"The U.S. Food and Drug Administration today approved Farxiga (dapaglifozin) tablets to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
Type 2 diabetes affects about 24 million people and accounts for "...
(metformin hydrochloride) Extended-release Tablets
Read the patient information that comes with GLUMETZA 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 talking with your doctor about your medical condition or treatment. 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?
Serious side effects can happen in people taking GLUMETZA, including:
Lactic Acidosis. Metformin hydrochloride, the medicine in 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 any of the following symptoms of lactic acidosis:
- feel very weak or tired
- have unusual (not normal) muscle pain
- have trouble breathing
- have unusual sleepiness or sleep longer than usual
- have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea
- feel cold, especially in your arms and legs
- feel dizzy or lightheaded
- have a slow or irregular heartbeat
You have a higher chance for getting lactic acidosis with GLUMETZA if you:
- have kidney problems. People whose kidneys are not working properly should not take GLUMETZA.
- have 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 do not drink enough fluids.
- have certain x-ray tests with injectable dyes or contrast agent
- have surgery
- have a heart attack, severe infection, or stroke
What is GLUMETZA?
- GLUMETZA is a prescription medicine that contains metformin hydrochloride used with diet and exercise to help control high blood sugar in adults with type 2 diabetes.
- GLUMETZA is not for people with type 1 diabetes.
- GLUMETZA is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).
It is not known if GLUMETZA is safe and effective in children younger than 18 years old.
Who should not take GLUMETZA?
Do not take GLUMETZA if you:
- have kidney problems
- are allergic to the metformin hydrochloride in GLUMETZA or any of the ingredients in GLUMETZA. See the end of this leaflet for a list of ingredients in GLUMETZA.
- you are going to get an injection of dye or contrast agents for an x-ray procedure, GLUMETZA will need to be stopped for a short time. Talk to your doctor about when you should stop GLUMETZA and when you should start GLUMETZA again. See “What is the most important information I should know about GLUMETZA?”
- have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in your blood or urine).
What should I tell my doctor before taking GLUMETZA?
Before you take GLUMETZA, tell your doctor if you:
- have type 1 diabetes. GLUMETZA should not be used to treat people with type 1 diabetes.
- have a history or risk for diabetic ketoacidosis (high levels of certain acids, known as ketones, in the blood or urine). GLUMETZA should not be used for the treatment of diabetic ketoacidosis.
- have kidney problems
- have liver problems
- have heart problems, including congestive heart failure.
- drink alcohol very often, or drink a lot of alcohol in short-term (binge) drinking
- are taking insulin
- have any other medical conditions
- are pregnant or planning to become pregnant. It is not known if GLUMETZA can harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant.
- are breastfeeding or plan to breastfeed. It is not known if GLUMETZA passes into your breast milk. Talk with your doctor about the best way to feed your baby while you take GLUMETZA.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. 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.
GLUMETZA may affect the way other medicines work, and other medicines may affect how GLUMETZA works.
How should I take GLUMETZA?
- Take GLUMETZA exactly as your doctor tells you.
- GLUMETZA should be taken 1 time per day with your evening meal.
- Swallow GLUMETZA tablets whole. Do not crush, cut, dissolve, or chew GLUMETZA.
- Tell your doctor if you cannot swallow tablets whole. Your doctor may prescribe a different medicine for you.
- You may sometimes pass a soft mass in your stools (bowel movement) that looks like GLUMETZA tablets. It is normal to see this in your stool.
- When your body is under some type of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine that you need may change. Tell your doctor right away if you have any of these problems.
- Your doctor should do blood tests to check how well your kidneys and liver are working before and during your treatment with GLUMETZA.
- Your healthcare provider will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.
- Follow your doctor's instructions for treating blood sugar that is too low (hypoglycemia). Talk to your doctor if low blood sugar is a problem for you. See “What are the possible side effects of GLUMETZA?”
- Check your blood sugar regularly and as your doctor tells you to.
- Stay on your prescribed diet and exercise program and test your blood sugar regularly while taking GLUMETZA.
- If you miss a dose of GLUMETZA, resume dosing according to schedule.
- If you take too much GLUMETZA, call your doctor, or go to the nearest hospital emergency room right away.
What are the side effects of GLUMETZA?
GLUMETZA can cause serious side effects, including:
- See “What is the most important information I should know about GLUMETZA?”
- Low blood sugar
(hypoglycemia). If you take GLUMETZA with
another medicine that can cause low blood sugar, such as sulfonylureas or
insulin, you have a higher risk of having low blood sugar. Tell your doctor if
you take other diabetes medicines. If you have symptoms of low blood sugar, you
should check your blood sugar and treat if low, then call your doctor. Symptoms
of low blood sugar include:
- rapid heartbeat
- change in vision
- change in mood
Common side effects of GLUMETZA include:
- upset stomach or stomach pain
Taking GLUMETZA with your evening meal can help lessen the common stomach side effects of metformin that usually happens at the beginning of treatment. If you have unexplained stomach problems, tell your doctor. Stomach problems that start later, during treatment may be a sign of something more serious.
Tell your doctor if these symptoms return, as they may be symptoms of lactic acidosis.
Tell your doctor if you have side effects that bother you or that do not go away.
These are not all of the possible side effects of GLUMETZA. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store GLUMETZA?
- Store GLUMETZA at 59°F to 86°F (15°C to 30°C).
Keep GLUMETZA and all medicines out of the reach of children.
General information about the safe and effective use of GLUMETZA.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. 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 Patient Information summarizes the most important information about GLUMETZA. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about GLUMETZA that is written for health professionals.
For more information, go to www.GlumetzaXR.com or call 1-800-508-0024.
What are the ingredients in GLUMETZA?
Active Ingredient: metformin hydrochloride
Inactive Ingredient: 500 mg tablet: coloring, hypromellose, magnesium stearate, microcrystalline cellulose and polyethylene oxide.
1000 mg tablet: colloidal silicon dioxide, polyvinyl alcohol, crospovidone, glyceryl behenate, polyacrylate dispersion, hypromellose, talc, polyethylene glycol, eudragit, titanium dioxide, simethicone emulsion, polysorbate and coloring.
What is type 2 diabetes?
Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems.
The main goal of treating diabetes is to lower your blood sugar to a normal level.
High blood sugar can be lowered by diet and exercise, and by certain medicines when necessary.
Talk to your doctor about how to prevent, recognize, and take care of low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and problems you have because of your diabetes.
Last reviewed on RxList: 5/27/2016
This monograph has been modified to include the generic and brand name in many instances.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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