Saxagliptin, Metformin Hydrochloride Oral tablet, extended-release

What is this medicine?

METFORMIN; SAXAGLIPTIN is a combination of 2 medicines used to treat type 2 diabetes. This medicine lowers blood sugar. Treatment is combined with a balanced diet and exercise.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• become easily dehydrated

• diabetic ketoacidosis

• gallstones

• heart disease

• high levels of triglyceride in the blood

• history of alcohol abuse problem

• history of pancreatitis

• if you often drink alcohol

• kidney disease

• liver disease

• low levels of vitamin B12 in the blood

• older than 80 years

• polycystic ovary syndrome

• serious infection or injury

• thyroid disease

• type 1 diabetes

• an unusual or allergic reaction to metformin, saxagliptin, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

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've 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.

What if I miss a dose?

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.

What may interact with this medicine?

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:

• amiloride

• antiviral medicines for HIV or AIDS

• calcium channel blockers

• certain antibiotics like clarithromycin and telithromycin

• certain medicines for fungal infections like ketoconazole and itraconazole

• cimetidine

• digoxin

• diuretics

• female hormones, like estrogens or progestins and birth control pills

• isoniazid

• medicines for diabetes

• morphine

• nefazodone

• niacin, niacinamide

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

• phenytoin

• procainamide

• quinidine

• quinine

• ranitidine

• steroid medicines like prednisone or cortisone

• stimulant medicines for attention disorders, weight loss, or to stay awake

• thyroid medicines

• trimethoprim

• vancomycin

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.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress.

Learn how to check your blood sugar. Learn the symptoms of high or low blood sugar and how to manage them.

If you have low blood sugar, eat or drink something that has sugar. Make sure others know to get medical help quickly if you have serious symptoms of low blood sugar, like if you become unconscious or have a seizure.

If you need surgery or if you will need a procedure with contrast drugs, tell your doctor or health care professional that you are taking this medicine.

Wear a medical identification bracelet or chain to say you have diabetes, and carry a card that lists all your medications.

What side effects may I notice from receiving this medicine?

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

• low blood sugar (ask your doctor or health care professional for a list of associated symptoms)

• muscle pains

• pain in the lower back

• unusual stomach upset or pain

• unusually weak or tired

• vomiting

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• diarrhea

• headache

• nausea

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.

Where should I keep my medicine?

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.