GLUCOPHAGE (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Table 12: GLUCOPHAGE Available Strengths, Units, and Appearance
GLUCOPHAGE Tablets
500 mg Bottles of 60 NDC 55289-211-60 round, white to off-white, film-coated debossed with “BMS 6060″ around the periphery on one side and “500″ debossed across the face of the other side

16.2 Storage

Store at 20°–25°C (68°–77°F); excursions permitted to 15°–30°C (59°–86°F). [See USP Controlled Room Temperature]
Dispense in light-resistant containers.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Lactic Acidosis:
Explain the risks of lactic acidosis, its symptoms, and conditions that predispose to its development. Advise patients to discontinue GLUCOPHAGE/GLUCOPHAGE XR immediately and to promptly notify their healthcare provider if unexplained hyperventilation, myalgias, malaise, unusual somnolence or other nonspecific symptoms occur. Counsel patients against excessive alcohol intake and inform patients about importance of regular testing of renal function while receiving GLUCOPHAGE/GLUCOPHAGE XR. Instruct patients to inform their doctor that they are taking GLUCOPHAGE/GLUCOPHAGE XR prior to any surgical or radiological procedure, as temporary discontinuation may be required [see Warnings and Precautions ( 5.1)].

Hypoglycemia
Inform patients that hypoglycemia may occur when GLUCOPHAGE/GLUCOPHAGE XR is coadministered with oral sulfonylureas and insulin. Explain to patients receiving concomitant therapy the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development [see Warnings and Precautions ( 5.3)].

Vitamin B12 Deficiency:
Inform patients about importance of regular hematological parameters while receiving GLUCOPHAGE/GLUCOPHAGE XR [see Warnings and Precautions ( 5.2)].

Females of Reproductive Age:
Inform females that treatment with GLUCOPHAGE/GLUCOPHAGE XR may result in ovulation in some premenopausal anovulatory women which may lead to unintended pregnancy [see Use in Specific Populations ( 8.3)].

GLUCOPHAGE XR Administration Information:
Inform patients that GLUCOPHAGE XR must be swallowed whole and not crushed, cut, or chewed, and that the inactive ingredients may occasionally be eliminated in the feces as a soft mass that may resemble the original tablet.

Distributed by:
Bristol-Myers Squibb Company
Princeton, NJ 08543 USA
GLUCOPHAGE® is a registered trademark of Merck Santé S.A.S., a subsidiary of Merck KGaA of Darmstadt, Germany, licensed to Bristol-Myers Squibb Company.

1390866A0
Rev May 2018

PATIENT INFORMATION GLUCOPHAGE ® [gloo-kō-fahzh] (metformin hydrochloride) Tablets and GLUCOPHAGE ® XR [gloo-kō-fahzh X-R]
(metformin hydrochloride) Extended-Release Tablets

Read the Patient Information that comes with GLUCOPHAGE and GLUCOPHAGE XR before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or treatment.
What is the most important information I should know about GLUCOPHAGE and GLUCOPHAGE XR?
Serious side effects can happen in people taking GLUCOPHAGE or GLUCOPHAGE XR, including:

Lactic Acidosis. Metformin hydrochloride, the medicine in GLUCOPHAGE and GLUCOPHAGE XR, can cause a rare, but serious, side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.
Stop taking GLUCOPHAGE or GLUCOPHAGE XR and call your healthcare provider right away if you get any of the following symptoms of lactic acidosis:

  • feel very weak and 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 of getting lactic acidosis if you:

  • have kidney problems. People whose kidneys are not working properly should not take GLUCOPHAGE OR GLUCOPHAGE XR.
  • have liver problems.
  • have congestive heart failure that requires treatment 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 agents.
  • have surgery.
  • have a heart attack, severe infection, or stroke.
  • are 80 years of age or older and have not had your kidney function tested.

What are GLUCOPHAGE and GLUCOPHAGE XR?

  • GLUCOPHAGE and GLUCOPHAGE XR are prescription medicines that contain metformin hydrochloride. GLUCOPHAGE and GLUCOPHAGE XR are used with diet and exercise to help control high blood sugar (hyperglycemia) in adults with type 2 diabetes.
  • GLUCOPHAGE and GLUCOPHAGE XR are not for people with type 1 diabetes.
  • GLUCOPHAGE and GLUCOPHAGE XR are not for people with diabetic ketoacidosis (increased ketones in your blood or urine).
    GLUCOPHAGE and GLUCOPHAGE XR have the same active ingredient. However, GLUCOPHAGE XR works longer in your body. Both of these medicines help 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. GLUCOPHAGE and GLUCOPHAGE XR do not cause your body to make more insulin.

