Metformin and pioglitazone is a combination of two oral diabetes medicines that help control blood sugar levels.

Metformin and pioglitazone is for people with type 2 diabetes who do not use daily insulin injections. This medication is not for treating type 1 diabetes.

Metformin and pioglitazone may also be used for purposes other than those listed in this medication guide.

Take this medication exactly as it was prescribed for you. Do not take the medication in larger or smaller amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Take metformin and pioglitazone with meals.

Metformin and pioglitazone is only part of a complete program of treatment that also includes diet, exercise, and weight control. It is important to use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested, and you may need regular eye exams. It is important that you not miss any scheduled visits to your doctor.

Your medication needs may change if you become sick or injured, if you have a serious infection, or if you have any type of surgery. Your doctor may want you to stop taking metformin and pioglitazone for a short time if any of these situations affect you.

Take care not to let your blood sugar get too low, causing hypoglycemia. You may have hypoglycemia if you skip a meal, exercise too long, drink alcohol, or are under stress.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them:

• hunger, headache, confusion, irritability;

• drowsiness, weakness, dizziness, tremors;

• sweating, fast heartbeat;

• seizure (convulsions); or

• fainting, coma (severe hypoglycemia can be fatal).

Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

Your doctor may have you take extra vitamin B12 while you are taking metformin and pioglitazone. Take only the amount of vitamin B12 that your doctor has prescribed.

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking metformin and pioglitazone. Be sure the surgeon knows ahead of time that you are using this medication.

Store metformin and pioglitazone at room temperature away from moisture and heat.

You may be more likely to have hyperglycemia (high blood sugar) if you are taking metformin and pioglitazone with other drugs that raise blood sugar. Drugs that can raise blood sugar include:

• isoniazid;

• diuretics (water pills);

• steroids (prednisone and others);

• phenothiazines (Compazine and others);

• thyroid medicine (Synthroid and others);

• birth control pills and other hormones;

• seizure medicines (Dilantin and others); and

• diet pills or medicines to treat asthma, colds or allergies.

You may be more likely to have hypoglycemia (low blood sugar) if you are taking metformin and pioglitazone with other drugs that lower blood sugar. Drugs that can lower blood sugar include:

• nonsteroidal anti-inflammatory drugs (NSAIDs);

• aspirin or other salicylates (including Pepto-Bismol);

• sulfa drugs (Bactrim and others);

• a monoamine oxidase inhibitor (MAOI);

• beta-blockers (Tenormin and others); or

• probenecid (Benemid).

Some medications may interact with metformin and pioglitazone. Tell your doctor if you are using any of the following drugs:

• furosemide (Lasix);

• nifedipine (Adalat, Procardia);

• cimetidine (Tagamet) or ranitidine (Zantac);

• amiloride (Midamor) or triamterene (Dyrenium);

• digoxin (Lanoxin);

• morphine (MS Contin, Kadian, Oramorph);

• procainamide (Procan, Pronestyl, Procanbid);

• quinidine (Cardioquin, Quinidex, Quinaglute);

• trimethoprim (Proloprim, Primsol, Bactrim, Cotrim, Septra); or

• vancomycin (Vancocin, Lyphocin).

If you are using any of these drugs, you may not be able to take metformin and pioglitazone, or you may require a dosage adjustment or special monitoring.

There may be other drugs not listed that can affect metformin and pioglitazone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Avoid drinking alcohol while taking metformin and pioglitazone. Alcohol lowers blood sugar and may increase the risk of lactic acidosis while you are taking this medicine.

Seek emergency medical attention if you think you have used too much of this medicine. You may have signs of low blood sugar, such as hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast heartbeat, seizure (convulsions), fainting, or coma.

An overdose of metformin and pioglitazone may cause a life-threatening condition called lactic acidosis. Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.

Take the missed dose as soon as you remember (be sure to take the medicine with food). If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Do not use metformin and pioglitazone if you have kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Before taking metformin and pioglitazone, tell your doctor if you have congestive heart failure or heart disease, a history of heart attack or stroke, liver disease, or eye problems caused by diabetes.

Some people have developed a life-threatening condition called lactic acidosis while taking metformin and pioglitazone. Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking metformin and pioglitazone. Be sure the surgeon knows ahead of time that you are using this medication.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them, including hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast heartbeat, seizure (convulsions), fainting, or coma (severe hypoglycemia can be fatal). Always keep a source of sugar available in case you have symptoms of low blood sugar.

Some women using metformin and pioglitazone have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.

Some people have developed a life-threatening condition called lactic acidosis while taking metformin and pioglitazone. Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.

You may be more likely to develop lactic acidosis if you have congestive heart failure.

Do not use metformin and pioglitazone if you have kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Before taking this medication, tell your doctor if you have:

• congestive heart failure or heart disease;

• a history of heart attack or stroke;

• liver disease; or

• eye problems caused by diabetes.

If you have any of these conditions, you may not be able to use metformin and pioglitazone, or you may need a dosage adjustment or special tests during treatment.

Some women using metformin and pioglitazone have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether metformin and pioglitazone passes into breast milk or if it could harm a nursing baby. Do not take metformin and pioglitazone without first talking to your doctor if you are breast-feeding a baby.

Older adults may have a higher risk of developing lactic acidosis. Talk with your doctor about your individual risk.

Your pharmacist has more information about metformin and pioglitazone written for health professionals that you may read.

Metformin and pioglitazone is available with a prescription under the brand name Actoplus Met. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Actoplus Met 15 mg/500 mg (pioglitazone/metformin)–off white oval, film-coated tablets

• Actoplus Met 15 mg/850 mg (pioglitazone/metformin)–off white pink, oval, film-coated tablets