What is the most important information I should know about empagliflozin and metformin?
You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.
In rare cases, this medicine can cause serious infections in the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or if you don't feel well.
What is empagliflozin and metformin?
Empagliflozin and metformin is a combination medicine used with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.
Empagliflozin and metformin is also used to lower the risk of death from heart attack, stroke, or heart failure in adults with type 2 diabetes who also have heart disease.
This medicine is not for treating type 1 diabetes.
Empagliflozin and metformin may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking empagliflozin and metformin?
You should not use this medicine if you are allergic to empagliflozin (Jardiance, Glyxambi) or metformin, or if you have:
- severe kidney disease (or if you are on dialysis); or
- metabolic acidosis or diabetic ketoacidosis (call your doctor for treatment).
If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking empagliflozin and metformin.
Tell your doctor if you have ever had:
- liver or kidney disease;
- heart problems, low blood pressure;
- a bladder infection or urination problems;
- problems with your pancreas, including surgery; or
- if you are on a low-salt diet.
You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.
Tell your doctor right away if you become pregnant. Empagliflozin may harm the unborn baby if you take this medicine during your second or third trimester.
Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.
You should not breastfeed while using this medicine.
Empagliflozin and metformin is not approved for use by anyone younger than 18 years old.
How should I take empagliflozin and metformin?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Take this medicine with food to prevent upset stomach.
Do not crush, chew, or break an extended-release tablet. Swallow it whole.
You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).
Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.
Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.
Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.
Your doctor may have you take extra vitamin B12 while you are taking empagliflozin and metformin. Take only the amount of vitamin B12 that your doctor has prescribed.
Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medicine, which can lead to severely low blood pressure or a serious electrolyte imbalance.
If you need surgery or medical tests, tell any doctor who treats you that you are using empagliflozin and metformin.
Empagliflozin and metformin is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.
Store at room temperature, away from moisture and heat.
What happens if I miss a dose?
Take the medicine (with food) as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have severely low blood sugar (extreme weakness, nausea, tremors, sweating, confusion, trouble speaking, fast heartbeats, or seizure).
What should I avoid while taking empagliflozin and metformin?
Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.
What are the possible side effects of empagliflozin and metformin?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Seek medical attention right away if you have signs of a rare but serious genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well. These symptoms may get worse quickly.
Call your doctor at once if you have:
- little or no urination;
-
dehydration symptoms --dizziness, weakness, feeling light-headed (like you might pass out);
-
ketoacidosis (too much acid in the blood) --nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing;
-
lactic acidosis --unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired; or
-
signs of a bladder infection --pain or burning when you urinate, increased urination, blood in your urine, fever, pain in your pelvis or back.
Side effects may be more likely to occur in older adults.
Common side effects may include:
- headache;
- stomach pain, gas, indigestion, nausea, vomiting, diarrhea;
- weakness; or
- runny nose, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect empagliflozin and metformin?
Many drugs can affect empagliflozin and metformin, making this medicine less effective or increasing your risk of lactic acidosis. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about empagliflozin and metformin.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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