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|Rosiglitazone/Metformin

Rosiglitazone/Metformin

Rosiglitazone/Metformin is used for:

Improving blood sugar levels, with diet and exercise, in patients with type 2 diabetes who are already being treated with both of these medicines or who are not adequately controlled on metformin alone.

Rosiglitazone/Metformin is a combination of an insulin resistance reducer and a biguanide. This combination medicine works in 2 ways to improve blood glucose levels (sugar). Rosiglitazone helps the cells use glucose, and metformin slows the liver"s production of glucose. Controlling high blood sugar helps prevent heart disease, strokes, kidney disease, blindness, circulation problems, and sexual function problems (impotence).

Do NOT use Rosiglitazone/Metformin if:

• you are allergic to any ingredient in Rosiglitazone/Metformin
• you have kidney problems
• you have type 1 diabetes; lactic acidosis; metabolic acidosis, including diabetic ketoacidosis; or diabetic coma
• you have congestive heart failure that requires treatment with medications

Contact your doctor or health care provider right away if any of these apply to you.

Before using Rosiglitazone/Metformin :

Some medical conditions may interact with Rosiglitazone/Metformin . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you are debilitated or dehydrated
• if you will be having surgery
• if you have liver disease, a history of swelling, heart failure, or a family history of heart failure
• if you have experienced yellowing of the skin or eyes caused by similar medications (eg, troglitazone)
• if you have low iron or low blood counts, diarrhea, gastroparesis, hypercorticoidism, hyperthyroidism, hypothyroidism, hypoxia, intestinal obstruction, malnutrition, vitamin B₁₂ deficiency, problems relating to ovulation, high cholesterol, burns, cardiopulmonary insufficiency, blood or tissue infection, vascular collapse, or vomiting
• if you are premenopausal
• if you have experienced severe trauma or shock

Some MEDICINES MAY INTERACT with Rosiglitazone/Metformin . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Rifampin because the effectiveness of Rosiglitazone/Metformin may be decreased
• Angiotensin-converting enzyme (ACE) inhibitors (eg, captopril), cimetidine, gemfibrozil, and maprotiline because the actions and side effects of Rosiglitazone/Metformin may be increased and very low blood sugar may occur
• Iodine-containing radiopaque agents used for x-ray or scanning procedures because the risk of sudden kidney failure may be increased and lactic acidosis may occur. Rosiglitazone/Metformin should not be used within 48 hours of iodine-containing radiopaque agents.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, celecoxib) because the risk of sudden kidney failure and lactic acidosis may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rosiglitazone/Metformin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Rosiglitazone/Metformin :

Use Rosiglitazone/Metformin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Rosiglitazone/Metformin preferably with meals.
• Rosiglitazone/Metformin may take effect within 1 to 2 weeks after beginning therapy. However, full effects may not occur for 2 to 3 months.
• Carefully follow the dietary guidelines and exercise plan given to you by your health care provider.
• For best results, it is important to take Rosiglitazone/Metformin regularly. To help you remember, take your dose at the same time each day.
• If a dose is missed, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your doctor. If more than 1 dose is missed, restart medication and advise your doctor or pharmacist at your next appointment.

Ask your health care provider any questions you may have about how to use Rosiglitazone/Metformin .

Important safety information:

• Avoid drinking alcohol while taking Rosiglitazone/Metformin . Actions of Rosiglitazone/Metformin , such as lowering blood sugar, may be increased if excessive alcohol is consumed while taking Rosiglitazone/Metformin .
• Before you have any medical or dental treatments, emergency care, or surgery, tell your doctor or dentist that you are using Rosiglitazone/Metformin .
• Carry an identification card at all times that says you are diabetic.
• Rosiglitazone/Metformin usually does not cause low blood sugar or hypoglycemia, but this effect may occur if you do not consume enough calories from food, juices, fruit, or other sources. The symptoms of low blood sugar include increased heartbeat, headache, chills, sweating, tremor, increased hunger, changes in vision, nervousness, weakness, dizziness, drowsiness, fainting. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you do not have a reliable source of glucose available, 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 prevent low blood sugar eat meals on a regular schedule and do not skip meals.
• During times of stress, such as fever, infection, injury or surgery, it may be more difficult to control your blood sugar. Consult your doctor, as a change in your medicine may be required.
• Symptoms of high blood sugar or hyperglycemia include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor immediately. Your medication dosage may need to be increased.
• LAB TESTS, including liver and kidney function tests, fasting blood sugar, glycosylated hemoglobin (hemoglobin A_1c), or complete blood cell counts, may be needed to check your progress or to monitor for side effects. Be sure to keep all doctor and lab test appointments.
• Use Rosiglitazone/Metformin with caution in the ELDERLY because they may be more sensitive to its effects.
• Use Rosiglitazone/Metformin with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• Rosiglitazone/Metformin may cause ovulation in women who have not reached menopause but do not ovulate. Be sure to use adequate contraception (birth control) while using Rosiglitazone/Metformin . In women of childbearing age, it is important to consider birth control methods while taking Rosiglitazone/Metformin .
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Rosiglitazone/Metformin during pregnancy. Insulin therapy may be preferred to control blood sugar during pregnancy. Discuss your treatment options with your doctor. It is unknown if Rosiglitazone/Metformin is excreted in breast milk. Do not breast-feed while taking Rosiglitazone/Metformin .

Possible side effects of Rosiglitazone/Metformin :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; metallic taste; trauma; weight gain.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abdominal or stomach pain; appetite loss; fluid retention; heart problems; liver problems (dark urine, yellowing of the skin or eyes); muscle pain; nausea; rapid weight gain; shortness of breath; vision changes; vomiting; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include: rapid or difficult breathing; severe drowsiness; slow or irregular heartbeat.

Store at room temperature at 77 degrees F (25 degrees C). Keep in a tightly closed, light-resistant container away from heat and moisture. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store in bathroom. Keep Rosiglitazone/Metformin out of the reach of children and away from pets.

General information:

• If you have any questions about Rosiglitazone/Metformin , please talk with your doctor, pharmacist, or other health care provider.
• Rosiglitazone/Metformin is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
• If using Rosiglitazone/Metformin for an extended period of time, obtain refills before your supply runs out.

This information is a summary only. It does not contain all information about Rosiglitazone/Metformin . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.