Metformin Hydrochloride (met-FOR-min hye-droe-KLOR-ide), Pioglitazone Hydrochloride (pye-oh-GLI-ta-zone hye-droe-KLOR-ide)

Treats type 2 diabetes.

Brand Name(s):

Actoplus Met

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet, Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• If you take the extended-release tablet, part of the tablet may pass into your stools. This is normal and is nothing to worry about.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how this medicine works. Tell your doctor about all other medicines that you are using, including the following:
  • Acetazolamide, cimetidine, dichlorphenamide, dolutegravir, gemfibrozil, isoniazid, nicotinic acid, phenytoin, ranolazine, rifampin, topiramate, vandetanib, zonisamide
  • Birth control pills (including estrogen)
  • Blood pressure medicine
  • Diuretic (water pill)
  • Insulin or other oral diabetes medicine
  • Medicine to treat mental illness
  • Steroid medicine
  • Thyroid medicine
• Limit how much alcohol you drink.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding. If you had problems ovulating or have irregular periods, this medicine may cause you to ovulate, which could lead to pregnancy if you are sexually active. Talk to your doctor about effective birth control while you are using this medicine.
• Tell your doctor if you have kidney disease, liver disease, heart failure, edema (fluid retention or swelling), macular edema (swelling of the back of the eye), adrenal or pituitary gland disease, vitamin B12 deficiency, or a history of alcohol abuse or bladder cancer.
• This medicine may cause the following problems:
  • Congestive heart failure
  • Lactic acidosis (too much acid in the blood)
  • Low blood sugar
  • Liver problems
  • Increased risk for bladder cancer if you use this medicine for a long time
  • Increased risk for broken bones
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may interact with the dye used for an x-ray or a CT scan.
• It is important to tell your doctor or dentist that you are using this medicine. You may need to stop using this medicine several days before having surgery or other procedures.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision or other changes in vision
• Change in how much or how often you urinate, painful urination, lower back or side pain, blood in your urine
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fast or troubled breathing, lightheadedness, severe weakness, tiredness, or confusion
• Rapid weight gain, swelling in your hands, ankles, or feet
• Severe joint pain
• Shaking, trembling, sweating, fast or pounding heartbeat, faintness, hunger, confusion

If you notice these less serious side effects, talk with your doctor:

• Cough, stuffy or runny nose, sore throat
• Diarrhea
• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088