Metformin Hydrochloride, Rosiglitazone Maleate Oral tablet

What is this medicine?

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.

What should I tell my health care provider before I take this medicine?

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

• anemia
• become easily dehydrated
• frequently drink alcohol-containing beverages
• heart disease
• heart failure
• history of diabetic ketoacidosis
• kidney disease
• liver disease
• polycystic ovary syndrome
• serious infection or injury
• swelling of the arms, legs, or feet; water retention
• undergoing surgery or certain x-ray procedures with injectable contrast agents
• 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 medicine?

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 medicine?

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

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

This medicine may also interact with the following medications:

• amiloride
• digoxin
• diuretics
• female hormones, like estrogens or progestins and birth control pills
• gemfibrozil
• isoniazid
• medicines for blood pressure, heart disease, irregular heart beat
• morphine
• nicotinic acid
• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• phenytoin
• procainamide
• quinidine
• quinine
• ranitidine
• rifampin
• steroid medicines like prednisone or cortisone
• stimulant medicines for attention disorders, weight loss, or to stay awake
• thyroid medicines
• trimethoprim
• vancomycin

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 medicine?

Visit your doctor or health care professional for regular checks on your progress.

Your health care professional will have to check blood tests regularly to assess the effect of this medication on your liver.

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

If you have low blood sugar, eat or drink something that has sugar. Make sure others know to get medical help quickly if you have serious symptoms of low blood sugar, like if you become unconscious or have a seizure.

If you need surgery or if you will need a procedure with contrast drugs, tell your doctor or health care professional that you are taking this medicine.

Wear a medical identification bracelet or chain to say you have diabetes, and carry a card that lists all your medications.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• bone or joint pain
• chest pain or tightness
• dark urine
• dizziness
• fever, chills, sore throat
• low blood sugar (ask your doctor or healthcare professional for a list of these symptoms)
• muscle aches or pains
• nausea, vomiting, unusual stomach upset or pain
• pain that radiates to the jaw or down the arm
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• sudden weight gain
• swelling of the ankles, feet, hands
• unusually weak or tired
• yellowing of the eyes or skin

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

• backache
• headache
• high blood sugar
• injury
• fatigue
• slow weight gain

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 medicine?

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.

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.