glyburide 1.25 mg-metformin 250 mg tablet

Generic name:
Glyburide/metformin - oral

Pronunciation
(GLYE-bure-ide/met-FOR-min)

Brand name(s)
Glucovance

Rarely, too much metformin can build up in the body and cause a serious (sometimes fatal) condition called lactic acidosis. Lactic acidosis is more likely if you are an older adult, if you have kidney or liver disease, dehydration, heart failure, heavy alcohol use, if you have surgery, if you have X-ray or scanning procedures that use iodinated contrast, or if you are using certain drugs. For some conditions, your doctor may tell you to stop taking this medication for a short time. Ask your doctor or pharmacist for more details.

Stop taking this medication and get medical help right away if you have any symptoms of lactic acidosis, such as unusual tiredness, dizziness, severe drowsiness, chills, blue/cold skin, muscle pain, fast/difficult breathing, slow/irregular heartbeat, or stomach pain with nausea/vomiting/diarrhea.

This combination medication is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. It may also be used with other diabetes medications.

This product contains 2 medications. Glyburide belongs to the class of drugs known as sulfonylureas. It lowers blood sugar by causing the release of your body's natural insulin and by decreasing the amount of sugar that your liver makes. Metformin works by decreasing the amount of sugar that your liver makes and that your stomach/intestines absorb. Both of these medications work by helping to restore your body's proper response to the insulin you naturally produce.

Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.

Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with meals as directed by your doctor, usually once or twice a day. Drink plenty of fluids while taking this medication unless otherwise directed by your doctor.

The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects (such as upset stomach and low blood sugar), your doctor may direct you to start this medication at a low dose and gradually increase your dose. Your doctor will adjust your dose based on your blood sugar to find the best dose for you. Follow your doctor's instructions carefully.

If you are already taking another diabetes drug (such as chlorpropamide), follow your doctor's directions carefully for stopping the old drug and starting this combination medication.

If you are also taking colesevelam, take glyburide/metformin at least 4 hours before colesevelam.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

It may take up to 2 weeks before you get the full benefit of this drug. Tell your doctor if your condition does not get better or if it gets worse (your blood sugar is too high or too low).

See also Warning section.

Nausea, stomach upset, diarrhea, or weight gain may occur. If any of these effects last or get worse, 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 right away. Stomach symptoms that occur after the first days of your treatment may be a sign of lactic acidosis.

Remember that this medication has been prescribed because your doctor 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:

• nausea that doesn't stop
• easy bleeding/bruising
• signs of infection (such as sore throat that doesn't go away, fever)
• 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 right away 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 increased thirst/urination. If these symptoms occur, tell your doctor right away. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

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 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

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
• heart disease (such as heart failure, recent heart attack)
• serious infection
• dehydration
• alcohol use
• breathing problems (such as obstructive lung disease, 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 iodinated contrast, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). You may need to stop this medication for a short time for the surgery/procedure. Ask your doctor or dentist for instructions before your surgery/procedure.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do anything that needs 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. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

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 breastfeeding.

See also How To Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

• bosentan

Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Beta-blocker medications (including metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar such as dizziness, hunger, or sweating are unaffected by these drugs.

Check the labels on all your medicines (such as cough-and-cold products) because they may contain ingredients that could affect your blood sugar. Ask your pharmacist about using those products safely.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: rapid breathing, severe drowsiness, slow/irregular heartbeat.

Do not share this medication with others.

Attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams.

Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar regularly as directed.

Lab and/or medical tests (such as kidney/liver function, blood sugar, hemoglobin A1c, complete blood counts) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.