If you are experiencing a medical emergency please dial 911 immediately
Pronunciation: LIN a GLIP tin and met FOR min
Do not use this medication if you are allergic to linagliptin (Onglyza) or metformin (Actoplus Met, Avandamet, Fortamet, Glucophage, Riomet), if you have kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).
Before you take linagliptin and metformin, tell your doctor if you have liver disease, a serious infection, heart disease, a history of pancreatitis, if you have recently had a heart attack, 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 linagliptin and metformin.
Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. 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, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.
Linagliptin and metformin 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. Linagliptin works by regulating the levels of insulin your body produces after eating.
The combination of linagliptin and metformin is used to treat type 2 diabetes. This medication is not for treating type 1 diabetes.
Linagliptin and metformin may also be used for purposes not listed in this medication guide.
Do not use this medication if you are allergic to metformin (Actoplus Met, Avandamet, Fortamet, Glucophage, Riomet) or linagliptin (Onglyza), if you have kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).
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 linagliptin and metformin. Be sure your caregivers know ahead of time that you are using this medication.
To make sure you can safely take linagliptin and metformin, tell your doctor if you have any of these other conditions:
Some people develop a life-threatening condition called lactic acidosis while taking metformin. You may be more likely to develop lactic acidosis if you have liver or kidney disease, congestive heart failure, a severe infection, if you are dehydrated, or if you drink large amounts of alcohol. Talk with your doctor about your individual risk.
FDA pregnancy category B. Linagliptin and metformin is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
It is not known whether linagliptin and metformin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using this medication.
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.
Take linagliptin and metformin twice daily with meals, unless your doctor tells you otherwise.
Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremor, irritability, or trouble concentrating.
Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.
Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.
Ask your doctor how to adjust your linagliptin and metformin dose if needed. Do not change your medication dose or schedule without your doctor's advice.
Your doctor may have you take extra vitamin B12 while you are taking metformin. Take only the amount of vitamin B12 that your doctor has prescribed.
Linagliptin and metformin is only part of a complete program of treatment that may also include diet, exercise, weight control, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.
Store at room temperature away from moisture and heat.
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.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have signs of low blood sugar, such as extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).
An overdose of metformin may cause lactic acidosis. Get emergency medical help if you have: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.
Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:
Stop using this medicine and call your doctor at once if you have a serious side effect such as:
Less serious side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your doctor about all other medicines you use, especially:
You may be more likely to have hyperglycemia (high blood sugar) if you take linagliptin and metformin with other drugs that can raise blood sugar, such as:
These lists are not complete and there are many other medicines that can increase or decrease the effects of linagliptin and metformin on lowering your blood sugar. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Your pharmacist can provide more information about linagliptin and metformin.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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