"The US Food and Drug Administration (FDA) has approved a new type 2 diabetes drug that combines the sodium glucose cotransporter 2 (SGLT2) inhibitor empagliflozin with metformin hydrochloride (Synjardy, Boehringer Ingelheim and Eli Lilly"...
Glucovance Consumer (continued)
Nausea, stomach upset, diarrhea, or weight gain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If stomach symptoms return later (after you are on the same dose for several days or weeks), tell your doctor immediately. Stomach symptoms that occur after the first days of your treatment may be a sign of lactic acidosis.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, signs of infection (such as persistent sore throat, fever), persistent nausea, severe stomach/abdominal pain, yellowing eyes/skin, dark urine.
This medication can cause low blood sugar (hypoglycemia). This may occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor immediately about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.
Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your dosage may need to be increased.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Glucovance (glyburide and metformin) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to glyburide or metformin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, conditions that may cause a low level of oxygen in the blood or poor circulation (such as severe congestive heart failure, recent heart attack, recent stroke), serious infection, severe loss of body fluids (dehydration), alcohol use, severe breathing problems (such as obstructive lung disease, severe asthma), blood problems (such as anemia, vitamin B12 deficiency), electrolyte imbalance (hyponatremia), fertility problems (such as ovulation problems), certain hormonal conditions (adrenal/pituitary insufficiency, thyroid disease, syndrome of inappropriate antidiuretic hormone-SIADH), a certain nervous system problem (autonomic neuropathy).
Before having surgery or any X-ray/scanning procedure using injectable iodinated contrast material, tell your doctor about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). You will need to temporarily stop this medication before the time of your surgery/procedure. Consult your doctor for further instructions.
You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.
Limit alcohol while taking this medication because it can increase the risk of developing low blood sugar and lactic acidosis. Rarely, alcohol can interact with glyburide and cause a serious reaction (disulfiram-like reaction) with symptoms such as facial flushing, nausea, vomiting, dizziness, or stomach pain. Consult your doctor or pharmacist about using alcohol safely.
It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.
This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
Older adults may be more sensitive to the side effects of this drug, especially lactic acidosis or low blood sugar.
This medication can cause changes in the menstrual cycle (promote ovulation) and increase the risk of becoming pregnant. Consult your doctor or pharmacist about the use of reliable birth control while using this medication.
During pregnancy, this medication should be used only when clearly needed. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may substitute insulin for this product during pregnancy. If you are using glyburide during your pregnancy, your doctor may switch you to insulin at least 2 weeks before the expected delivery date because of glyburide's risk of causing low blood sugar in your newborn. Discuss the risks and benefits with your doctor.
It is unknown if glyburide passes into breast milk. Metformin passes into breast milk. Consult your doctor before breast-feeding.
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