Pioglitazone; Metformin Extended Release Tablets

What is this medication?

PIOGLITAZONE; METFORMIN (pye oh GLI ta zone; met FOR min) treats type 2 diabetes. It works by decreasing your blood sugar (glucose). Changes to diet and exercise are often combined with this medication.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Actoplus Met XR

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Anemia
• Bladder cancer
• Dehydration
• Eye disease, vision problems
• Heart disease
• Heart failure
• If you often drink alcohol
• Kidney disease
• Liver disease
• Polycystic ovary syndrome
• Serious infection or injury
• Vomiting
• An unusual or allergic reaction to pioglitazone, metformin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Take this medication with food. Swallow whole, do not crush or chew. Take your doses at regular intervals. Do not take your medication more often than directed. Do not stop taking except on your care team's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following medications:

• Certain contrast medications given before X-rays, CT scans, MRI, or other procedures
• Dofetilide

This medication may also interact with the following medications:

• Acetazolamide
• Alcohol
• Atorvastatin
• Certain antivirals for HIV or hepatitis
• Certain medications for blood pressure, heart disease, irregular heart beat
• Cimetidine
• Dichlorphenamide
• Digoxin
• Diuretics
• Female hormones, like estrogens or progestins and birth control pills
• Gemfibrozil
• Glycopyrrolate
• Insulin
• Isoniazid
• Ketoconazole
• Lamotrigine
• Memantine
• Methazolamide
• Metoclopramide
• Midazolam
• Midodrine
• Niacin
• Phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• Phenytoin
• Ranitidine
• Ranolazine
• Rifampin
• Steroid medications like prednisone or cortisone
• Stimulant medications for attention disorders, weight loss, or to stay awake
• Thyroid medications
• Topiramate
• Trimethoprim
• Trospium
• Vandetanib
• Zonisamide

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. You may need regular tests to make sure your liver is working properly.

A test called the HbA1C (A1C) will be monitored. This is a simple blood test. It measures your blood sugar control over the last 2 to 3 months. You will receive this test every 3 to 6 months.

Learn how to check your blood sugar. Learn the symptoms of low and high blood sugar and how to manage them.

Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. They must get medical help at once.

Tell your care team if you have high blood sugar. You might need to change the dose of your medication. If you are sick or exercising more than usual, you might need to change the dose of your medication.

Do not skip meals. Ask your care team if you should avoid alcohol. Many nonprescription cough and cold products contain sugar or alcohol. These can affect blood sugar.

This medication may increase your risk of having certain heart problems. Get medical help right away if you have any chest pain or tightness, or pain that radiates to the jaw or down the arm, and shortness of breath. These may be signs of a serious medical condition.

The tablet shell for some brands of this medication does not dissolve. This is normal. The tablet shell may appear whole in the stool. This is not a cause for concern.

This medication may cause ovulation in premenopausal women who do not have regular monthly periods. This may increase your chances of becoming pregnant. You should not take this medication if you become pregnant or think you may be pregnant. Talk with your care team about your birth control options while taking this medication. Contact your care team right away if you think you are pregnant.

If you are going to need surgery, an MRI, CT scan, or other procedure, tell your care team that you are taking this medication. You may need to stop taking this medication before the procedure.

Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medication and dosage times.

This medication may cause a decrease in folic acid and vitamin B12. You should make sure that you get enough vitamins while you are taking this medication. Discuss the foods you eat and the vitamins you take with your care team.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Change in vision such as blurry vision, seeing halos around lights, vision loss
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• High lactic acid level—muscle pain or cramps, stomach pain, trouble breathing, general discomfort and fatigue
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low vitamin B12 level—pain, tingling, or numbness in the hands or feet, muscle weakness, dizziness, confusion, trouble concentrating
• Red or dark brown urine, pain or trouble when passing urine, passing frequent amounts of urine

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Diarrhea
• Headache
• Nausea
• Runny or stuffy nose

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement for a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.