Metformin; Rosiglitazone tablet

What are Metformin; Rosiglitazone tablets?

METFORMIN; ROSIGLITAZONE (Avandamet™) is a combination medicine used to treat type 2 diabetes mellitus. Drug therapy for diabetes should be combined with a balanced diet, weight loss and exercise. This medicine lowers blood sugar and helps your body to use insulin more efficiently. Generic metformin; rosiglitazone tablets are not yet available.

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

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

• frequently drink alcohol or alcohol-containing beverages

• become easily dehydrated

• heart attack or other heart problems

• heart failure that is treated with medications

• history of diabetic ketoacidosis (DKA)

• hormone changes or problems

• kidney disease

• liver disease

• polycystic ovaries

• serious infection or injury

• swelling of the arms, legs, or feet; water retention

• thyroid disease

• use insulin

• undergoing surgery or certain x-ray procedures with injectable contrast agents

• an unusual reaction to metformin; rosiglitazone, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should this medicine be used?

Take metformin; rosiglitazone tablets by mouth, with meals. Follow the directions on the prescription label. Swallow the tablets with a drink of water. Take your doses at the same time each day; do not take more often than directed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

Patients over 65 years old may need a smaller dose than younger adults.

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 drug(s) may interact with Metformin; Rosiglitazone?

• adefovir

• cephalexin

• cimetidine

• digoxin

• dofetilide

• entecavir

• insulin

• itraconazole

• ketoconazole

• lamivudine

• montelukast

• nitrates like amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin

• morphine

• nifedipine

• other medicines for diabetes

• procainamide

• propantheline

• quinidine

• quinine

• ranitidine

• rifampin

• trimethoprim

• trospium

• vancomycin

• vitamin B12, cyanacobalamin

• water pills

Many medications may cause changes (increase or decrease) in blood sugar, these include:

• alcohol-containing beverages

• angiotensin converting enzyme inhibitors (ACE inhibitors), often used for high blood pressure or heart problems (examples: captopril, enalapril, lisinopril)

• antiretroviral protease inhibitors (examples: indinavir, ritonavir, saquinavir)

• aspirin and aspirin-like drugs

• baclofen

• beta-blockers, often used for high blood pressure or heart problems (examples: atenolol, metoprolol, propranolol)

• calcium channel blockers, often used for high blood pressure or heart problems (examples: amlodipine, nifedipine)

• certain medicines used for mental depression, emotional, or psychotic disturbances

• chromium

• cisapride

• clonidine

• cyclosporine

• diazoxide

• disopyramide

• epinephrine

• female hormones, such as estrogens or progestins, birth control pills

• fibric acid derivatives, used to treat high cholesterol (examples: fenofibrate and gemfibrozil)

• glucagon

• growth hormone (somatropin)

• guanethidine

• isoniazid

• lithium

• metoclopramide

• male hormones or anabolic steroids

• medications to suppress appetite or for weight loss

• medicines for allergies, asthma, cold, or cough

• niacin

• nicotine (including nicotine found in patches and gum)

• octreotide

• pentamidine

• phenytoin

• quinolone antibiotics (examples: ciprofloxacin, levofloxacin, ofloxacin)

• some herbal dietary supplements

• steroid medicines such as prednisone or cortisone

• sulfonamides, medicines for infection (examples: Azulfidine®, Bactrim®, Gantrisin® Septra®)

• tacrolimus

• tegaserod

• thyroid hormones

• water pills (diuretics)

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking Metformin; Rosiglitazone?

Contact your health care professional if you experience symptoms of low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia).

Visit your prescriber or health care professional for regular checks on your progress. Your prescriber will check your blood sugar, kidney function, liver function and other tests from time to time.

Learn how to monitor blood or urine sugar and urine ketones regularly. Do not skip meals. If you are exercising much more than usual you may need extra snacks to avoid side effects caused by low blood sugar. If you have mild symptoms of low blood sugar, eat or drink something containing sugar at once and contact your prescriber or health care professional. It is wise to check your blood sugar to confirm that it is low. It is important to recognize your own symptoms of low blood sugar so that you can treat them quickly. Make sure family members know that you can choke if you eat or drink when you have serious symptoms of low blood sugar, such as seizures or unconsciousness. They must get medical help at once.

If you develop severe diarrhea, nausea or vomiting, or are unable to maintain proper fluid intake, you should contact your prescriber. 'Sick-days' may require adjustments to your dosage or your illness may need to be evaluated. Ask your prescriber what you should do if you become ill.

If you are going to have surgery or will need an x-ray procedure that uses contrast agents, tell your prescriber or health care professional that you are taking this medicine.

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

What side effects may I notice from receiving Metformin; Rosiglitazone?

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

• anxiety or nervousness, confusion, difficulty concentrating

• blurred vision

• breathing difficulties or shortness of breath

• cold sweats, increased sweating

• cool, pale skin

• dark yellow or brown urine, or yellowing of the eyes or skin

• dizziness

• muscle aches or pains

• passing out or fainting

• rapid gain in weight

• severe vomiting or prolonged diarrhea

• skin rash or hives

• slow or irregular heartbeat

• swelling of the hands, legs, and/or feet

• tremors or shakiness

• unusual stomach pain or discomfort

• unusual fatigue, tiredness or weakness

Symptoms of low blood sugar (hypoglycemia). Know the symptoms of low blood sugar, so that you can quickly treat them; which may include:

• anxiety or nervousness, confusion, difficulty concentrating, hunger, pale skin, nausea, fatigue, sweating, headache, palpitations, numbness of the mouth, tingling in the fingers, tremors, muscle weakness, blurred vision, cold sensations, uncontrolled yawning, irritability, rapid heartbeat, shallow breathing, and loss of consciousness. Hypoglycemia may cause you to not be aware of your actions or surroundings if it is severe, so you should let others know what to do if you cannot help yourself in a severe reaction.

Symptoms of high blood sugar (hyperglycemia) include:

• dizziness, dry mouth, flushed dry-skin, loss of appetite, nausea, stomach cramping, unusual thirst, frequent passing of urine

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

• backache

• decreased appetite

• diarrhea

• gas

• headache

• heartburn

• metallic taste in the mouth

• slow weight gain

• weight loss

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

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.