Patients should be informed of the potential risks and benefits
of GLUMETZA and of alternative modes of therapy. They should also be informed
about the importance of adherence to dietary instructions, of a regular exercise
program, and of regular testing of blood glucose, glycosylated hemoglobin, renal
function, and hematologic parameters.
The risks of lactic acidosis, its symptoms, and conditions
that predispose to its development, as noted in the GLUMETZA sections, should
be explained to patients. Patients should be advised to discontinue GLUMETZA
immediately and to promptly notify their health practitioner if unexplained
hyperventilation, myalgia, malaise, unusual somnolence, or other nonspecific
symptoms occur. Once a patient is stabilized on any dose level of GLUMETZA,
gastrointestinal symptoms, which are common during initiation of metformin therapy,
are unlikely to be drug related. Later occurrence of gastrointestinal symptoms
could be due to lactic acidosis or other serious disease. Patients should be
counseled against excessive alcohol intake, either acute or chronic, while receiving
GLUMETZA. GLUMETZA(metformin hydrochloride extended-release tablets) alone does
not usually cause hypoglycemia, although it may occur when GLUMETZA is used
in conjunction with oral sulfonylureas and insulin. When initiating combination
therapy, the risks of hypoglycemia, its symptoms and treatment, and conditions
that predispose to its development should be explained to patients and responsible
Patients should be informed that GLUMETZA must be swallowed
whole and not crushed or chewed, and that the inactive ingredients may occasionally
be eliminated in the feces as a soft mass that may resemble the original tablet.
GLUMETZA (Gloo-met-za) (metformin hydrochloride extended-release
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 doctors 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 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
feel very weak or tired.
have unusual (not normal) muscle pain.
have trouble breathing.
have stomach pain with nausea and vomiting, or diarrhea.
feel cold, especially in your arms and legs.
feel dizzy or lightheaded.
have a slow or irregular heartbeat.
medical condition suddenly changes.
You have a higher chance for getting lactic acidosis with GLUMETZA
· 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 dont drink enough fluids.
· have certain x-ray tests
with injectable dye used
· have surgery
· have a heart attack, severe
infection, or a stroke
· are 80 years of age of
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
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
· are allergic to GLUMETZA
or to any of its ingredients. See the end of this leaflet for a list of ingredients
What should I tell my doctor before taking GLUMETZA?
Tell your doctor about all of your medical conditions including
· 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
· 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.
GLUMETZA once a day in the evening with food.
· Swallow GLUMETZA tables
whole. Never crush 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
· 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.
you miss a dose of GLUMETZA resume dosing according to schedule.
you take too much GLUMETZA or overdose, call your doctor or poison control center
· 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 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 condition, called
lactic acidosis (a buildup of an acid in the 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 you doctor or pharmacist.
How should I store GLUMETZA?
GLUMETZA at room temperature, 59° to 86° F (15° to 30° C).
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-BIOVAIL (246-799-8245), option 3.
You can also visit email@example.com for additional information.
What are the ingredients in GLUMETZA?
Active Ingredient: 500 mg or 1000 mg of metformin HCL
Inactive Ingredients: Each 500 mg tablets contain coloring,
hypromellose, magnesium stearate, microcrystalline cellulose and polyethylene
oxide. Each 1000 mg tablet contains crospovidone, dibutyl sebacate, ethylcellulose,
glyceryl behenate, polyvinyl alcohol, polyvinylpyrrolidone, and silicon dioxide.
GLUMETZA 500 and 1000 mg tablets both utilize advanced, polymer-based, oral
drug delivery systems, which allow delivery of metformin HCL to the upper GI