Empagliflozin; Metformin extended-release tablets

What is this medicine?

EMPAGLIFLOZIN; METFORMIN (EM pa gli FLOE zin; met FOR min) 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.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Swallow the tablets whole. Do not cut, crush or chew this medicine. Take this medicine with food. Follow the directions on the prescription label. Take your doses 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.

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

• dizziness

• feeling faint or lightheaded, falls

• muscle aches or pains

• muscle weakness

• penile discharge, itching, or pain in men

• signs and symptoms of a genital infection, such as fever; tenderness, redness, or swelling in the genitals or area from the genitals to the back of the rectum

• 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

• signs and symptoms of a urinary tract infection, such as fever, chills, a burning feeling when urinating, blood in the urine, back pain

• trouble passing urine or change in the amount of urine, including an urgent need to urinate more often, in larger amounts, or at night

• slow or irregular heartbeat

• unusual stomach pain or discomfort

• unusually tired or weak

• vaginal discharge, itching, or odor in women

• 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

• mild increase in urination

• nausea

• stomach gas, upset

• thirsty

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

This medicine may also interact with the following medications:

• acetazolamide

• alcohol

• certain antivirals for HIV or hepatitis

• certain medicines for blood pressure, heart disease, irregular heart beat

• cimetidine

• dichlorphenamide

• digoxin

• diuretics

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

• glycopyrrolate

• isoniazid

• lamotrigine

• memantine

• methazolamide

• metoclopramide

• midodrine

• niacin

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

• phenytoin

• ranolazine

• steroid medicines like prednisone or cortisone

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

• thyroid medicines

• topiramate

• triamterene

• trospium

• vandetanib

• zonisamide

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.

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.

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

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

• anemia

• dehydration

• diabetic ketoacidosis

• diet low in salt

• eating less due to illness, surgery, dieting, or any other reason

• having surgery

• heart disease

• high cholesterol

• history of pancreatitis or pancreas problems

• history of yeast infection of the penis or vagina

• if you often drink alcohol

• infections in the bladder, kidneys, or urinary tract

• kidney disease

• liver disease

• low blood pressure

• polycystic ovary syndrome

• problems urinating

• serious infection or injury

• type 1 diabetes

• uncircumcised male

• vomiting

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

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

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

This medicine can cause a serious condition in which there is too much acid in the blood. If you develop nausea, vomiting, stomach pain, unusual tiredness, or breathing problems, stop taking this medicine and call your doctor right away. If possible, use a ketone dipstick to check for ketones in your urine.

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 low and high 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.

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.