Who should not take GLUCOPHAGE or GLUCOPHAGE XR?

Some conditions increase your chance of getting lactic acidosis, or cause other problems if you take either of these medicines. Most of the conditions listed below can increase your chance of getting lactic acidosis.​​

Do not take GLUCOPHAGE or GLUCOPHAGE XR if you:

  • have kidney problems
  • are allergic to the metformin hydrochloride in GLUCOPHAGE or GLUCOPHAGE XR or any of the ingredients in GLUCOPHAGE or GLUCOPHAGE XR. See the end of this leaflet for a complete list of ingredients in GLUCOPHAGE and GLUCOPHAGE XR.
  • are going to get an injection of dye or contrast agents for an x-ray procedure or if you are going to have surgery and not able to eat or drink much. In these situations, GLUCOPHAGE or GLUCOPHAGE XR will need to be stopped for a short time. Talk to your healthcare provider about when you should stop GLUCOPHAGE or GLUCOPHAGE XR and when you should start GLUCOPHAGE or GLUCOPHAGE XR again. See “What is the most important information I should know about GLUCOPHAGE or GLUCOPHAGE XR?”

What should I tell my healthcare provider before taking GLUCOPHAGE or GLUCOPHAGE XR?

Before taking GLUCOPHAGE or GLUCOPHAGE XR, tell your healthcare provider if you:

  • have type 1 diabetes. GLUCOPHAGE or GLUCOPHAGE XR 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). GLUCOPHAGE or GLUCOPHAGE XR should not be used for the treatment of diabetic ketoacidosis.
  • have kidney problems.
  • have liver problems.
  • have heart problems, including congestive heart failure.
  • are older than 80 years. If you are over 80 years old you should not take GLUCOPHAGE or GLUCOPHAGE XR unless your kidneys have been checked and they are normal.
  • 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 plan to become pregnant. It is not known if GLUCOPHAGE or GLUCOPHAGE XR will harm your unborn baby. If you are pregnant, talk with your healthcare provider about the best way to control your blood sugar while you are pregnant.
  • are breast-feeding or plan to breast-feed. It is not known if GLUCOPHAGE or GLUCOPHAGE XR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you take GLUCOPHAGE or GLUCOPHAGE XR.

Tell your healthcare provider 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 healthcare provider and pharmacist when you get a new medicine.

  • GLUCOPHAGE or GLUCOPHAGE XR may affect the way other medicines work, and other medicines may affect how GLUCOPHAGE or GLUCOPHAGE XR works.

Can GLUCOPHAGE or GLUCOPHAGE XR be used in children?

GLUCOPHAGE has been shown to effectively lower glucose levels in children (ages 10-16 years) with type 2 diabetes. GLUCOPHAGE has not been studied in children younger than 10 years old. GLUCOPHAGE has not been studied in combination with other oral glucose-control medicines or insulin in children. If you have any questions about the use of GLUCOPHAGE in children, talk with your doctor or other healthcare provider.
GLUCOPHAGE XR has not been studied in children.

How should I take GLUCOPHAGE or GLUCOPHAGE XR?

  • Take GLUCOPHAGE or GLUCOPHAGE XR exactly as your healthcare provider tells you.
  • GLUCOPHAGE or GLUCOPHAGE XR should be taken with meals to help lessen an upset stomach side effect.
  • Swallow GLUCOPHAGE or GLUCOPHAGE XR whole. Do not crush, cut, or chew GLUCOPHAGE XR.
  • You may sometimes pass a soft mass in your stools (bowel movement) that looks like GLUCOPHAGE or GLUCOPHAGE XR tablets. This is not harmful and will not affect the way GLUCOPHAGE XR works to control your diabetes.
  • When your body is under some types 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 healthcare provider right away if you have any of these problems.
  • Your healthcare provider should do blood tests to check how well your kidneys are working before and during your treatment with GLUCOPHAGE or GLUCOPHAGE XR.
  • Your healthcare provider will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.
  • Follow your healthcare provider’s instructions for treating blood sugar that is too low (hypoglycemia). Talk to your healthcare provider if low blood sugar is a problem for you. See “What are the possible side effects of GLUCOPHAGE or GLUCOPHAGE XR?”
  • Check your blood sugar as your healthcare provider tells you to.
  • Stay on your prescribed diet and exercise program while taking GLUCOPHAGE or GLUCOPHAGE XR.
  • If you miss a dose of GLUCOPHAGE or GLUCOPHAGE XR, take your next dose as prescribed unless your healthcare provider tells you differently. Do not take an extra dose the next day.
  • If you take too much GLUCOPHAGE or GLUCOPHAGE XR, call your healthcare provider, local Poison Control Center, or go to the nearest hospital emergency room right away.

