Kombiglyze XR (Saxagliptin Hydrochloride / Metformin Hydrochloride)

They need to know if you have any of these conditions: -anemia -become easily dehydrated -diabetic ketoacidosis -heart disease -heart failure -history of alcohol abuse problem -if you often drink alcohol -kidney disease -liver disease -low levels of vitamin B12 in the blood -older than 80 years -pancreatitis -polycystic ovary syndrome -previous swelling of the tongue, face, or lips with difficulty breathing, difficulty swallowing, hoarseness, or tightening of the throat -serious infection or injury -thyroid disease -type 1 diabetes -undergoing surgery or certain procedures with injectable contrast agents -an unusual or allergic reaction to metformin, saxagliptin, other medicines, foods, dyes, or preservatives -pregnant or trying to get pregnant -breast-feeding

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine with the evening meal. Do not cut, crush or chew this medicine. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Do not take this medicine with any of the following medications: -certain contrast medicines given before X-rays, CT scans, MRI, or other procedures -dofetilide -gatifloxacin This medicine may also interact with the following medications: -acetazolamide -amiloride -certain antiviral medicines for HIV infection or hepatitis -calcium channel blockers -certain antibiotics like clarithromycin and telithromycin -certain medicines for fungal infections like ketoconazole and itraconazole -cimetidine -crizotinib -digoxin -diuretics -female hormones, like estrogens or progestins and birth control pills -glycopyrrolate -isoniazid -lamotrigine -memantine -methazolamide -midodrine -morphine -nefazodone -niacin, niacinamide -phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine -phenytoin -procainamide -propantheline -quinidine -quinine -ranitidine -ranolazine -steroid medicines like prednisone or cortisone -stimulant medicines for attention disorders, weight loss, or to stay awake -thyroid medicines -topiramate -trimethoprim -trospium -vancomycin -vandetanib -zonisamide

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

Visit your doctor or health care professional for regular checks on your progress. A test called the HbA1C (A1C) will be monitored. This is a simple blood test. It measures your blood sugar control over the last 2 to 3 months. You will receive this test every 3 to 6 months. Learn how to check your blood sugar. Learn the symptoms of high or low blood sugar and how to manage them. Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. They must get medical help at once. Tell your doctor or health care professional if you have high blood sugar. You might need to change the dose of your medicine. If you are sick or exercising more than usual, you might need to change the dose of your medicine. Do not skip meals. Ask your doctor or health care professional if you should avoid alcohol. Many nonprescription cough and cold products contain sugar or alcohol. These can affect blood sugar. This medicine may cause ovulation in premenopausal women who do not have regular monthly periods. This may increase your chances of becoming pregnant. You should not take this medicine if you become pregnant or think you may be pregnant. Talk with your doctor or health care professional about your birth control options while taking this medicine. Contact your doctor or health care professional right away if you think you are pregnant. If you are going to need surgery, a MRI, CT scan, or other procedure, tell your doctor that you are taking this medicine. You may need to stop taking this medicine before the procedure. If you see part of the tablet in your stool, and this occurs several times, tell your doctor or health care professional. Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times. This medicine may cause a decrease in folic acid and vitamin B12. You should make sure that you get enough vitamins while you are taking this medicine. Discuss the foods you eat and the vitamins you take with your health care professional.

Side effects that you should report to your doctor or health care professional as soon as possible: -allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue -breathing problems -feeling faint or lightheaded, falls -fever, chills -joint pain -muscle aches or pains -pain in the lower back -signs and symptoms of low blood sugar such as feeling anxious, confusion, dizziness, increased hunger, unusually weak or tired, sweating, shakiness, cold, irritable, headache, blurred vision, fast heartbeat, loss of consciousness -slow or irregular heartbeat -unusual stomach upset or pain -unusually weak or tired -vomiting Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome): -diarrhea -headache -heartburn -metallic taste in mouth -nausea -runny or stuffy nose -stomach gas, upset

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep out of the reach of children. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.