"The U.S. Food and Drug Administration today approved three new related products for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes: Nesina (alogliptin) tablets, Kazano (alogliptin and metformin hydrochlor"...
Avandaryl Consumer (continued)
Headache or sore throat may occur. If either of these effects persist or worsen, notify 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 immediately if this unlikely but serious side effect occurs: bone fracture.
Tell your doctor immediately if any of these rare but very serious side effects occur: yellowing eyes/skin, stomach/abdominal pain, persistent nausea/vomiting, dark urine, easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat), mental/mood changes, seizures, vision changes (e.g., color or night vision problems).
This medication can cause low blood sugar (hypoglycemia). This effect may occur if you do not consume enough calories (from food, juices, fruit, etc.). The symptoms include chills, cold sweat, blurred vision, dizziness, drowsiness, shaking, rapid heart rate, weakness, 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 are in a situation where you don't have these reliable forms of glucose, eat a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda to quickly raise your blood sugar level. Tell your doctor immediately about the reaction. To help prevent hypoglycemia, eat meals on a regular schedule and do not skip meals.
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 medication dosage may need to be increased.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 Avandaryl (rosiglitazone maleate and glimepiride) 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 rosiglitazone or glimepiride; or to other "glitazones" (e.g., pioglitazone); 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.
Promptly talk with your doctor or pharmacist about the benefits and possible risks of this medication, even if you have been taking it for awhile, especially if you have heart problems. Do not stop taking it unless directed to do so.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: newly diagnosed or worsening heart failure (acute congestive heart failure), history of liver disease, active liver disease.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., chronic congestive heart failure, heart attack, angina), fluid in your lungs, swelling (edema, fluid retention), kidney disease, thyroid problems, certain hormonal conditions (adrenal/pituitary insufficiency, SIADH-syndrome of inappropriate secretion of antidiuretic hormone), mineral imbalance (hyponatremia), anemia, high blood cholesterol, eye (retina) problems, bone problems (e.g., osteoporosis, osteopenia).
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).
During times of stress, such as fever, infection, injury or surgery, it may be more difficult to control your blood sugar. Consult your doctor because a change in your medication may be required.
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 (upper arm, hand, foot) 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 hypoglycemia while using this drug.
This medication can cause changes in the menstrual cycle (promote ovulation) in women with certain fertility problems. Consult your doctor or pharmacist about the use of reliable birth control while taking this medication.
This medication is not recommended for use during pregnancy. Insulin treatment may be preferred. Use of rosiglitazone/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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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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