Metformin Oral - SUSTAINED

Metformin Oral - SUSTAINED - ACTION TABLET

Warnings
Metformin can rarely cause a serious (sometimes fatal) condition called lactic acidosis. Stop taking metformin and seek immediate medical attention if you develop any of the following symptoms of lactic acidosis: unusual tiredness, severe drowsiness, chills, blue/cold skin, muscle pain, fast/difficult breathing, unusually slow/irregular heartbeat.

Lactic acidosis is more likely to occur in patients who have certain medical conditions, including kidney or liver disease, conditions that may cause a low oxygen blood level or poor circulation (e.g., severe congestive heart failure, recent heart attack, recent stroke), heavy alcohol use, a severe loss of body fluids (dehydration), X-ray or scanning procedures that require an injectable iodinated contrast drug, recent surgery, or a serious infection. Tell your doctor immediately if any of these conditions occur or if you notice a big change in your overall health. You may need to stop taking metformin temporarily. The elderly are also at higher risk, especially those older than 80 years who have not had kidney tests. (See also Side Effects and Precautions sections.)

Uses
Metformin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes (non-insulin-dependent diabetes). Controlling high blood sugar helps prevent heart disease, strokes, kidney disease, blindness, circulation problems, and decreased sexual ability. Metformin belongs to the class of drugs known as biguanides. It works by helping to restore your body's proper response to the insulin you naturally produce, and by decreasing the amount of sugar that your liver makes and that your stomach/intestines absorb.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Metformin may be used with lifestyle changes such as diet and exercise to prevent diabetes in people who are at high risk for becoming diabetic. It is also used in women with a certain disease of the ovaries (polycystic ovarian syndrome). By helping your body to respond better to insulin, metformin may decrease the risk of diabetes, make menstrual cycles more regular, and increase fertility.

How to use Metformin Oral

Read the Patient Information Leaflet if available from your pharmacist before you start using metformin and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth, usually once daily with the evening meal or as directed by your doctor. Drink plenty of fluids while taking this medication unless otherwise directed by your doctor.

Swallow this medication whole. Do not crush, chew, or break the tablets. Doing so can destroy the long action of the drug and may increase side effects.

The dosage is based on your medical condition and response to therapy. Your doctor may direct you to take a low dose at first, gradually increasing the dose to lower the chance of side effects such as upset stomach. Your doctor will adjust your dose based on your blood sugar levels to find the best dose for you. Follow your doctor's directions carefully.

If you are already taking another anti-diabetic drug (e.g., chlorpropamide), follow your doctor's directions carefully for stopping/continuing the old drug and starting metformin.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.

Inform your doctor if your condition persists or worsens (e.g., blood sugar levels are high). It may take up to 2 weeks before the full benefit of this drug takes effect.

Precautions

Before taking metformin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease, liver disease, conditions that may cause a low level of oxygen in the blood or poor circulation (e.g., severe congestive heart failure, recent heart attack, recent stroke), metabolic acidosis (e.g., diabetic ketoacidosis), serious infection, severe loss of body fluids (dehydration).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: adrenal/pituitary gland problems, severe breathing problems (e.g., obstructive lung disease, severe asthma), blood problems (e.g., anemia, vitamin B12 deficiency), fertility problems (e.g., ovulation problems), alcohol use.

Before having surgery or any X-ray/scanning procedure using injectable iodinated contrast material, tell your doctor that you are taking this medication. You will need to temporarily stop this medication before the time of your surgery/procedure. Consult your doctor for further instructions.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Use caution while driving, using machinery, or taking part in any other activity that requires clear vision and alertness.

Limit alcohol while using this medication to lower your risk of lactic acidosis.

It may be harder to control your blood sugar when your body is stressed (e.g., due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be a greater risk for side effects such as lactic acidosis or low blood sugar while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Your doctor may substitute insulin for this drug during your pregnancy. Follow your doctor's instructions carefully.

This medication can cause changes in the menstrual cycle (promote ovulation) and increase the risk of becoming pregnant. Consult your doctor or pharmacist about the use of reliable birth control while using this medication.

It is not known whether this drug passes into breast milk. This drug could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Additional Information

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Overdose can cause lactic acidosis and low blood sugar. Symptoms of overdose may include: rapid breathing, severe drowsiness, slow/irregular heartbeat.

NOTES:

Do not share this medication with others.

You should attend a diabetes education program to learn more about diabetes and all the important aspects of its treatment, including meals/diet, exercise, personal hygiene, medications, and getting regular eye/foot/medical exams.

Keep all medical appointments. Laboratory and/or medical tests (e.g., liver and kidney function tests, fasting blood glucose, hemoglobin A1c, complete blood counts) should be performed periodically to check for side effects and monitor your response to therapy. Check your blood sugar levels regularly as directed.

MISSED DOSE:

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE:

Store the US product between 68-77 degrees F (20-25 degrees C) away from light and moisture. Brief storage from 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT:
Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Side Effects

See also Warning section.

Nausea, stomach upset, diarrhea, or a metallic taste in the mouth may occur at first as your body adjusts to the medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If stomach symptoms return later (after you are on the same dose for several days or weeks), tell your doctor immediately. Stomach symptoms that occur after the first days of your treatment may be a sign of lactic acidosis.

An empty tablet shell may appear in your stool. This is harmless.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication does not usually cause low blood sugar (hypoglycemia). However, low blood sugar may occur, especially if you take other medications for diabetes, drink large amounts of alcohol, do unusually heavy exercise, or do not consume enough calories from food. Symptoms include cold sweat, blurred vision, dizziness, drowsiness, shaking, fast heartbeat, headache, fainting, tingling of the hands/feet, and hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor about the reaction immediately. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your dosage may need to be increased.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Interactions

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs that may affect the kidney's ability to remove metformin from the body (e.g., cimetidine, cephalexin), "water pills"/diuretics (e.g., furosemide, thiazide diuretics such as hydrochlorothiazide).

Many drugs can affect your blood sugar levels, making it more difficult to control your blood sugar. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor about the results and of any symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your anti-diabetic medication, exercise program, or diet.

Some medications (e.g., beta blockers such as propranolol) may mask the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of low blood sugar such as dizziness, hunger, or sweating are unaffected by these drugs.

Check the labels on nonprescription/herbal products carefully. Some products may contain sugar/alcohol and may affect blood sugars. Ask your doctor or pharmacist about using these products safely.

Cimetidine is a nonprescription drug that is commonly used to treat extra stomach acid. Because it may interact with metformin, ask your pharmacist about other products to treat stomach acid.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.