This combination product contains 2 medications: saxagliptin and metformin. Together they work to control blood glucose levels. Metformin belongs to the class of medications called oral hypoglycemics, which are medications that lower blood sugar. Saxagliptin belongs to the group of medications called DPP-4 inhibitors. It works by increasing the amount of incretin released by the intestine. Incretin is a hormone that raises insulin levels when blood sugar is high and decreases the amount of sugar made by the body. These medications are used to control blood glucose (blood sugar) for people with type 2 diabetes when diet, exercise, and weight reduction have not been found to lower blood glucose well enough on their own. This medication should be used as part of an overall diabetes management plan that includes a diet and exercise program.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended daily dose of saxagliptin-metformin is based on the dose needed to effectively control blood glucose levels and how side effects are tolerated. The usual starting dose for adults who have not been taking saxagliptin is the dose of the metformin you are taking plus 2.5 mg of saxagliptin taken twice daily. If you are switching from taking saxagliptin and metformin separately, you may be prescribed the saxagliptin-metformin equal to that which you are currently taking. The maximum daily dose is 5 mg of saxagliptin and 2,000 mg of metformin.

This medication should be taken twice daily with meals, to reduce the stomach side effects that metformin can cause.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that this medication be taken exactly as prescribed by your doctor.

If you miss a dose, take it as soon as possible with food and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

2.5 mg/500 mg
Each pink, biconvex, round, film-coated tablet with "2.5/500" printed on one side and "4245" printed on the reverse side in blue ink contains 2.5 mg of saxagliptin and 500 mg of metformin. Nonmedicinal ingredients: magnesium stearate, povidone, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc, and red iron oxide.

2.5 mg/850 mg
Each light-brown-to-brown, biconvex, round, film-coated tablet with "2.5/850" printed on one side and "4246" printed on the reverse side in blue ink contains 2.5 mg of saxagliptin and 850 mg of metformin. Nonmedicinal ingredients: magnesium stearate, povidone, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc, and a combination of red and yellow iron oxide.

2.5 mg/1000 mg
Each pale-yellow-to-light-yellow, biconvex, oval, film-coated tablet with "2.5/1000" printed on one side and "4247" printed on the reverse side in blue ink contains 2.5 mg of saxagliptin and 1,000 mg of metformin. Nonmedicinal ingredients: magnesium stearate, povidone, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc, and yellow iron oxide.

Do not take saxagliptin-metformin if you:

• are allergic to saxagliptin or another DPP-4 inhibitor, metformin or any ingredients of this medication
• are experiencing pre-coma, coma, or diabetic ketoacidosis (these conditions should be treated with insulin)
• are experiencing or recovering from severe infections, trauma, or surgery
• are pregnant or breast-feeding
• are suffering severe dehydration (have lost a lot of water from your body)
• are suffering from shock
• are undergoing radiologic studies involving use of iodinated contrast materials
• drink large amounts of alcohol in the short term or on a regular basis
• have a history of lactic acidosis or acute/chronic metabolic acidosis (too much acid in the blood)
• have diseases associated with lack of oxygen to the tissues such as cardio-respiratory insufficiency
• have severely reduced kidney function, are receiving dialysis, or have end-stage renal disease
• have liver disease
• have type 1 diabetes (people with type 1 diabetes should always be using insulin)
• have type 2 diabetes with severe, frequent changes in blood glucose

