Glumetza

PATIENT INFORMATION
Rx Only

GLUMETZA (Gloo-met-za) (metformin hydrochloride extended-release tablets)

Read this information carefully before you start taking this medicine and each time you refill your prescription. There may be new information. This information does not take the place of your doctor's advice. Ask your doctor or pharmacist if you do not understand some of this information or if you want to know more about this medicine.

What is the most important information I should know about GLUMETZA?

Warning: GLUMETZA can cause a rare, but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital. Stop taking GLUMETZA and call your doctor right away if you get the following symptoms of lactic acidosis.

You feel very weak or tired.

You have unusual (not normal) muscle pain.

You have trouble breathing.

You have stomach pain with nausea and vomiting, and diarrhea.

You feel cold, especially in your arms and legs.

You feel dizzy or lightheaded.

You have a slow or irregular heartbeat.

Your medical condition suddenly changes.

You have a higher chance for getting lactic acidosis with GLUMETZA if you:

have kidney or liver problems.

have congestive heart failure that requires treatments with medicines.

drink a lot of alcohol (very often or short-term "binge" drinking).

get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and don't drink enough fluids.

have certain x-ray test with injectable dye used.

have surgery.

have a heart attack, severe infection, or a stroke.

are 80 years of age or older and have not had your kidney function tested.

What is GLUMETZA?

GLUMETZA is used along with diet and exercise to improve blood sugar control in adults with type 2 diabetes. GLUMETZA may also be used with another anti-diabetes medicine called a sulfonylurea or with insulin to improve blood sugar levels in adults. GLUMETZA helps control your blood sugar in a number of ways. These include helping your body respond better to the insulin it makes naturally, decreasing the amount of sugar your liver makes, and decreasing the amount of sugar your intestines absorb. GLUMETZA has not been studied in children under 18 years of age.

Who should not take GLUMETZA?

Do not take GLUMETZA if you:

have kidney problems.
have heart failure that is treated with medicines.
have a condition called metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin.
are allergic to GLUMETZA or to any of its ingredients. See the end of this leaflet for a list of ingredients in GLUMETZA.

What should I tell my doctor before taking GLUMETZA?
Tell your doctor about all of your medical conditions including if you:

have kidney problems.
have liver problems.
have heart problems.
drink a lot of alcohol.
are pregnant or planning to become pregnant. It is not known if GLUMETZA can harm your unborn baby. Talk to your doctor about the best way to control your blood sugar levels while pregnant.
are breastfeeding. It is not known if GLUMETZA passes into your milk and if it can harm your baby. Talk to your doctor about the best way to feed your baby while taking GLUMETZA.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. GLUMETZA and some of your other medicines can interact. You may need to have the dose of GLUMETZA or certain other medicines adjusted. Certain other medicines can affect your blood sugar control.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist. Talk to your doctor before you start any new medicine.

How should I take GLUMETZA?

Take GLUMETZA exactly as prescribed. Your doctor will usually start you on a low dose and increase your dose slowly to control your blood sugar levels. Do not change your dose unless told to do so by your doctor.
Take GLUMETZA once a day in the evening with food.
Swallow GLUMETZA tablets whole. Never crush, split or chew GLUMETZA tablets. Tell your doctor if you cannot swallow tablets whole. Your doctor will prescribe a different medicine for you.
You may see the GLUMETZA tablet shell in your stool. You may also see a soft mass of the GLUMETZA inactive ingredients in your stool. Both of these are normal to see in your stool.
Stay on your exercise and diet program and test your blood sugar regularly while taking GLUMETZA.
Your doctor should monitor your diabetes and do blood tests on you from time to time to check your kidneys and your liver.
If you miss a dose of GLUMETZA resume dosing according to schedule.
If you take too much GLUMETZA or overdose, call your doctor or poison control center right away.
You may need to stop GLUMETZA for a short period of time if you:
- are sick with severe vomiting, diarrhea or fever, or if you drink a much lower amount of liquid than normal.
- plan to have surgery.
- are having an x-ray procedure with an injection of dye.

Call your doctor right away for instructions.

What should I avoid while taking GLUMETZA?

Do not drink a lot of alcoholic drinks while taking GLUMETZA. This means you should not binge drink for short periods, and you should not drink a lot of alcohol on a regular basis. Alcohol can increase the chance of getting lactic acidosis.

What are the side effects of GLUMETZA?

GLUMETZA can cause a rare, but serious side effect called lactic acidosis (a buildup of an acid in your blood) that can cause death. See "What is the most important information I should know about GLUMETZA?"

The most common side effects of GLUMETZA include diarrhea, nausea, and upset stomach. These side effects usually go away after you take the medicine for a while. Taking your medicine with the evening meal can help reduce these side effects.

GLUMETZA rarely causes low blood sugar (hypoglycemia) by itself. However, low blood sugar can happen if you do not eat enough, if you drink alcohol, or if you take other medicines to lower blood sugar.

Tell your doctor if you have side effects that bother you, last for more than a few weeks, come back after they have gone away, or start later in therapy. You may need a lower dose or need to stop taking GLUMETZA.

These are not all the side effects with GLUMETZA. For more information, ask your doctor or pharmacist.

How should I store GLUMETZA?

Store GLUMETZA at room temperature, 59° to 86° F (15° to 30° C).
Keep GLUMETZA and all medicines out of the reach of children.

General information about GLUMETZA.

