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Here is important safety and warning information regarding the use of Invokamet (canagliflozin/metformin). Please review these points carefully and consult your healthcare provider with any questions or concerns.

• Lactic Acidosis: Metformin, an ingredient in Invokamet, can rarely cause lactic acidosis, a potentially fatal condition characterized by an excessive buildup of lactic acid in the blood. The risk is heightened in individuals over 65, those with kidney or liver issues, heart problems, dehydration, or a history of alcohol use. It can also occur after surgery or imaging procedures involving contrast dye. Certain medications, such as topiramate, zonisamide, and acetazolamide, may increase this risk. Discontinue the medication and seek immediate medical attention if you experience symptoms like unusual fatigue, dizziness, severe drowsiness, chills, cold skin, muscle pain, rapid or difficult breathing, irregular heartbeat, or gastrointestinal distress.

• Risk of Amputation: Invokamet may slightly increase the risk of leg or foot amputations, particularly in individuals with a history of such procedures, cardiovascular issues, or diabetic foot ulcers. If you notice new pain, sores, ulcers, or infections on your legs or feet, contact your healthcare provider promptly for assessment and management.

• Ketoacidosis: This medication may lead to ketoacidosis, a serious condition where excessive ketones make the blood acidic, posing life-threatening risks. This risk is higher in those with Type 2 diabetes, high doses of canagliflozin, recent surgery, or reduced calorie intake. Monitor for symptoms such as dry mouth, fruity breath, fatigue, nausea, abdominal pain, or breathing difficulties, and seek urgent medical care if they occur.

• Dehydration and Low Blood Pressure: Invokamet can cause dehydration, potentially leading to low blood pressure or kidney damage. This is more likely in individuals over 65, those with kidney issues, on a low-sodium diet, or taking diuretics. Stay hydrated and report symptoms like dizziness or reduced urination to your provider.

• Genital and Urinary Infections: There is an increased risk of genital and urinary tract infections, which can occasionally be severe. Symptoms to watch for include painful urination, frequent urination, lower abdominal pain, or any unusual genital odors or discomfort.

• Hypoglycemia: When used with other diabetes medications, such as insulin or sulfonylureas, Invokamet can increase the risk of low blood sugar. Symptoms include nervousness, shakiness, drowsiness, confusion, rapid heartbeat, sweating, and intense hunger. Be aware of these signs, monitor your blood sugar, and know when to seek emergency help.

• Allergic Reactions: Rarely, severe allergic reactions may occur. Symptoms may include rash, hives, difficulty breathing, or swelling of the face, lips, tongue, or throat, requiring immediate medical attention.

• Bone Fractures: There is a potential increase in the risk of bone fractures, which can occur as early as three months after starting treatment. Discuss bone health strategies with your provider.

• Low Vitamin B12 Levels: Long-term use of metformin can lead to reduced vitamin B12 levels, causing anemia. Report persistent fatigue, muscle weakness, appetite loss, or sensory changes to your provider for evaluation.

Contraindications: Invokamet should not be used by individuals with severe kidney problems, those undergoing dialysis, people with ketoacidosis, or those allergic to canagliflozin or metformin. Always consult your healthcare provider to determine if this medication is safe for you.

When taking this medication, you may experience some common side effects, which are usually mild and manageable. These include nausea, vomiting, stomach upset, diarrhea, bloating, gas, frequent urination, unusual dry mouth, weakness, and constipation. Vaginal yeast infections in females and male genital yeast infections may also occur, along with urinary tract infections (UTIs). If these symptoms persist or worsen, consult your healthcare provider.

More serious side effects require immediate attention. These include symptoms of a urinary tract infection such as burning or painful urination, signs of kidney problems like changes in urine output, and signs of high blood sugar, such as increased thirst and urination. Dehydration can occur, leading to serious kidney damage, so it is important to stay hydrated, especially if experiencing vomiting, diarrhea, or heavy sweating.

In rare cases, the medication may cause high levels of potassium in the blood, leading to muscle weakness or irregular heartbeat, as well as potentially causing bone loss or fractures. There is also a risk of severe infections such as Fournier's gangrene, which requires urgent care if symptoms like pain, redness, or swelling in the genital or anal area occur.

Canagliflozin might increase the risk of lower limb loss, especially in individuals with a history of heart disease or circulation issues. Watch for any unusual pain, tenderness, or sores on your legs and feet. In addition, this medication may lead to lactic acidosis, indicated by symptoms such as dizziness, unusual muscle pain, or irregular heartbeat. Lastly, a severe allergic reaction, though rare, can manifest as rash, swelling, or difficulty breathing, and demands immediate medical attention. Always discuss with your healthcare provider for personalized advice and any concerns about the side effects you experience.