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal bloating
• diarrhea
• fatigue
• gas
• headache
• heartburn
• indigestion
• loss of appetite
• metallic taste in mouth
• nausea
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• rash
• severe joint pain
• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of heart problems (e.g., fast, irregular heartbeat or pulse, chest pain, sudden weight gain, difficulty breathing, leg swelling)
• signs of muscle damage (e.g., unexplained muscle pain, tenderness or weakness, or brown or discoloured urine)
• symptoms of a urinary tract infection (e.g., cloudy-looking or foul-smelling urine, frequent urge to urinate, pain or burning when urinating)
• symptoms of an upper respiratory tract infection (e.g., cough, fever, headache, runny nose, sore throat)
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• symptoms of underactive thyroid (e.g., weight gain, tiredness, hair loss, muscle weakness, feeling cold, dry skin, constipation, puffy face, change in menstrual periods, enlarged thyroid gland)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• symptoms of low blood sugar (e.g., shaking, sweating, fast heartbeat, vision changes, hunger, headache, mood swings, slurred speech)
• symptoms of peripheral neuropathy (nerve damage; e.g., gradual onset of numbness, prickling or tingling in feet or hands, decreased coordination, muscle weakness)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of altered thinking (e.g., muscle weakness in one area, poor decision-making, poor concentration, twitching, difficulty speaking or swallowing)
• signs of lactic acidosis (e.g., nausea, vomiting, increased breathing rate, abdominal pain, unusual muscle pain, unusual tiredness, dizziness, rapid heart rate)
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Alcohol intake: Alcohol may increase the risk of developing lactic acidosis for people who take metformin. Avoid drinking large amounts of alcohol if you are taking this medication.

Anemia: Metformin can cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Blood sugar control: If you are taking other medications to treat diabetes, you may be more likely to experience decreased blood sugar levels. Symptoms of low blood sugar include shaking, sweating, hunger, headache and vision and mood changes. Talk to your doctor about how to treat temporary episodes of low blood sugar.

If you develop or have fever, trauma, infection, or surgery, a temporary loss of blood sugar control may occur. If this happens, your doctor may think it is necessary to stop this medication and temporarily inject insulin. This medication may be started again after the problem is resolved. Talk to your doctor if you have fever, infection, or are about to undergo surgery.

Blood sugar monitoring: Monitor your blood sugar regularly at intervals as discussed with your doctor or diabetes educator.

Congestive heart failure (CHF): Heart failure has been reported in people taking saxagliptin. When metformin is used by people with CHF, there is an increased risk of developing lactic acidosis. If you have CHF, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Diet: Saxagliptin-metformin is a treatment to be taken in combination with a proper diet. It is not a substitute for proper diet.

Drowsiness/reduced alertness: Low blood sugar can affect awareness, judgement and physical abilities needed to perform complex activities, such as driving or operating machinery. Because saxagliptin - metformin may cause low blood sugar, avoid these activities until you know how this medication affects you.

Immune system: If you have a weakened immune system (e.g., you have had an organ transplant or have HIV), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Lactic acidosis: Lactic acidosis is a rare but serious problem that occurs when metformin builds up in the body (i.e., the body doesn't get rid of it fast enough) during treatment. If you have severe kidney disease you are at higher risk of developing lactic acidosis. Since alcohol may increase the risk of lactic acidosis, do not drink a lot of alcohol over the short- or long-term while taking this medication. When it does occur (very rarely), it is fatal in 50% of cases. If you experience symptoms of lactic acidosis (e.g., weakness, tiredness, drowsiness, unusual muscle pain, trouble breathing, stomach pain with nausea, vomiting or diarrhea, feeling cold, dizziness, light-headedness, or slow or irregular heartbeat), stop taking this medication and get immediate medical attention.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. People with decreased liver function who take metformin may be at an increased risk of developing lactic acidosis. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Pancreatitis: Saxagliptin-metformin can cause the pancreas to become inflamed. People with a history of pancreatitis, gallstones, alcoholism, or high triglycerides, may be more at risk of experiencing this. If you have a history of pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

Thyroid function: This medication may decrease thyroid hormone levels. Your doctor will monitor your thyroid levels with blood tests while you are taking this medication.

Vitamin B12 levels: Metformin may decrease vitamin B12 levels. Your doctor will monitor your B12 levels with blood tests while you are taking this medication.

Pregnancy: This medication should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if saxagliptin or metformin pass into breast milk. If you are breast-feeding and taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: Seniors are more likely to have reduced kidney function and as a result may experience more side effects from this medication.

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.