Metformin; Rosiglitazone tablet

What is this medication?

METFORMIN; ROSIGLITAZONE (met FOR min; roe si GLI ta zone) is a combination medicine used to treat type 2 diabetes. It helps to control blood sugar. Treatment is combined with diet and exercise.

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

COMMON BRAND NAME(S): Avandamet

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

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

• anemia
• 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 metformin, rosiglitazone, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine with meals. Take your medicine at the same time each day. Do not take more often than directed.

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 pediatrician regarding the use of this medicine in children. Special care may be needed.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

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 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 medicine with any of the following medications:

• certain contrast medicines given before X-rays, CT scans, MRI, or other procedures
• dofetilide

This medicine may also interact with the following medications:

• acetazolamide
• alcohol
• certain antivirals for HIV or hepatitis
• certain medicines for blood pressure, heart disease, irregular heart beat
• cimetidine
• dichlorphenamide
• digoxin
• diuretics
• female hormones, like estrogens or progestins and birth control pills
• gemfibrozil
• glycopyrrolate
• isoniazid
• lamotrigine
• memantine
• methazolamide
• metoclopramide
• midodrine
• niacin
• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• phenytoin
• ranolazine
• rifampin
• steroid medicines like prednisone or cortisone
• stimulant medicines for attention disorders, weight loss, or to stay awake
• thyroid medicines
• topiramate
• 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 doctor or health care professional 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 doctor or health care professional if you have high blood sugar. You might need to change the dose of your medicine. If you are sick or exercising more than usual, you might need to change the dose of your medicine.

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

This medicine 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.

This medicine 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 medicine if you become pregnant or think you may be pregnant. Talk with your doctor or health care professional about your birth control options while taking this medicine. Contact your doctor or health care professional right away if you think you are pregnant.

If you are going to need surgery, a MRI, CT scan, or other procedure, tell your doctor that you are taking this medicine. You may need to stop taking this medicine before the procedure.

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

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

What side effects may I notice from receiving this medication?

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• changes in vision
• feeling faint or lightheaded, falls
• muscle aches or pains
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• signs and symptoms of heart failure like breathing problems, fast, irregular heartbeat, sudden weight gain; swelling of the ankles, feet, hands; unusually weak or tired
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• signs and symptoms of low blood sugar such as feeling anxious, confusion, dizziness, increased hunger, unusually weak or tired, sweating, shakiness, cold, irritable, headache, blurred vision, fast heartbeat, loss of consciousness
• slow or irregular heartbeat
• unusual stomach pain or discomfort

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

• diarrhea
• gas
• headache
• heartburn
• metallic taste in mouth
• nausea
• stuffy or runny nose
• upset stomach

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.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture and light. Throw away any unused medicine after the expiration date.

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.