Linagliptin/metformin (By mouth)

Introduction

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

Treats type 2 diabetes. Used together with diet and exercise to control high blood sugar.

Brand Name(s)

Jentadueto

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• Take this medicine with a meal.
• Carefully follow your doctor's instructions about any special diet, exercise, or weight loss. Test your blood sugar regularly.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

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

• Make sure your doctor knows if you also use insulin or diabetes medicine that you take by mouth such as glipizide, glyburide, Actos®, Amaryl®, Avandia®, or Glucotrol®.
• Make sure your doctor knows if you are also using acetazolamide (Diamox®), dichlorphenamide (Daranide®), digoxin (Lanoxin®), morphine, procainamide, quinidine (Quinidex®), quinine (Qualaquin®), ranitidine (Zantac®), cimetidine (Tagamet®), rifampin (Rifadin®, Rimactane®), topiramate (Topamax®), trimethoprim (Bactrim®, Primsol®, Proloprim®, Septra®), vancomycin, or zonisamide (Zonegram®).
• Make sure your doctor knows if you use heart or blood pressure medicine (such as amlodipine, atenolol, metoprolol, nifedipine, propranolol, timolol, verapamil, Adalat®, Cardizem®, Inderal®, Lotrel®, Norvasc®, Procardia®, Tiazac®, or Toprol®).
• Some medicines affect your blood sugar level, so they might also affect how this medicine works. Tell your doctor if you are taking a vitamin B supplement, phenytoin (Dilantin®), isoniazid, a diuretic (water pill, such as amiloride, furosemide, hydrochlorothiazide [HCTZ], triamterene, Dyrenium®, Lasix®, or Midamor®), a steroid medicine (such as dexamethasone, prednisolone, prednisone, or Medrol®), a phenothiazine medicine (such as prochlorperazine, Compazine®, Mellaril®, Phenergan®, Thorazine®, or Trilafon®), thyroid replacement (such as levothyroxine, liothyronine, Cytomel®, or Synthroid®), estrogen, or birth control pills.
• Limit how much alcohol you drink, because alcohol can increase your risk of serious side effects.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, anemia, vitamin B12 deficiency, congestive heart failure, problems with your adrenal or pituitary gland, or a history of alcoholism.
• This medicine may cause a rare but serious condition called lactic acidosis. This is more likely to happen if you have kidney, liver, or heart disease. Lactic acidosis is also more likely if you drink too much alcohol or if you become dehydrated. Stop taking this medicine and call your doctor right away if you have unusual tiredness or weakness, muscle pain, changes in breathing, slow heartbeat, dizziness or lightheadedness, or feel cold. Also call your doctor right away if you start to have nausea or other stomach problems after you have been taking this medicine for awhile.
• Do not let yourself get dehydrated. Drink extra fluids when you exercise or increase your activity or if you have vomiting or diarrhea.
• Make sure any doctor or dentist who treats you knows that you are using this medicine.
• You may need to stop using this medicine several days before having surgery or medical tests. You could also have more side effects from this medicine if you have to stop eating or drinking for a medical procedure or test. Also, this medicine may affect the results of some medical tests.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.
• This medicine is only part of a complete program to help control diabetes. It is important that you always eat a healthy diet, watch your weight, and get regular exercise.

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
• Changes in breathing, trouble breathing, nausea, or vomiting
• Decrease in how much or how often you urinate
• Extreme weakness, tiredness, or confusion
• Feeling cold, dizzy, or lightheaded
• Increased hunger, shakiness, sweating, or thirst
• Slow or uneven heartbeat
• Sudden and severe stomach pain, nausea, vomiting, fever, lightheadedness
• Unusual bleeding or bruising

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