Kombiglyze® XR

What is metformin and saxagliptin?

Metformin and saxagliptin are oral diabetes medicines that help control blood sugar levels. Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Saxagliptin works by regulating the levels of insulin your body produces after eating.

Metformin and saxagliptin is a combination medicine that is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. This medicine is not for treating type 1 diabetes.

Metformin and saxagliptin may also be used for purposes not listed in this medication guide.

Important Information

You should not use this medicine if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment with insulin).

Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. Stop taking this medicine and get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, trouble breathing, stomach pain, nausea, and feeling very weak or tired.

Before taking this medicine

You should not use this medicine if you are allergic to metformin or saxagliptin (Onglyza), or if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment with insulin).

Some people taking metformin develop a serious condition called lactic acidosis. This may be more likely if you have liver or kidney disease, congestive heart failure, a heart attack or stroke, a severe infection, if you are 65 or older, if you are dehydrated, or if you drink a lot of alcohol. Talk with your doctor about your risk.

To make sure metformin and saxagliptin is safe for you, tell your doctor if you have:

• kidney disease (your kidney function may need to be checked before you take this medicine);

• liver disease;

• heart disease;

• pancreatitis;

• high triglycerides (a type of fat in the blood);

• gallstones;

• a history of alcoholism; or

• if you are over 80 years old and have not recently had your kidney function checked.

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking metformin and saxagliptin. Be sure your caregivers know ahead of time that you are using this medication.

This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether this medicine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

This medicine is not approved for use by anyone younger than 18 years old.

How should I take metformin and saxagliptin?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take metformin and saxagliptin with a meal.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Your doctor may want you to stop taking this medicine for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

This medicine is only part of a complete program of treatment that may also include diet, exercise, weight control, blood tests, foot care, and eye care. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take the medicine with food). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What should I avoid while taking metformin and saxagliptin?

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

Metformin and saxagliptin side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medicine and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, or fast heartbeats.

Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. Stop taking this medicine and get emergency medical help if you have even mild symptoms such as:

• muscle pain or weakness;

• numb or cold feeling in your arms and legs;

• trouble breathing;

• feeling dizzy, light-headed, tired, or very weak;

• stomach pain, nausea with vomiting; or

• slow or uneven heart rate.

Call your doctor at once if you have:

• a severe autoimmune reaction--itching, blisters, breakdown of the outer layer of skin;

• severe or ongoing pain in your joints;

• pain or burning when you urinate; or

• heart problems--shortness of breath (even while lying down), feeling weak or tired, rapid weight gain, swelling (especially in your feet, legs, or midsection).

Common side effects may include:

• diarrhea, mild nausea;

• headache; or

• cold symptoms such as runny or stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect metformin and saxagliptin?

Many drugs can interact with metformin and saxagliptin. Some drugs can affect how well metformin and saxagliptin controls your blood sugar. Other drugs may increase your risk of lactic acidosis.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• an antibiotic or antifungal medicine;

• insulin or oral diabetes medicine; or

• medicine to treat HIV or AIDS.

This list is not complete. Other drugs may interact with metformin and saxagliptin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.