Linagliptin (lin-a-GLIP-tin), Metformin Hydrochloride (met-FOR-min hye-droe-KLOR-ide)

Treats type 2 diabetes.

Brand Name(s):

Jentadueto, Jentadueto XR

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet, Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• 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. Keep the tablets dry.

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 medicines can affect how linagliptin/metformin works. Tell your doctor if you are using any of the following:
  • Cimetidine, digoxin, dolutegravir, morphine, quinine, ranitidine, ranolazine, vandetanib
  • Birth control pills (including estrogen)
  • Blood pressure medicine (including amiloride)
  • Diuretic (water pill)
  • Insulin or other diabetes medicine
  • Medicine for heart rhythm problems (including procainamide, quinidine)
  • Medicine to treat infections (including isoniazid, rifampin, trimethoprim, vancomycin)
  • Medicine to treat seizures (including phenytoin, topiramate, zonisamide)
  • Phenothiazine medicine
  • Steroid medicine
  • Thyroid medicine
• Limit how much alcohol you drink.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, adrenal or pituitary gland disease, vitamin B12 deficiency, or a history of alcohol abuse, heart failure, or pancreas problems.
• This medicine may cause the following problems:
  • Lactic acidosis (too much acid in the blood, which can be life-threatening)
  • Pancreatitis
  • Heart failure
  • Low blood sugar, when used with other diabetes medicines
• This medicine may cause some patients to become dehydrated. Drink plenty of water every day, during exercise, or in hot weather.
• 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, severe weakness, tiredness, or confusion
• Increased hunger, headache, shaking, trembling, sweating
• Lightheadedness, dizziness, fainting
• Rapid weight gain, swelling in your hands, ankles, or feet
• Severe joint pain
• Sudden and severe stomach pain, nausea, vomiting, fever
• Trouble breathing, cold sweat, bluish-colored skin

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

• Cough, stuffy or runny nose, sore throat
• Diarrhea

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