Pioglitazone/metformin (geneic ACTOPLUS) 15/850mg x30s Tablets

Pioglitazone/metformin {generic-ACTOPLUS} Tablets

Patient Education - English

• Generic Name: metformin and pioglitazone

• Pronounced: met FOR min and PYE o GLI ta zone

• Brand Names: Actoplus Met, Actoplus Met XR

What is the most important information I should know about metformin and pioglitazone?

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

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 metformin and pioglitazone. Be sure your caregivers know ahead of time that you are using this medication.

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, eye problems caused by diabetes, or if you are 80 years or older.

Some people develop lactic acidosis while taking metformin and pioglitazone. 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 irregular heart rate, dizziness, or feeling very weak or tired.

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.

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.

What is metformin and pioglitazone?

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 other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking metformin and pioglitazone?

Some people develop a life-threatening condition called lactic acidosis while taking metformin and pioglitazone. 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 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). You should not use this medication if you are allergic to metformin (Glucophage) or pioglitazone (Actos), or if you have:

• kidney problems;
• severe heart failure; 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 metformin and pioglitazone. Be sure your caregivers know ahead of time that you are using this medication.

If you have any of these other conditions, you may need a dose adjustment or special tests:

• congestive heart failure or heart disease;
• a history of heart attack or stroke;
• liver disease;
• eye problems caused by diabetes; or
• if you are 80 years or older.

Taking 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 with metformin and pioglitazone.

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. It is not known whether metformin and pioglitazone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

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 this medication.

How should I take metformin and pioglitazone?

Take 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. Your doctor may occasionally change your dose to make sure you get the best results.

Take metformin and pioglitazone 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.

Your dose needs may change if you become ill, have a fever or infection, or if you have surgery or a medical emergency. 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, or fainting (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.

Metformin and pioglitazone is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, and eye care. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Store at room temperature away from moisture and heat.

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. 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.

What should I avoid while taking metformin and pioglitazone?

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.

What are the possible side effects of metformin and pioglitazone?

This medication 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: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any other serious side effects, such as:

• feeling short of breath, especially when lying down;
• swelling or rapid weight gain;
• vision changes;
• 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 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.

What other drugs will affect metformin and pioglitazone?

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:

• insulin or other oral diabetes medications;
• 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 (Quin-G);
• trimethoprim (Proloprim, Primsol, Bactrim, Cotrim, Septra); or
• vancomycin (Vancocin, Lyphocin).

This list is not complete and other drugs may interact with metformin and pioglitazone. 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 metformin and pioglitazone.

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Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.