
If you forget to take Vokanamet
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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Vokanamet and talk to a doctor or go to the nearest hospital immediately if you have any of the following serious side effects:
Severe allergic reaction (rare, may affect up to 1 in 1,000 people)
Possible signs of severe allergic reaction may include:
Lactic acidosis (very rare, may affect up to 1 in 10,000 people)
Vokanamet may cause a very rare but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens, you must stop taking Vokanamet and talk to a doctor or go to the nearest hospital immediately, as lactic acidosis may lead to coma.
Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people)
These are the signs of diabetic ketoacidosis (see also section 2):
This may occur regardless of blood glucose level. The doctor may decide to temporarily or permanently stop the treatment with Vokanamet.
Dehydration (uncommon, may affect up to 1 in 100 people)
Tell your doctor as soon as possible if you have any of the following side effects:
Hypoglycaemia (very common, may affect more than 1 in 10 people)
Your doctor will tell you how to treat low blood sugar levels and what to do if you have any of the signs above.
Urinary tract infections (common, may affect up to 1 in 10 people)
Although uncommon, if you see blood in your urine, tell your doctor immediately.
Other side effects when taking canagliflozin alone:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Not known (frequency cannot be estimated from the available data)
Side effects when taking metformin alone that were not described for canagliflozin:
Reporting of side effects
If you get 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 which is stated on the bottle and 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 the packaging is damaged or shows signs of tampering.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Vokanamet contains
What Vokanamet looks like and contents of the pack
Vokanamet is available in HDPE bottles with child-resistant closure. The pack sizes are cartons of 20 and 60 tablets, and multipack cartons of 180 tablets (3 bottles containing 60 tablets each).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was approved in June 2020.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
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