"Boehringer Ingelheim and Eli Lilly have filed a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) based on cardiovascular risk reduction data from the landmark EMPA-REG OUTCOME trial for their SGLT2 inhibitor"...
Duetact Consumer (continued)
Headache, dizziness, diarrhea, nausea, muscle pain, sore throat, or tooth problems may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
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: new/worsening vision problems (e.g., color or night vision problems), bone fracture, reddish-colored urine, urgent need to urinate, pain while urinating, loss of appetite, yellowing eyes/skin, dark urine, mental/mood changes (e.g., hallucinations, confusion), seizures, easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat).
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 include cold sweat, blurred vision, dizziness, drowsiness, shaking, fast heartbeat, headache, fainting, tingling of the hands/feet, and hunger. 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 about the reaction immediately. 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 Duetact (pioglitazone hydrochloride and glimepiride tablets) 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 pioglitazone or glimepiride; or to other "glitazones" (e.g., rosiglitazone); or to other sulfonylureas (e.g., glipizide, tolbutamide); 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 taking this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., congestive heart failure), fluid in your lungs, swelling (edema, fluid retention), liver problems, kidney disease, thyroid problems, certain hormonal conditions (adrenal/pituitary insufficiency, syndrome of inappropriate secretion of antidiuretic hormone-SIADH), mineral imbalance (hyponatremia), anemia, eye (retina) problems, bladder cancer.
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 your risk of developing low blood sugar (hypoglycemia).
It may be harder to control your blood sugar when your body is stressed (e.g., due to fever, infection, injury, or surgery). In these cases, consult your doctor because you 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.
This medication may increase the risk of bone fracture (e.g., upper arm, hand, foot, ankle) in female patients. To lower the chance of getting injured, use caution when doing activities such as contact sports.
Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, the elderly may be at greater risk for low blood sugar while using this drug.
This medication can cause changes in the menstrual cycle (promote ovulation) in women with certain fertility problems. Women of child-bearing age should use a reliable form of birth control while taking this medication. Consult your doctor for more details.
This medication is not recommended for use during pregnancy. Your doctor may direct you to switch to insulin treatment during your pregnancy. Use of pioglitazone/glimepiride close to the expected delivery date may increase the risk of low blood sugar in your newborn. Consult your doctor for more details, and follow all instructions carefully.
It is unknown if this medication passes into breast milk, and it may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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