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 Komboglyze. If you are concerned about side effects, discuss the risks and benefits of Komboglyze with your doctor.

The following side effects have been reported by at least 1% of people taking Komboglyze. 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
• gas
• headache
• heartburn
• indigestion
• loss of appetite
• metallic taste in mouth
• nausea

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.

• rash
• signs of infection (symptoms may include Fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• stomach pain
• 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 low blood sugar (e.g., shaking, sweating, fast heartbeat, vision changes, hunger, headache, mood swings, slurred speech)

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

• 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 Komboglyze.

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 saxagliptin 2.5 mg and metformin 500 mg. Nonmedcinal ingredients: magnesium stearate and povidone. In addition, the film coating contains the following inactive ingredients: 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 saxagliptin 2.5 mg and metformin 850 mg. Nonmedicinal ingredients: magnesium stearate and povidone. In addition, the film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc, and yellow iron oxide.

2.5 mg/1000 mg
Each pale yellow to light yellow, biconvex, oval shaped, film-coated tablet with "2.5/1000" printed on one side and "4247" printed on the reverse side in blue ink contains saxagliptin 2.5 mg and metformin 1000 mg. Nonmedicinal ingredients: magnesium stearate and povidone. In addition, the film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc, or a combination of red and yellow iron oxides.

Do not take saxagliptin-metformin if you:

• are allergic to saxagliptin, metformin or any ingredients of Komboglyze
• have Type 1 Diabetes, pre-coma or 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 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 reduced kidney function
• have liver disease
• have type 1 diabetes (people with type 1 diabetes should always be using insulin)

There may be an interaction between saxagliptin-metformin and any of the following:

If you are taking any of these 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.

Medications other than those listed above may interact with Komboglyze. 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.

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 Komboglyze.

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.

Blood sugar control: 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 Komboglyze 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): The safety of taking saxagliptin when you have congestive heart failure (CHF) has not been studied. 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 Komboglyze may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Komboglyze, 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.

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 Komboglyze may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Komboglyze, and whether any special monitoring is needed.

Kidney function: Kidney Disease or reduced kidney function may cause Komboglyze to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Komboglyze may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Komboglyze, 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 Komboglyze. 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 Komboglyze and get immediate medical attention.

Liver function:  Liver disease or reduced liver function may cause Komboglyze to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Komboglyze may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Komboglyze, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Komboglyze.

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 Komboglyze may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Komboglyze, 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.

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

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

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

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