Linagliptin-metFORMIN

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. 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:

• severe or ongoing pain in your joints;
• swelling, rapid weight gain; or
• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• cough, sore throat
• sinus pain, stuffy nose;
• upset stomach, diarrhea; or
• weight gain.

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.

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

Other drugs may increase or decrease the effects of linagliptin and metformin on lowering your blood sugar. Tell your doctor about all your current medicines and any you start or stop using, especially:

• rifampin (to treat tuberculosis); or
• insulin or other oral diabetes medicine.

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

Linagliptin & Metformin is part of the drug class:

• Combinations of oral blood glucose lowering drugs

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other medicines that can lower your blood sugar
• rifampin (Rifadin, Rimactane, Rifater, Rifamate), an antibiotic that is used to treat tuberculosis

This is not a complete list of linagliptin/metformin drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects can happen in people taking linagliptin/metformin, including:

1. Lactic Acidosis. Metformin, one of the medicines in linagliptin/metformin, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.

Stop taking linagliptin/metformin and call your doctor right away if you get any of the following symptoms of lactic acidosis:

• feel very weak or tired
• have unusual (not normal) muscle pain
• have trouble breathing
• have unusual sleepiness or sleep longer than usual
• have sudden stomach or intestinal problems with nausea and vomiting or diarrhea
• feel cold, especially in your arms and legs
• feel dizzy or lightheaded
• have a slow or irregular heartbeat

You have a higher chance of getting lactic acidosis with linagliptin/metformin if you:

• have kidney problems. People whose kidneys are not working properly should not take linagliptin/metformin.
• have liver problems
• have congestive heart failure that requires treatment with medicines
• drink alcohol very often, or drink a lot of alcohol in short-term ("binge" drinking)
• get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids.
• have certain x-ray tests with dyes or contrast agents that are injected into your body
• have surgery
• have a heart attack, severe infection, or stroke
• are 80 years of age or older and have not had your kidneys tested

2. Low blood sugar (hypoglycemia). If you take linagliptin/metformin with another medication that can cause low blood sugar, such as sulfonylureas or insulin, you have a higher risk of having low blood sugar. Tell your doctor if you take other diabetes medicines. If you have symptoms of low blood sugar, you should check your blood sugar and treat it if it is low; then call your doctor. Symptoms of low blood sugar include:

• shaking
• sweating
• rapid heartbeat
• change in vision
• hunger
• headache
• change in mood

3. Severe and persistent joint pain. If you experience severe and persistent joint pain, contact your doctor right away. Do not stop taking your medication. Your doctor will decide if your medication is the possible cause of severe  joint pain and will discontinue the drug if appropriate.

Do not take linagliptin/metformin if you:

• have kidney problems
• have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine).
• are allergic to linagliptin, metformin, or any of the ingredients in linagliptin/metformin.

Symptoms of a serious allergic reaction to linagliptin/metformin are:

• rash
• raised red patches on your skin (hives)
• swelling of your face, lips, and throat that may cause difficulty breathing or swallowing

Before you take linagliptin/metformin, tell your doctor if you:

• have kidney problems
• are going to get an injection of dye or contrast agents for an x-ray procedure. Linagliptin/metformin will need to be stopped for a short time. Talk to your doctor about when you should stop linagliptin/metformin and when you should start linagliptin/metformin again. 
• have liver problems
• have heart problems, including congestive heart failure
• drink alcohol very often, or drink a lot of alcohol in short term "binge" drinking
• have any other medical conditions
• are pregnant or planning to become pregnant. It is not known if linagliptin/metformin will harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant.
• are breastfeeding or plan to breastfeed. It is not known if linagliptin/metformin passes into your breast milk. Talk with your doctor about the best way to feed your baby if you take linagliptin/metformin.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Linagliptin/metformin falls into category B. In animal studies, pregnant animals were given linagliptin, and some babies had problems. There are no well-done studies that have been done in humans with linagliptin.

It is not known if linagliptin/metformin crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using linagliptin/metformin.