Empagliflozin; Metformin Extended-Release Tablets

What is this medication?

EMPAGLIFLOZIN; METFORMIN (EM pa gli FLOE zin; met FOR min) treats type 2 diabetes. It works by decreasing your blood sugar (glucose). Changes to diet and exercise are often combined with this medication.

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

COMMON BRAND NAME(S): Synjardy XR

What should I tell my care team before I take this medication?

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

• Changes to diet, eating less
• Changes to your insulin dose
• Dehydration
• Diet low in salt
• Frequently drink alcohol
• Have had an amputation
• Have had diabetic ketoacidosis (DKA)
• Have had foot sores caused by diabetes
• Have had genital infections
• Have had urinary tract infections (UTIs)
• Having a CT or X-ray scan
• Having surgery
• Have or have had pancreatitis
• Heart attack
• Heart disease
• Impaired blood circulation, peripheral vascular disease
• Infection
• Irregular menstrual cycles
• Kidney disease
• Liver disease
• Low levels of calcium in your blood
• Low levels of vitamin B in your blood
• Nerve pain, tingling or numbness in the hands or feet
• Stroke
• Trouble passing urine
• Type 1 diabetes
• An unusual or allergic reaction to empagliflozin, metformin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Take it with food at the start of a meal. Do not cut, crush, or chew this medication. Swallow the tablets whole. Keep taking it unless your care team tells you to stop.

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 care team about the use of this medication in children. While it may be prescribed for children as young as 10 years for selected conditions, precautions do apply.

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.

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 medication?

Do not take this medication with any of the following:

• Certain contrast agents used before CT, MRI, or X-ray scans

This medication may also interact with the following:

• Acetazolamide
• Alcohol
• Cimetidine
• Dichlorphenamide
• Dolutegravir
• Lithium
• Ranolazine
• Topiramate
• Vandetanib
• Zonisamide

Some medications may affect your blood sugar levels or hide the symptoms of low blood sugar (hypoglycemia). Talk with your care team about all the medications you take. They may suggest checking your blood sugar levels more often.

Medications that may affect your blood sugar levels include:

• Alcohol
• Certain antibiotics, such as ciprofloxacin, levofloxacin, sulfamethoxazole; trimethoprim
• Certain medications for blood pressure or heart disease, such as benazepril, enalapril, lisinopril, losartan, valsartan
• Certain medications for mental health conditions, such as fluoxetine or olanzapine
• Diuretics, such as hydrochlorothiazide (HCTZ)
• Estrogen and progestin hormones
• Other medications for diabetes
• Steroid medications, such as prednisone or cortisone
• Testosterone
• Thyroid hormones

Medications that may mask symptoms of low blood sugar include:

• Beta-blockers, such as atenolol, metoprolol, propranolol
• Clonidine
• Guanethidine
• Reserpine

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 medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medication. Your care team will monitor your HbA1C (A1C). This test shows what your average blood sugar (glucose) level was over the past 2 to 3 months.

Know the symptoms of low blood sugar and know how to treat it. Always carry a source of quick sugar with you. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink if your blood sugar is too low and you are unable to care for yourself. Get medical help at once.

Tell your care team if you have high blood sugar. Your medication dose may change if your body is under stress. Some types of stress that may affect your blood sugar include fever, infection, and surgery.

Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card.

Make sure you stay hydrated while taking this medication. Drink water often. Eat fruits and veggies that have a high water content. Drink more water when it is hot or you are active. Talk to your care team right away if you have fever, infection, vomiting, diarrhea, or if you sweat a lot while taking this medication. The loss of too much body fluid may make it dangerous for you to take this medication.

Tell your care team you are taking this medication before you have surgery or an imaging scan, such as a CT or X-ray. You may need to stop taking this medication for a while before and after the procedure. Your care team will tell you when to stop and when to start taking it again.

Drinking alcohol with this medication can increase the risk of side effects.

The tablet shell for some brands of this medication does not dissolve. This is normal. The tablet shell may appear whole in the stool. This is not a cause for concern.

Make sure you get enough vitamin B12 while you are taking this medication. Discuss the foods you eat and the vitamins you take with your care team.

This medication may cause you to ovulate, which may increase your chances of becoming pregnant. Talk with your care team about contraception while you are taking this medication. Contact your care team if you think you might be pregnant.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Dehydration—increased thirst, dry mouth, feeling faint or lightheaded, headache, dark yellow or brown urine
• Diabetic ketoacidosis (DKA)—increased thirst or amount of urine, dry mouth, fatigue, fruity odor to breath, trouble breathing, stomach pain, nausea, vomiting
• Genital yeast infection—redness, swelling, pain, or itchiness, odor, thick or lumpy discharge
• High lactic acid level—muscle pain or cramps, stomach pain, trouble breathing, general discomfort and fatigue
• Infection or redness, swelling, tenderness, or pain in the genitals, or area from the genitals to the back of the rectum
• Low vitamin B12 level—pain, tingling, or numbness in the hands or feet, muscle weakness, dizziness, confusion, trouble concentrating
• New pain or tenderness, change in skin color, sores or ulcers, infection of the leg or foot
• Urinary tract infection (UTI)—burning when passing urine, passing frequent small amounts of urine, bloody or cloudy urine, pain in the lower back or sides

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Gas
• Headache
• Nausea
• Stomach pain
• Vomiting

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 medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.