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use GLUMETZA for a condition for which it was not prescribed. Do not give GLUMETZA to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about GLUMETZA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about GLUMETZA that is written for health professionals or contact 1-866-458-6389.

What are the ingredients in GLUMETZA?

Active Ingredient: 500 mg or 1000 mg of metformin HCL
Inactive Ingredient: Each 500 mg tablet contains coloring, hypromellose, magnesium stearate, microcrystalline cellulose and polyethylene oxide. Each 1000 mg tablet contains colloidal silicon dioxide, polyvinyl alcohol, crospovidone, glyceryl behenate, polyacrylate dispersion, hypromellose, talc, polyethylene glycol, titanium dioxide, simethicone emulsion, polysorbate and coloring. GLUMETZA 500 mg and 1000 mg tablets both utilize advanced, polymer-based, oral drug delivery systems, which allow delivery of metformin HCL to the upper GI tract.

Important Safety Considerations

GLUMETZA® (metformin hydrochloride extended release tablets) is indicated as an adjunct to diet and exercise to improve glycemic control in patients 18 years of age and older with type 2 diabetes.

Lactic Acidosis:
Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with GLUMETZA; when it occurs, it is fatal in approximately 50% of cases. Lactic acidosis may also occur in association with a number of pathophysiologic conditions, including diabetes mellitus, and whenever there is significant tissue hypoperfusion and hypoxemia. Lactic acidosis is characterized by elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio. When metformin is implicated as the cause of lactic acidosis, metformin plasma levels >5 µg/mL are generally found. The reported incidence of lactic acidosis in patients receiving metformin hydrochloride is very low (approximately 0.03 cases/1000 patient-years, with approximately 0.015 fatal cases/1000 patient-years). In more than 20,000 patient-years exposure to metformin in clinical trials, there were no reports of lactic acidosis. Reported cases have occurred primarily in diabetic patients with significant renal insufficiency, including both intrinsic renal disease and renal hypoperfusion, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications. Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure who are at risk of hypoperfusion and hypoxemia, are at increased risk of lactic acidosis. The risk of lactic acidosis increases with the degree of renal dysfunction and the patient’s age. The risk of lactic acidosis may, therefore, be significantly decreased by regular monitoring of renal function in patients taking GLUMETZA and by use of the minimum effective dose of GLUMETZA. In particular, treatment of the elderly should be accompanied by careful monitoring of renal function. GLUMETZA treatment should not be initiated in patients ≥ 80 years of age unless measurement of creatinine clearance demonstrates that renal function is not reduced, as these patients are more susceptible to developing lactic acidosis. In addition, GLUMETZA should be promptly withheld in the presence of any condition associated with hypoxemia, dehydration, or sepsis. Because impaired hepatic function may significantly limit the ability to clear lactate, GLUMETZA should generally be avoided in patients with clinical or laboratory evidence of hepatic disease. Patients should be cautioned against excessive alcohol intake, either acute or chronic, when taking GLUMETZA , since alcohol potentiates the effects of metformin hydrochloride on lactate metabolism. In addition, GLUMETZA should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure (See also PRECAUTIONS). The onset of lactic acidosis often is subtle, and accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. These may be associated hypothermia, hypotension, and resistant bradyarrhythmias with more marked acidosis.

The patient and the patient’s physician must be aware of the possible importance of such symptoms and the patient should be withdrawn until the situation is clarified. Serum electrolytes, ketones, blood glucose and, if indicated, blood pH, lactate levels, and even blood metformin levels may be useful. Once a patient is stabilized on any dose level of GLUMETZA, gastrointestinal symptoms, which are common during initiation of therapy, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease. Levels of fasting venous plasma lactate above the upper limit of normal but less than 5 mmol/L in patients taking GLUMETZA do not necessarily indicate impending lactic acidosis and may be explainable by other mechanisms, such as poorly controlled diabetes or obesity, vigorous physical activity, or technical problems in sample handling. (See also PRECAUTIONS.) Lactic acidosis should be suspected in any diabetic patient with metabolic acidosis lacking evidence of ketoacidosis (ketonuria and ketonemia). Lactic acidosis is a medical emergency that must be treated in a hospital setting. In a patient with lactic acidosis who is taking GLUMETZA, the drug should be discontinued immediately and general supportive measures promptly instituted. Because metformin hydrochloride is dialyzable (with a clearance of up to 170 mL/min under good hemodynamic conditions), prompt hemodialysis is recommended to correct the acidosis and remove the accumulated metformin. Such management often results in prompt reversal of symptoms and recovery. (See also CONTRAINDICATIONS and PRECAUTIONS.)

GLUMETZA® is contraindicated in patients with renal dysfunction, known hypersensitivity to metformin HCl or metabolic acidosis, including diabetic ketoacidosis. Use of concomitant medications that affect renal function or hemodynamic change may interfere with the disposition of metformin and should be used with caution. Hypoglycemia does not occur in patients receiving GLUMETZA® alone but could occur in deficient caloric intake or during concomitant use with other glucose-lowering agents or ethanol. Loss of glycemic control may occur when a stabilized patient is exposed to stress. In clinical trials, of GLUMETZA® combined with a sulfonylurea, the most common side effects included hypoglycemia, diarrhea, and nausea.

Please see accompanying full Prescribing Information.

Information for Vermont prescribers of prescription drugs. Vermont prescribers of GLUMETZA® may access average wholesale price information in accordance with Vermont law 33 V.S.A. § 2005a through www.vtrxlaw.com