Metformin Hydrochloride (Page 5 of 6)
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
Metformin Hydrochloride Extended-Release Tablets are supplied as:
500 mg | Bottles of 60 | NDC 0591-2719-60 | white-colored, unscored biconvex-shaped, film-coated extended-release tablets imprinted with Andrx logo and 574 on one side |
1,000 mg | Bottles of 60 | NDC 0591-2720-60 | white-colored, unscored biconvex-shaped, film-coated extended-release tablets imprinted with Andrx logo and 575 on one side |
16.2 Storage
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] excursions permitted to 15° to 30°C (59° to 86°F). Avoid excessive heat and humidity.
Keep tightly closed (protect from moisture). Protect from light.
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 metformin hydrochloride extended-release tablets 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 metformin hydrochloride extended-release tablets. Instruct patients to inform their doctor that they are taking metformin hydrochloride extended-release tablets 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 metformin hydrochloride extended-release 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 metformin hydrochloride extended-release tablets [see Warnings and Precautions (5.2) ].
Females of Reproductive Age:
Inform females that treatment with metformin hydrochloride extended-release may result in ovulation in some premenopausal anovulatory women which may lead to unintended pregnancy [see Use in Specific Populations (8.3) ].
Administration Information:
Inform patients that metformin hydrochloride extended-release tablets 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.
Manufactured by:
Actavis Laboratories FL, Inc.
Fort Lauderdale, FL 33314 USA
Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
Rev. A 11/2018
PATIENT INFORMATION
Metformin (met-Fore-min) Hydrochloride Extended-Release Tablets | |
What is the most important information I should know about metformin hydrochloride extended-release tablets ? Metformin hydrochloride extended-release tablets can cause serious side effects including: Lactic Acidosis. Metformin hydrochloride, the medicine in metformin hydrochloride extended-release tablets 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 metformin hydrochloride extended-release tablets and call your healthcare provider right away if you get any of the following symptoms of lactic acidosis: | |
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You have a higher chance of getting lactic acidosis if you:
Tell your healthcare provider if you have any of the problems in the list above. Tell your healthcare provider that you are taking metformin hydrochloride extended-release tablets before you have surgery or x-ray tests. Your healthcare provider may need to stop metformin hydrochloride extended-release tablets for a while if you have surgery or certain x-ray tests. Metformin hydrochloride extended-release tablets can have other serious side effects. See “What are the possible side effects of metformin hydrochloride extended-release tablets ?” | |
What is metformin hydrochloride extended-release tablets ?
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Do not take metformin hydrochloride extended-release tablets if you:
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Before taking metformin hydrochloride extended-release tablets , tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter 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. Metformin hydrochloride extended-release tablets may affect the way other medicines work, and other medicines may affect how metformin hydrochloride extended-release tablets works. | |
How should I take metformin hydrochloride extended-release tablets?
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What should I avoid while taking metformin hydrochloride extended-release tablets? Do not drink a lot of alcoholic drinks while taking metformin hydrochloride extended-release tablets. 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 possible side effects of metformin hydrochloride extended-release tablets? Metformin hydrochloride extended-release tablets may cause serious side effects, including:
Common side effects of metformin hydrochloride extended-release tablets include:
These are not all the possible side effects of metformin hydrochloride extended-release tablets. 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 metformin hydrochloride extended-release tablets? Store metformin hydrochloride extended-release tablets at room temperature between 68°F to 77°F (20°C to 25°C). See insert. Keep bottle tightly closed between each use to protect the metformin hydrochloride extended-release tablets from moisture. Protect from light. Keep metformin hydrochloride extended-release tablets and all medicines out of the reach of children. | |
General information about the safe and effective use of metformin hydrochloride extended-release tablets Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use metformin hydrochloride extended-release tablets for a condition for which it was not prescribed. Do not give metformin hydrochloride extended-release tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about metformin hydrochloride extended-release tablets that is written for health professionals. | |
What are the ingredients in metformin hydrochloride extended-release tablets? Active ingredients: metformin hydrochloride. Inactive ingredients: candelilla wax, cellulose acetate, hypromellose, magnesium stearate, polyethylene glycols (PEG 400, PEG 8000), polysorbate 80, povidone, sodium lauryl sulfate, synthetic black iron oxides, titanium dioxide, and triacetin. Manufactured by:Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by:Actavis Pharma, Inc. Parsippany, NJ 07054 USA For more information call Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 |
This Patient Information has been approved by the U.S. Food and Drug Administration
Revised: A 11/2018
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