Actoplus Met

Generic Name: metformin and pioglitazone (met FOR min and PYE o GLI ta zone)
Brand Names: Actoplus Met, Actoplus Met XR

What is Actoplus Met?

Actoplus Met contains a combination of metformin and pioglitazone, two oral diabetes medicines that help control blood sugar levels.

Actoplus Met is for people with type 2 diabetes who do not use daily insulin injections. This medication is not for treating type 1 diabetes.

Actoplus Met may also be used for purposes not listed in this medication guide.

Important information about Actoplus Met

You should not use Actoplus Met if you are allergic to metformin (Glucophage) or pioglitazone (Actos), or if you have kidney problems, severe heart failure, active bladder cancer, or metabolic acidosis. Do not use Actoplus Met if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Do not take Actoplus Met for longer than recommended. Taking pioglitazone for longer than 1 year (12 months) may increase your risk of developing bladder cancer. Talk with your doctor about your specific risk.

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If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking Actoplus Met.

Before taking Actoplus Met, tell your doctor if you have congestive heart failure or heart disease, a history of bladder cancer, a history of heart attack or stroke, liver disease, eye problems caused by diabetes, or if you are 80 years or older.

Some people can develop lactic acidosis while taking Actoplus Met. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

Before taking Actoplus Met

You should not use Actoplus Met if you are allergic to metformin (Glucophage) or pioglitazone (Actos), or if you have:

• kidney problems;

• severe heart failure;

• active bladder cancer; or

• metabolic acidosis.

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking Actoplus Met. Be sure your caregivers know ahead of time that you are using this medication.

To make sure you can safely take Actoplus Met, tell your doctor if you have any of these other conditions:

• congestive heart failure or heart disease, or a history of heart attack or stroke;

• liver disease;

• a history of bladder cancer;

• eye problems caused by diabetes; or

• if you are 80 years or older.

Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes.

Some women using Actoplus Met 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.

Women may also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking this medication. Talk with your doctor if you are concerned about this possibility.

Do not take this medicine for longer than recommended. Taking pioglitazone for longer than 1 year (12 months) may increase your risk of developing bladder cancer. Talk with your doctor about your specific risk.

FDA pregnancy category C. It is not known whether Actoplus Met will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether metformin and pioglitazone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while taking Actoplus Met.

See also: Actoplus Met pregnancy and breastfeeding warnings (in more detail)

Do not give this medication to anyone under 18 years old without medical advice.

Some people have developed a life-threatening condition called lactic acidosis while taking Actoplus Met. You may be more likely to develop lactic acidosis if you have liver or kidney disease, congestive heart failure, a severe infection, if you are dehydrated, or if you drink large amounts of alcohol. Talk with your doctor about your individual risk. Do not use Actoplus Met if you have kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

How should I take Actoplus Met?

Take Actoplus Met exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take Actoplus Met with meals. Take the extended-release (XR) tablet once daily with your evening meal. Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating.

Your doctor may want you to stop taking Actoplus Met for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.

Ask your doctor how to adjust your dose if needed. Do not change your medication dose or schedule without your doctor's advice.

If you take extra vitamin B12 while you are taking Actoplus Met, take only the amount of vitamin B12 that your doctor has prescribed.

Store Actoplus Met at room temperature away from moisture and heat.

See also: Actoplus Met dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take the medicine with food). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Actoplus Met?

Avoid drinking alcohol while taking Actoplus Met. It can lower your blood sugar and may increase your risk of lactic acidosis.

Actoplus Met side effects

Actoplus Met may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or irregular heart rate, dizziness, or feeling very weak or tired.

Get emergency medical help if you have any of these signs of an allergic reaction to Actoplus Met: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any other serious side effects while taking Actoplus Met, such as:

• stomach pain, blood in your urine, painful urination;

• feeling short of breath, especially when lying down;

• swelling or rapid weight gain;

• pale skin, feeling light-headed, rapid heart rate, trouble concentrating;

• sudden unusual pain in your hand, arm, or foot; or

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious Actoplus Met side effects may include:

• headache;

• diarrhea, upset stomach; or

• sneezing, runny nose, cough or other signs of a cold.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Actoplus Met side effects (in more detail)

What other drugs will affect Actoplus Met?

Tell your doctor about all other medicines you use, especially:

• bosentan (Tracleer);

• delavirdine (Rescriptor);

• digoxin (Lanoxin);

• gemfibrozil (Lopid);

• morphine (MS Contin, Kadian, Oramorph);

• tolbutamide (Orinase);

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

• vancomycin (Vancocin, Lyphocin);

• amiloride (Midamor), furosemide (Lasix), or triamterene (Dyrenium);

• cimetidine (Tagamet) or ranitidine (Zantac);

• fluconazole (Diflucan) or ketoconazole (Nizoral);

• nicardipine (Cardene) or nifedipine (Nifedical, Procardia);

• procainamide (Procan, Pronestyl, Procanbid), quinidine (Quin-G), or quinine (Qualaquin);

• rifampin (Rifater, Rifadin, Rifamate) or rifapentine (Priftin);

• a non-steroidal anti-inflammatory drug (NSAID) such as flurbiprofen (Ansaid), ibuprofen (Advil, Motrin), indomethacin (Indocin), mefenamic acid (Ponstel), or piroxicam (Feldene); or

• seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin), phenobarbital (Solfoton), primidone (Mysoline), and others.

You may be more likely to have hyperglycemia (high blood sugar) if you take Actoplus Met with other drugs that can raise blood sugar, such as:

• isoniazid;

• diuretics (water pills);

• steroids (prednisone and others);

• heart or blood pressure medication (Cartia, Cardizem, Covera, Isoptin, Verelan, and others);

• niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, 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.

These lists are not complete and there are many other medicines that can increase or decrease the effects of Actoplus Met on lowering your blood sugar. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about Actoplus Met.