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|Fortomet Extended-Release Tablets

Fortomet Extended-Release Tablets

Fortomet Extended-Release Tablets is used for:

Treating type 2 diabetes. It is used along with diet and exercise. It may be used alone or with other antidiabetic medicines.

Fortomet Extended-Release Tablets is a biguanide antidiabetic. It works by decreasing the amount of sugar that the liver produces and the intestines absorb. It also helps to make your body more sensitive to the insulin that you naturally produce.

Do NOT use Fortomet Extended-Release Tablets if:

• you are allergic to any ingredient in Fortomet Extended-Release Tablets
• you have congestive heart failure that is treated by medicine
• you have a severe infection, low blood oxygen levels, kidney or liver problems, high blood ketone or acid levels (eg, diabetic ketoacidosis), or severe dehydration
• you have had a stroke or a recent heart attack, or you are in shock
• you are 80 years old or older and have not had a kidney function test
• you will be having surgery or certain lab procedures

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fortomet Extended-Release Tablets:

Some medical conditions may interact with Fortomet Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of heart problems (eg, heart failure), lung or breathing problems, thyroid problems, stomach or bowel problems (eg, paralysis, blockage), adrenal or pituitary problems, or lactic acidosis
• if you have vomiting, diarrhea, poor health or nutrition, low blood calcium or vitamin B₁₂ levels, or anemia, or if you are dehydrated
• if you have an infection, fever, recent injury, or moderate to severe burns
• if you drink alcohol or have a history of alcohol abuse
• if you will be having surgery or certain lab procedures
• if you take a beta-blocker (eg, propranolol)

Some MEDICINES MAY INTERACT with Fortomet Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Amiloride, cimetidine, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin because they may increase the risk of Fortomet Extended-Release Tablets"s side effects
• Calcium channel blockers (eg, nifedipine), corticosteroids (eg, prednisone), diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), insulin, isoniazid, nicotinic acid, phenothiazine (eg, chlorpromazine), phenytoin, sulfonylureas (eg, glipizide), sympathomimetics (eg, albuterol, pseudoephedrine), or thyroid hormones (eg, levothyroxine) because the risk of high or low blood sugar may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fortomet Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fortomet Extended-Release Tablets:

Use Fortomet Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Fortomet Extended-Release Tablets. Talk to your pharmacist if you have questions about this information.
• Take Fortomet Extended-Release Tablets by mouth with the evening meal unless your doctor tells you otherwise.
• Swallow Fortomet Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
• Drinking extra fluids while you are taking Fortomet Extended-Release Tablets is recommended. Check with your doctor for instructions.
• Take Fortomet Extended-Release Tablets on a regular schedule to get the most benefit from it. Taking Fortomet Extended-Release Tablets at the same time each day will help you remember to take it.
• Continue to take Fortomet Extended-Release Tablets even if you feel well. Do not miss any doses.
• If you miss a dose of Fortomet Extended-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Fortomet Extended-Release Tablets.

Important safety information:

• Fortomet Extended-Release Tablets may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Fortomet Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Follow the diet and exercise program given to you by your health care provider.
• Do not drink large amounts of alcohol while you use Fortomet Extended-Release Tablets. Talk to your doctor or health care provider before you drink alcohol while you use Fortomet Extended-Release Tablets.
• Tell your doctor or dentist that you take Fortomet Extended-Release Tablets before you receive any medical or dental care, emergency care, or surgery.
• If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
• You may notice undissolved parts of Fortomet Extended-Release Tablets in your stool. This is normal and not a cause for concern.
• Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Fortomet Extended-Release Tablets exactly as prescribed, tell your doctor.
• Fortomet Extended-Release Tablets does not usually lower your blood sugar levels. Low blood sugar may be more likely to occur if you skip a meal, exercise heavily, or drink alcohol. It may also be more likely if you take Fortomet Extended-Release Tablets along with certain medicines for diabetes (eg, sulfonylureas, insulin). It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
• Fever, infection, injury, or surgery may increase your risk for high or low blood sugar levels. If any of these occur, check your blood sugar closely and tell your doctor right away.
• Fortomet Extended-Release Tablets may commonly cause stomach upset, indigestion, nausea, vomiting, or diarrhea at the beginning of treatment. If you develop unusual or unexpected stomach problems, or if you develop stomach problems later during treatment, contact your doctor at once. This may be a sign of lactic acidosis.
• Lab tests, including kidney function, fasting blood glucose, hemoglobin A_1c, and blood counts, may be performed while you use Fortomet Extended-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Fortomet Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects. Low blood sugar levels may also be more difficult to recognize in the elderly.
• Fortomet Extended-Release Tablets should not be used in CHILDREN younger than 17 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fortomet Extended-Release Tablets while you are pregnant. It is not known if Fortomet Extended-Release Tablets is found in breast milk. Do not breast-feed while taking Fortomet Extended-Release Tablets.

When used for long periods of time, Fortomet Extended-Release Tablets may not work as well. If your blood sugar has been under control and then becomes hard to manage, contact your doctor. Do not change the dose of your medicine without checking with your doctor.

Possible side effects of Fortomet Extended-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; gas; headache; indigestion; nausea; stomach pain or upset; temporary metallic taste; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or discomfort; dizziness or lightheadedness; fast or difficult breathing; feeling of being unusually cold; fever, chills, or persistent sore throat; general feeling of being unwell; muscle pain or weakness; slow or irregular heartbeat; unusual drowsiness; unusual or persistent stomach pain or discomfort; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include dizziness or lightheadedness; fast or difficult breathing; feeling of being unusually cold; general feeling of being unwell; muscle pain or tenderness; slow or irregular heartbeat; unusual drowsiness; unusual stomach discomfort; unusual weakness or tiredness.

Store Fortomet Extended-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fortomet Extended-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Fortomet Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Fortomet Extended-Release Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Fortomet Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.