Actoplus Met Warnings and Precautions (Cont.)

• Actoplus Met can cause fluid retention (known medically as edema). For most people, this is not dangerous. However, fluid retention can be serious in people with congestive heart failure (CHF). It is possible for fluid retention to lead to heart failure, even in people who have no history of heart failure or any other heart disease. There may be an increased risk of edema or heart failure for people taking both Actoplus Met and insulin.

Contact your healthcare provider if you notice:

 

• Unexplained weight gain (three to five pounds or more in a week)
• Swelling of the ankles, feet, or legs
• Cough
• Shortness of breath.

 

(Click Symptoms of Congestive Heart Failure for more information).

• Very rarely, metformin (one of the active ingredients of Actoplus Met) can cause a life-threatening condition called lactic acidosis. Your risk of lactic acidosis increases with other medical conditions, including congestive heart failure, kidney failure, and liver problems, including liver failure and cirrhosis (see Metformin and Lactic Acidosis).
   
• Drinking alcohol with Actoplus Met can increase your risk of lactic acidosis. Drinking large amounts of alcohol on a regular basis or drinking a large amount of alcohol at once (binge drinking) should be avoided while taking Actoplus Met (see Metformin and Alcohol).
   
• Since liver disease (including liver failure and cirrhosis) can increase your risk of developing lactic acidosis, you should not take Actoplus Met if your liver is not functioning normally. Also, your kidney function needs to be monitored while you are taking Actoplus Met. This means that you should have blood tests that check your kidneys before you start Actoplus Met and then at least once every year. If your kidney function is poor, you should not take Actoplus Met, due to increased risk of lactic acidosis.
   
• Taking metformin (one of the active ingredients in Actoplus Met) and contrast dye at the same time can increase your risk of kidney damage. Contrast dye is used for certain radiology procedures, including some x-rays, CT scans, and heart catheterizations (see Metformin and Contrast Medium). Also, Actoplus Met should be temporarily stopped for most major surgeries and should be restarted when you are eating normally again.
   
• Fever, infections, injury, or surgery can temporarily increase your blood sugar, even in people with well-controlled diabetes. Actoplus Met may not be enough to treat your diabetes at these times, and the use of insulin may be required. Contact your healthcare provider if you have a fever, infection, injury, or will be having surgery. Also, make sure you know the symptoms of high blood sugar and how to check your blood sugar levels (see Actoplus Met and Blood Sugar).
   
• Let your healthcare provider know if you have an illness that causes severe vomiting, diarrhea, or fever, or if you drink a lower amount of liquid than normal. These conditions can lead to severe dehydration (loss of water in your body). You may need to stop taking Actoplus Met for a short time.
   
• Actoplus Met can decrease your levels of vitamin B₁₂. Your healthcare provider should monitor your vitamin B₁₂ levels, especially if you have a vitamin B₁₂ deficiency (including pernicious anemia).
   
• There have been reports of Actoplus Met causing macular edema (a condition of the eye). Tell your healthcare provider if you have any vision changes while taking the drug.

• Actoplus Met may increase the risk of fractures (broken bones) in women. These fractures are typically different than those seen in postmenopausal women with osteoporosis. In a recent study, women taking Actoplus Met were more likely to have broken bones, especially in the upper arm, hand, lower leg, ankle, or foot.

   
• If you are a premenopausal woman who has infertility problems due to lack of ovulation, Actoplus Met may increase your chances of ovulation (and pregnancy). Talk to your healthcare provider about birth control options if you would like to avoid pregnancy while taking Actoplus Met.
   
• Actoplus Met may cause increased liver enzymes. Very rarely, this has led to liver damage. It is recommended that liver enzymes be checked in all people before starting Actoplus Met and then again periodically. Liver enzymes are checked using a blood test. Actoplus Met should not be started in people with high liver enzymes, and the drug should be stopped if liver enzymes increase and continue to stay high, as this may be a sign of liver damage.
   
• Actoplus Met can cause weight gain. In studies, people taking medications similar to Actoplus Met gained up to four pounds on average (see Actoplus Met and Weight Gain). Talk to your healthcare provider about rapid weight gain, as this may be a sign of fluid retention.
   
• Actoplus Met can interact with certain medications (see Actoplus Met Drug Interactions).
   
• Actoplus Met is considered a pregnancy Category C medication. This means that it may not be safe to use during pregnancy. Talk to your healthcare provider about the risks and benefits of using Actoplus Met during pregnancy (see Actoplus Met and Pregnancy).
   
• It is not known if Actoplus Met passes through breast milk. Therefore, if you are breastfeeding or plan to start breastfeeding, talk with your healthcare provider about this first.
   
• Rarely, Actoplus Met can cause low blood sugar (hypoglycemia), usually when it is combined with other diabetes drugs. This has been more common in elderly people and in people with adrenal, pituitary, liver, or kidney problems. It is also more likely to occur during fasting before surgery and after prolonged exercise. Low blood sugar symptoms may include irritability, trembling, cold sweats, or blurry vision, among other things (see Metformin and Blood Sugar).