(Canagliflozin Hemihydrate/Metformin Hydrochloride)
Brand Name Choices
No generic medication is available for Invokamet (Canagliflozin Hemihydrate/Metformin Hydrochloride)
What Invokamet 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.
How to take Invokamet
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. 5 Taking this medicine
• Swallow the tablet whole with 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 or go to the nearest hospital immediately. 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.
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:
• swelling of the face, lips, mouth, tongue, or throat that 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 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):
•increased levels of “ketone bodies” in your urine or blood
•rapid weight loss
•feeling sick or being sick
•stomach pain 6
•fast and deep breathing
•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. 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)
• 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. 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)
• 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 are:
•trembling, sweating, looking pale
•a change in mood or feeling anxious or confused. Your doctor will tell you how to treat low blood sugar levels and what to do if you have any of the signs above.
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)
• urinary tract infections
• changes in urination (including urinating more frequently or in larger amounts, urgent need to urinate, need to urinate at night)
• feeling thirsty
• feeling sick (nausea)
• blood tests may show changes in blood fat (cholesterol) levels and increases in the amount of red blood cells in your blood (haematocrit).
Uncommon (may affect up to 1 in 100 people)
• rash or red skin
•this may be itchy and include raised bumps, oozing fluid or blisters.
• blood tests may show changes related to kidney function (increased creatinine or urea) or increased potassium
• blood tests may show increases in your blood phosphate level
• bone fracture 7
• kidney failure (mainly as a consequence of loss of too much fluid from your body).
• lower limb amputations (mainly of the toe) especially if you are at high risk of heart disease.
• phimosis – difficulty pulling back the foreskin around the tip of the penis. Side effects when taking metformin alone that were not described for canagliflozin:
• very common: feeling sick (nausea), being sick (vomiting), diarrhoea, stomach ache, and loss of appetite
• common: a metallic taste (taste disturbance)
• very rare: decreased vitamin B12 levels (may cause anaemia – low count of red blood cells), liver function test disorders, hepatitis (a problem with your liver), and itching.
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. In the UK: You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. In Ireland, you can also report side effects directly via: HPRA Pharmacovigilance Earlsfort Terrace IRL – Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected] In Malta, report side effects to: ADR reporting Website: www.medicinesauthority.gov.mt/adrportal By reporting side effects, you can help provide more information on the safety of this medicine.
How to Store Invokamet
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.
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