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Precautions and Warnings With Pioglitazone and Metformin XR

Specific Pioglitazone and Metformin XR Precautions and Warnings

Warnings and precautions to be aware of prior to taking this medication include the following:
  • Studies suggest that pioglitazone (one of the active ingredients in this medication) may increase the risk of bladder cancer, particularly in people who have taken the medication for one year or longer. You should not take this medication if you have bladder cancer. Additionally, this medication should be used very cautiously in people who have had bladder cancer in the past.


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). 

Also, pioglitazone and metformin XR should be stopped temporarily for most major surgeries and should be restarted when you are eating normally again.  

  • In rare cases, metformin (one of the active ingredients) can cause a life-threatening condition called lactic acidosis. Your risk of this problem 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 pioglitazone and metformin XR 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 this drug (see Metformin and Alcohol).
  • Since liver disease (including liver failure and cirrhosis) can increase your risk of developing lactic acidosis, you should not take pioglitazone and metformin XR if your liver is not functioning normally. Also, your kidney function needs to be monitored while you are taking pioglitazone and metformin XR.

This means that you should have blood tests that check your kidneys before you start this medicine and then at least once every year. If your kidney function is poor, you should not take pioglitazone and metformin XR, due to increased risk of lactic acidosis.  

  • Fever, infections, injury, or surgery can temporarily increase your blood sugar, even in people with well-controlled diabetes. Pioglitazone and metformin XR 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.  

  • 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 pioglitazone and metformin XR for a short time.
  • Pioglitazone and metformin XR 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 pioglitazone and metformin XR causing macular edema (a condition affecting the eye). Tell your healthcare provider if you have any vision changes while taking the drug.
  • Pioglitazone and metformin XR may increase the risk of fractures (broken bones) in women. These fractures are typically different from those seen in postmenopausal women with osteoporosis. In a recent study, women taking this drug 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, pioglitazone and metformin XR 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 this drug.
  • This medication may cause increased liver enzymes. In rare cases, this has led to liver damage. Liver enzymes should be checked using a blood test in all people before starting pioglitazone and metformin XR and then again periodically.

Pioglitazone and metformin XR 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.  

  • Pioglitazone and metformin XR can cause weight gain. In studies, people taking medications similar to pioglitazone and metformin XR gained up to four pounds, on average (see Actoplus Met XR and Weight Gain). Talk to your healthcare provider about rapid weight gain, as this may be a sign of fluid retention.
  • This product can react with certain medications (see Drug Interactions With Pioglitazone and Metformin XR).
  • Pioglitazone and metformin XR 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 this drug when pregnant (see Actoplus Met XR and Pregnancy).
  • At least one of the active ingredients in pioglitazone and metformin XR passes through breast milk. Therefore, if you are breastfeeding or plan to start, talk with your healthcare provider prior to taking this drug (see Actoplus Met XR and Breastfeeding).
  • In rare cases, pioglitazone and metformin XR 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.  

7 Signs of High Blood Sugar

Pioglitazone and Metformin XR Information

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