When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to linagliptin or metformin.

How to Use This Medicine:
Tablet, Long Acting Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• If you take the extended-release tablet, part of the tablet may pass into your stools. This is normal and is nothing to worry about.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Drink plenty of fluids to help prevent dehydration.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how linagliptin/metformin works. Tell your doctor if you are using any of the following:
  
  • Acetazolamide, amiloride, cimetidine, dichlorphenamide, digoxin, isoniazid, morphine, phenytoin, procainamide, quinidine, quinine, ranitidine, rifampin, topiramate, triamterene, trimethoprim, vancomycin, zonisamide
  • Blood pressure medicine
  • Insulin or other diabetes medicine
• Some medicines may affect your blood sugar level, including a diuretic (water pill), birth control pills, corticosteroid (including dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone), phenothiazine medicine (including chlorpromazine, perphenazine, prochlorperazine, promethazine, thioridazine), thyroid medicine, some cold and allergy medicines, niacin, and isoniazid.
• Limit the amount of alcohol you drink while you are using this medicine. Too much alcohol increases your risk of lactic acidosis.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart failure, adrenal or pituitary gland disease, vitamin B12 deficiency, or a history of pancreas problems.
• This medicine may cause the following problems:
  
  • Lactic acidosis (rare problem with too much acid in the blood, which can be life-threatening)
  • Pancreatitis
  • Low blood sugar levels
  • Low levels of vitamin B12
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may interact with the dye used for an x-ray or a CT scan.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Fast or trouble breathing, paleness, severe weakness, tiredness, or confusion
• Severe joint pain
• Shaking, trembling, sweating, fast or pounding heartbeat, faintness, hunger
• Sudden and severe stomach pain, nausea, vomiting, fever, lightheadedness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Stuffy or runny nose

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088