Do NOT use Actoplus Met if:

• you are allergic to any ingredient in Actoplus Met
• you have type 1 diabetes
• you have moderate to severe heart failure
• you have a severe infection, low blood oxygen levels, kidney or liver problems, or high blood ketone or acid levels (eg, diabetic ketoacidosis), or you are severely dehydrated
• you have had a stroke or a recent heart attack, or you are in shock
• you are 80 years old or more and have not had a kidney function test
• you will be having surgery or certain lab procedures
• you have a history of liver problems, including jaundice (yellowing of the skin or eyes), during therapy with a similar medicine called troglitazone.

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

Some medical conditions may interact with Actoplus Met. 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 have a history of heart problems (eg, heart failure), abnormal liver function tests, lung or breathing problems, thyroid problems, stomach or bowel problems (eg, paralysis, blockage), adrenal or pituitary problems, eye or vision problems (eg, macular degeneration), bladder cancer, or lactic acidosis
• if you have fluid retention or swelling problems, vomiting, diarrhea, poor health or nutrition, low blood calcium or vitamin B₁₂ levels, or anemia, or if you are dehydrated
• if you have an infection, fever, recent injury, or moderate to severe burns
• if you have a history of bone fracture, weak bones (eg, osteoporosis), or low calcium intake
• if you drink alcohol or have a history of alcohol abuse
• if you will be having surgery or certain lab procedures
• if you take a beta-blocker (eg, propranolol).

Some medicines may interact with Actoplus Met. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Calcium channel blockers (eg, nifedipine), corticosteroids (eg, prednisone), diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), insulin, isoniazid, nicotinic acid, oral antidiabetics (eg, glipizide), phenothiazines (eg, chlorpromazine), phenytoin, sympathomimetics (eg, albuterol, pseudoephedrine), or thyroid hormones (eg, levothyroxine) because the risk of high or low blood sugar may be increased
• Amiloride, cimetidine, digoxin, gemfibrozil, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin because they may increase the risk of Actoplus Met's side effects
• Rifampin because it may decrease Actoplus Met's effectiveness, resulting in high blood sugar
• Anticoagulants (eg, warfarin) because their effectiveness may be decreased or the risk of their side effects may be increased by Actoplus Met.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Actoplus Met 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.

Important safety information:

• Actoplus Met may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Actoplus Met with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Follow the diet and exercise program given to you by your health care provider.
• Inform your doctor if you are going to drink alcohol while you use Actoplus Met.
• Tell your doctor or dentist that you take Actoplus Met before you receive any medical or dental care, emergency care, or surgery.
• Do not take more than the recommended dose without checking with your doctor.
• Be careful not to become dehydrated, especially during hot weather, while you are being active, or if you have vomiting or diarrhea. Dehydration may increase your risk of side effects from Actoplus Met.
• Actoplus Met may cause ovulation in women who have not reached menopause but do not ovulate. Women who wish to avoid pregnancy should be sure to use effective birth control while using Actoplus Met.
• Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Actoplus Met exactly as prescribed, tell your doctor.
• Actoplus Met does not usually cause low blood sugar. Low blood sugar may be more likely to occur if you skip a meal, exercise heavily, or drink alcohol. It may also be more likely if you take Actoplus Met along with certain other medicines for diabetes (eg, sulfonylureas, insulin). It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
• Fever, infection, injury, or surgery may increase your risk for high or low blood sugar levels. If any of these occur, check your blood sugar closely and tell your doctor right away.
• Actoplus Met may commonly cause stomach upset, indigestion, nausea, or diarrhea at the beginning of treatment. If you develop unusual or unexpected stomach problems, or if you develop stomach problems later during treatment, contact your doctor at once. This may be a sign of lactic acidosis.
• An increased incidence of bone fracture has been reported in women who take Actoplus Met. Tell your doctor if you have a history of bone fracture, low calcium intake, or weak bones (eg, osteoporosis). Tell your doctor right away if you experience any unusual bone pain.
• Actoplus Met may be associated with an increased risk of bladder cancer. Discuss any questions or concerns with your doctor.
• Lab tests, including kidney and liver function, fasting blood glucose, hemoglobin A_1c, blood counts, and eye examinations, may be performed while you use Actoplus Met. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Actoplus Met with caution in the elderly; they may be more sensitive to its effects. Low blood sugar levels may also be more difficult to recognize in the elderly.
• Actoplus Met should not be used in children; safety and effectiveness in children have not been confirmed.
• Pregnancy and breast-feeding: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Actoplus Met while you are pregnant. It is not known if Actoplus Met is found in breast milk. Do not feed breast while taking Actoplus Met.

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:

Cold-like symptoms; diarrhea; headache; indigestion; mild weight gain; nausea; stomach upset.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; bone pain; chest pain or discomfort; dark urine; difficult or painful urination; dizziness or lightheadedness; fainting; fast or difficult breathing; feeling of being unusually cold; general feeling of being unwell; muscle pain or weakness; pale stools; persistent loss of appetite; severe or persistent headache, nausea, or vomiting; shortness of breath; slow or irregular heartbeat; sudden unexplained weight gain; swelling of the hands, ankles, or feet; unusual stomach pain or discomfort; unusual drowsiness; unusual tiredness or weakness; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.