What should I avoid while taking GLUCOPHAGE or GLUCOPHAGE XR?

Do not drink a lot of alcoholic drinks while taking GLUCOPHAGE or GLUCOPHAGE XR. 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 GLUCOPHAGE and GLUCOPHAGE XR?

  • Lactic acidosis. Metformin, the active ingredient in GLUCOPHAGE and GLUCOPHAGE XR, 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.

Call your doctor right away if you have any of the following symptoms, which could be signs of lactic acidosis:

  • you feel cold in your hands or feet
  • you feel dizzy or lightheaded
  • you have a slow or irregular heartbeat
  • you feel very weak or tired
  • you have trouble breathing
  • you feel sleepy or drowsy
  • you have stomach pains, nausea or vomiting

Most people who have had lactic acidosis with metformin have other things that, combined with the metformin, led to the lactic acidosis. Tell your doctor if you have any of the following, because you have a higher chance for getting lactic acidosis with GLUCOPHAGE or GLUCOPHAGE XR if you:

  • have severe kidney problems, or your kidneys are affected by certain x-ray tests that use injectable dye
  • have liver problems
  • drink alcohol very often, or drink a lot of alcohol in 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 surgery
  • have a heart attack, severe infection, or stroke

Common side effects of GLUCOPHAGE and GLUCOPHAGE XR include diarrhea, nausea, and upset stomach. These side effects generally go away after you take the medicine for a while. Taking your medicine with meals can help reduce these side effects. Tell your doctor if the side effects bother you a lot, last for more than a few weeks, come back after they’ve gone away, or start later in therapy. You may need a lower dose or need to stop taking the medicine for a short period or for good.
About 3 out of every 100 people who take GLUCOPHAGE or GLUCOPHAGE XR have an unpleasant metallic taste when they start taking the medicine. It lasts for a short time.

GLUCOPHAGE and GLUCOPHAGE XR rarely cause hypoglycemia (low blood sugar) by themselves. However, hypoglycemia can happen if you do not eat enough, if you drink alcohol, or if you take other medicines to lower blood sugar.

How should I store GLUCOPHAGE and GLUCOPHAGE XR?
Store GLUCOPHAGE and GLUCOPHAGE XR at 68°F to 77°F (20°C to 25°C).
Keep GLUCOPHAGE and GLUCOPHAGE XR and all medicines out of the reach of children.

General information about the use of GLUCOPHAGE and GLUCOPHAGE XR
If you have questions or problems, talk with your doctor or other healthcare provider. You can ask your doctor or pharmacist for the information about GLUCOPHAGE and GLUCOPHAGE XR that is written for healthcare professionals. Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use GLUCOPHAGE or GLUCOPHAGE XR for a condition for which it was not prescribed. Do not share your medicine with other people.

What are the ingredients of GLUCOPHAGE and GLUCOPHAGE XR?

Active ingredients of GLUCOPHAGE: metformin hydrochloride.

Inactive ingredients in each tablet of GLUCOPHAGE: povidone and magnesium stearate. In addition, the coating for the 500 mg and 850 mg tablets contain hypromellose and the coating for the 1000 mg tablet contains hypromellose and polyethylene glycol.

Active ingredients of GLUCOPHAGE XR: metformin hydrochloride.

Inactive ingredients in each tablet of GLUCOPHAGE XR 500 mg: sodium carboxymethyl cellulose, hypromellose, microcrystalline cellulose, and magnesium stearate.

Inactive ingredients in each tablet of GLUCOPHAGE XR 750 mg: sodium carboxymethyl cellulose, hypromellose, and magnesium stearate.

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 healthcare provider 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.

GLUCOPHAGE ® is a registered trademark of Merck Santé S.A.S., a subsidiary of Merck KGaA of Darmstadt, Germany, licensed to Bristol-Myers Squibb Company.

Other brands listed are the trademarks of their respective owners.


Distributed by:
Bristol-Myers Squibb Company
Princeton, NJ 08543 USA
1390866A0
Rev May 2018

GLUCOPHAGE®
(metformin hydrochloride) Tablets
Rx only 500 mg

image
(click image for full-size original)
GLUCOPHAGE metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55289-211(NDC:0087-6060)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE, UNSPECIFIED
MAGNESIUM STEARATE
HYPROMELLOSES
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code BMS;6060;500
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55289-211-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020357 06/01/2009
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (55289-211)

Revised: 11/2018 PD-Rx Pharmaceuticals, Inc.

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